[House Hearing, 112 Congress]
[From the U.S. Government Printing Office]
TAKING MEASURE OF COUNTERMEASURES
PARTS I & II
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HEARING
before the
SUBCOMMITTEE ON EMERGENCY
PREPAREDNESS, RESPONSE,
AND COMMUNICATIONS
of the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TWELFTH CONGRESS
FIRST SESSION
__________
APRIL 13, 2011 and MAY 12, 2011
__________
Serial No. 112-18
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Printed for the use of the Committee on Homeland Security
[GRAPHIC] [TIFF OMITTED]
Available via the World Wide Web: http://www.gpo.gov/fdsys/
__________
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COMMITTEE ON HOMELAND SECURITY
Peter T. King, New York, Chairman
Lamar Smith, Texas Bennie G. Thompson, Mississippi
Daniel E. Lungren, California Loretta Sanchez, California
Mike Rogers, Alabama Sheila Jackson Lee, Texas
Michael T. McCaul, Texas Henry Cuellar, Texas
Gus M. Bilirakis, Florida Yvette D. Clarke, New York
Paul C. Broun, Georgia Laura Richardson, California
Candice S. Miller, Michigan Danny K. Davis, Illinois
Tim Walberg, Michigan Brian Higgins, New York
Chip Cravaack, Minnesota Jackie Speier, California
Joe Walsh, Illinois Cedric L. Richmond, Louisiana
Patrick Meehan, Pennsylvania Hansen Clarke, Michigan
Ben Quayle, Arizona William R. Keating, Massachusetts
Scott Rigell, Virginia Vacancy
Billy Long, Missouri Vacancy
Jeff Duncan, South Carolina
Tom Marino, Pennsylvania
Blake Farenthold, Texas
Mo Brooks, Alabama
Michael J. Russell, Staff Director/Chief Counsel
Michael S. Twinchek, Chief Clerk
I. Lanier Avant, Minority Staff Director
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SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS
Gus M. Bilirakis, Florida, Chairman
Joe Walsh, Illinois Laura Richardson, California
Scott Rigell, Virginia Hansen Clarke, Michigan
Tom Marino, Pennsylvania, Vice Vacancy
Chair Bennie G. Thompson, Mississippi
Blake Farenthold, Texas (Ex Officio)
Peter T. King, New York (Ex
Officio)
Kerry A. Kinirons, Staff Director
Natalie Nixon, Deputy Chief Clerk
Curtis Brown, Minority Professional Staff Member
C O N T E N T S
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Page
STATEMENTS
APRIL 13, 2011
The Honorable Gus M. Bilirakis, a Representative in Congress From
the State of Florida, and Chairman, Subcommittee on Emergency
Preparedness, Response, and Communications..................... 1
The Honorable Laura Richardson, a Representative in Congress From
the State of California, and Ranking Member, Subcommittee on
Emergency Preparedness, Response, and Communications........... 2
WITNESSES
Panel I
Ms. Cynthia A. Bascetta, Managing Director, Health Care,
Government Accountability Office:
Oral Statement................................................. 4
Prepared Statement............................................. 6
Dr. Segaran P. Pillai, Chief Medical and Science Advisor,
Chemical and Biological Division, Science and Technology
Directorate, Department of Homeland Security:
Oral Statement................................................. 14
Prepared Statement............................................. 16
Dr. Richard J. Hatchett, Chief Medical Officer and Deputy
Director, Strategic Sciences and Management, Department of
Health and Human Services:
Oral Statement................................................. 21
Prepared Statement............................................. 23
Dr. Gerald W. Parker, Jr., Deputy Assistant to the Secretary of
Defense, Chemical and Biological Defense, Department of
Defense:
Oral Statement................................................. 29
Prepared Statement............................................. 30
Panel II
Ms. Phyllis Arthur, Senior Director, Vaccines,
Immunotherapeutics, and Diagnostics Policy, Biotechnology
Industry Organization:
Oral Statement................................................. 44
Prepared Statement............................................. 45
Mr. John M. Clerici, Principal, Tiber Creek Partners, LLC:
Oral Statement................................................. 48
Prepared Statement............................................. 50
Dr. Daniel B. Fagbuyi, Medical Director, Disaster Preparedness
and Emergency Management, Children's National Medical Center:
Oral Statement................................................. 55
Prepared Statement............................................. 57
APPENDIX
Questions From Chairman Gus M. Bilirakis for Cynthia A. Bascetta. 69
Questions From Ranking Member Laura Richardson for Richard J.
Hatchett....................................................... 69
Questions From Chairman Gus M. Bilirakis for Gerald W. Parker.... 72
MAY 12, 2011
The Honorable Gus M. Bilirakis, a Representative in Congress From
the State of Florida, and Chairman, Subcommittee on Emergency
Preparedness, Response, and Communications..................... 75
The Honorable Laura Richardson, a Representative in Congress From
the State of California, and Ranking Member, Subcommittee on
Emergency Preparedness, Response, and Communications........... 76
WITNESSES
Panel I
Dr. Alexander G. Garza, MD, MPH, Assistant Secretary for Health
Affairs, Chief Medical Officer, Department of Homeland
Security:
Oral Statement................................................. 80
Prepared Statement............................................. 82
Dr. Ali S. Khan, MD, MPH, Director, Officer of Public Health
Preparedness and Response, Centers for Disease Control and
Prevention:
Oral Statement................................................. 85
Prepared Statement............................................. 87
Panel II
Mr. Mike McHargue, Director of Emergency Operations, Division of
Emergency Medical Operations, Florida Department of Health:
Oral Statement................................................. 92
Prepared Statement............................................. 94
Mr. David Starr, Director, Countermeasures Response Unit,
Emergency Preparedness and Response, New York City Department
of Health and Mental Hygiene:
Oral Statement................................................. 98
Prepared Statement............................................. 100
Mr. Lawrence E. Tan, Emergency Medical Services Division,
Department of Public Safety, New Castle County, Delaware:
Oral Statement................................................. 102
Prepared Statement............................................. 105
Mr. Jeffrey Levi, PhD, Executive Director, Trust for America's
Health:
Oral Statement................................................. 107
Prepared Statement............................................. 109
FOR THE RECORD
The Honorable Gus M. Bilirakis, a Representative in Congress From
the State of Florida, and Chairman, Subcommittee on Emergency
Preparedness, Response, and Communications:
Statement of The National Association of Chain Drug Stores..... 78
APPENDIX
Questions From Chairman Gus M. Bilirakis for Alexander G. Garza.. 119
Questions From Chairman Gus M. Bilirakis for Mike McHargue....... 121
Questions From Chairman Gus M. Bilirakis for Ali S. Khan......... 122
TAKING MEASURE OF COUNTERMEASURES (PART I): A REVIEW OF GOVERNMENT AND
INDUSTRY EFFORTS TO PROTECT THE HOMELAND THROUGH ACCELERATED RESEARCH,
DEVELOPMENT, AND ACQUISITION OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND
NUCLEAR MEDICAL COUNTERMEASURES
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Wednesday, April 13, 2011
U.S. House of Representatives,
Subcommittee on Emergency Preparedness, Response,
and Communications,
Committee on Homeland Security,
Washington, DC.
The subcommittee met, pursuant to call, at 2:10 p.m., in
Room 311, Cannon House Office Building, Hon. Gus M. Bilirakis
[Chairman of the subcommittee] presiding.
Present: Representatives Bilirakis, Marino, and Richardson.
Mr. Bilirakis [presiding]. The Subcommittee on Emergency
Preparedness, Response, and Communications will come to order.
The subcommittee is meeting today to receive testimony on the
efforts of Federal agencies to work with each other and with
industry to research, develop, and procure vital medical
countermeasures.
I now recognize myself for an opening statement.
I would like to welcome all of our witnesses here today and
thank you for your dedication to making our Nation more secure
from terrorist threats. The events of October 2001, when our
Nation was attacked through the mail with anthrax letters,
changed the face of medical preparedness. These tragic events
instilled an urgency to prepare for bioterror threats in a way
that we had never done before.
The 2009 H1N1 influenza pandemic similarly caused us to
turn inward and review the successes of our public health
response as well as our failures. The catastrophic events in
Japan--two natural disasters and a subsequent industrial
disaster, an entirely unforeseen combination of events--once
again force us to assess our preparedness capacity, this time
for radiological and nuclear threats.
This hearing was planned well before Japan was hit with an
unimaginable crisis. We are here today to discuss the ways we
can and must be proactive, not just reactive, to chemical,
biological, radiological, and nuclear threats, both nature and
manmade.
The responsibility begins with the Department of Homeland
Security. The threats must be recognized, defined, and
prioritized.
The DHS threat and risk assessments are central to this
effort. These tools have become instrumental in providing an
awareness of the threat. They are designed not to instill fear,
but rather to provide a healthy recognition of reality and an
effective means by which to prioritize limited resources.
I look forward to hearing from our DHS witnesses today on
how these assessments have grown, surpassed criticism, and are
providing their customers with an indispensible tool.
One of those customers is the Department of Health and
Human Services and its Biomedical Advanced Research and
Development Authority. BARDA is responsible for advanced
development and procurement of CBRN medical countermeasures. We
look forward to learning from the witnesses about BARDA
successes that must be supported as well as continued
challenges to forging an effective and fruitful relationship
with the private sector.
We know that BARDA has the authorities it needs to develop
and acquire countermeasures. What is less clear is why it has
not made use of those authorities.
Of particular concern are the contracting delays. These
delays seem to have increased in the past, since the
contracting and procurement functions were taken out of BARDA
and placed under the assistant secretary for preparedness and
response.
What is the strategic direction that BARDA is looking to
take to allow development and procurement of the best
countermeasures and in the most expedient, transparent, and
industry-friendly way possible? What are the countermeasures
that are missing from our stockpile? Do we need vaccines for
hemorrhagic fevers or rapid diagnostics to know who has been
exposed? How the material threat determinations are informing
HHS investments and meeting the needs laid out by DHS is a
central question.
The contributions of the Department of Defense to the
health of our Nation through medical countermeasure development
go back decades. DOD was a pioneer in this area. I look forward
to hearing today how DOD's program has matured and how its best
practices and expertise are leveraged by DHS and HHS.
DOD and HHS have a unique relationship--that of a shared
stockpile. The shared anthrax stockpile, for example, allows
fewer vaccines to expire and therefore better resource
efficiencies.
Of course, we would also like to see a next-generation
anthrax vaccine developed, and I am aware of considerable
delays on the part of BARDA to procure that, pushing this until
at least 2018, from what I understand. I look forward to
hearing from DOD and HHS on how we can meet these and other
pressing countermeasure needs.
So once again, I thank our witnesses for being here and for
working to protect our health, protect our homeland, and foster
more jobs and a healthier economy in the process.
I now recognize the Ranking Minority Member, Ms.
Richardson, from California, for any statement she may have.
Ms. Richardson. That timing wasn't planned.
[Laughter.]
Ms. Richardson. Good afternoon to all of you. Actually, I
am going to hold most of my comments since I just walked in,
but it would suffice to say that I am glad we have the
witnesses before us. I am very concerned in light of some of
the things that have occurred.
I concur with Mr. Bilirakis in terms of my concern with the
timing of the anthrax. I think that all the delegates probably
have some questions about that.
Then I would also like to talk about this potassium iodide.
I have some concerns in those areas, so I will hold the rest of
my comments and submit my full statement into the record. Thank
you.
Mr. Bilirakis. Thank you. Appreciate it.
Other Members of the subcommittee are reminded that opening
statements may be submitted for the record. Before I introduce
our first panel I would ask unanimous consent to insert in the
record a statement from Mr. Morris, of Anbex, Inc. If there are
no objections, so ordered.
I am pleased to welcome our witnesses. I will note,
however, that I am disappointed that Dr. O'Toole, Dr. Lurie,
and Mr. Weber declined to attend today's hearing. I certainly
hope their failure to attend does not indicate a lack of
attention or commitment to this very important issue.
That being said, I look forward to hearing from our
witnesses. Our first witness is Ms. Cynthia Bascetta. Ms.
Bascetta is the managing director of the Government
Accountability's Office, GAO, health care team. She has led the
programs designed to protect and enhance public health.
She is currently leading GAO's public health work with its
focus on quality of care and disaster preparedness and
response. Ms. Bascetta joined GAO in 1983 after conducting
regulatory impact analysis of major occupational health rules
at the U.S. Department of Labor.
In 2008 Ms. Bascetta was a finalist for the Service to
America Medical for career achievement. She has a Bachelor's
Degree in government from Smith College, a Master's in applied
economics from the University of Michigan, a Master's in public
health from the University of Michigan.
Our next witness is Dr. Segaran Pillai. Dr. Pillai serves
as the chief medical and scientific officer in the division of
chem bio and Department of Homeland Security's science and
technology directorate. In this role he serves as an advisor
for all DHS S&T initiatives to deter, detect, or mitigate a
biological attack on the Nation.
Prior to joining S&T, Dr. Pillai served as director of the
Florida Department of Health State Public Health Laboratory in
Miami and as the clinical services director for the Miami-Dade
County Health Department. Dr. Pillai is board certified by the
American Academy of Microbiology and the American Society for
Clinical Pathology.
He received a Bachelor's Degree with honors in microbiology
and a Master's of Science Degree with honors in medical
physiology from the Pittsburgh State University. He also
received his Ph.D. in molecular genetics and biochemistry from
the University of Kansas.
Following Dr. Pillai, we will hear from Dr. Richard
Hatchett. Dr. Hatchett is chief medical officer and deputy
director for strategic sciences and management at the
Biomedical Advanced Research and Development Authority, of
course, BARDA, within the Department of Health and Human
Services office of the assistant secretary for preparedness and
response.
Prior to joining BARDA, Dr. Hatchett served as director for
medical preparedness policy on the White House National
security staff, where he worked on issues related to the
development of medical countermeasures. Dr. Hatchett received
his undergraduate and medical degrees from Vanderbilt
University.
Finally, we will hear testimony from Dr. Gerald Parker. Dr.
Parker serves as the deputy assistant to the Secretary of
defense for chemical and biological defense. In this role Dr.
Parker is responsible for chemical and biological defense
program oversight throughout the Department of Defense and
integration with interagencies and international partners.
Prior to joining DOD, Dr. Parker served as the principal
deputy assistant secretary in the office of the assistant
secretary for preparedness and response at the Department of
Health and Human Services. Dr. Parker also served in the United
States Army for 26 years.
Dr. Parker graduated from Texas A&M University with a
Bachelor's of Science in veterinary medicine and with a degree
of Doctor of Veterinarian Medicine. He holds a Doctorate in
psychology from Baylor College of Medicine in Houston, Texas,
and a Master's of Science in resourcing the National strategy
from the Industrial College of the Armed Forces.
I want to welcome all our witnesses. Your entire written
statements will appear in the record. I ask that you each
summarize your testimony for 5 minutes, and we will begin with
Ms. Bascetta.
Welcome.
STATEMENT OF CYNTHIA A. BASCETTA, MANAGING DIRECTOR, HEALTH
CARE, GOVERNMENT ACCOUNTABILITY OFFICE
Ms. Bascetta. Thank you very much.
Mr. Bilirakis. Thank you. Is the microphone on?
Ms. Bascetta. Now it is.
Mr. Chairman, Ranking Member Richardson, and Representative
Marino, I am pleased to be here to discuss the acquisition and
development of medical countermeasures to protect the public
health in the event of exposure to chemical, radiological,
biological, and nuclear threats, whether intentional or
accidental. The 2001 anthrax attacks and the on-going nuclear
disaster in Japan are just two reminders of the need for CBRN
countermeasures to mitigate the potentially devastating effects
of exposure. Members of Congress, Federal commissions, and
other experts have all noted the need for acquiring available
countermeasures as well as developing new ones.
Today my remarks will focus on HHS, which leads Federal
efforts to determine countermeasure priorities as well as to
develop and acquire them. HHS coordinates these efforts through
the interagency public health emergency medical countermeasures
enterprise, known as PHEMCE, which is responsible for all
hazards, from bioterrorism to naturally occurring epidemics.
PHEMCE was established in 2006 and it includes several HHS
components as well as DHS, DOD, VA, Department of Agriculture,
and the Executive Office of the President. Through PHEMCE, DOD
and HHS also coordinate an integrated portfolio to identify
common civilian and military medical countermeasure priorities.
HHS's acquisition strategy is based on a four-step process,
as shown on the dark blue side of our graphic, shown overhead.
With input from HHS in Step No. 1, DHS identifies and assesses
CBRN agents to determine which ones pose a material threat to
National security, as required by the Project BioShield Act.
DHS develops material threat assessments using plausible,
high-consequence scenarios to provide estimates of the number
of people likely to be exposed to an agent. Since 2004 DHS has
determined that 13 CBRN agents pose a material threat.
In Step No. 2, PHEMCE assesses medical and public health
consequences of attacks with CBRN agents. HHS and its PHEMCE
partners use the DHS material threat assessment scenarios along
with other scientific data and expert consultation to model the
public health and medical consequences of a CBRN event. This
modeling estimates the number of individuals who may become
ill, be hospitalized, or die after exposure to CBRN agents with
or without medical intervention.
In Step No. 3, PHEMCE establishes medical countermeasure
requirements. PHEMCE uses the consequence modeling results to
determine how much of a countermeasure is needed, how it would
be administered, and how it would need to be stored. Preferred
characteristics, such as oral administration instead of
injection and room temperature storage instead of
refrigeration, are an important part of this step.
In Step No. 4, PHEMCE prioritizes development and
acquisition of medical countermeasures needed for the Strategic
National Stockpile. Its acquisition priorities include
diagnostic devices in drugs or vaccines to mitigate the health
effects of exposure to all of the agents that DHS deemed to be
material threats.
PHEMCE acquires any countermeasures that are immediately
available and it also supports research and development for the
many countermeasures that are not immediately available. This
occurs in four additional stages led by NIH and BARDA, as shown
in the light blue areas of our graphic.
First, basic research is geared to better understand the
health effects of CBRN agents. Next, applied research validates
and tests concepts to identify the potential countermeasures
and scientific or practical limitations of any products
produced.
Early development demonstrates basic safety,
reproducibility, and ability to use the countermeasures in
humans. Advanced development further evaluates the safety and
effectiveness of countermeasures. In addition, in this stage
HHS determines whether manufacturing, scale-up production, and
licensing can be achieved in a timely and reliable manner.
I would like to take just another minute to highlight
several development challenges that serve to temper what we can
expect from this process no matter how well it is implemented.
One challenge is that the failure rate in research and
development of CBRN medical countermeasures can be high; HHS
estimates it may exceed 80 percent for products in early
development.
Another is the difficulty of attracting large
pharmaceutical companies who have the experience needed to meet
complex requirements but little incentive to participate. Other
challenges can be addressed through process or management
improvements, such as regulatory challenges with the Animal
Rule, regulatory challenges in determining appropriate
countermeasure doses for children, and logistical challenges
that HHS faces in managing the Strategic National Stockpile.
That concludes my remarks and I would be happy to answer
your questions or those of the other committee Members.
[The statement of Ms. Bascetta follows:]
Prepared Statement of Cynthia A. Bascetta
April 13, 2011
gao highlights
Highlights of GAO-11-567T, a testimony before the Subcommittee on
Emergency Preparedness, Response, and Communications, Committee on
Homeland Security, House of Representatives.
Why GAO Did This Study
The anthrax attacks of 2001 and a radiation leak after the recent
natural disaster in Japan highlighted concerns that the United States
is vulnerable to threats from chemical, biological, radiological, and
nuclear (CBRN) agents, which can cause widespread illness and death.
Medical countermeasures--such as drugs, vaccines, and diagnostic
devices--can prevent or treat the health effects of exposure, but few
are currently available for many of these CBRN agents.
GAO was asked to testify on the Department of Health and Human
Services' (HHS) CBRN medical countermeasure development and acquisition
activities. This statement focuses on: (1) How HHS determines needed
CBRN medical countermeasures and priorities for development and
acquisition and (2) selected challenges to medical countermeasure
development and acquisition. This statement of preliminary findings is
based on on-going work. To do this work, GAO examined relevant laws and
Presidential directives, analyzed Federal agency documents and reports
from advisory boards and expert groups, and interviewed officials from
HHS and the Department of Homeland Security (DHS) about the processes
for developing and acquiring CBRN medical countermeasures and the
challenges related to those efforts. GAO shared the information in this
statement with HHS. HHS provided technical comments, which GAO
incorporated as appropriate.
public health preparedness.--developing and acquiring medical
countermeasures against chemical, biological, radiological, and nuclear
agents
What GAO Found
HHS coordinates and leads Federal efforts to determine CBRN medical
countermeasure priorities and develop and acquire CBRN medical
countermeasures, primarily through an interagency body that includes
other Federal agencies with related responsibilities, such as DHS and
the Department of Defense. HHS's medical countermeasure acquisition
strategy is based on a four-step process: (1) Identify and assess the
threat of CBRN agents, (2) assess medical and public health
consequences of attacks with these agents, (3) establish medical
countermeasure requirements, and (4) identify and prioritize near-,
mid-, and long-term development and acquisition. Through these
processes, HHS determines which countermeasures to buy for specific
CBRN agents, including the desired characteristics of these
countermeasures--such as how many doses a vaccine requires to confer
immunity--the needed quantity of certain medical countermeasures, and
the acquisition priorities. While a few CBRN countermeasures can be
immediately acquired, most have not yet been developed. Therefore, HHS
and the interagency body support and oversee several stages of research
and development to try to obtain usable countermeasures. These include
basic cellular and biological research to understand the effects of
these agents on humans; applied research to validate approaches, such
as testing the effectiveness of treatment in animals; early development
to assess the safety of potential countermeasures; and advanced
development, in which the products are more fully evaluated for safety
and effectiveness, including their formulation and manufacturing
processes.
The Federal Government faces a variety of challenges in developing
and acquiring medical countermeasures, such as the high failure rate in
research and development and difficulties meeting regulatory
requirements. For example, the failure rate for development and
licensure of most drugs, vaccines, and diagnostic devices can be more
than 80 percent, depending on the stage of scientific research and
development. Given this risk, as well as a lack of a commercial market
for most medical countermeasures, attracting large, experienced
pharmaceutical firms to research and develop them is challenging.
Smaller biotechnology companies are more likely to be developing
medical countermeasures, but HHS must provide more guidance to these
less experienced small companies than might be typical with larger
companies. In addition, several challenges exist related to regulatory
processes for evaluating promising medical countermeasures. These
challenges include: (1) Proving a countermeasure's effectiveness using
animals as proxies for humans, because humans cannot ethically be used
in studies involving CBRN agents; (2) determining appropriate doses of
countermeasures for children, who may be more vulnerable to exposure to
CBRN agents; and (3) evaluating the safety and effectiveness of medical
countermeasures for use in a public health emergency if they have not
yet been approved or licensed. Finally, HHS faces the logistical
challenge of on-going replenishment of expiring medical countermeasures
in the U.S. Strategic National Stockpile, the National repository of
medications, medical supplies, and equipment for public health
emergencies.
Chairman Bilirakis, Ranking Member Richardson, and Members of the
subcommittee: I am pleased to be here today to discuss the Department
of Health and Human Services' (HHS) chemical, biological, radiological,
and nuclear (CBRN) medical countermeasure development and acquisition
activities and associated challenges.\1\ The anthrax attacks of 2001
raised concerns that the United States is vulnerable to intentional
threats from CBRN agents. In addition, the recent earthquake and
resulting tsunami in Japan that caused a nuclear reactor to rupture
highlighted a population's vulnerability to unintentional CBRN
exposure, such as to radiation. CBRN agents have the potential to cause
widespread illness and death, which can be partially mitigated through
the use of medical countermeasures. Medical countermeasures for CBRN
agents include drugs, vaccines, and devices to diagnose, treat,
prevent, or mitigate potential effects of exposure. Members of
Congress, Federal commissions, and other experts have noted the need
for the United States to acquire available medical countermeasures and
develop new ones to protect the public from attacks with CBRN agents.
While rapid diagnosis, treatment, and prevention may minimize the
public health impact of a release of these agents, there are currently
few countermeasures available for many CBRN agents, and research and
development to create usable countermeasures is a lengthy and complex
process.
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\1\ See appendix I for a list of abbreviations used in this
statement.
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You asked us to provide information about HHS's CBRN medical
countermeasure development and acquisition activities. My statement
today addresses: (1) How HHS determines needed CBRN medical
countermeasures and priorities for development and acquisition, and (2)
selected challenges to Federal CBRN medical countermeasure development
and acquisition.
To develop preliminary findings based on our on-going work on HHS's
CBRN medical countermeasure development and acquisition activities and
selected challenges of these activities, we reviewed relevant laws and
agency documents and interviewed Federal officials. Specifically, to
understand how HHS determines needed CBRN medical countermeasures and
priorities for developing and acquiring them, we examined relevant laws
and reviewed Presidential directives that guide HHS's CBRN medical
countermeasure development and acquisition activities. We obtained and
analyzed HHS planning documents for medical countermeasure development
and acquisition, such as public health and medical consequence modeling
reports and strategy and implementation plans for medical
countermeasure development and acquisition priorities. We interviewed
officials from the Department of Homeland Security (DHS) about their
activities related to CBRN agents and medical countermeasures. We also
interviewed officials from HHS offices and agencies, including the
Biomedical Advanced Research and Development Authority (BARDA) within
the Office of the Assistant Secretary for Preparedness and Response
(ASPR), the Centers for Disease Control and Prevention (CDC), the Food
and Drug Administration (FDA), and the National Institutes of Health
(NIH), to obtain information on their activities related to medical
countermeasure development and acquisition. These officials participate
in the Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE), HHS's interagency decision-making body responsible for
providing recommendations to the Secretary of HHS regarding CBRN
medical countermeasure development and acquisition. To identify
selected challenges that the Federal Government faces in developing and
acquiring CBRN medical countermeasures, we reviewed reports from
Federal agencies, advisory boards, and nongovernmental organizations
and interviewed Federal officials from the agencies identified above
and other experts. We included selected challenges that were discussed
in multiple reports published by Federal agencies or other expert
groups, such as the Institute of Medicine, or those mentioned to us by
officials from multiple Federal agencies or organizations. We did not
include any challenges that related to interagency coordination and
agency investments in medical countermeasure development and
acquisition because we are currently examining these issues for on-
going audit work. In addition, because it was not the focus of this
hearing, we excluded HHS processes for and challenges in distributing
CBRN medical countermeasures from the scope of this statement. We
shared the information in this statement with HHS. HHS provided
technical comments, which we incorporated as appropriate.
We are conducting this performance audit in accordance with
generally accepted Government auditing standards. This statement is
based on work conducted from March 2011 to April 2011. The performance
audit standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
background
Several Federal departments and agencies have responsibilities for
assessing the threat of CBRN agents and determining requirements and
priorities for developing and acquiring medical countermeasures for
these agents, as part of their mission and, in some cases, as
specifically required by law.
DHS leads Federal interagency coordination and planning for
emergency response to catastrophic CBRN incidents. Under the Project
BioShield Act of 2004, DHS is required, in consultation with HHS, to
assess the threat of CBRN agents.\2\
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\2\ 42 U.S.C. 247d-6b(c)(2)(A).
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HHS leads the Federal medical and public health response to
potential CBRN incidents.
HHS established PHEMCE in 2006. PHEMCE is a Federal
interagency decision-making body responsible for providing
recommendations to the Secretary of HHS on: (1) Prioritized
requirements for CBRN medical countermeasures, (2) coordination
of medical countermeasure development and acquisition
activities to address the requirements, and (3) strategies for
distributing medical countermeasures held in the U.S. Strategic
National Stockpile (SNS), the National repository of
medications, medical supplies, and equipment for use in a
public health emergency. As required by the Pandemic and All-
Hazards Preparedness Act of 2006, PHEMCE also conducts annual
reviews of the SNS, the results of which are used to make
necessary additions or modifications to its contents.\3\ PHEMCE
is composed primarily of officials from HHS's ASPR, BARDA, CDC,
FDA, and NIH, which also have specific agency responsibilities
for countermeasure development and acquisition. In addition,
PHEMCE includes officials from DHS, the Department of Defense
(DOD), the Department of Veterans Affairs, the Department of
Agriculture, and the Executive Office of the President.
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\3\ 42 U.S.C. 247d-6b(a)(1).
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Within HHS, ASPR is responsible for leading Federal
Government efforts to research, develop, evaluate, and acquire
public health emergency medical countermeasures to prevent,
treat, or mitigate the potential health effects from exposure
to CBRN agents. Under the Project BioShield Act, HHS is
responsible for arranging for the acquisition of certain
medical countermeasures, some of which may not yet be FDA-
approved or licensed.\4\ These countermeasures also include
those for children and other vulnerable populations, such as
those for the elderly and immunocompromised individuals. The
Project BioShield Act authorized the Special Reserve Fund for
acquisition of these countermeasures.\5\
---------------------------------------------------------------------------
\4\ 42 U.S.C. 247b(c)(7)(C)(i).
\5\ 42 U.S.C. 247d-6b(c)(1)(A). The Department of Homeland
Security Appropriations Act of 2004 appropriated over $5.5 billion to
the Special Reserve Fund to be available for obligation from fiscal
year 2004 through fiscal year 2013. Pub. L. No. 108-90, 117 Stat. 1137,
1148 (2003). The Project BioShield Act also authorizes the Federal
Government to use specific contracting authorities to procure certain
medical countermeasures for these agents and requires HHS to report on
these contracting authorities and procurements using the Special
Reserve Fund, among other information. 42 U.S.C. 247d-6b, 247d-6c.
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Within ASPR, BARDA--established by the Pandemic and All-
Hazards Preparedness Act of 2006--is responsible for overseeing
and funding advanced development and acquisition of CBRN
medical countermeasures.\6\
---------------------------------------------------------------------------
\6\ 42 U.S.C. 247d-7e. The act also gave BARDA the authority to
make advance and milestone-based payments to vendors prior to product
delivery to the SNS. 42 U.S.C. 247d-7e(c)(5)(C), (D).
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CDC is responsible for maintaining the SNS. CDC also
supports State and local public health departments in their
efforts to detect and respond to public health emergencies such
as CBRN incidents, including providing guidance and
recommendations for the mass distribution and use of medical
countermeasures.
FDA is responsible for assessing the safety and
effectiveness of CBRN medical countermeasures and regulates
their development, approval and licensure, and postmarket
surveillance.\7\ FDA also provides technical support for the
development of tools to support medical countermeasure
development. Under the Project BioShield Act, as delegated by
the HHS Secretary, FDA may temporarily authorize the emergency
use of unapproved or unlicensed medical products in certain
circumstances through emergency use authorizations (EUA).\8\
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\7\ In FDA regulations, drugs are ``approved,'' vaccines and other
biologics are ``licensed,'' and devices may either be ``approved'' or
``cleared.'' For this statement, we use the term ``approve'' to refer
to both approval and clearance.
\8\ 21 U.S.C. 360bbb-3. FDA can issue EUAs only after the HHS
Secretary declares a public health emergency and under certain
circumstances. For example, FDA can issue EUAs in declared emergencies
only if the agent specified in the emergency declaration can cause a
serious or life-threatening disease or condition; the known and
potential benefits outweigh the known and potential risks of the
countermeasure to diagnose, prevent, or treat the condition; and there
is no adequate, approved, and available alternative to the product,
among other requirements. FDA has issued 19 EUAs since 2004. In 2005,
FDA issued an EUA for an anthrax vaccine to allow vaccination of DOD
personnel. FDA has also issued several EUAs for medical countermeasures
to diagnose and treat pandemic strains of influenza. The only currently
active EUA is for anthrax antibiotics in home kits for postal workers
to be used in the event of an anthrax attack.
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The National Institutes of Health (NIH) is responsible for
conducting and coordinating basic and applied research to
develop new or enhanced medical countermeasures and related
medical tools for CBRN agents.
The National Biodefense Science Board (NBSB), established by
the Pandemic and All-Hazards Preparedness Act, provides the HHS
Secretary with expert advice and guidance on scientific and
technical matters related to current and future CBRN agents,
including those that occur naturally.\9\
---------------------------------------------------------------------------
\9\ 42 U.S.C. 247d-7f.
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DOD has exclusive responsibility for research, development,
acquisition, and deployment of medical countermeasures to prevent or
mitigate the health effects of CBRN agents and naturally occurring
diseases on Armed Forces personnel. Under the PHEMCE structure, DOD
also coordinates with HHS on the Integrated Portfolio to identify
common medical countermeasure priorities.\10\
---------------------------------------------------------------------------
\10\ The Integrated Portfolio is intended to reduce duplication of
effort and provide a mechanism for HHS and DOD to share information and
resources for common CBRN medical countermeasure priorities.
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hhs, through phemce, uses a four-step process to determine acquisition
priorities for medical countermeasures and oversees their development
HHS coordinates and leads Federal efforts to determine CBRN medical
countermeasure priorities and develop and acquire CBRN medical
countermeasures, primarily through PHEMCE. HHS's medical countermeasure
acquisition strategy is based on a four-step process: (1) Identify and
assess the threat of CBRN agents, (2) assess medical and public health
consequences of attacks with these agents, (3) establish medical
countermeasure requirements, and (4) identify and prioritize
near-, mid-, and long-term development and acquisition programs.\11\
Because desired CBRN medical countermeasures may not be immediately
available for acquisition, HHS oversees and supports the various stages
of research and development of these countermeasures, also under
PHEMCE. (See figure 1.)
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\11\ PHEMCE's near-term development and acquisition period is
fiscal years 2007 and 2008; the mid-term period is fiscal year 2009
through fiscal year 2013, and the long-term period is beyond fiscal
year 2013. PHEMCE established these development and acquisition periods
to correspond with appropriations for the Special Reserve Fund. The
Department of Homeland Security Appropriations Act appropriated over
$5.5 billion for the Special Reserve Fund to be available for
obligation through fiscal year 2013 but provided that no more than $3.4
billion may be obligated through fiscal year 2008.
[GRAPHIC(S)] [NOT AVAILABLE IN TIFF FORMAT]
With input from HHS, DHS leads the first step in the process to
assess, on an on-going basis, the threat of CBRN agents and determine
which of these agents pose a material threat to National security, as
required by the Project BioShield Act.\12\ The material threat
assessments (MTA) that DHS issues examine the threat posed by given
CBRN agents or classes of agents for plausible, high-consequence
scenarios and provide estimates of the number of people exposed to
different dose levels of an agent in the scenarios. Since 2004, DHS has
determined that 13 of these CBRN agents pose a material threat, based
on the MTAs.\13\
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\12\ Pub. L. No. 108-276, 3(a), 118 Stat. 835, 842 (2004)
(codified as amended at 42 U.S.C. 247d-6b(c)(2)(A)(B)).
\13\ The 13 agents that DHS determined pose a material threat to
National security and public health are Bacillus anthracis (anthrax),
Burkholderia mallei (glanders), Burkholderia pseudomallei
(melioidosis), Clostridium botulinum (botulism toxin), Ebola virus
(hemorrhagic fever), Francisella tularensis (tularemia), Junin virus
(hemorrhagic fever), Marburg virus (hemorrhagic fever), multidrug-
resistant Bacillus anthracis (MDR anthrax), Rickettsia prowazekii
(typhus), Variola major (smallpox), Yersinia pestis (plague), and
radiological and nuclear materials.
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In the second step, HHS and its PHEMCE partners use the data from
the MTA scenarios to assess the public health and medical consequences
of an attack using these agents.\14\ Public health consequence modeling
estimates the number of individuals who may become ill, be
hospitalized, or die from exposure to and infection with CBRN agents,
with or without medical intervention. To develop these estimates from
the MTA exposure data, HHS consults with experts and uses available
scientific data, such as data on how much of an agent is needed to
cause infection and how long it takes to develop symptoms of disease
after exposure. In addition, HHS assesses the status of current
countermeasure development and availability, including applicable
countermeasures that DOD may be developing. Through consequence
modeling, HHS determines the public health impact on the affected
population in terms of the potential health effects throughout the
course of disease based on different time frames for medical
countermeasure delivery and treatment. According to HHS officials,
consequence modeling allows PHEMCE to consider public health
preparedness needs, such as whether a particular countermeasure is
plausible or feasible for a certain CBRN agent and the amount that
would be needed.
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\14\ To date, DHS has not issued determinations that any of the
assessed chemical agents pose a material threat to the United States.
Nevertheless, HHS has assessed the public health consequences of
chemical agents for which DHS has developed MTAs.
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In the third step, PHEMCE uses the consequence modeling results to
determine requirements for needed medical countermeasures, including
the needed quantity and the desired characteristics, such as how they
would be used and stored. HHS officials told us that these requirements
would include the preferred method of administration, such as oral
administration of a medicine that can be stored at room temperature.
PHEMCE partners consult with experts and incorporate intelligence
information and information on State and local response capabilities to
determine ideal countermeasure characteristics. If countermeasures that
meet these characteristics are not immediately available, HHS may
acquire countermeasures that are currently available and work with
manufacturers over time to develop countermeasures that better meet the
ideal characteristics.\15\
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\15\ For example, HHS officials said that they would like to
acquire an anthrax vaccine that confers immunity in a single dose, but
because no such vaccine was available when HHS set the requirements,
the Department initially acquired a vaccine that could provide immunity
in six doses. Through further research, HHS was able to determine that
this vaccine could be administered in fewer doses.
---------------------------------------------------------------------------
In the fourth step, the established medical countermeasure
requirements help HHS assess and prioritize its countermeasure
investments, and, according to HHS officials, form the basis for
development and acquisition solicitations and contracts. Based on the
requirements, in 2007, PHEMCE set its medical countermeasure
acquisition priorities to focus on spending the remainder of the
Project BioShield Special Reserve Fund for certain CBRN agents that DHS
determined posed a material threat to National security. In addition,
PHEMCE priorities focus on obtaining medical countermeasures for
postexposure prevention or treatment of disease caused by those CBRN
agents. HHS grouped these priorities in time frames for the near term
(fiscal year 2007 through fiscal year 2008), midterm (fiscal year 2009
through fiscal year 2013), and long term (beyond fiscal year 2013).
PHEMCE's stated priorities include acquiring diagnostics for each
biological agent deemed a material threat, smallpox vaccine, medical
countermeasures for Ebola and Marburg viruses, and medications to treat
the acute and delayed effects of radiation. PHEMCE also uses the
results of its annual SNS review to reassess prioritization of CBRN
medical countermeasures, based on any SNS acquisitions made after the
initial 2007 prioritizations.
BARDA oversees the acquisition and delivery of medical
countermeasures into the SNS. If a medical countermeasure is not FDA-
approved or licensed, its acquisition is funded by BARDA using the
Project BioShield Special Reserve Fund. If a medical countermeasure is
FDA-approved or licensed for use in treating the health effects of a
CBRN agent, CDC purchases the countermeasure for the SNS. HHS officials
told us that once FDA approves or licenses a countermeasure acquired
with the Special Reserve Fund, BARDA is still responsible for
overseeing its acquisition through the end of the Project BioShield
contract. BARDA is also responsible for negotiating with the
manufacturer to obtain additional quantities of the countermeasure in
the event of a CBRN attack. CDC officials told us that they develop a
5-year project plan for each countermeasure in the SNS upon acquisition
to evaluate specific needs over time--such as shelf life, replacement
costs of expiring products, and storage and space requirements--and
update the plan every year, or more frequently if conditions change.
HHS officials told us that of the few available medical
countermeasures for CBRN agents, some are FDA-approved or licensed
specifically for CBRN use. Other countermeasures that HHS has acquired
for CBRN use have been approved or licensed for other uses only. For
example, there are no currently available rapid diagnostic tools for
any of the biological agents that DHS deemed material threats other
than anthrax, nor are there any available medical countermeasures for
postexposure prevention of disease for Ebola and Marburg viruses.
NIH and BARDA oversee and support CBRN medical countermeasure
research and development, which is conducted in several stages.\16\
(See figure 1.)
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\16\ FDA works with researchers throughout the development stages,
to review safety and effectiveness test results, ensure that research
meets FDA's regulatory requirements, and approve successful products
for licensure.
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Early research.--Early, or basic, research seeks to better
understand CBRN agents and the response of the host organism to
the agents through the study of the cellular and molecular
biology of agents and hosts, their physiologic processes, and
their genome sequences and structures. According to NIH
officials, individual researchers typically initiate research
in this stage. NIH assesses these research projects and their
application for specific CBRN agents.
Applied research.--Applied, or translational, research
builds on basic research by validating and testing concepts in
practical settings to identify potential products. NIH
officials told us that the agency funds applied research to
identify scientific or practical limitations that may affect
the potential of a scientific concept to develop into a medical
countermeasure product.
Early development.--NIH moves successful concepts from the
applied research stage into the early development stage, in
which it funds research to demonstrate basic safety,
reproducibility, and ability to be used in humans. In its
requests for research proposals for early development, NIH
officials told us that the agency specifies its needs by
product modes and categories, such as therapeutics,
diagnostics, and vaccines; NIH can further specify the
characteristics of a medical countermeasure, and companies
agree to the terms of the contract up front.
Advanced development.--BARDA oversees and funds CBRN
advanced research and development. In this stage, potential
medical countermeasures are further evaluated in animal studies
to demonstrate safety and effectiveness for preventing,
diagnosing, or treating disease in humans. Successful products
are then available for development and acquisition. In
addition, in this stage, BARDA determines that manufacturing,
scale-up production, and licensing of countermeasures can be
achieved in a timely and reliable manner. BARDA also awards
contracts using the Project BioShield Special Reserve Fund to
acquire medical countermeasures for the SNS that are reasonably
expected to qualify for FDA approval or licensure within 8
years.
challenges to development and acquisition of medical countermeasures
include high failure rates in research and difficulties meeting
regulatory requirements
The Federal Government faces a variety of challenges in developing
and acquiring medical countermeasures, such as the high failure rate in
research and development and difficulties meeting regulatory
requirements. One scientific challenge is that, as with other medical
products, the failure rate for development of certain CBRN medical
countermeasures can be high, depending on the stage of scientific
research and development. HHS estimates that the failure rate for
development and licensure of most drugs, vaccines, and diagnostic
devices in the early development stage can be more than 80 percent,
with an increasing probability of success as the product moves further
through development. Because most CBRN research does not result in
viable medical countermeasures, HHS officials told us that they try to
fund a larger set of candidates in earlier stages of research in order
to increase the likelihood that at least one candidate countermeasure
may be successful. HHS officials noted that they would ideally prefer
to have at least two successfully developed medical countermeasures
from different manufacturers available for a particular CBRN agent for
several reasons, such as if certain segments of the population are
resistant to one of the countermeasures or if one of the companies
experiences manufacturing problems.
Given the high risk of failure in research, as well as a lack of a
commercial market for most CBRN countermeasures, attracting companies
experienced in meeting the complex requirements necessary to develop a
new product is also challenging. The private sector--especially large
pharmaceutical companies--has little incentive to invest millions of
dollars to develop a potential new medical countermeasure because the
lack of a commercial market makes a return on investment less likely or
less lucrative. The Project BioShield Act facilitates the creation of a
Government market by authorizing the Government to commit to make the
Special Reserve Fund available to acquire certain medical
countermeasures, including those that are not yet licensed or approved,
provided they meet certain conditions.\17\ In addition, the Pandemic
and All-Hazards Preparedness Act established BARDA to support advanced
research and development by, for example, awarding contracts and grants
for countermeasure advanced research and development.\18\ BARDA
provides funding for advanced research and development for those
countermeasures that are not eligible for the Special Reserve Fund.
Nevertheless, despite the Special Reserve Fund and BARDA support, HHS
and others have noted that engaging large pharmaceutical companies
remains a challenge. In addition, smaller biotechnology companies
conducting much of the research and development for medical
countermeasures generally have less experience with drug development.
As a result, FDA officials told us that they have to provide more
regulatory and scientific guidance to these companies than they might
provide to larger pharmaceutical companies, which generally have more
experience with bringing products through the regulatory process.
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\17\ 42 U.S.C. 247d-6b(c)(4)(A).
\18\ 42 U.S.C. 247d-7e(c)(4)(B).
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There are also several challenges related to the regulatory
processes for evaluating the development of promising medical
countermeasures. For example, researchers face challenges proving the
effectiveness of potential countermeasures because they cannot
ethically or feasibly test the effectiveness of countermeasures on
humans due to the dangers posed by CBRN agents. However, because FDA
requires evidence of a countermeasure's effectiveness for approval or
licensure, researchers can submit evidence of effectiveness obtained
from appropriate studies in animals in accordance with FDA's Animal
Rule. The Animal Rule states that in selected circumstances, when it is
neither ethical nor feasible to conduct human efficacy studies, FDA may
grant marketing approval based on adequate and well-controlled animal
studies when the results of those studies establish that the drug or
biological product is reasonably likely to produce clinical benefit in
humans.\19\ Under this rule, researchers can demonstrate effectiveness
of medical countermeasures if the way a disease occurs in the animal
being studied adequately mimics the way the disease occurs in humans.
However, animals that manifest the disease in the same way as humans
may not always exist for a given CBRN agent. For example, according to
FDA officials, smallpox occurs only in humans, and related viruses that
occur in animals, such as monkey pox, may not be similar enough to
mimic smallpox in humans. Because of the complexities of using animal
studies as models for human reactions to agents and potential
countermeasures, FDA would prefer to meet with researchers earlier and
more frequently, and FDA takes longer to evaluate product applications
for CBRN medical countermeasures than to evaluate other medical
products. In addition, the NBSB and others have reported that
researchers face difficulty in applying FDA's draft guidance on the
Animal Rule, which is currently under revision. According to the
guidance, the agent tested in the animal must be identical to the agent
that causes human disease. However, as discussed above, some animal
studies may not meet that criterion and therefore cannot be used to
demonstrate a countermeasure's effectiveness. To date, FDA has not
approved any newly developed CBRN medical countermeasures based on
animal model testing.\20\
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\19\ 21 C.F.R. 314.600-.650; 601.90-.95.
\20\ Under the Animal Rule, FDA has approved existing products for
CBRN use, such as drugs to treat the effects of nerve gas and cyanide
exposure.
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Determining appropriate doses of CBRN countermeasures for children,
who may be more vulnerable to the adverse effects of a CBRN agent, also
involves regulatory challenges.\21\ Most approved or licensed CBRN
medical countermeasures have been approved for use in adults only and
lack pediatric dosing information. In addition, several candidate
medical countermeasures currently in development lack or have limited
pediatric dosing information. Regulations restrict children's
participation in clinical trials when they do not benefit from
them;\22\ therefore, developing pediatric dosing information relies on
existing adult data or data from animal studies.
---------------------------------------------------------------------------
\21\ See National Commission on Children and Disasters, 2010 Report
to the President and Congress (Rockville, MD: October 2010). According
to the report, in a CBRN incident children may be more vulnerable to
exposure than adults because children inhale more air and consume more
water in comparison to their body weight than adults.
\22\ 21 C.F.R. 50.50-.56.
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There are also challenges in the processes for evaluating the
emergency use of a promising medical countermeasure that has not been
FDA-approved or licensed for treatment or postexposure prevention of
disease for a given CBRN agent. In order for the Government to use an
unapproved countermeasure to respond to a CBRN event, FDA must issue an
EUA. FDA can issue EUAs only after the HHS Secretary declares a public
health emergency. In order for FDA to issue an EUA, CDC, or another
Government or private entity has to submit detailed information for FDA
to evaluate, such as available safety and effectiveness information, a
discussion of risks and benefits of using the unapproved
countermeasure, draft fact sheets for health care providers and
patients, and instructions for using the countermeasure. While CDC or
other entities may submit all available data for FDA review in advance,
such as when CDC acquires a countermeasure for the SNS, the agency must
formally submit the EUA request at the time of the declared emergency.
In the event of an attack with a CBRN agent that can cause disease
within hours or days after exposure, CDC and FDA would have to process
the final documents quickly in order for FDA to issue EUAs for
appropriate medical countermeasures. Further, the Project BioShield Act
precludes the use of data collected during the emergency use of an
unapproved product to constitute a clinical investigation to support
later product approval.\23\
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\23\ 21 U.S.C. 360bbb-3(k).
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Finally, CDC faces the logistical challenge of on-going
replenishment of expiring medical countermeasures in the SNS. CDC can
work with FDA to extend the expiration date of certain drugs in the
stockpile, and thereby defer the cost of replacing the countermeasure
and extend its availability for use in a potential CBRN event. In such
cases, however, FDA has to conduct studies to ensure stability and
quality of each drug. In addition, CDC faces the cost of relabeling the
products to reflect the new expiration date. If the shelf life of an
expiring countermeasure cannot be extended, CDC must replace it. For
some countermeasures in the SNS, CDC may not face this challenge. For
example, CDC officials told us that anthrax vaccine is moved out of the
SNS before expiration because CDC rotates it out to DOD facilities for
routine use.\24\ In addition, other countermeasures may be held for the
SNS by private vendors and can be used commercially, provided that the
vendors hold a certain amount for use in the event of a public health
emergency.
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\24\ CDC and DOD have an agreement to share anthrax vaccine, which
CDC holds in the SNS for DOD use.
---------------------------------------------------------------------------
Chairman Bilirakis, this concludes my prepared statement. I would
be happy to answer any questions that you, Ranking Member Richardson,
or other Members of the subcommittee may have.
Appendix I: Abbreviations
ASPR: Office of the Assistant Secretary for Preparedness and Response
BARDA: Biomedical Advanced Research and Development Authority
CBRN: Chemical, Biological, Radiological, and Nuclear
CDC: Centers for Disease Control and Prevention
DHS: Department of Homeland Security
DOD: Department of Defense
EUA: Emergency Use Authorization
FDA: Food and Drug Administration
HHS: Department of Health and Human Services
MTA: Material Threat Assessment
NBSB: National Biodefense Science Board
NIH: National Institutes of Health
PHEMCE: Public Health Emergency Medical Countermeasures Enterprise
SNS: U.S. Strategic National Stockpile
Mr. Bilirakis. Thank you very much.
Dr. Pillai, you are recognized for 5 minutes.
STATEMENT OF SEGARAN P. PILLAI, CHIEF MEDICAL AND SCIENCE
ADVISOR, CHEMICAL AND BIOLOGICAL DIVISION, SCIENCE AND
TECHNOLOGY DIRECTORATE, DEPARTMENT OF HOMELAND SECURITY
Dr. Pillai. Good afternoon, Chairman Bilirakis, Ranking
Member Richardson, and distinguished Members of the
subcommittee. It is an honor to appear before you today.
In fulfilling the Department of Homeland Security's mission
to protect the American people the Science and Technology
Directorate strives to equip the decision-makers with tools for
better assessing the significant risk that chemical,
biological, radiological, and nuclear threats pose to the
Nation. In my statement today I intend to discuss the
utilization of DHS S&T's Risk Assessment and Material Threat
Assessment products which support the issuance of the Material
Threat Determinations (MTD) that inform the Federal
Government's medical countermeasures position.
On July 21, 2004 President George W. Bush signed into law
the Project BioShield Act of 2004. The purpose of BioShield is
to celebrate and encourage the research, development,
acquisition, and availability of safe and effective medical
countermeasures to protect the United States from CBRN threats.
It requires the Secretary of Homeland Security, in consultation
with the Secretary of Health and Human Services and the heads
of other agencies as appropriate, to make determinations of
CBRN agents that are material threats to the U.S. population.
It also authorizes the Secretary of Health and Human
Services to determine the public health consequence and
recommend countermeasures to such threats. If suitable
countermeasures do not already exist this process can result in
a joint DHS-HHS recommendation to the President or his
delegate, the director of the Office of Management and Budget,
to authorize the use of BioShield special reserve funds.
The BioShield medical countermeasure acquisition strategy
must be driven by many factors, including threat agents'
potential cause to public health emergencies sufficient to
affect National security and the potential for effective,
feasible, and pragmatic medical interventions to counter their
effects. Thus, the first step in the BioShield process is to
determine the relative risks and threat of specific CBRN
agents.
To support this, DHS S&T conducts quantitative Terrorism
Risk Assessments of CBRN agents as mandated under HSPD 10, 18,
and 22, which provide the combined understanding of the
likelihood and the specific consequence of a broad range of
possible CBRN terrorist attacks. These assessments inform the
relative risk associated with specific CBRN agents and assist
the understanding as to which agents pose a relatively higher
or lower threat to the American public.
These risk assessments support Federal, State, and local
agencies to guide their--defense and preparations and
preparedness-related investments, as well as the direct HHS
planning requirements by identifying the top-tier CBRN agents
that poses a high risk to the Nation. In addition, DHS
leverages the risk assessments to conduct the material threat
assessments on high-risk agents.
Specific to the material threat assessment process, DHS
develops and models the possible high-consequence scenario
taking into account acquisition, production, examination
efficacy--conditions. This model is used to derive an estimate
of the number of potentially exposed individuals. These
estimates are then provided to HHS to conduct its public health
consequence model studies, which serves as the basis for
determining public health impacts.
At the conclusion of these studies, a meeting within DHS
and HHS takes place to collectively determine the public health
impact of an agent and its potential to affect National
security. If the material threat assessments results indicate
that a significant number of fatalities will result from the
possible high-consequence scenario it is deemed a threat and
the under secretary for science and technology, in
collaboration and coordination with the office of health
effects, infrastructure protection, intelligence analysis, and
policy recommends to the DHS Secretary for consideration to
issue an NPD. To date, DHS has issued 12 NPDs for biological
agents, one for radiological materials, and one for nuclear
detonation impacts.
Correct provision of CBRN agents and terrorism risk is an
inherently dynamic and challenging problem. As the threat space
evolves so do the technical approaches. Continually updating
and gathering new data and feedback ensures that the
assessments are backed by state-of-the-art science.
DHS is committed to continual improvement of the risk and
threat assessments, as it is vital to appropriately capture the
CBRN landscape to help prioritize resources.
In conclusion, I would like to thank you for the
opportunity to discuss DHS S&T's risk assessment and material
threat assessment products, which supports the material threat
determinations that informs medical countermeasures decisions.
I look forward to answering any questions you may ask and
working with you to solve the homeland security challenges of
our time.
[The statement of Mr. Pillai follows:]
Prepared Statement of Segaran P. Pillai
April 13, 2011
introduction
Good afternoon, Chairman Bilirakis, Ranking Member Richardson and
distinguished Members of the subcommittee. It is an honor to appear
before you today. In fulfilling the Department of Homeland Security's
(DHS) mission to protect the American people, the Science and
Technology Directorate (S&T) strives to equip decisionmakers with tools
for better assessing the significant risks that chemical, biological,
radiological, and nuclear (CBRN) threats pose to the Nation. In my
statement today, I intend to discuss the utilization of the DHS S&T's
Risk Assessment and Material Threat Assessment products which support
the issuance of the Material Threat Determinations (MTD) that inform
the Federal Government's medical countermeasure decisions.
On July 21, 2004, President George W. Bush signed into law the
Project BioShield Act of 2004 (Pub. L. 108-276) (BioShield). The
purpose of BioShield is to accelerate and encourage the research,
development, acquisition, and availability of safe and effective
medical countermeasures to protect the United States from CBRN threats.
In 2004 Congress appropriated $5.6 billion for a Special Reserve Fund
for use over 10 years (fiscal year 2004-fiscal year 2013) to acquire
those medical countermeasures. Section 3(a)(2) of BioShield, adding
section 319F-2(c)(2) to the Public Health Service Act, requires the
Secretary of Homeland Security, in consultation with the Secretary of
Health and Human Services (HHS) and the heads of other agencies as
appropriate, to make determinations of CBRN agents that are material
threats to the U.S. population. Section 319F-2(c)(2)(B) authorizes the
Secretary of HHS to determine the public health consequences and
recommend countermeasures to such threats. If suitable countermeasures
do not already exist, this process can culminate in a joint DHS-HHS
recommendation to the President or his delegate, the Director of the
Office of Management and Budget, to authorize the use of BioShield
special reserve funds.
To determine the most effective ways to mitigate the effects of
CBRN threats or incidents, it is essential to understand that the
threat classes (i.e., chemical, biological, radiological, and nuclear)
are distinct in their feasibility, likelihood of use, and potential
public health consequences. The BioShield medical countermeasure
acquisition strategy must be driven by many factors, including threat
agents' potential to cause a public health emergency affecting National
security and the potential for effective, feasible, and pragmatic
medical intervention to counter their effects. Thus, the first step in
the BioShield process is determining the relative risks of specific
CBRN agents. DHS conducts quantitative Terrorism Risk Assessments
(TRAs) of biological, chemical, radiological, and nuclear attacks to
better understand the likelihood and associated consequences of
specific types of CBRN terrorist attacks. The TRAs accomplish this by
integrating the information derived from the intelligence and law
enforcement communities with input from the scientific, medical, and
public health communities. The assessments establish the relative risk
associated with specific chemical, biological, radiological, and
nuclear agents and assist with understanding which agents pose
relatively higher or lower threats to the American public. ``High
risk'' agents are then subjected to a secondary, detailed analysis
called the Material Threat Assessment (MTA) to support DHS issuance of
MTDs in collaboration with HHS.
summary of terrorism risk assessment process
Under Homeland Security Presidential Directives (HSPD) 10, 22, and
18, DHS is mandated to conduct the Biological Terrorism Risk
Assessment, the Chemical Terrorism Risk Assessment, the Radiological
and Nuclear Terrorism Risk Assessment, and the Integrated CBRN
Terrorism Risk Assessment.
Federal agency stakeholders provide input on the scope of each TRA
by participating in the Terrorism Risk Assessment Working Groups. These
recommendations form the basis of each assessment's models,
methodology, and improvements. DHS has conducted biennial TRAs since
2006 and each updated assessment includes refinements to the
methodology and technical approach that are guided by input obtained
from HHS, DoD, EPA, the intelligence agencies and other Federal
agencies and stakeholders, as well as the National Academy of Sciences.
Once Federal agency stakeholder inputs are established, the next
phase of the process involves refining the assessments through
stakeholder coordination. This phase begins with the elicitation of
intelligence from the law enforcement community on threats, including
adversary group types and weaponization preferences. Each assessment
incorporates a broad set of scenarios that consider multiple routes of
exposure, multiple targets, different dissemination approaches and
scales of attack, and modeling data from sources across Government,
academic, and private sectors. These results are then shared with the
inter- and intra-agency stakeholders in a draft report for review and
comment.
After inter- and intra-agency reviews have been conducted and input
incorporated, the final TRA reports are released to the National
Security Staff and interagency stakeholders. The Risk Assessments
address HHS planning requirements by identifying top-tier CBRN agents
(i.e. relative risk ranking where risk is the likelihood of an attack
combined with the associated consequences) that pose a high risk to the
Nation. These Risk Assessments are then leveraged to support the
conduct of MTAs on high-risk agents. Results of the MTAs are a critical
element of consideration in issuing an MTD.
dhs terrorism risk assessment products
Biological Terrorism Risk Assessment (BTRA).--To inform decisions
about biodefense investments, DHS S&T performs the BTRA every 2 years.
The BTRA is a comprehensive, probabilistic risk assessment that
integrates the judgments of the intelligence and law enforcement
communities with input from the scientific, medical, and public health
communities. The BTRA is a strategic level assessment designed to: (1)
Aide in identifying and prioritizing credible, high-impact threats, (2)
aid in identifying and prioritizing vulnerabilities and knowledge gaps,
and (3) provide a systematic, science-based, common framework for
``what if'' analyses.
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The probabilistic risk assessment methodology captures the
scenarios in an event tree format allowing the model to address
different classes of agents, including a full spectrum of attack
scenarios, beginning with the relevant characteristics of the adversary
groups under consideration, and ending with the effectiveness of the
response. In the simple example above, the terrorist enters the event
tree on the left-hand side with attack conception. The first branch in
this simple binary example is the selection of the bioagent. The tree
then splits and the second event is the selection of the target,
followed by production and dissemination, etc. The accumulation of all
steps in the sequence defines a scenario, with a total relative
probability defined by the product of the all of the branch
probabilities. For each scenario, an estimate of the overall
consequence is made. The risk from each branch is then determined as
the probability times the consequences, and the total risk is the sum
of the risks of all of the branches. Of course, for the branches in
which the terrorist fails, there are no consequences and therefore the
risk is zero.
The event tree in the 2010 BTRA has 21 events and multiple branches
at each event level. The 2010 study scope considers four terrorist
types (international, state-sponsored, domestic, lone wolf) exploiting
43 different bioagents (38 human, five livestock pathogens) that may be
obtained from two locations (foreign and domestic) by five routes of
acquisition (among them theft and environmental isolation). The
adversary may use multiple methods of production and weaponization to
attack any of 20 different targets (including a subway, stadium,
transportation, or outdoor events) using eight modes of dissemination
(food, aerosol, etc.). Human health and economic consequences are then
calculated for each scenario path in the event tree and combined with
probabilities to estimate the risk associated with millions of
enumerated scenarios. This enables a comprehensive evaluation of not
only what is possible but also probable in bioterrorism. The study
model allows for risk data visualization by agent, target, adversary
group and other factors to inform understanding. The probabilistic risk
assessment methodology also supports an evaluation of the impact of
knowledge gaps and incorporates explicit consideration of the inherent
uncertainty in bioterrorism modeling.
Chemical Terrorism Risk Assessment (CTRA).--The CTRA provides a
comprehensive analysis of the homeland security risks from a broad
range of chemical threat agent materials, including toxic industrial
chemicals, traditional chemical warfare agents, and emerging threats.
The CTRA, developed by S&T's Chemical Security Analysis Center (CSAC),
uses information from across the intelligence community, the law
enforcement community, and technical experts from the Government and
chemical industries to assess the capabilities and intentions of
different types of terrorist groups, and the feasibility of acquiring a
given chemical threat material. Multiple Federal agencies are involved
in providing information on medical consequences of these attacks, and
the capabilities that are available to mitigate the effects of an
attack. Using scientific information and advanced modeling
capabilities, the consequences of possible chemical attack scenarios
are calculated, providing information on the numbers of people likely
to be killed or injured in the attacks.
The final estimates of overall risk produced by the assessment
combine the likelihood of each attack scenario, the possibility of law
enforcement interdiction, and the magnitude of the consequences for
each attack. The 2010 CTRA provides a relative risk assessment of 100
representative chemicals for three routes of exposure (inhalation,
dermal, ingestion) over 30 different scenario types. This relative
assessment of the chemical risk captures the broad range of threats
posed by a number of classes of chemical compounds.
CSAC is applying the same probabilistic methodology to assess the
risks of chemicals regulated under the Chemical Facility Antiterrorism
Standards. This assessment, termed the Chemical Infrastructure Risk
Assessment, provides DHS with tools to understand the risk of a
chemical release from chemical facilities or while in transport, and to
determine the impact of current threat reduction activities.
Radiological and Nuclear Terrorism Risk Assessment (RNTRA).--A
collaborative effort led by S&T and Domestic Nuclear Detection Office
(DNDO), the RNTRA assessment is updated biennially with information
from the intelligence community, coordinated by the DHS Office of
Intelligence and Analysis, and the interagency contributions from the
Department of Energy, Nuclear Regulatory Commission, HHS, the
Department of Defense (DoD), the Environmental Protection Agency (EPA),
and many other Federal agencies. The RNTRA includes over 2 million
attack scenarios from the highest consequence to most plausible. These
scenarios consider: International and domestic terrorist groups as well
as lone wolf scenarios; 11 radiological agents and three sizes of
improvised nuclear devices; multiple modes of radiological agent
dissemination; and many plausible targets such as public entertainment
venues, transportation targets, and supply chain networks. The
scenarios are coupled with analyzing the public health response,
management and distribution of medical countermeasures and resultant
fatalities, illnesses and economic consequences using integrated
dispersion modeling and National laboratory nuclear effects modeling.
This assessment provides decision-makers with an understanding of
radiological and nuclear terrorism risks as they relate to illnesses
and injuries, fatalities, latent cancer morbidities and mortalities and
economic cost from both regional and National perspectives.
Integrated CBRN Terrorism Risk Assessment (ITRA).--The ITRA is the
only Federal report that provides an assessment of the relative risks
associated with chemical, biological, radiological, and nuclear
terrorism in the homeland. The assessment is conducted biennially and
provided to the Executive Office of the President's National Security
Staff as mandated by HSPD-18. While the purpose of the ITRA intended by
HSPD-18 is to inform resource allocation for medical countermeasures,
the assessment can be leveraged by a broader range of Federal decision-
makers to support development of risk management strategies that have
tangible operational impact on WMD terrorism risk such as prevention,
protection, surveillance and detection, response and recovery
activities. The ITRA capability is based on integration and
harmonization of each of the threat agent specific assessments (BTRA,
CTRA and RNTRA) augmented with intelligence information that
establishes the relative likelihood that a terrorist will select a
biological, chemical, radiological, or nuclear weapon. The ITRA
encompasses more than 10 million attack scenarios across broad ranges
of consequence and likelihood. They include various terrorist
organizations, more than 150 specific agents, multiple modes of agent
dissemination, and many potential targets such as public entertainment
venues, transportation targets, and certain supply chain networks.
These types of scenarios are coupled with modeling of the public health
response, management and distribution of medical countermeasures to
arrive at an estimated risk of fatalities, illnesses, and economic
consequences associated with attack scenarios.
Federal, State, and local agencies can leverage these assessments
to guide their WMD defense-related investments focused on prevention,
protection, surveillance, detection, response and recovery-related
preparedness efforts. This includes guiding prioritization,
development, acquisition, and maintenance of medical countermeasures.
The assessments are accomplished through formal DHS working groups,
where DHS engages with HHS, DoD, the National intelligence agencies,
and several other Federal agencies such as EPA and NRC. This approach
includes several steps in which working group members engage with DHS
to develop requirements, provide technical input, and conduct a
critical review of the TRAs.
material threat assessment process
The first step in the BioShield process is threat identification
and prioritization in order to inform medical countermeasure
development and acquisition. DHS has the lead in threat identification
and leverages the DHS Integrated Terrorism Risk Assessment findings to
determine which CBRN agents present a greater risk based on the
relative risk ranking against the U.S. population sufficient to affect
National security. Specifically, for the highest-ranked agents in the
TRA, DHS evaluates the intelligence and threat information and develops
and models a highly plausible consequence scenario taking into account
acquisition, production, dissemination efficacy, source strength, and
meteorological conditions. This model is used to derive an estimate of
the number of potentially exposed individuals at various levels of
exposure, which becomes part of the MTA. The estimates are provided to
HHS, which conducts its Public Health Consequence Modeling (PHCM) as
the basis for determining public health impacts. At the conclusion of
these studies, a meeting between DHS and HHS takes place to
collectively determine the potential impact on public health and its
potential to affect National security. If the PHCM results indicate
that a significant number of fatalities will result from the highly
plausible scenario with a particular agent, it is deemed a ``threat''
and the DHS Under Secretary of Science and Technology recommends to the
DHS Secretary the issuance of an MTD, as outlined in Figure 2. Although
the predominant role of DHS in the initial stages of the BioShield
process is in conducting the MTAs, assessing the findings of the PHCM
and issuing MTDs, DHS is actively involved in the subsequent
interagency process and has the joint statutory responsibility with HHS
in recommending to the Office of Management and Budget (OMB) to release
the BioShield Special Reserve Funds.
For agents considered to be a material threat, HHS determines
whether these agents lack an existing, effective countermeasure and
whether a countermeasure should be procured using BioShield reserve
funds. If so, then HHS uses the interagency Public Health Emergency
Medical Countermeasure Enterprise (PHEMCE), created by HHS in 2006, to
define countermeasure requirements and acquisition options. The PHEMCE
is overseen by an Enterprise Senior Council (ESC), previously known as
the Enterprise Governance Board, to take a more integrated, systematic,
end-to-end approach to the medical countermeasure mission, including
research, development, acquisition, storage, maintenance, deployment,
and guidance for utilization. Currently, the ESC serves as the primary
conduit for communication among entities involved in the medical
countermeasure mission and coordinates the implementation not only of
BioShield, but also: HSPDs 18 and 22; the National Pandemic Influenza
Strategy; the Strategic Plan for Countermeasure Research, Development,
and Procurement required by the Pandemic and All-Hazards Preparedness
Act; and other strategic planning documents. The DHS Office of Health
Affairs and S&T are both members of the ESC. To date, DHS has issued 12
MTDs for biological agents, one MTD for radiological materials, and one
MTD for nuclear detonation effects.
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tra improvement on process and methodology limitations identified
through the national academies report and stakeholder feedback
Since their origin, the DHS Risk Assessment Programs have been very
proactive in soliciting internal and external expert review of
methodology, data inputs, outputs, and findings. Characterization of
the biothreat and bioterrorism risk is an inherently dynamic problem.
DHS is committed to continual improvement of the Terrorism Risk
Assessments to support stakeholder decision-making. The main challenges
we face in evaluating the WMD terrorism risk are that we must rely on
historical data and information about our adversaries' future plans--
both of which are limited. DHS continues to work closely with HHS, DoD,
EPA, and other stakeholders to provide transparency and to address,
document, codify, and implement requirements aimed to improve the
technical quality and utility of the TRAs.
As the first Biological Terrorism Risk Assessment represented the
pioneer of the TRAs, it garnered much attention. In response to the
DHS-commissioned 2008 National Academy of Sciences (NAS) Report:
``Department of Homeland Security Bioterrorism Risk Assessment: A Call
for Change,'' the National Research Council provided 13
recommendations. S&T was able to take action on several NAS
recommendations in 2008, addressed others in the 2010 BTRA, and has
research dollars invested to address the longer-term challenges, such
as modeling the intelligent, adaptive adversary. Since 2006, BTRA has
improved in its lexicon, transparency, and external peer review; the
scope of consequences considered; platform flexibility; validation and
verification; normalization methodology; communication strategy; and
overall approach.
The BTRA program has been pushing forward on improvements as
quickly as science allows, and the process remains committed to
addressing any and all deficiencies noted in the report. Meanwhile, the
scientific community continues to debate the evolving new science of
terrorism risk assessment and S&T continues to research new approaches.
It is clear that providing sound risk-informed guidance to our
leadership is a job that is too important not to get right. The models
are continually reviewed, updated, and exercised to support partner
decision making, and by doing so, DHS adds significant value to the
biodefense decision and policy development National dialog.
informing current biological defense research and the value of
knowledge products
In order to enable our TRAs and MTAs to achieve greater fidelity,
the National Biodefense Analysis and Countermeasures Center (NBACC)
supports S&T by providing knowledge and understanding of biological
agents, closing the knowledge gaps on those known agents, and
supporting attribution. The direction and prioritization of NBACC's
scientific research are informed by DHS in coordination with
interagency partners who serve on our science advisory groups. Reducing
the uncertainty in the BTRA is an important target outcome of NBACC's
work.
In the current fiscal year, DHS's priority for the National
Biological Threat Characterization Center (NBTCC) within NBACC is to
develop plans for assessing and reducing knowledge gaps for
traditional/nontraditional threat agents. These include specific and/or
general properties associated with acquisition, production,
dissemination, stability, virulence and pathogenesis, and medical
countermeasure efficacy.
conclusion
Thank you for the opportunity to discuss DHS's S&T Risk Assessment
products and the Material Threat Assessment products which support the
Material Threat Determinations that inform medical countermeasure
decisions.
Characterizing CBRN agents and terrorism risk is an inherently
dynamic and challenging problem. As the threat space evolves, so do
technical approaches; by continually updating and gathering new data
and feedback on the TRAs and MTAs, we ensure that the assessments are
backed by the best available science, and that risk reduction
strategies are continually re-evaluated to support program
effectiveness. DHS is committed to the continual improvement of risk
assessments to support stakeholder decision making, investments, and
strategic planning initiatives. It is vital to appropriately capture
the CBRN terrorism landscape to help prioritize resources and indicate
areas which may need additional focus.
Thank you for inviting me to appear before you today. I look
forward to answering any questions you may have.
Mr. Bilirakis. Thank you, Dr. Pillai.
Dr. Hatchett, you are recognized for 5 minutes.
STATEMENT OF RICHARD J. HATCHETT, CHIEF MEDICAL OFFICER AND
DEPUTY DIRECTOR, STRATEGIC SCIENCES AND MANAGEMENT, DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Dr. Hatchett. Thank you.
Good afternoon, Chairman Bilirakis, Ranking Member
Richardson, Representative Marino. I am pleased to discuss our
efforts to develop medical countermeasures against chemical,
biological, radiological, and nuclear threats. The drugs,
vaccines, and biological therapeutics, and diagnostic and non-
pharmaceutical devices we use to prevent, mitigate, and treat
the health consequences of CBRN agents are one of our chief
bulwarks against such threats.
The Department of Health and Human Services has invested
more than a decade and billions of dollars in developing such
products to protect civilian populations. Within the
interagency PHEMCE, BARDA works closely with the NIH, CDC, and
FDA, as well as the Departments of Homeland Security, Defense,
Veterans Affairs, and Agriculture, to define and prioritize
requirements, coordinate research, product development and
procurement, and establish strategies for the deployment and
use of products held in the Strategic National Stockpile, or
SNS.
Requirements answer the question of: What do we need and
how much should we buy? Dr. Pillai described DHS's role in
establishing material threat determinations and developing
material threat assessments of the number of people who might
be exposed in a given event. These, in turn, inform public
health consequence assessments of how many people would benefit
from a given medical countermeasure.
DHS also provides the integrated terrorism risk assessment,
which helps us determine program priorities. Collectively,
these assessments help us to align and prioritize our
investments while coordinating our efforts with those of our
Federal partners.
A prime example of our commitment to such coordination is
the integrated portfolio for CBRN medical countermeasures
managed by HHS and the Department of Defense. Through the
integrated portfolio, HHS and DOD leverage each other's efforts
to address a broad range of common threats and requirements
with greater efficiency and economy.
The enterprise has notable successes to its credit. We have
procured eight countermeasures for the SNS using Project
BioShield funds, reducing our vulnerability to anthrax,
smallpox, botulism, and radiation threats in the process. The
SNS has an adequate supply of smallpox vaccine for the entire
country and we have met our requirement for heptavalent
botulinum antitoxin.
But our efforts to support the development of medical
countermeasures have faced and continue to face many
challenges. Eight years ago Congress envisioned that the
authorities and funding provided through Project BioShield
would solve our medical countermeasures problem.
The important authorities and funding from Project
BioShield have been necessary but not sufficient conditions for
success. We have spent the years since Project BioShield was
established coming to better understand our private sector
partners and the challenges they face, and in making
improvements--not least through Congress' passage of the
Pandemic and All-Hazards Preparedness Act--to our model for
partnering with them.
Under the form of last year's PHEMCE review we stepped back
and took a systems approach to addressing these challenges. The
result of the review is that we have undertaken an ambitious
and important initiative involving multiple components to
fundamentally alter the environment within which medical
countermeasures development occurs. The goal is to shape a
tightly integrated end-to-end enterprise in which promising
concepts and discoveries are readily translated into candidate
countermeasures and moved through the development pipeline with
the Government coming to the table at every stage as a full and
active partner.
The four major initiatives proposed by the review--the
creation of, first, a concept acceleration program at the
National Institute of Allergy and Infectious Diseases; second,
a nonprofit, independent medical countermeasures strategic
investor; third, centers for innovation in advanced development
and manufacturing; and fourth, a robust medical countermeasures
regulatory science program at the FDA--will create a more
complete arch of support across the entire chain of
development.
Collectively, these initiatives will mitigate the
technical, regulatory, business, and Governmental risks that
companies face in undertaking medical countermeasures
development while simultaneously reducing their opportunity
costs for working in this area. In parallel, we are also
restructuring the way we do business, with all of the HHS
components working together and seamlessly from the beginning
with a focus on continual quality improvement.
Let me be clear about one thing: These initiatives are not
substitutes for the market guarantee provided by Project
BioShield. By altering the environment within which medical
countermeasures development occurs and by increasing the speed
and rapidity with which products enter and move through the
pipeline we believe these initiatives will help Project
BioShield realize its full potential.
Thank you, again, for inviting me to testify, and I would
certainly be happy to answer any questions that you may have in
this----
[The statement of Dr. Hatchett follows:]
Prepared Statement of Richard J. Hatchett
April 13, 2011
Good afternoon Chairman Bilirakis, Ranking Member Richardson, and
distinguished Members of the subcommittee. Thank you for inviting me
here today to testify on the Department of Health and Human Services'
(HHS) efforts to prepare for and protect against chemical, biological,
radiological, and nuclear (CBRN) threats. My name is Richard Hatchett
and I serve as the Chief Medical Officer and Deputy Director for
Strategic Sciences and Management at the HHS Biomedical Advanced
Research and Development Authority. I am pleased to join my Department
of Homeland Security and Department of Defense colleagues, as well as
the Government Accountability Office, to discuss these very important
issues. The threats that our Nation faces continue to evolve, and we
know that we cannot identify and characterize them all in advance. It
is critical that we have the capability, as a Nation, to be resilient
when disaster strikes--and to be resilient, we must be able to respond
quickly and effectively to all disasters with the appropriate resources
necessary to limit casualties and disruptions to communities.
introduction--aspr/barda mission
The HHS Assistant Secretary for Preparedness and Response, Dr.
Nicole Lurie, serves as the principal advisor to the Secretary on all
matters related to Federal public health and medical preparedness and
response for public health emergencies. The Office of the ASPR (or
ASPR) promotes community preparedness and resilience; builds public
health partnerships with Federal departments and agencies, State and
local governments, non-governmental organizations, academic
institutions and private sector partners; and coordinates Federal
public health and medical response capabilities.
Within ASPR, the Biomedical Advanced Research and Development
Authority (BARDA) is responsible for developing and procuring safe and
effective medical countermeasures (MCMs) against CBRN threats, pandemic
influenza, and emerging infectious diseases. A principal BARDA
responsibility is to help bring promising MCMs through the so-called
``valley of death.'' The ``valley of death'' describes a period of time
during MCM research and development when promising innovative
technologies fail to advance to a marketable product due to
entrepreneurial capital shortage or other similar cause. Left to their
own devices and resources, most of our small biotech partners would
find that the ``valley of death'' poses a nearly insuperable set of
financial, technical, and regulatory challenges. BARDA provides the
financial and technical resources our partners need to address these
challenges. BARDA supports medical countermeasure activities such as
industrialization, non-clinical and clinical testing, development of
manufacturing technologies and scale-up, submissions for FDA regulatory
review, and procurement for the Strategic National Stockpile (SNS).
BARDA works closely with its HHS partners at the National Institutes of
Health (NIH), the Centers for Disease Control and Prevention (CDC), the
U.S. Food and Drug Administration (FDA), as well as at the Department
of Defense (DoD) and the Department of Homeland Security (DHS) to
ensure the Nation has appropriate MCMs to save lives during a CBRN
event.
As the BARDA Chief Medical Officer and Deputy Director for
Strategic Sciences and Management, one of my primary responsibilities
is to ensure we have safe and effective medical countermeasures
available for our response efforts. One of the key avenues BARDA uses
to align its work with that of our HHS and interagency partners is the
HHS Public Health Emergency Medical Countermeasures Enterprise, or
PHEMCE, which encompasses the development, manufacturing, production,
stockpiling, and deployment and use strategies of products deemed
critical to protecting or treating our population against a variety of
CBRN threats, as well as against pandemic influenza and other emerging
infectious diseases. My written testimony discusses the PHEMCE MCM
requirements setting process; BARDA's MCM procurement and advanced
research and development efforts; our collaboration with Federal
partners and outreach efforts to industry; and identified gaps and
challenges related to MCM development and procurement and how we are
addressing these challenges.
the public health emergency medical countermeasure enterprise
In July 2006, HHS established the Public Health Emergency Medical
Countermeasures Enterprise to improve the Federal coordination of
Government policy, investments, and activities related to the
development and procurement of medical countermeasures for CBRN
threats. The overarching mission of the PHEMCE is to:
define and prioritize requirements for public health
emergency medical countermeasures;
coordinate research, early and late stage product
development, and procurement activities addressing these
requirements; and
set deployment and use strategies for medical
countermeasures held in the SNS.
ASPR leads the PHEMCE, which includes the CDC, the FDA, and the
NIH. The PHEMCE also includes key interagency partners from DHS, DoD,
the VA, and the USDA. The PHEMCE uses a decision forum named the
Enterprise Senior Council (ESC) for MCM policy and implementation
development. The ESC is chaired by the ASPR and is comprised of the
senior leadership of the Enterprise. Together, the PHEMCE organizations
and agencies work to improve our preparedness for public health
emergencies with respect to the development, stockpiling, and use of
medical countermeasures.
PHEMCE MCM Requirement-Setting Process
Simply stated, medical countermeasure requirements answer the
questions of ``What do we need, and how much should we buy?'' For CBRN
threats, these MCM requirements serve two critical functions:
to improve the outcome of public health emergencies by
focusing MCM activities across a wide range of key
stakeholders, and
to align the multibillion-dollar investments of the NIH,
BARDA, and CDC in the discovery, advanced development,
acquisition, deployment, and use of MCMs; and
to coordinate programs effectively with interagency partners
at USDA, VA, DoD and DHS.
The current PHEMCE MCM requirements process includes the following
activities:
Threat Assessments.--DHS develops Material Threat
Assessments (MTAs) to support use of Project BioShield Special
Reserve Fund acquisitions based on ``plausible, high-
consequence'' scenarios. To date, CBRN medical countermeasure
requirements have derived from these scenarios. The classified
MTAs prepared by DHS estimate the number of people in the
population exposed to specified levels of a given threat agent.
Issuance by DHS of a Material Threat Determination (MTD) based
on the information in the MTA and on risk assessments is a
requirement for use of Project BioShield Special Reserve Funds.
Medical and Public Health Consequence Assessments.--ASPR
modeling staff collaborate with threat-specific Requirement
Working Groups (including Subject Matter Experts) to develop
medical and public health consequence assessments using
epidemiological modeling tools that estimate the number of
people who would benefit from a particular medical
countermeasure using the population exposure numbers derived
from the MTA. Subject Matter Experts review and discuss the
appropriate disease-related parameters that should be included
in the modeling and what those values should be. They review
the modeling outputs and provide feedback on the model and the
results in an iterative and highly collaborative process.
Consultation with Subject Matter Experts.--ASPR staff
consult with a wide range of Federal subject matter experts
(with expertise in areas including, but not limited to,
microbiology, health physics, chemistry, toxicology, medical
care, and diagnostics) through the PHEMCE Requirements Working
Groups and Integrated Program Teams. Expertise from non-Federal
personnel is sought as needed and appropriate.
Consultation with End-Users.--Through one-on-one, small, and
large group settings, PHEMCE partners work with emergency
planners as well as public health, first responder, and
hospital-based end-users of medical countermeasures at the
local, State, regional, and National levels to understand the
concept of operations (CONOPs) under which the medical
countermeasures will actually be used. Examples of past
interactions include roundtable settings, one-on-one interviews
supporting interactive design methodologies, and the annual
PHEMCE Stakeholders Workshop. Of note, there is an Institute of
Medicine Study Committee presently looking at issues related to
pre-deployment of MCMs in community settings.
Leadership Approval.--CBRN medical countermeasure
requirements are approved through a formal governance process
within the PHEMCE. Following concurrence by the appropriate
PHEMCE Requirements Working Group and Integrated Program Team,
the draft requirements are briefed to the interagency
Enterprise Executive Committee and to interagency leadership at
the Enterprise Senior Council.
Requirement Revision.--ASPR leads re-examination and update
of requirements at the request of the PHEMCE leadership or as
needed as response capabilities and CONOPs evolve or new
technological or threat information is gained, or as real
events present new information through lessons learned (e.g.
2009 H1N1, or the Japan nuclear crisis).
MCM requirements fall into two major classes: (1) Scenario-based
requirements, and (2) product-specific requirements.
(1) Scenario-Based Requirements establish the classes and
quantities of MCMs necessary to effectively respond to
plausible, high-consequence scenarios for each threat agent.
Medical and public health consequence assessments are used to
inform these requirements.
(2) Product-Specific Requirements determine the acceptable
(threshold) and ideal (objective) characteristics for
individual MCM product types. These are set through
consideration of existing research and development technologies
and response capabilities, and are communicated in the form of
a Target Product Profile that calls out minimal qualities
acceptable and goal characteristics for medical countermeasures
HHS will pursue. Product-Specific Requirements also specify the
quantity of a product with ideal characteristics that might be
acquired to meet the specified needs, along with an indication
of how variations in product characteristics might affect the
quantity sought. Final acquisition quantities are determined
based on product-specific characteristics and other
considerations in the acquisition strategy and plans developed
by program staff.
mcm procurements, advanced research and development, and outreach to
industry
Once the requirements setting process is complete, and the PHEMCE
determines that advanced development or acquisition of unlicensed
medical countermeasures is appropriate to meet these requirements,
BARDA funds these activities to protect the American civilian
population against CBRN and naturally occurring threats to public
health. Further, BARDA collaborates with intra- and inter-agency
partners in MCM research that may be a precursor need for meeting these
requirements and has a robust process for screening new technologies
and interacting with the private sector on novel MCM technologies and
products.
Project BioShield MCM Procurements
Project BioShield, authorized by the Project BioShield Act of 2004
(Pub. L. 108-276), established the Special Reserve Fund, a market
signal, a guarantee, and a secure funding source for the procurement of
critical medical countermeasures, such as vaccines, therapeutics, and
diagnostics that are close to licensure. It provides a tangible
guarantee to industry that a market will exist for these products. The
Project BioShield Act also provides additional and more flexible
authorities and funding to support and expedite the development and
procurement of CBRN MCMs. Finally, the Project BioShield Act provides
the Secretary with the authority to authorize the use of unapproved
products or the unapproved use of approved products during emergencies.
In 2003, Congress appropriated $5.593 billion to support Project
BioShield over a 10-year period. Since its inception, ASPR has used
Project BioShield funds to procure:
anthrax therapeutics and vaccines;
heptavalent botulinum antitoxin;
smallpox vaccine; and
a number of MCM products intended for use after radiological
and/or nuclear events.
Of the $5.593 billion originally appropriated, $2.348 billion
remains available. The difference includes $2.130 billion directed
towards the procurement of MCMs and $1.114 billion transferred,
rescinded, or spent on ARD contracts.
Advanced Research and Development
Using its Advanced Research and Development (ARD) authority, BARDA
bridges the ``valley of death'' funding gap that exists between the
early stages of product development and the procurement of approved or
approvable medical countermeasures under Project BioShield. Given that
commercial markets do not exist for many of the products we are trying
to develop, robust funding for ARD is essential if we are to build a
substantial pipeline of products to diagnose and treat illness with, or
prevent the effects of CBRN agents. The fiscal year 2011 budget
includes a request that $476 million be made available from Project
BioShield balances to support such ARD projects. Current priority
investment areas include anthrax vaccines and treatments, broad
spectrum antimicrobial drugs, and treatments and diagnostics for
illnesses associated with exposure to radiation. In fiscal year 2012,
the budget requests another $765 million from Project BioShield
balances to support these priorities.
Integrated Portfolio for CBRN Medical Countermeasures
The DoD and HHS each identify medical countermeasure requirements
to address their different missions and focus. Historically, DoD has
prioritized the development of MCMs to protect our military prior to
exposure to CBRN agents, whereas HHS's focus has been on responding to
threats to the civilian population once exposure has occurred. However,
there are areas of common requirements or interest where medical
countermeasure candidates, resources, and information can be
appropriately shared to maximize opportunities for success in the
development of medical countermeasures for the highest priority
threats. BARDA, in partnership with other HHS and DoD partners, is
leading an Integrated Portfolio for CBRN Medical Countermeasures to
leverage resources and programs across the agencies that develop and
acquire CBRN medical countermeasures to more effectively address the
broad range of common threats and requirements. Members of the
Integrated Portfolio working to integrate HHS and DoD efforts include
BARDA, biodefense programs at NIH, and multiple elements of the DoD
Chemical and Biological Defense Program.
BARDA TechWatch Program
BARDA has developed an active TechWatch program, which provides an
opportunity for external organizations to meet with the Federal
Government to discuss their new and innovative medical countermeasure
technologies. Companies may request meetings with Government subject
matter experts to discuss their products and plans for submitting
proposals in response to BARDA's Broad Agency Announcements (BAAs)
through the PHEMCE portal website www.medicalcountermeasures.gov. These
meetings provide the Federal Government with the latest information
about emerging technology and inform strategic and programmatic
planning for effective public health emergency response. The TechWatch
program has been highly successful in improving communication with
potential partners. Those companies who utilize TechWatch prior to
submitting a white paper in response to a BAA are three times more
likely to be invited to submit a full proposal than companies that
proceed directly to the white paper without the benefit of a TechWatch
meeting.
medical countermeasure enterprise review
Recently, our department undertook an effort to address gaps and
challenges in MCM development and procurement by improving the
efficiency of our translational efforts, enhancing the advanced
development and manufacturing services we provide our partners,
clarifying regulatory pathways, and building a strong base for MCM
regulatory science at the FDA. These initiatives, once implemented,
will provide the capability to speed MCM development and respond faster
and more effectively to rapidly evolving public health threats. In
December 2009, on the heels of the 2009-H1N1 pandemic, HHS Secretary
Kathleen Sebelius requested a complete review of the MCM enterprise and
assigned this responsibility to ASPR. The goal of the review was the
end-to-end transformation of the enterprise: To improve its
performance, enhance collaborations with the private sector, and
prepare the Nation for the threats of the 21st Century--those we can
predict as well as those we cannot. The MCM Enterprise Review, released
in August 2010, identifies ``processes, policies, and infrastructure
required to take a product concept derived from a national requirement
through research, early and advanced development, manufacturing,
regulatory approval, procurement, and stockpiling.'' Specifically, this
review looked across the entire arc of product development, from early
discovery through regulatory approval, and identified the chokepoints
where product development was stalling or failing. To address these
chokepoints, which create technical, business, and regulatory risks for
small innovator companies and form the basis of the MCM ``valley of
death,'' the Review proposes a series of initiatives:
The establishment of a Concept Acceleration Program at the
NIH National Institute of Allergy and Infectious Diseases to
work with partner agencies, academic researches, biotech
companies, and large pharmaceutical companies to identify
promising scientific discoveries and expedite their
transformation into practical, usable products.
The establishment of a nonprofit [501(c)3 or equivalent]
Strategic Investor firm to spur innovation by supporting
companies that possess strategic technologies that might
otherwise lack the necessary financial capital or business
acumen to develop a commercially viable approved product.
The establishment of U.S.-based Centers for Innovation in
Advanced Development and Manufacturing.
A major investment in regulatory sciences and review
capabilities at the FDA focused on CBRN MCMs.
The Concept Acceleration Program will leverage existing intramural
and extramural research programs as well as applied and translational
resources throughout NIH, CDC, FDA, and DOD to speed the translation of
promising concepts into candidate MCMs.
The Strategic Investor initiative would spur innovation and provide
the kinds of business and financial services and support that venture
capital firms typically provide, mitigating the risk that funded
pharmaceutical manufacturing firms will fail because of poor
management, an inadequate business model, or lack of financial
expertise. The Strategic Investor initiative is critical to
transitioning MCM development and procurement from a ``one bug, one
drug'' approach to an enterprise capable of responding to any threat at
any time.
The Centers for Innovation will be created to reduce risk, increase
product yields, and reduce total life-cycle costs through flexible
manufacturing. These U.S.-based Centers are expected primarily to
provide, on a routine basis, core services that include advanced
development and manufacturing capabilities of USG-supported developers
of medical countermeasures for chemical, biological, radiological, and
nuclear MCMs to address National preparedness and response priorities
and needs. In the event of a pandemic, the Centers will also be
available to assist in the manufacture of influenza vaccine and other
biologics. The Request for Proposals for this latter initiative was
published on March 30, 2011, and we have been working closely with our
colleagues at DoD, who are preparing a complementary initiative for
release in the near future.
Finally, expanding regulatory science and review capabilities at
the FDA will strengthen and clarify the MCM regulatory process, which
will expedite MCM development.
Collectively, these initiatives, once implemented, will help us
establish a more nimble and diversified approach in preparing for and
responding to CBRN and other threats.
mcm distribution--executive order 13527
Finally, Mr. Chairman and Members of the subcommittee, I must
address the importance of the entire MCM continuum--from research and
development to procurement to distribution and dispensing. The MCM
enterprise is one component of a broader response strategy to mitigate
the effects of a CBRN event. To be resilient in the face of CBRN
disasters, we need a fully integrated and coordinated strategy to
address how the various sectors of our health care system will work
together to respond and save lives. We need an integrated health care
system that can address patients' needs when and where necessary. After
we work to procure valuable CBRN medical countermeasures, we need
adaptable distribution and dispensing plans in place capable of quickly
delivering these countermeasures to every American who needs them.
On December 30, 2009, the President issued Executive Order 13527
establishing the Federal Government policy, in the event of a
biological attack, to plan and prepare for the timely provision of
medical countermeasures to the American people through a rapid Federal
response in coordination with State, local, territorial, and Tribal
governments. Section 2 of the Executive Order tasks HHS and DHS, in
coordination with the USPS to develop a national USPS medical
countermeasures dispensing model for U.S. cities to respond to a large-
scale biological attack, with anthrax as the primary threat
consideration. This dispensing model was delivered to the President on
June 30, 2010 and was included in a recent grant announcement issued
through ASPR. The President's fiscal year 2011 budget requested $10
million to fund this initiative. However, these funds were eliminated
in the previous, current, and proposed continuing resolutions to fund
Government operations in fiscal year 2011. The President's fiscal year
2012 budget requests $5 million for this initiative.
conclusion
In closing, I want to reiterate that as the threats we face evolve,
we will continue to work closely with our colleagues at DHS, DoD, and
across Government to ensure that our investments are rational and
sustainable. We understand the importance of thorough surveillance and
early detection to limit the impact of a CBRN event and will continue
to work closely with our partners to build upon existing infrastructure
and align supporting investments and capabilities. We continue to face
significant challenges in the realm of MCM research and development and
hope that through implementation of the priorities established in the
MCM Enterprise Review, we can transform the way we collaborate with our
industry partners while demonstrating our sustained commitment to
developing new and promising MCMs. Medical countermeasures are a
bulwark against the deliberate and natural threats we face, a critical
link in the chain of preparedness.
I speak for all my colleagues throughout HHS in saying that we look
forward to working with you on the matters I have raised this
afternoon. With the leadership and support of Congress, and in
collaboration with our agency partners, we have made substantial
progress in MCM development and procurements. We have accumulated a
great deal of practical experience over the last decade and have a deep
understanding of the challenges our private sector and academic
partners face. To meet these challenges, we have made changes in our
governance--continual improvements in our processes and institutions,
our standard operating procedures, and our collaborations with our DHS
and DoD partners. We are in the process of transforming the MCM
Enterprise to ensure its sustainability while meeting the threats of
the future.
Let me assure you that we take our mission of preparing the Nation
against these threats with the utmost seriousness and that we know how
much we still have left to do.
Thank you again for inviting me to testify. At this time I would be
happy to address any questions you may have.
Mr. Bilirakis. Thank you, Dr. Hatchett.
Dr. Parker, you are recognized for 5 minutes and then we
will recess because we have four votes. Then we will come back
as soon as the last vote is completed.
So you are recognized, sir, for 5 minutes.
STATEMENT OF GERALD W. PARKER, JR., DEPUTY ASSISTANT TO THE
SECRETARY OF DEFENSE, CHEMICAL AND BIOLOGICAL DEFENSE,
DEPARTMENT OF DEFENSE
Dr. Parker. Thank you.
Chairman Bilirakis, Ranking Member Richardson, and
Representative Marino, I am honored to be here to discuss the
Department of Defense efforts to develop medical
countermeasures to protect the warfighter and the Nation. First
I would like to briefly describe the DOD chemical and
biological defense enterprise. We have a process in place to
analyze threats and gaps in our capabilities so we provide our
warfighters the protection they need to carry out their
mission, protect our country, and come home safe and healthy.
The joint staff works with the services and combatant
commands through the joint requirements office to establish
requirements. Our joint science and technology office manages
research and development to fill our S&T product development
pipeline. As medical countermeasure candidates mature, products
transition to the joint holding executive office for advanced
development, manufacturing, and testing to address all
regulatory requirements leading to FDA approval.
From research to acquisition our efforts are product-
focused, with target product profiles developed early to guide
countermeasure development.
The DOD works in close partnership with HHS and DHS through
the integrated National portfolio to ensure we are not
duplicating efforts and to leverage capabilities. It is a great
partnership.
I have a unique perspective of having worked on biodefense
with each of the agencies represented here today, and I would
also like, though, to emphasize the exceptional DOD outcome-
based, product-focused contributions. We have a rich history in
infectious disease and medical biological defense R&D, with DOD
playing a significant role in developing eight of the 15 adult
vaccines licensed in the United States since 1962. Since 2000
our efforts have led to eight more FDA approvals for
diagnostics and licensed medical countermeasures for anthrax,
smallpox, and nerve agents.
However, we recognize that we must develop new ways to
confront the growing and evolving risk of chemical, biological,
radiological, and nuclear threats as well as emerging
infectious disease. The average 12 to 15 years to develop a
medical countermeasure against a single threat is too long and
too costly.
This National security challenge demands new approaches.
The Department's needs for specific medical countermeasures are
variable in number, ranging from tens of thousands of doses to
a few million doses, owing to unique operational requirements
and our global presence.
The potential spectrum of threats and the many diseases we
confront globally are diverse. Yet, today we have numerous
unmet requirements for medical countermeasures. It is crucial
that we close these gaps.
DOD is responding to this challenge by building an
integrated capability to respond to the threat through enhanced
diagnostics, detection, and global biosurveillance and through
innovative industrial capacity for advanced development and
adaptive manufacturing capabilities that will capitalize on
multi-use platform technologies. DOD pioneered this approach
beginning in 2006 when we initiated the Transformational
Medical Technologies Initiative, or TMT, to change the approach
to medical countermeasures development and the science base and
to invigorate the S&T pipeline.
TMT has made exceptional progress in our ability to
identify, characterize, and discover new drug candidates
rapidly. But we need to apply similar innovative approaches to
establish new development, regulatory sciences, and
manufacturing capabilities.
We are preparing to implement the Medical Countermeasures
Initiative through our cooperative partnership with industry to
establish industrial capacity and expertise for the rapid
development agile manufacturing of medical countermeasures. To
this end, we are collaborating closely with the Department of
Health and Human Services to create and integrate National
capability to produce medical countermeasures in a more cost-
effective manner and rapidly in the face of any attack or
threat.
The DOD is looking to address the operational needs of the
military while HHS must address the large-scale production
needed to meet the needs of the U.S. population. Both efforts
are integrated and complementary.
During fiscal year 2012 the DOD plans to award a long-term
contract to establish an advanced development and agile
manufacturing capability. The Department of Defense must have
the ability to fight and win in an environment that might be
compromised by threats of a bioattack or endemic diseases. This
includes the timely provision of safe and effective vaccines
and treatments for our military and our coalition partners.
These threats on our troops and citizens are very real and
ever-changing in the 21st Century. I appreciate the strong
leadership from the White House and the Congress on this
critical issue and the opportunity to testify today. I will be
pleased to answer your questions.
Thank you.
[The statement of Dr. Parker follows:]
Prepared Statement of Gerald W. Parker, Jr.
April 13, 2011
introduction
Chairman Bilirakis, Ranking Member Richardson, and Members of the
subcommittee, thank you for giving me this opportunity to discuss
Department of Defense efforts to develop medical countermeasures to
protect the Warfighter and the Nation.
DoD has to confront the growing and evolving risk of chemical,
biological, radiological, and nuclear threats, and emerging infectious
disease. Our National security is challenged to both accurately
identify and rapidly respond to an attack or naturally occurring
outbreak with countermeasures that limit impacts and loss of life. DoD
is responding to this challenge by building an end-to-end, integrated
capability to respond to the threat through enhanced diagnostics,
detection, and biosurveillance; and through innovative industrial
capacity for advanced development and adaptive manufacture of medical
countermeasures for rapid response.
The potential threats today are much more difficult to plan
against. We face a broad array of both natural and man-made challenges.
The world is smaller so global pandemics come to our shores faster, and
DoD personnel are deployed around the world coming into contact with
endemic diseases unlikely to be seen in North America. The emergence
and rapid advance of synthetic biology will make it easier over time
for an adversary, whether state or non-state, to develop modified
pathogens. These challenges will only increase with the exponential
growth in the field of biotechnology, global industrialization, and the
wealth of scientific information becomes even more available through
mass communications.
Our over-arching goal, of course, is to prevent an attack or
infectious disease outbreak in the first place. The Department has
expanded prevention efforts underway that include international
scientific engagements to promote a culture of laboratory
responsibility, enhance scientific collaboration, and to secure
dangerous pathogens. Should a crisis occur, however, we will have to
act swiftly and decisively with the capability to rapidly indentify and
characterize the threat, activate response plans, and rapidly
distribute and disseminate medical countermeasures in sufficient
quantities.
Before addressing medical countermeasure development challenges and
solutions, I want to take the opportunity to emphasize the strong and
productive collaboration we share with the Department of Health and
Human Services and the Department of Homeland Security on many levels,
and particularly through the Public Health Emergency Medical
Countermeasures Enterprise. Through this Medical Countermeasures
Enterprise, we have developed the Integrated Portfolio for CBRN Medical
Countermeasures to develop medical countermeasures required for
National and Homeland Security. Our relationship with HHS and DHS
through the Enterprise is synergy at its best--we team our expertise,
avoid duplicating efforts, and participate in joint acquisition and
stockpiling when possible.
As a former laboratory director, I want to mention that the
Department of Defense has an incomparable set of laboratory assets and
scientific expertise based throughout the United States and around the
globe engaging in basic and applied research, advanced technology
development to prove concepts for medical products and information, and
response to threats against health and performance. These include
medical research and technology aimed at endemic disease threats,
chemical and biological warfare threats, environmental hazards, battle
sequelae, systems hazards, operational stressors, and combat injuries.
Our overseas laboratories are National assets that advance U.S.
diplomacy through the study of infectious diseases of critical regional
public health importance. By contributing to the health infrastructure
of another country, we contribute to that country's security and by
extension to U.S. security as well. The laboratory missions also
include the evaluation of vaccines, therapeutic agents, diagnostic
assays, and vector control measures. New international collaborations
include the Republic of Georgia-U.S. Biosurveillance and Research
Center which engages scientists in diagnostic and epidemiological
studies, and medical countermeasures research. DoD endeavors with
coalition partners are exemplified by the work in the Republic of South
Korea where diagnostic, detection, biosurveillance, and laboratory
capabilities to protect U.S. forces are tested and deployed. This work
is done in collaboration with the Republic of Korea Defense, Health,
and other Ministries to improve our collective preparedness and
response posture to emerging infectious disease threats of any origin
in this critical geographic region.
challenges to progress on medical countermeasures
The December 2010 National Strategy for Countering Biological
Threats highlighted the significant threat posed by especially
dangerous pathogens to our people, forces, and coalition partners. The
Department of Defense must have the ability to fight and win in an
environment that might be compromised by diseases or threat of a
bioattack. This includes the timely provision of safe and effective
vaccines and treatments for our Joint Service Members and our coalition
partners.
The events of the 2009 H1N1 pandemic, along with the on-going
challenges and costs associated with development of chemical,
biological, radiological, and nuclear medical countermeasures, revealed
major gaps in advanced development and access to domestic surge
manufacturing capacity. These and other challenges underscored by the
Public Health Emergency Medical Countermeasures Enterprise Review in
August 2010, revealed the need for a whole-of-government approach.
Factors that have limited progress for developing biodefense
vaccines include the inability to leverage the expertise and
capabilities of larger, experienced biopharmaceutical companies due to
the high opportunity costs of entering the limited chemical,
biological, radiological, and nuclear medical countermeasure market.
The result is a reliance on small biotechnology firms that are engines
of innovation and critical for discovery and early development of
medical countermeasure candidates, but they have limited advanced
development and regulatory experience and limited manufacturing
capabilities. This is a costly, inefficient, and risky approach to meet
critical biodefense and public health needs.
The cost and time required to develop and obtain Food and Drug
Administration approval to market a new biologic and/or drug is costly,
takes years, and is a risky endeavor even for large, experienced
pharmaceutical companies or for medical countermeasure candidates that
have well-established regulatory and development pathways and a
commercial market.
The Department's needs for medical countermeasures are variable in
number, ranging from tens of thousands to a few million doses, owing to
unique operational vaccine and treatment requirements due to our global
presence. The potential spectrum of CBRN threats and emerging
infectious diseases is diverse, and we have too many gaps and unmet
requirements for medical countermeasure vaccines and treatments.
It is crucial that we close the vaccine, antimicrobial, and
antiviral drug gaps. We cannot afford to take the average 12 to 15
years to develop a medical countermeasure against a single threat, nor
can we afford to use the traditional and costly ``one bug-one drug''
development paradigm. This National security challenge requires new
approaches for medical countermeasure advanced development and
manufacturing to counter anticipated and unanticipated threats from an
attack or naturally occurring infectious disease threats. The DoD
approach to overcome some of these challenges is to bring innovation to
manufacturing processes in an analogous way that the Transformational
Medical Technology program brought innovation to discovery and early
development. The approach will capitalize on platform technologies that
can be multi-use and give us an ability to quickly characterize the
pathogen and promptly develop a countermeasure.
integrated biodefense approach
The Department will address these gaps holistically and as an
integrated set of capabilities including establishment of critical
industrial capacity to respond swiftly and effectively to these
evolving threats. These capabilities focus on the need to quickly and
precisely detect, diagnose, and identify the threat, develop, or refine
a medical countermeasure, and manufacture quickly those countermeasures
in useful quantities.
Detection and Initial Response
The first step in this integrated set of functions is detection,
and includes the entire system and processes that can quickly determine
the nature of the infectious disease or emerging threat. Our ability to
obtain early warning about the emergence and progression of new and/or
particularly dangerous threats feeds directly into our ability to
prepare effective vaccines and therapeutics.
Detection capabilities are a priority for DoD and include pursuit
of research, development, and acquisition of medical diagnostics,
environmental detection, and data fusion, management, and decision
tools.
One diagnostic capability currently fielded with our forces in over
300 locations worldwide is the Joint Biological Agent Identification
and Diagnostic System. It is capable of rapidly identifying multiple
biological agents, such as anthrax, plague, and avian influenza. In
response to the 2009 H1N1 pandemic, genomic signatures and assays
obtained from the CDC were quickly ported to the JBAID system under FDA
Emergency Use Authorization enabling use of this deployed platform for
both military and public health needs. The utility of this genomic
based diagnostic system has been very successful, enough to warrant
investments and a new development thrust in next-generation
diagnostics.
We are also working closely with the Department of Homeland
Security and the Department of Health and Human Services on
biosurveillance, diagnostics, environmental detection, laboratory
capabilities, integrating operations, and data systems, and
participating in joint exercises in support of a National biomonitoring
architecture. In BioWatch cities, for example, military installations
are included in the local emergency management and public health
incident command centers enabling shared situational awareness through
local, State, and National operations centers. We are also integrated
through the National Biosurveillance Integration System, which serves
as the platform for information exchange between agencies and
facilitates the early recognition of biological events, including
natural disease outbreaks, accidental or intentional use of biological
agents, and emergent biohazards. DoD also collaborates with the DHS
National Biodefense Analysis and Countermeasures Center for biological
risk assessments and bioforensic analysis to support attribution.
DoD global biosurveillance activities are enhanced by establishing
strategic research partnerships and scientific cooperation efforts with
partner nations. Global biosurveillance initiatives and medical
diplomacy through overseas labs foster on-going communication,
collaboration, and information networks among the U.S. Government
agencies, non-governmental organizations, academia, and international
partners. The Armed Forces Health Surveillance Center Global Emerging
Infections Surveillance and Response System is a centralized
communication hub to help coordinate DoD resources and link with other
U.S. and international disease surveillance efforts. This center links
DoD laboratories, research facilities, and the military health system
to facilitate rapid recognition and response to protect the health of
the forces and National security. Within DoD, a new laboratory
information and communications system, the Electronic Integrated
Disease Surveillance System, can link together the different levels of
a National disease surveillance network within a country providing
near-real-time information flow that can be disseminated to the
appropriate organizations in a timely manner. DoD's overarching
interest is to improve the capability for international surveillance,
countering biological threats, and responding to emerging infectious
diseases of intentional or natural origins. This is done in close
collaboration with CDC global disease detection efforts.
DoD supports civil authorities in chemical, biological,
radiological, and nuclear consequence management operations to save
lives and reduce the effects of a weapon of mass destruction attack. We
recognize the importance of maintaining a force that is ready and able
to respond to these special threats and is prepared to rapidly support
civil authorities in response to an event. The Department has
established elements to provide forces as soon as possible to support
any consequence management scenario that may occur. This includes
command and control, decontamination of personnel and equipment,
hazardous material handling and disposal, air and land transportation,
aerial evacuation, emergency medical treatment, and sustainment. Other
units provide casualty/patient decontamination, emergency medical
support, and casualty search and extraction. We are continually looking
for ways to improve support to civil authorities, increasing life-
saving capabilities and reducing response times. By the end of 2012
there will be 10 Homeland Response Force units capable of responding
within hours in each of the FEMA regions to provide more life-saving
capabilities faster using the same approximately 18,000 personnel
assigned to this mission.
Medical Countermeasures Discovery and Development
The second step of our integrated biodefense enterprise includes
the entire scope of efforts to discover and develop a medical
countermeasure candidate to a chemical, biological, radiological, and
nuclear threat or new pathogen. These countermeasures must be rapidly
demonstrated to be safe and effective through streamlined, but still
rigorous, techniques. The Transformational Medical Technologies
program, established as a DoD Initiative in 2006, focuses on the
discovery and refinement of medical countermeasures in response to
emerging threats and has been so successful it is now becoming the base
approach for the entire medical discovery program.
The Transformational Medical Technologies program addresses novel
threats, biologically engineered pathogens, or emerging infectious
diseases by developing new detection and therapeutic capabilities. The
goal is to provide a rapid response capability to identify and
characterize an unknown, and then apply a broad spectrum medical
countermeasure. If none exist, a therapeutic platform will discover and
develop medical countermeasure candidates quickly.
For example, in 2009 we redirected a therapeutic platform focused
on developing therapeutics for hemorrhagic fever viruses to discover
and refine medical countermeasures against an outbreak of an unknown
pathogen. Our systems quickly identified the unknown sample as the H1N1
virus, and a new antiviral was synthesized within 14 days. This is a
revolutionary change from traditional discovery methods which can take
years. However, traditional advanced development and manufacturing is
not rapid, and will require further innovation. Even so, the H1N1
antiviral showed great promise in animal studies and is now entering
clinical trials. Still, we must bring innovation to advanced
development and manufacturing as well.
Advanced Development and Manufacturing
The essential third step is access to critical industrial capacity
and expertise for the agile development and manufacturing of medical
countermeasures in quantities to treat affected populations rapidly. We
are preparing to implement the Medical Countermeasures Initiative
through a cooperative partnership with industry. One of the innovation
drivers will be the ability to manufacture medical countermeasures in a
flexible fashion to include ``on-demand'' surge capacity for specific
products in the event of a National security emergency or change
manufacturing runs on different products as the need arises. The
Medical Countermeasures Initiative encompasses two components: Science
and technology, and advanced development and manufacturing. A related
component is the planned National test and evaluation facility for
animal studies necessary for FDA approval. The science and technology
component will concentrate on three areas: Novel platform/expression
systems, advancement of regulatory science, and advancements in
flexible manufacturing technologies. The advanced development component
will concentrate on integrating novel platform/expression systems into
a production process and establishing a Technical Center of Excellence
to provide advanced development core services and a flexible
manufacturing capability for DoD and National security needs.
Ultimately, the Medical Countermeasures Initiative will coalesce to
provide a ``one-stop'' shop for all future DoD medical countermeasure
development.
Although platform and new manufacturing technologies coupled with
new facility design make this approach technically feasible, it is not
without risks and challenges. The technologies are new and the
underpinning regulatory science will have to be developed in parallel
as the products develop.
DoD intends to engage the most capable performer(s) to integrate
innovative manufacturing technologies and to perform advanced
development using scalable commercial manufacturing processes for
meeting the Department's medical countermeasure requirements.
Developing the right industry partnerships, small biotechnology
endeavors generating new innovations needed for the revolutionary
breakthroughs and larger companies with advanced development and
licensure experience, will require the right incentives. We anticipate
the need to motivate entry into the MCM niche, possibly cost-sharing,
intellectual property rights, indemnification, or other attributes
deemed necessary to generate interest.
interagency collaboration
The FDA has already started promoting regulatory innovation and
investment in regulatory science in order to provide private sector
partners with more access to regulators and greater clarity about the
pathways to product approval. We are collaborating with the FDA and our
other interagency, private sector, and academic partners to explore
solutions to complex scientific regulatory problems and to identify
situations in which the application of new science could simplify or
speed product development and streamline the FDA regulatory approval
process for medical countermeasures. Regulatory science is a critical
enabling factor, particularly for unique challenges of developing
biological defense medical countermeasures where pivotal efficacy
studies must be done in animal model systems. Together, we will develop
strategies and assemble new tools for mutual success. Whether it is a
member of our Armed Forces in the field or a fellow citizen in our
neighborhood, safe and effective FDA approved medical countermeasures
are needed when an event occurs.
Collaboration with the Department of Health and Human Services is
essential to the successful implementation of the DoD Medical
Countermeasures Initiative. Not only does this include the FDA, but the
DoD advanced development and manufacturing capability must complement
the parallel, but distinct, Biomedical Advanced Research and
Development Authority work to establish Centers of Excellence for
Advanced Development and Manufacturing. Leveraging the regulatory
sciences component of the DoD's Medical Countermeasures Initiative will
aid in surmounting these challenges by supporting the FDA in developing
new methods for regulatory assessments so those assessments will not
hamper moving advanced development programs forward. By working closely
with HHS, we expect to provide one part of a National advanced
development and manufacturing capability to support National security
and meet unique DoD operational requirements.
Our Nation must have the nimble, flexible capability to produce
medical countermeasures in a more cost-effective manner and rapidly in
the face of any attack or threat, whether known or unknown, novel or
reemerging, natural or intentional. President Obama called for this in
last year's State of the Union Address. Our effort, along with the
complementary manufacturing efforts within the Department of Health and
Human Services, will provide surge production when necessary and will
address the science and technology efforts to develop the next
generation medical countermeasure platform technologies, critical
industrial manufacturing systems and regulatory science technologies.
DoD has to commit to flexible manufacturing technologies because of the
breadth of medical countermeasures we need to protect our troops and
support global operations, and because of the varying numbers of doses
required for each of these. We do not need to give every service member
every vaccine, but we do need to be prepared to provide the levels of
protection required.
There is no way to draw a line between National security and public
health so we coordinate closely with our public health colleagues. We
have a great partnership with other U.S. agencies and are careful to
maintain our focus on National security to avoid overlap with
established U.S. public health efforts.
The Department of Defense has a long and proud history in
infectious disease medical research and development. The DoD played a
significant role in developing eight of the 15 adult vaccines licensed
in the United States since 1962. Currently used worldwide, these
include vaccines for influenza, meningococcal disease, hepatitis,
rubella, adenovirus, typhoid, and Japanese encephalitis. In the high-
risk business of vaccine production, experience breeds proficiency and
efficiency, curbing the scientific, regulatory, and financial risk that
can stifle product development. Since 2000, biodefense efforts have
resulted in eight FDA approvals for diagnostics and medical
countermeasures (including licensed medical countermeasures for
anthrax, smallpox, and nerve agents) generated in our pipeline. Still
in the advanced development pipeline are 14 candidates for next-
generation countermeasures against anthrax, smallpox, botulism,
alphaviruses, plague, influenza, and other emerging infectious
diseases; chemical agents; and radiological threats. We anticipate more
FDA approvals in the next 5 years.
DoD brings a unique capability to the National biodefense
portfolio: Detection and diagnostics sound the alarm, the
Transformational Medical Technologies program or similar rapid response
efforts generate new medical countermeasure candidates, and the Medical
Countermeasures Initiative will establish the critical industrial
capacity and expertise for advanced development and manufacture of
medical countermeasure.
conclusion
We are putting more emphasis on biodefense, particularly medical
biodefense, leveraging the rapid growth in new technologies for our
purposes. These threats on our troops or citizens are very real and
ever-changing in the 21st Century. The Department of Defense must
develop a nimble and agile program to respond. My organization is
working to strengthen our capabilities to effectively prevent, deter,
and defeat these threats. We are working with interagency partners, to
include the Departments of Homeland Security and Health and Human
Services, to better detect threats and protect the Nation from harm
before an event occurs: We are changing the way we address research and
development so we can be better stewards of the pipeline that we share
with HHS, and we are becoming more responsive and proactive. I
appreciate the opportunity to testify today and would be pleased to
answer your questions.
Mr. Bilirakis. Thank you very much. Appreciate it, Dr.
Parker.
Again, the subcommittee will stand in recess until the
conclusion of the votes. We will reconvene immediately
following the last vote as soon as I get a quorum.
So thank you very much and thanks for your understanding.
We will see you in a few minutes. We have four votes.
[Recess.]
Mr. Bilirakis. Okay. We will go ahead and continue.
Appreciate you waiting for us. Appreciate your patience.
The Ranking Member is ready, so I will ask--I will
recognize myself for 5 minutes to ask questions.
The first question will be for Dr. Pillai and Dr. Hatchett.
In what ways does DHS work with HHS on the threat assessments
so as to ensure that, as a customer, HHS is getting what it
needs out of the assessments?
Dr. Pillai. We from DHS are responsible for conducting the
threat assessments and risk assessments. Based on the products
that we develop is the support of customers at HHS as well as
interagencies. With that said, we have actually held multiple
working group meetings as well as multiple durations of the
product in the draft stage.
In the working group meetings we have participation from
HHS, ask for members from BARDA, members from CDC, FDA, NIH,
and AID, a factor, as well as members from DOD, the intel
community, as well as EPA and others. So collectively we try to
leverage all of the information and knowledge from all of the
subject matter experts to develop the material threat
assessments and the risk assessment products to support HHS in
the process.
Basically, it is very collectively, collaborative
architecture to support this effort. With that said, that we
have been very proactive in soliciting comments and
recommendations and suggestions from HHS to better improve the
product over the period of time.
We continue to receive comments from them, and we continue
to address them as appropriate, and we continue to refine these
models and these tools to support HHS to the best of our
ability.
Mr. Bilirakis. Dr. Hatchett.
Dr. Hatchett. Yes, sir. Just to reiterate what Dr. Pillai
said, we felt we have contributed subject matter experts in the
early stages of the development of the various assessments. We,
through the PHEMCE--I should underscore the public health
emergency medical countermeasures enterprise incorporates DHS
subject matter experts in our on-going assessments once we
receive the material threat assessments in performing our
public health consequence modeling and in making subsequent
determinations about requirements as they relate to medical
countermeasures, per se.
The integrated terrorism risk assessment has been an
integrated process since that process was initiated several
years ago. There have been multiple iterations--of course, the
National Academy of Science's report, and it is a process of
continual improvement towards our goal of an integrated threat
assessment and we work closely with our colleagues at DHS.
Mr. Bilirakis. Thank you.
Next question for Dr. Pillai: Are you confident that your
single high-consequence scenario is the best approach for
setting medical countermeasure requirements? If not, what are
the plans for revisiting the material threat assessments to
increase their reliability and utility?
Dr. Pillai. There are many approaches that one can take to
support medical countermeasures requirements. One of these
approaches is basically taking a look at the high possible
consequence scenario and then utilizing that particular
scenario to drive the medical countermeasures requirement.
The benefit of doing that is basically you are capturing
all of the threat space and potentially, if you develop
countermeasure requirements, supposedly addressing the high-
consequence scenario, basically captured all of the potential
low-consequence scenarios that might take place. With that
said, originally when we started developing our material threat
assessments at DHS the intent of the material threat
assessments were basically to support material threat
determination in support of the Secretary at DHS. With that
said, there is on-going discussions and collaborations at the
current time between HHS and DHS to better refine the product
so that we can support HHS in their medical countermeasures
requirement generation process.
With that said, one of the ideas and suggestions we ask is
potentially redefining the MTAs, or refining the MTAs in such a
fashion that it will take a look at multiple scenarios so that
it has got much broader application in terms of supporting HHS
in their MCM requirements. The other alternate approach is
basically leveraging the integrated CBNR risk assessment with
some minor refinement along with some risk mitigation
strategies to support HHS in their needs in terms of medical
countermeasures requirement.
Mr. Bilirakis. One last question for Ms. Bascetta.
Your office is undertaking a look at DHS's threat and risk
assessments to try to understand how this work informs HHS
investments. I understand that your analysis is still underway,
but have you formed any initial impressions about how this
process between the two departments is working? Similarly, can
you speak to relationships within HHS, such as between BARDA
and CDC for the setting the requirements and priorities?
Ms. Bascetta. You are correct that our work is underway,
and we are actually not at the point where we have findings or
conclusions that I could share. But I am happy to say that, in
fact, I believe that since 2004 and especially since PHEMCE was
established in 2006 there has been a significant amount of
progress and we have a lot of documentation about constructive
meetings that have gone on between HHS and DHS.
Within HHS we haven't looked at how well the components are
working together, but I can say that in other work that we have
done we have noted that HHS is a large department and many of
their components are set up with different specific missions.
You know, in the spirit of maximizing their resources we would
encourage them to continue to look for ways to reduce
fragmentation and to ensure that there isn't overlap that, you
know, isn't--to ensure that there is, you know, better traction
from the resources that they have. But we don't have evidence,
at this point, that there is a problem that we would point to.
Mr. Bilirakis. Okay. Thank you very much.
I now recognize our Ranking Member, Ms. Richardson, for 5
minutes or so.
You are recognized.
Ms. Richardson. Thank you, Mr. Chairman. My questions are
for Mr. Hatchett.
Mr. Hatchett, with regard to the potassium iodide, the
scientific need for this particular countermeasure is obviously
well-established over many years. Congress, in fact, has done
its part by providing the financial mechanisms to stockpile KI
with the Project BioShield Act of 2004, which funds
countermeasures against biological and chemical, radiological,
and nuclear agents, roughly some $5.6 billion through fiscal
year 2013.
Could you please explain to this subcommittee why KI has
not been stockpiled as directed by Congress? What specific
countermeasures have been done? Where has the money been spent
thus far?
Dr. Hatchett. Representative Richardson, with respect to
potassium iodide, it actually was procured for the Strategic
National Stockpile. ThyroShield, the liquid formulation of
potassium iodide, was procured and offered to States in
compliance with the 2002 Bioterrorism Act.
The current domestic requirements for potassium iodide have
been met through the existing program that is administered by
the Nuclear Regulatory Commission in conjunction with FEMA and
State and local authorities in States that have nuclear power
plants or are adjacent to nuclear power plants. So----
Ms. Richardson. So, have you--the various State agencies to
see if, in fact, they have sufficient stockpile that is
required?
Dr. Hatchett. Well, as I said, this is a long-standing
program between Nuclear Regulatory Commission and FEMA
specifically for the procurement, distribution, and dispensing
of potassium iodide, so I would defer the question to my
colleagues at NRC. I will say that when we had ThyroShield in
the Strategic National Stockpile and we offered it to States
there were some States that accepted the offer of the liquid
potassium iodide solutions.
Ms. Richardson. So, could you give this committee an update
of where the States are regarding this issue?
Dr. Hatchett. Yes, ma'am. I will need to get back to you
for the record, if that is acceptable.
Ms. Richardson. So----
Dr. Hatchett. HHS administers the Project BioShield funds.
We have used Project BioShield, actually, for the procurement
of the ThyroShield product as well as for the procurement of
another radiation countermeasure, calcium-DTPA, and its--zinc-
DTPA.
Ms. Richardson. So can you provide for this committee where
the $5.6 billion has gone?
Dr. Hatchett. Yes. A detailed explanation would be easier
to submit in writing, but I would be happy to do that.
Ms. Richardson. Okay. If you say that States are ready, I
don't know if you know much about--but I come by way of
California, and of the more recent situation with Japan where
there is quite an outcry for potassium iodide, and in fact, it
was not available. So how is it that you can say that it is
supposed to be available when in my State it wasn't and we
were, you know, one of the States along the pathway of the
potential radiation?
Dr. Hatchett. Couple of answers. The Nuclear Regulatory
Commission program focuses on the emergency protection zones
around nuclear power plants, and so its focus, in terms of
purchasing and distributing the potassium iodide focuses on the
EPZs around the nuclear power plants. Potassium iodide is an
over-the-counter medication. It is available.
I will say, with respect to the demand for potassium iodide
in California, public health officials had a great deal of
concern about that demand because there was not an indication
for people to take potassium iodide, and potassium iodide, if
taken inappropriately, can be associated with toxic events.
Ms. Richardson. Okay. So whether folks were supposed to
have taken it or not, it is my understanding that KI is
currently only required to be stockpiled within the 10-mile
radius. In light of what happened at Chernobyl or Fukushima and
the Pacifica tolls in Nevada and Utah they are testing, and
radioactive iodine has traveled 100 miles, which is far beyond
the 10-mile area.
Dr. Hatchett. Yes, ma'am. We are actively initiating a
process to review our requirement for potassium iodide in the
Strategic National Stockpile. This was initiated as a response
to the Fukushima Daiichi catastrophe.
We will certainly take the lessons learned from that in
reassessing our requirement.
Ms. Richardson. So, to your knowledge, are you saying that
you are not aware that the administration is still concurring
that 10 miles is sufficient? Is that not correct?
Dr. Hatchett. The current policy is that 10 miles is
sufficient. That would----
Ms. Richardson. You are currently reviewing that--is that
what you said?
Dr. Hatchett. What we will be reviewing at HHS is the role
of potassium iodide in a centralized Strategic National
Stockpile. I am certain that there will be an interagency
broader review that will look at the zero-to-10-mile issue, but
that would involve other interagency partners such as DHS,
FEMA, and the Nuclear Regulatory Commission.
Ms. Richardson. So, will you supply this committee that
information and then also supply us the information regarding
the stockpile, verifying whether, in fact, that is happening
within the States?
Dr. Hatchett. Yes, ma'am.
Ms. Richardson. Okay. Then I do have a second round of
questions----
Mr. Bilirakis. Yes. We are going to do a second round, yes.
I am interested in that issue too, as you are.
So please supply that information to us. I would really
appreciate it.
Dr. Hatchett, by the way of reorganization the assistant
secretary for preparedness and response directed that the
activities of BARDA's contracts office be separated from those
of BARDA's technical group, yet the contracts office has
contracting officers, not the scientific expertise needed to
determine whether or not companies have met their scientific
milestones. We have heard from many avenues that this model is
ineffective.
Can you explain to the committee why this action was taken?
How do you explain the substantial complaints about
contracting, that contracts take too long, that streamlining
authorities are not being taken advantage of, and that
contracting officers are making decisions that should be made
by policy or technical staff? This is no small question and it
appears to be the source of serious development and procurement
problems at BARDA. So that is my first question and I have a
second question.
Dr. Hatchett. Okay. I think you have actually asked
multiple questions and----let me take them in sequence.
The change in reporting for the head of the contracting
office--the head of the contracting office used to report to
Dr. Robinson, the director of BARDA. He now reports to Dr.
Lurie, the assistant secretary for preparedness and response.
Physically, the contracting office is physically still in its
same location, which is in an office that is shared with BARDA
staff, so there has been no disruption of the relationships
between BARDA program staff and BARDA contracting staff.
The idea that technical decisions are being made by
contracting officers actually is not correct. BARDA and the
contracting staff and their office of finance within ASPR has
created a decision gate process that is modeled on other
substantial acquisition programs at the Department of Defense,
Department of Energy, NASA, et cetera, and as well as--it
included a review of similar cost estimates in private sector
pharmaceutical companies.
That decision gate process provides for milestone-based
decisions about moving forward with specific projects, and
those milestone-based decisions are--they use an in-process
review, which brings in subject matter experts from across HHS
and the interagency to review the progress of specific projects
and to make appropriate decisions about whether they should
move forward or whether sufficient concerns have arisen that
adjustments need to be made.
Is that a sufficient answer to your question, sir?
Mr. Bilirakis. I think that is it, but I would like to
speak with you, again, follow up on this.
Then the next question is, why hasn't HHS ever exercised
its other transaction authority?
Dr. Hatchett. I think certainly we have not identified, to
date, a specific requirement for using the other transaction
authority. We actually do anticipate that we will be using it
in the relatively near term, particularly in support of our
broad spectrum antimicrobial program. The other transaction
authority will help facilitate public-private partnerships for
the development of multiuse countermeasures, particularly where
some of those uses for which the products are being developed
fall outside the CBRN sphere. So I would ask you to standby and
we hope to be----
Mr. Bilirakis. All right. Thank you.
Dr. Parker, I am pleased to hear from your testimony that
DOD works in tandem with DHS and HHS to leverage your efforts
and expertise. Unfortunately, for the civilian medical
countermeasures enterprise some will argue that much of
industry has already been lost, that the barriers to effective
partnership with the Federal Government for developing CBRN
medical countermeasures are too high.
But yet, DOD made the public-private development
partnership work for stealth bombers. Why can't we do the same
for medical countermeasures?
Dr. Parker. Well, actually in medical countermeasures DOD
shares some of the very similar challenges that HHS shares in
this arena, and we are both--we are working together to--
actually have worked together to much better understand what
those challenges are. The collective approaches we are taking
now are trying to address those barriers so we can create much
more effective partnerships and real-time communication between
the Government at all levels, our industry partners, and also
to encourage and promote the gleaning together with our
industry partners the right looks of what we need from
innovation, particularly from small biotechnology companies.
But also we need to leverage and take advantage of some of
the experience base of some of the larger pharmaceutical
companies that have more demonstrated experience navigating the
regulatory pathway, the scale-up manufacturing, and so forth,
and trying to calibrate, you know, the exact-like index of
Government partners, the experience of folks in industry, and
our innovators from biotechnology, including coming in from
academia.
The experiences, you know, in Chernobyl and just in the
last 5 to 6 years in this area, we have learned a lot, I think,
both in Government and both industry about the challenges.
Biodefense is a hard area. It really is--does demand a very
multidisciplinary approach and an interagency approach.
Collectively, I think, with our Government partners and our
industry partners I think today we have a much better
understanding and we are trying to work on those and reduce
those barriers so we can deliver those needed medical
countermeasures for our citizens and our troops.
Mr. Bilirakis. Thank you, Dr. Parker.
Now I will recognize Ms. Richardson for 5 minutes.
Ms. Richardson. Thank you, Mr. Chairman.
First of all, for Dr. Pillai--I apologize if I pronounced
that wrong--several weeks ago this committee had a hearing
featuring the head of DHS office of health affairs. Questions
remain regarding how OHA fits inside the DHS enterprise. This
committee wants to ensure that the roles are clearly defined in
order to prevent an overlap and a duplication of efforts.
What role will the science and technology S&T directorate
play in the biodefense in DHS and how does that role differ
from or overlap with the statutory responsibilities of the
chief medical officer who is statutorily required to coordinate
the biodefense at DHS?
Dr. Pillai. Thank you, ma'am for the question. From DHS
science and technology perspective we are focused, really, on
the R&D aspects. We conduct research and development-related
activities as well as threat assessments, risk assessments to
support the director as well as the Department as a whole.
The office of health affairs has the responsibility to
oversee the--such as Biowatch and--in addition to that, they
also serve as the chief medical advisor to the Secretary of DHS
in terms of medical countermeasures procurement-related
activities as well as our requirements-related activities.
Ms. Richardson. Okay.
Mr. Hatchett, could you describe for me what is the process
regarding anthrax vaccine, what is available?
Dr. Hatchett. Yes, ma'am. Thank you for the question.
We, as you are probably aware, do currently stockpile
anthrax vaccine, the AVA, Anthrax Vaccine Adsorbed, in the
Strategic National Stockpile. We are supporting, through
advanced development contracts, the development of recombinant
protective energy vaccines, which are considered to be next-
generation vaccines.
We are also supporting----
Ms. Richardson. When you say supporting what do you mean by
supporting? Because it is my understanding we have had some
problems in that area.
Dr. Hatchett. We are funding the advanced development of
the RPA vaccines. We have funded the procurement of the AVA
vaccine for the Strategic National Stockpile.
I would say that the technical challenges have certainly
been profound in terms of developing the next-generation
vaccine. We have been supporting these vaccines for many years
and we continue to support them.
Ms. Richardson. Okay. It is my understanding that--
opportunity to--companies, and it is my understanding that we
are using a 40-year-old vaccine, other products are potentially
available, that there has been much delay in terms of--well,
first of all, confusion in terms of whether a product should be
developed in the United Kingdom, whether it should be done here
in the United States, and once companies make a commitment and
they come here then it is on and on with multiple changes.
So have you had an opportunity or who within your
organization has been working on this project?
Dr. Hatchett. We have an anthrax vaccine group within the
CBRN division of BARDA that superintends our contracts in this
area. The AVA vaccine has been licensed for some time. I don't
know the length of time.
But we are actually working--our colleagues at the National
Institutes of Health are currently funding studies to improve
and optimize the existing vaccine. We are funding a number of
contracts, as I said, to develop the next-generation vaccines.
I can't, in this forum, speak to the commercial and proprietary
details of the individual contracts but would be happy to get
back to you for the record.
Ms. Richardson. So would you be willing to discuss some of
the problems that we are having? I might have pronounced it
improperly, but I can supply you with the details if you need
it.
Dr. Hatchett. Yes, ma'am. I think you mean----
Ms. Richardson. Yes. Thank you.
Dr. Hatchett. We are currently working with them. I mean,
they are receiving funding from us currently.
Ms. Richardson. But I don't know if you are aware of some
of the difficulties that have been brought to this committee's
attention.
Dr. Hatchett. I am aware of them, but this isn't the
appropriate forum to discuss them for proprietary reasons.
Ms. Richardson. Okay. But it is the appropriate forum if it
is not being done correctly and the American public is at risk
because--have been delayed. This is actually the forum. So I am
going to suffice to say, do we have a commitment from you that
you will meet with them and get an understanding of what the
problems are and then give an update to the committee?
Dr. Hatchett. Yes, ma'am.
Ms. Richardson. Okay. Thank you.
I would also like to acknowledge we have the CEO, Mr. Alan
Morris, who is with Anbex Corporation, and they work with
potassium iodide. Similarly, as I said, coming from California,
it is my understanding some of these companies who actually
work with the Government, who supply to the Government, don't
seem to have some of the same communication open levels to be
able to get us where we need to be.
Because if in the event something happens then it is not
probably--we need to make sure it is going to be our
responsibility, as a part of being on this committee, that we
didn't sit idly by knowing that you are not ready. I am not
convinced at this point that we are properly ready.
Dr. Hatchett. Yes, ma'am. Thank you for the comment.
With respect to potassium iodide and the manufacturers, we
have been in frequent contact both with Anbex, with their U.S.
distributor--I believe their U.S. distributor, Heyltex, and
with Fleming, which is the manufacturer of ThyroShield--to
understand the current demand for the products, to understand
their production capacity and how long it would take to
manufacture additional potassium iodide should there be a
requirement for immediate procurement. So we have battled very
aggressively to stay on top of those issues.
Ms. Richardson. Will you follow up with them as well?
Dr. Hatchett. We are in at least weekly touch with them
already, but yes, we will continue to do that.
Ms. Richardson. Give a report to the committee?
Dr. Hatchett. Yes, ma'am.
Ms. Richardson. Thank you.
Mr. Bilirakis. Thank you very much.
I believe that we will finish with this panel. I thank you
very much for your patience. Thanks for your testimony, and you
are dismissed.
We will call up the second panel.
Good afternoon. Thanks for your patience.
I welcome our second panel. Our first witness is Ms.
Phyllis Arthur. Ms. Arthur is senior director for vaccines,
immunotherapeutics--I am sorry, that is a mouthful--and
diagnostics policy at the Biotechnology Industry Organization.
In this role Ms. Arthur is responsible for working with member
companies on vaccines, molecular diagnostics, and biodefense
policy on policy, legislative, and regulatory issues.
Ms. Arthur joined BIO in July 2009. Prior to joining BIO
she held numerous positions with Merck. Ms. Arthur received her
Bachelor's in economic and international politics from Goucher
College and her MBA from the University of Pennsylvania Wharton
School of Business.
Our next witness is Mr. John Clerici. Mr. Clerici is a
founding principal of Tiber Creek Partners and a partner in the
Government contracts practice at McKenna Long & Aldridge, where
he assists companies developing biotechnology for emerging
disease and engineer threats.
Mr. Clerici was instrumental in the passage of the Public
Readiness and Emergency Preparedness Act as well as the
creation of BARDA. Mr. Clerici has also served as a judge
advocate in the United States Air Force. He received his
undergraduate degree from Catholic University and his Juris
Doctor from the University of North Carolina at Chapel Hill.
Welcome.
Finally, we will receive testimony from Dr. Daniel Fagbuyi.
Dr. Fagbuyi is the medical director of disaster preparedness
and emergency management at Children's National Medical Center
in Washington, DC. He is an assistant professor of pediatrics
and emergency medicine at George Washington University School
of Medicine with board certification in pediatrics and
pediatric emergency medicine.
Dr. Fagbuyi was recently appointed to the National
Biodefense Science Board by Secretary Sebelius. Dr. Fagbuyi
served in the United States Army where he served as a battalion
surgeon during Operation Iraqi Freedom. Dr. Fagbuyi received
his medical degree from George Washington University School of
Medicine.
Welcome to all the panelists, and we look forward to your
testimony.
Ms. Arthur, you are recognized to testify for 5 minutes.
Thank you, and welcome.
STATEMENT OF PHYLLIS ARTHUR, SENIOR DIRECTOR, VACCINES,
IMMUNOTHERAPEUTICS, AND DIAGNOSTICS POLICY, BIOTECHNOLOGY
INDUSTRY ORGANIZATION
Ms. Arthur. Thank you.
Good afternoon, Chairman Bilirakis, Ranking Member
Richardson, other Members, and ladies and gentlemen. As you may
know, BIO represents more than 1,100 companies, academic
institutions, State biotechnology centers and related
organizations in all 50 States.
BIO members include a broad mix of small, medium, and large
companies involved in medical countermeasures, or MCMs. These
companies develop and manufacture products for the detection,
diagnosis, treatment, prevention, and delivery of
countermeasures in the response to CBRN threats.
Ensuring the availability of MCMs that will save lives
during a public health crisis or man-made attack is the
responsibility of the U.S. Government. The lack of a viable
commercial market for countermeasures necessitates the active
engagement of the Government in their development.
Bipartisan Congressional efforts have created and funded an
enterprise that has begun to show success, leading to the
stockpiling of several new countermeasures in the areas of
smallpox and anthrax as well as the awarding of new procurement
contracts for other countermeasures. Future investments are
pivotal to continue that success and further strengthen and
improve our responsiveness.
BIO has identified three core areas that have limited
industry's participation in the countermeasures enterprise:
First, defining a viable market value for MCMs versus the
opportunity cost of investing in a different area; second,
management of cost and risk, especially in the regulatory
process; and third, sustainability of this market over time.
The Project BioShield Act of 2004 accomplished several
important goals, including the creation of a special reserve
fund, or SRF. BioShield was designed to guarantee companies
that the Government will purchase new successfully developed
countermeasures for placing in the Strategic National
Stockpile.
Annual appropriations to BARDA and the existence of the SRF
define the marketplace for MCMs. Companies can save these funds
when comparing the opportunity costs of developing--of pursuing
the development of specific countermeasures. Company time and
funds spend on developing these products devotes scarce
resources away from commercial products and must be subjected
to the same rate of return analysis.
In addition, private investors place little value on this
type of research as the market is difficult to calculate and a
guarantee of product success is not certain. Therefore, there
are limited private sector funds.
Part of the opportunity costs assessed by industry is the
time required to achieve success. While the industry finds
BARDA an effective partner in advanced development, the
acquisition and contracting functions to acquire new
countermeasures are viewed as lengthy, opaque, and
unpredictable.
The development of countermeasures is a unique, resource-
intensive, complex process that can impact the opportunity
costs. Countermeasures are approved via a convoluted regulatory
pathway requiring use of animal models to prove efficacy, which
adds an extra dimension of risk and uncertainty.
BIO strongly supports the recommendations to invest
significantly in FDA review and regulatory science processes.
FDA needs to be given an affirmative role in solving the
scientific and regulatory hurdles--of solving the regulatory
hurdles of MCMs. BIO recommends that the FDA be strongly
encouraged to work collaboratively with company sponsors to
design development plans and associated studies, especially
those requiring the use of animal models.
Due to the long development timelines for biological
products, industry partners need to be able to plan and
communicate with their investors. BIO recommends that Congress
formally establish a process by which HHS and all its relevant
agencies develop an integrated 5-year plan that can be shared
with all stakeholders, and specifically industry.
Lastly, it is critical the United States build capability
to detect and identify new threats, such as emerging diseases
or genetically modified pathogens. To increase speed and
accuracy in detecting emerging diseases and threats BIO
recommends that efforts be made to extend the surveillance
network and invest in new platforms and design tools that can
increase efficiency and reduce costs.
The reauthorization of PAHPA and the replenishment of the
BioShield SRF are critical to these efforts. Therefore, BIO
strongly urges Congress to replenish the SRF simultaneously
with the reauthorization of PAHPA. The SRF should be funded at
a level that incentivizes private industry to actively
participate in the MCM process.
BIO commends the committee for holding this important
hearing and stands ready to work with Congress on these
important issues. Congress has the opportunity to implement
changes to the PHEMCE that will improve preparedness,
accelerate approvals, and reduce the cost of developing
essential medical countermeasures, and we look forward to
working together with you on these efforts.
Thank you.
[The statement of Ms. Arthur follows:]
Prepared Statement of Phyllis Arthur
April 13, 2011
Good morning Chairman Bilirakis, Ranking Member Richardson, Members
of the committee, ladies and gentleman. I am Phyllis Arthur, Senior
Director for Vaccines, Immunotherapeutics, and Diagnostics Policy at
the Biotechnology Industry Organization (BIO). BIO represents more than
1,100 companies, academic institutions, State biotechnology centers and
related organizations in all 50 States.
In the area of biodefense, BIO represents a broad mix of small,
medium, and large companies involved in the research, development, and
manufacturing of medical countermeasures or MCM's. These companies
develop and manufacture biological products for the detection,
diagnosis, treatment, prevention, and delivery of countermeasures in
response to chemical, biological, radiological, and nuclear events.
Ensuring the availability of MCM's that will save lives during a
public health crisis (such as pandemic influenza) or weapons of mass
destruction attack (such as anthrax) is the responsibility of the U.S.
Government. BIO and its members were therefore encouraged when
Secretary Sebelius engaged the Department of Health and Human Services
(HHS) in an intense review of the Public Health and Emergency
Preparedness Enterprise (PHEMCE). BIO actively engaged in this process,
participating in stakeholder meetings related to most facets of the
Enterprise. Some of the recommendations from industry were incorporated
into the final review and still others can be included in the upcoming
reauthorization of the Pandemic and All-Hazards Preparedness Act
(PAHPA) or other biodefense-related vehicles moving through Congress.
The lack of a viable commercial market for most of these products
necessitates the active engagement of the Government in the development
of these essential products. Over the last 10 years, bipartisan
Congressional efforts have created and funded an Enterprise that has
begun to show success. In the past 2 years, several key countermeasures
in the area of smallpox and anthrax have been delivered to the
Strategic National Stockpile. Furthermore several key procurement
contracts have been issued that will lead to the final development of
other countermeasures. Future plans and investments are pivotal to
continue that success and further strengthen and improve the
responsiveness of the United States.
One of the goals of the U.S. Government in conducting the MCM
review was to identify and solve those issues limiting companies of all
sizes from successfully engaging in the countermeasures process. BIO
identified three core issues that have limited industry's participation
in PHEMCE. These issues fall into three categories: (1) Defining a
viable market value for MCMs versus the opportunity cost of investing
in a different area; (2) management of cost and risk, especially in the
regulatory process; and (3) sustainability of the market over time.
(1) defining a viable market value for mcms
The Project BioShield Act of 2004 accomplished several important
goals, but the most significant part was the creation of the Special
Reserve Fund (SRF). BioShield is designed to guarantee companies that
the Government will purchase new, successfully developed
countermeasures for placement in the Strategic National Stockpile
(SNS). Annual appropriations to the Biomedical Advanced Research and
Development Authority (BARDA), which was created in 2006 and manages
Project Bioshield and PHEMCE, and the existence of the SRF, define the
marketplace for MCM's. Companies consider the amount of resources
available through BARDA and the SRF when comparing the opportunity cost
of pursuing the development of a specific countermeasure. The time, and
company funds, spent on these products diverts R&D and manufacturing
resources away from commercial products and must be subjected to the
same rates of return analysis. In addition, private investors place
little to no value on this type of research as the market is difficult
to calculate and the guarantee of Government purchase is uncertain.
Therefore, there are very limited private sector funds to support
companies in the MCM space.
Part of the opportunity cost assessed by industry is the time
required to achieve success. While industry, particularly small
biotechnology companies, finds BARDA an increasingly desirable and
effective partner in advanced development, the acquisition and
contracting functions to acquire new countermeasures are viewed as
lengthy, opaque, and unpredictable. The trigger to transition a program
from advanced development to procurement is unclear. Target dates to
complete contract awards are typically not met, some acquisitions are
delayed by years or canceled. The negotiation process is needlessly
lengthy with technical and security issues resolved prior to pricing
discussions. The rationale and potential triggers for contract options
are unclear. Lastly, while Federal Acquisition Regulations (FAR
12.102(f)(1)) states that contracting officers ``may treat any
acquisition of supplies or services that, as determined by the head of
the agency, are to be used to facilitate defense against or recovery
from nuclear, biological, chemical, or radiological attack, as an
acquisition of commercial items,'' not a single novel countermeasure
has been designated as a commercial item. The signal to industry is
that despite the enormous risks of development of novel
countermeasures, pricing of new drugs and vaccines developed as
countermeasures, is far below that in commercial markets.
(2) management of cost and risk and the regulatory process for mcms
The development of countermeasures is a unique, resource-intensive,
and complex process that can be costly and fraught with risk. One of
the most significant risks is that countermeasures are approved via a
convoluted regulatory pathway. In many respects the regulatory process
for MCM's is no different from commercial biologicals. Products can
take 8-12 years to develop at a cost of $800 million to $1 billion and
failure is common at all stages of development. Yet in other ways MCM
development and approval is much more complicated. The required use of
animal models to prove efficacy adds an extra dimension of risk and
uncertainty to this process.
The coordination and collaboration between the various Government
agencies involved in the Enterprise can add to the overall uncertainty
surrounding MCM's. The prioritization of threats is not transparent so
it is not clear which pathogens, platforms, indications and target
populations are the most important. Indeed one Government agency may
view these threats in different ways from the others, thus leading to
conflicting or overlapping programs with differing priorities. While
BARDA and its Department of Defense counterparts have been working more
collaboratively to coordinate their requirements, the FDA has not been
as involved in the discussion of threats or in the early development of
these requirements. The lack of full integration across the Enterprise,
especially as it pertains to the approval process for countermeasures,
has, in several instances, led to significant delays and new regulatory
actions by companies in order to achieve licensure for a product.
One of the most significant recommendations from the PHEMCE review
was the recommendation to invest significantly in the FDA review and
regulatory science processes. This is a recommendation that is strongly
supported by BIO and its members. The FDA has tremendous expertise in
the science of drug development and the manufacturing of complex drugs,
diagnostics, and biologics. Effectively integrating FDA into the MCM
development efforts will ensure that the Government can have more rapid
access to fully licensed medicines, devices, and diagnostics for
National security threats in a cost-effective manner.
To meet this goal FDA needs to be given an affirmative role in
solving the scientific and regulatory hurdles, not just the review and
approval, of MCM's. This can best be accomplished by encouraging the
FDA to work collaboratively with company sponsors to design development
plans and associated studies, especially those requiring use of animal
models. The current structure and resources provide a disincentive for
FDA to spend time on these complex issues in partnership with industry.
Additionally, FDA funding targeted to improving MCM efforts should be
linked to measurable metrics.
BIO recommends that the FDA become more involved in the development
of MCM's through a combination of planning and coordination activities
and implementation of specific measurements for MCM initiatives.
(3) sustainability of the mcm market
The Project BioShield Act and PAHPA helped to build processes to
advance clinical and manufacturing infrastructure to protect against a
multitude of biological threats. While there have been successes in
several strategic portfolios within HHS, currently the United States is
decades away from having an adequate arsenal of countermeasures to
safeguard our citizens. In addition to developing and stockpiling
countermeasures against currently anticipated threats, it is critical
that the United States builds capability to respond to new threats such
as newly emerging diseases and genetically-modified pathogens.
The reauthorization of PAHPA and the replenishment of the BioShield
SRF are critical to these efforts. Therefore BIO strongly urges
Congress to replenish the Special Reserve Fund simultaneously with the
reauthorization of PAHPA. The SRF should be funded at a level that
incentivizes private industry to actively participate in the MCM
process.
The PHEMCE review highlighted the importance of a 5-year plan for
the Enterprise with goals tied to measurable outputs and outcomes. Due
to the long development timelines for biological products, industry
partners need to be able to plan and communicate with their investors
on the anticipated value and impact of its MCM projects with some
increased level of certainty. BIO recommends that Congress formally
establish a process by which HHS and its relevant agencies (NIH, CDC,
FDA, and ASPR) develop an integrated 5-year plan that can be shared
with all stakeholders. A systematic, transparent vision from the U.S.
Government will help companies assess the viability of both their
existing and future countermeasures' programs. This multi-year
strategic plan, coupled with modifications to the contracting
processes, could encourage increased industry participation.
Lastly, one of the most critical parts of responsiveness involves
the Nation's ability to detect and identify these threats to best mount
the proper and timely response. BIO members are also concerned that the
U.S. Government make the right investments in global and U.S.
surveillance testing and reporting networks. Efforts should be made to
extend the network and invest and explore common platforms and design
tools that can increase efficiency and reduce costs. Improving
interagency coordination within the U.S. National network, while
striving to modernize its technical and technological capabilities,
would increase speed and accuracy in detecting emerging diseases and
threats.
BIO commends the committee for holding this important hearing and
stands ready to work with Congress on these important issues. Ensuring
the availability of MCMs is a critical responsibility of the U.S.
Government. The lack of viable commercial markets for these products
necessitates the active engagement of Government in supporting the
development of these essential products. Over the last 10 years,
bipartisan Congressional efforts have created and funded a public
health emergency medical countermeasure enterprise (PHEMCE) that has
begun to show success. Future plans and investments are essential to
this effort.
Congress has the opportunity to implement changes to the PHEMCE
that will improve preparedness, accelerate approvals and reduce the
cost of developing essential medical countermeasures, including medical
devices, and we look forward to working together with you in these
efforts.
Mr. Bilirakis. Thank you, Ms. Arthur. Appreciate it.
Mr. Clerici, you are recognized for 5 minutes.
STATEMENT OF JOHN M. CLERICI, PRINCIPAL, TIBER CREEK PARTNERS,
LLC
Mr. Clerici. Thank you.
Good afternoon Mr. Chairman and Congresswoman Richardson.
For the last decade my colleagues and I have had the
opportunity to work with dozens of companies pursuing medical
countermeasures targeting CBRN and emerging infectious disease.
From this vantage point I have personally seen both the good
and the bad of the process and am delighted to share those
observations with you today.
As the subcommittee is aware, in the last decade Congress
has passed several pieces of legislation to address public
health preparedness, including the PAHPA legislation. In
addition, Congress has provided billions in appropriation.
The PAHPA legislation created BARDA, and it has achieved
its goals of providing BARDA with the toolbox it needs to do
its job. PAHPA should be reauthorized this year by Congress
without need for significant modification.
However, the toolbox provided to BARDA through PAHPA has
been locked away while the organization is subjected to
persistent internal and external reviews as well as constant
shifts in strategic direction. Following what was generally
viewed by the informed public health community as a very
successful response to the 2009 influenza pandemic, BARDA
underwent no less than three internal and external reviews
during the course of 2010 to analyze its effectiveness. These
reviews resulted in near standstill activity for almost a year
and culminated in yet another shift of priorities for the
organization.
The solution here is simple. There must be a clear
statement of priorities, including the allocation of resources
and funding, with a realistic and achievable schedule for
implementation that will actually be followed without delay.
This does not require legislative change or even a future
appropriation.
Turning to my second observation, there have been several
recent examples where a public health emergency has presented a
situation that allows public health officials to
retrospectively and proactively examine what could be done
better or learned from the event. I am concerned that several
of these situations have passed without proactive action. Let
me offer an example to make this point.
In March 2009 there was a widely reported incident in San
Diego where a young Marine developed progressive vaccinia, a
disease that closely resembles smallpox, after he received a
smallpox vaccination. There was a tremendous response by
military doctors, the CDC, and the FDA to respond to this
incident. However, curiously, neither ASPR nor its parent
organization ASPR--pardon me, neither BARDA nor its parent
organization, ASPR, was part of this response.
There were multiple products used to treat this patient,
including products currently in the Strategic National
Stockpile, as well as experimental products in late-stage
development for a smallpox incident. The lessons learned from
this case are extremely valuable for understanding what a mass
casualty event involving smallpox would look like and
determining effective therapeutics.
Based on my understanding, there has been no affirmative
outreach by either BARDA or ASPR to debrief the industry
responders to understand what they learned about this incident.
To the opposite, when BARDA was asked during the course of an
active procurement by a prospective offerer to affirmatively
consider the experience of human use of these products in
evaluating which products were most appropriate for stockpile
that request was declined.
My strong belief is this failure to be proactive is not a
result of inaction or lack of forethought by the BARDA
leadership. Rather, the likely cause is unnecessary
interference with the BARDA leadership and program managers by
the contracting officers based upon perceived restrictions of
Federal acquisition regulations.
I emphasize the word perceived given that there is
absolutely nothing that prevents these interactions from taking
place. Yet, it has been my experience that communications from
the BARDA leadership have been unnecessarily constrained by
contracting officers to the significant detriment of BARDA's
mission.
My final observation is the need to be a greater focus on
the sustainability of the overall public health enterprise.
Reauthorization of Project BioShield and replenishment of the
SRF is a key component in this sustainability. I strongly
encourage Congress to do both in conjunction with the
reauthorization of PAHPA.
To ensure sustainability the first order of business must
be to make sure that the products currently in the SNS are
maintained at their current level. For products such as the
licensed anthrax vaccine or smallpox vaccines that means
ensuring CDC has both the funding and the processes it needs to
ensure the levels of non-expired vaccine in the stockpile at a
very minimum are maintained.
The CDC must also stockpile adequate levels of
countermeasures to match the material threat assessments
conducted by the Department of Homeland Security. For products
that have yet to achieve FDA approval, including the anthrax
therapeutics and next-generation smallpox vaccines, that also
means that BARDA must expeditiously exercise the options in
those contracts to retain the supply of unexpired products at
the level currently in the stockpile. This will also ensure the
substantial investment BARDA has made in the manufacturing
capacity to support these products is not lost.
Next, the medical countermeasures review correctly placed
significant importance upon the need to procure broad spectrum,
dual-use products--that is, products that both have a CBRN and
commercial use. Once approved by the FDA for commercial
indication, the cost to the Government to sustain these
products for CBRN use is far lower than the need to re-procure
and stockpile products that are usable only for a public health
emergency.
Although the benefits of dual-use technologies are clear,
it appears that products that lack this dual-use potential are
still being favored for procurement under Project BioShield,
although BARDA has funded these programs in advanced
development. This lack of consistency with the clear mandate of
medical countermeasure review is puzzling.
Given the clear investment in creating and staffing the
organization, BARDA should also have a clear role in the
response to non-biodefense public threats, such as the rise of
multi-drug resistant pathogens, the super bugs that are killing
far more people at every--far more people every year than 9/11
and even HIV. Emerging tropical diseases like dengue and global
health diseases such as tuberculosis are impacting the United
States, with a growing number of cases of dengue and TB in
Florida, Hawaii, and elsewhere. BARDA should play a significant
role in addressing these emerging diseases.
This is one area where I believe Congress should
affirmatively act to modify PAHPA legislation to explicitly
give BARDA the mandate to address drug resistance as well as
emerging infectious disease. This may require additional
appropriations to support this expanded mission, but it is an
area that needs to be addressed and BARDA is likely suited
for--is ideally suited for this mission.
In closing, I would like to go back to the discussion about
Japan. If we look towards Japan, the lack of proactive
decisions to inventory what drugs are currently available to
respond to a nuclear emergency, of not ensuring that well-
conceived protocols are written in advance of these
emergencies, and the failing to hear the wake-up call the
events of the last month to prepare America for a nuclear
incident could be devastating, as Congressman Richardson
already pointed out.
The decision made here--made today, or better yet, the
decisions that are not being made today, will almost certainly
result in leaving our homeland vulnerable.
I thank you, Mr. Chairman and Congresswoman Richardson, for
doing everything you can to protect our homeland. Thank you.
[The statement of Mr. Clerici follows:]
Prepared Statement of John M. Clerici
April 13, 2011
Good afternoon Mr. Chairman, Congresswoman Richardson, and Members
of the subcommittee. My name is John Clerici and I am a principal of
Tiber Creek Partners, a firm dedicated to assisting biotechnology
companies throughout the world to ensure the development of the very
best products that will have a positive impact upon public health and
emerging infectious disease. For the last decade, my colleagues and I
have had the opportunity to work with dozens of companies pursuing
medical countermeasures targeting chemical, biological, radiological,
and nuclear (CBRN) threats, many of which now sit in the U.S. Strategic
National Stockpile and a number of which were deployed for use during
the 2009 influenza pandemic. We have been involved in nearly every
effort by the U.S. Government to support and purchase these products
over the last 12 years, including working with many of your colleagues
in Congress to support legislation to protect the American people from
a variety of public health threats. From this vantage point, I
personally have seen both the good and the bad of this process and I am
delighted to share those observations with you in the hope that we can
build upon the successes and learn from the challenges over the last
decade with the mutual goal of ensuring our Nation is as prepared as
possible.
I have three main observations that I would like to share with the
subcommittee this afternoon regarding the current efforts by what
collectively is known as the ``Public Health Emergency Medical
Countermeasures Enterprise'' in identifying and procuring medical
countermeasures to address bioterrorism, nuclear preparedness, and
emerging infectious disease.
First, the current laws passed during the last decade have proved
generally satisfactory to provide the relevant public health officials
with the legal authorities, funding and structure necessary to carry
out their mission. However, the implementation of these laws has been
unnecessarily burdened by constant internal and external reviews,
delayed action, bureaucracy, and a lack of transparency. This has had a
devastating effect upon the willingness of the private sector to
participate in these programs. Second, there have been several recent
instances, to include the on-going crisis in Japan, where there has
appeared to be a lack of proactive efforts to look toward an incident
as a reminder that we need to bolster the knowledge base and
understanding of what a mass casualty event in the United States would
look like, and additionally demonstrates our need to more fully
understand how medical countermeasures would be used, what resources
are needed that are not currently available, and how best to reach
those in need. I am concerned we are not being proactive to learn the
proper lessons from these events. Last, there is a similar lack of
proactive planning to address the sustainability of the medical
countermeasures that have already been developed and purchased to
maximize the value of the investments already made, as well to take
full advantage of the benefits of sustainable, dual-use, broad-spectrum
technologies.
With your permission, I would like discuss each of these
observations in greater detail and offer some thoughts on proposed
solutions that I believe are easily achievable in the short term.
As the subcommittee is aware, in the last decade, Congress has
passed several key pieces of legislation to address public health
preparedness, including the Bioterrorism Act of 2002, the Project
BioShield Act of 2004, the PREP Act of 2005, and the Pandemic and All
Hazards Preparedness Act of 2006 (known as PAHPA). In addition,
Congress has provided billions in appropriations to support these
programs. The PAHPA legislation, which created the Biomedical Advanced
Research and Development Authority (BARDA), was meant to fill in the
gaps in Project BioShield to help companies through the ``valley of
death'' between advanced development and FDA approval, as well as
streamline the procurement process. This bipartisan legislation, which
earned the unanimous support of the House and Senate, was carefully
crafted to provide the Executive branch all the authorities needed to
carry out this important public health mission. I do not think it can
be disputed that PAHPA achieved its goal of providing BARDA with the
toolbox it needs to do its job. Thus PAHPA should be reauthorized by
Congress this year without the need for significant modification.
However, what was not anticipated by Congress in passing PAHPA, and
what requires immediate attention, is the reality that the toolbox
Congress provided to BARDA has been locked away while the organization
is subjected to persistent internal and external reviews, as well as
constant shifts in strategic direction, that have left industry
confused and disheartened. Following what was generally viewed by the
informed public health community as a very successful response to the
2009 influenza pandemic, BARDA underwent no less than three internal
and external reviews during the course of 2010 to analyze its
effectiveness. These reviews resulted in a near stand-still of activity
for almost a year and culminated in yet another shift in priorities for
the organization. This included a transfer in critical human and
financial resources away from implementing the Draft Strategic Plan
announced in 2007, and toward implementation of the August 2010
``Public Health Emergency Medical Countermeasures Enterprise Review.''
Although the Medical Countermeasures Review provides broad suggestions,
it does not provide the necessary transparency to industry regarding
what products are required, in what quantities, and paid for with what
budgets, all of which had been outlined in the 2007 Draft Strategic
Plan. This information is absolutely critical in order for industry to
devote its scarce resources to the public health preparedness sector.
This is not to say that all of the recommendations of the MCM
review are flawed or that reviews are unwarranted. However, this
constant shift in priorities and funding, along with delays, has
presented considerable uncertainty that has directly impacted the
ability of companies to participate in medical countermeasure
initiatives. This lack of transparency is an enormous barrier to long-
term private sector interest in working the U.S. Government on medical
countermeasures.
Moreover, the continued delays in both issuing requests for
proposal and awarding contracts have placed tremendous pressure upon
industry to justify its continued participation in the U.S.-funded
public health efforts. As you can imagine, in these financial times,
when the management of a biotech, no matter the size, cannot tell its
investors when an opportunity is coming and how much the opportunity
will be potentially worth to the company, the resources dedicated in
pursuit of that effort will be cut, plain and simple. The solution to
this problem is not to make the function into a Government-run entity,
as some have suggested, but rather to adjust the Government's
performance to maximize private sector participation as envisioned by
Project BioShield.
To exemplify this point, consider that there are currently four
FDA-approved products that have the immediate potential to benefit
victims of a nuclear incident--regardless of whether it was caused by
nature, as in what has happened in Japan, or detonation of a improvised
nuclear device, an event the co-chairs of the 9/11 Commission described
as ``certain'' to occur in their lifetime. Three of these products are
made by the two of the largest of biotechnology companies in the world
and have not only been on the market for over 10 years, but have been
used in nuclear accidents in the past. The BARDA leadership is well
aware of these products and is eager to see procurement of these
products move forward. Yet after over 2 years of discussions, no
Requests for Proposal have been issued to allow the Government to
acquire these products, even though the funding is currently available
in the Special Reserve Fund under Project BioShield to do so.
I am aware that at least two of these companies are under extreme
pressure from their management to justify any continued efforts in
pursuing these projects due to these delays. One of those companies
feeling this pressure is a small, yet well-funded, biotech, whose
investors view efforts to try to assist BARDA as an unwarranted
distraction, even though this company has an FDA-approved product that
would have an immediate benefit to victims of a terrorist attack, as
well as a natural disaster. Small biotechs are exactly the innovative
engines the Government needs to address these public health problems.
If these companies ultimately have to walk away due to these
unwarranted delays, there is no question it will cost lives in the
future.
The solution here is simple. There must be a clear statement of
priorities, including allocation of resources and funding, with a
realistic and achievable schedule for implementation that will actually
be followed without delay. This does not require legislative change or
even future appropriations. But it is absolutely critical in order for
industry's participation in public health preparedness efforts to
continue.
Turning to my second observation, there are several recent examples
where a public health emergency has presented a situation that allows
public officials to not only assess the ability of the United States to
respond in a ``live fire'' exercise, but also to retrospectively, and
proactively, examine what could be done better or could be learned from
the event. I'm concerned that several of these situations have passed
without proactive action to learn from the event. Let me offer three,
specific examples to make this point.
The subcommittee is well aware of the growing challenges facing
Japan as well as the flurry of discussions these incidents have sparked
regarding the state of U.S. preparedness for all three aspects--the
earthquake, the tsunami, and the nuclear emergency--of the disaster.
There are medical countermeasures currently available as well as
products under development in the United States, many of which are
funded by BARDA and DOD, which could play an important role in one or
more the elements of the response in Japan.
It is completely understandable that the United States cannot and
should not act without being requested to do so by the Japanese
government. It is equally understandable that BARDA cannot and should
not be placed in the position of supporting the use of a non-FDA
approved product outside of the authority provided by Project
BioShield. However, it seems that it would be appropriate for BARDA to
proactively reach out to its industry partners to: (1) Determine what
products, if any, are currently available should they be requested by
Japan and in what quantities and location; and (2) should these
products be requested for use in Japan, what type of protocols,
including Phase 4 and Emergency Use protocols, need to be in place to
ensure the products are used as safely and effectively as possible.
Having this information in hand today is key to being able to respond
immediately if a request for assistance is received from Japan (or any
other country facing a nuclear incident), rather than having to delay
the response while this information is collected in a reactionary
fashion. None of these actions require a request by Japan from
assistance, nor do they require legislative action or additional
funding. Yet, based upon discussions with several of the relevant
companies, this proactive outreach has not occurred.
In a similar vein, the subcommittee may be aware that there have
been several recent incidents of anthrax infection in heroin users in
Scotland. The U.K. public health officials have faced unique challenges
with these patients and have gained considerable insights into how
different therapeutics have contributed to and failed to contribute to
the survival of these patients. I personally met with the lead U.K.
officials handling this response in September of last year and, as you
would imagine, they had a wealth of unique and valuable information
regarding the course of the disease in these patients. I understand
this information has been shared by the United Kingdom with their U.S.
counterparts. But yet again, based upon, my discussions with industry
and the U.K officials, there has yet to be a proactive effort by U.S.
officials to share the information and data gleaned from these
incidents with the companies developing anthrax treatments, nor has it
been shared with researchers who are working to understand disease
pathogenesis.
Finally, in March 2009, there was a widely reported incident in San
Diego where a young Marine developed Progressive Vaccinia, a virus that
closely resembles smallpox, after having received a smallpox
vaccination. There was a tremendous response by military doctors, the
Centers for Disease Control and Prevention, and the FDA to respond to
this incident. There were multiple products used to treat this patient,
including products currently in the Strategic National Stockpile as
well as experimental products in late stage development for use in a
smallpox incident. The lessons learned from this case are extremely
valuable for understanding what a mass casualty event involving
smallpox would look like, and for determining effective deployment of
therapeutics. But yet again, based upon my understanding, there has
been no affirmative outreach by BARDA or DOD to debrief the industry
responders to understand what they learned from this incident. To the
opposite, when BARDA was asked during the course of an active
procurement by a prospective offeror to affirmatively consider the
experience of the human use of these products in evaluating which
products were most appropriate for stockpile, the request was declined.
These examples demonstrate a frustrating pattern where
opportunities to learn are being lost and relevant information is not
being even accumulated, much less considered. At the same time,
companies that are being asked to propose to various procurement
opportunities must develop a ``Target Product Profile,'' not only as
part of their proposal, but more importantly, to guide the interactions
with FDA. However, it is impossible to develop a TPP in the absence of
an accurate understanding for how the product will be used in a public
health emergency. This understanding can only be gained through a
meaningful dialogue between industry and Government--incidents such as
those I've outlined present a very unique situation for such a dialogue
that is being utterly missed.
My strong belief is this failure to be proactive is not a result of
inaction or lack of forethought by the leadership at BARDA. Rather, the
likely cause is an unnecessary and non-productive interference with the
ability of the BARDA leadership and program managers to communicate
with industry by the perceived restrictions of the Federal Acquisition
Regulations (FAR). I emphasize the word ``perceived'' given that based
on the clear language of the FAR and my over 16 years of experience in
Government contracts law (both inside and outside the Government) there
is absolutely nothing the prevents such interactions from taking place.
To the contrary, as was recently made clear in a memorandum issued by
Dan Gordon, President Obama's head of the Office of Federal Procurement
Policy, transparent interactions with industry are an essential part of
the procurement system and should not be inappropriately constrained by
agency contracting officers. Despite this clear guidance from the top
procurement officials in the administration, it has been my experience
that communications from the BARDA leadership and program managers has
been unnecessarily constrained by the contracting officials to the
significant detriment of BARDA's mission.
In the past, the procurement function and the contracting officers
themselves were part of BARDA, and thus, the BARDA Director had greater
influence to ensure both transparent communication as well as proper
allocation of priorities by the contracting officers supporting the
procurement process for medical countermeasures. Just over a year ago,
this function was moved outside of the direct supervision of the BARDA
Director, as was the requirement setting process. Since this has
occurred, there has been a marked decline in the speed and efficiency
of the contracting process. Reverting back to the prior organization,
where the BARDA Director has responsibility and accountability for the
contracting officers and requirements process supporting BARDA, would
be a welcome change that would not require any change in legislation or
additional costs to implement. Further, increased Congressional
oversight to encourage greater proactive response from the Public
Health Enterprise, as a whole, would most certainly be a benefit.
The final observation I'd like to discuss today is the need for
there to be greater focus on the sustainability of the overall Public
Health Enterprise to ensure the investments made by BARDA are
maximized. Reauthorization of Project BioShield and the replenishment
of the soon-to-be exhausted Special Reserve Fund is a key component of
sustainability. I strongly encourage Congress to do both in conjunction
with the reauthorization of PAHPA. That said, even without any
legislative action or additional funding, it is incumbent upon the
Public Health Enterprise to make the best use possible of the remaining
balance of BioShield funding and other resources to ensure
sustainability.
The first order of business must to be to ensure that the products
currently in the SNS are maintained at their current level. For
products such as the licensed anthrax and smallpox vaccines, that means
ensuring the CDC has both the funding and processes it needs to ensure
the levels of non-expired vaccine in the stockpile, at a very minimum,
are maintained. However, it should be a top priority that we stockpile
levels of countermeasures to match the Material Threat Assessments
conducted by the Department of Homeland Security in order to protect
the civilian population, our first responders, and our military men and
women should an event occur. For example, we currently fall far short
of having adequate stockpiles of licensed anthrax vaccine to meet the
stated 75 million dose requirement set by the Material Threat
Assessment. Addressing this should be a priority.
For products that have yet to achieve FDA approval, including
anthrax therapeutics and next-generation smallpox vaccines being
procured under Project BioShield, that also means BARDA must exercise
the options in those contracts to retain the supply of unexpired
products at the levels currently in the stockpile, as well as to ensure
that the substantial investment BARDA has made in the manufacturing
capacity to support those products is not lost. Given that BARDA has
recently undertaken an effort to create multiple ``Centers of
Innovation for Advanced Development and Manufacturing'' to supplement
the Nation's manufacturing capacity, an effort that is expected to take
decades and cost billions to achieve, it seems the first, near-term
step in maintaining a viable manufacturing capacity for medical
countermeasures must begin with ensuring the investments made in the
current capacity are not lost.
Next, the Medical Countermeasures Review correctly placed
significant importance upon the need to procure broad spectrum, dual-
use products--that is, products that have both a CBRN and commercial
use. These products will be, by definition, more likely to achieve FDA
approval given that the human data derived to support the commercial
indication will supplement the animal data needed for approval under
the Animal Efficacy Rule for the CBRN indication. Once approved by FDA
for a commercial indication, the cost to the Government to sustain
these products for CBRN use is also far lower than the need to re-
procure and stockpile products that are only usable in the event of a
public health emergency. Although the benefits of dual-use technologies
are clear, and are articulated in the 2010 Medical Countermeasures
Review, it appears that products that lack this dual-use potential are
still being favored for procurement under Project BioShield. This lack
of consistency with the clear mandate of Medical Countermeasures Review
is puzzling to say the least.
Given the investment in creating and staffing the organization,
BARDA should also have a clear role in the response to non-biodefense
threats to public health such as the rise of multi-drug resistant
pathogens--the ``super bugs'' that are killing far more people every
year than the losses we suffered on 9/11. Emerging tropical diseases
like dengue and global health diseases such as tuberculosis are also
impacting the United States, with a growing number of cases of dengue
and TB in Florida, Hawaii, and elsewhere. BARDA should play a
significant role addressing these diseases. The investment in the
infrastructure to create and support BARDA, as well as the obvious
benefits and synergies of expanding the mission to include emerging
infectious disease, make clear this is a worthy focus for BARDA. This
is the one area where I believe Congress should affirmatively act to
modify the PAHPA legislation to explicitly give BARDA the mandate to
address drug resistance--both bacterial and viral--as well as emerging
infectious disease as a whole. This may require additional
appropriations to support this expanded mission, but it is an area that
needs to be addressed and BARDA is ideally suited to take on this
mission.
In closing, I would like to return to both the 2009 influenza
pandemic as well as the events in Japan.
On the morning of September 11, 2001, a trusted advisor to the
Secretary of HHS had a meeting scheduled with the Secretary to raise
the issue of the emergence of the H5N1 virus in Asia and how the United
States should prepare for an influenza pandemic like the one that
devastated the world in 1918 as described in John Barry's book ``The
Great Influenza.'' That meeting never occurred that day for obvious
reasons, however, it was eventually rescheduled. HHS went on to make
critical investments to secure the egg supply for flu vaccines, to
bolster the U.S. vaccine base, stockpile millions of doses of flu
antivirals, as well as diagnostics, and to support the passage of
legislation to address liability issues that up-to-then had restrained
our ability to prepare. That trusted advisor became the first Assistant
Secretary for Preparedness, where, as the precursor to what is now
BARDA, he made critical decisions regarding influenza vaccines and
therapeutics, anthrax vaccine and therapeutics, smallpox vaccines, and
radiation countermeasures. These decisions were implemented by a
skeleton staff made up mostly of detailees from other parts of HHS and
retired public health leaders who offered their time in order to help
protect the Nation. The procurements were managed by a single
contracting officer at the CDC, for which this was an extra duty. About
half of those decisions, in retrospect, ultimately did not result in
outcomes that immediately protected the homeland. However, about half
of them did. The Assistant Secretary withstood enormous criticism for
the decisions that did not appear to be immediately beneficial, and got
little credit for the decisions that proved right, including those
critical decisions that helped prepare the Nation for the 2009
pandemic. Mr. Chairman, as the baseball teams that have Spring Training
in your district are aware, a .500 batting average is something to be
proud off. The bottom line is decisions were made then that clearly
protected the United States. Yet, today, decision-making is ground to a
halt by concerns about the perception that could result from a failure
and overly bureaucratic procedures while the security of our homeland
suffers.
If we look toward to Japan, the lack of proactive decisions to
inventory what drugs are currently available to respond to a nuclear
emergency, of not ensuring that well-conceived protocols are written in
advance to ensure their appropriate deployment if these products are
ever used, and of failing to hear the wakeup call the events of the
last month signal for the need to prepare in America could prove
devastating. The decisions made to today--or better put, the decisions
that are not being made today--will almost certainly result in leaving
our Homeland vulnerable. I thank you Mr. Chairman and this committee
for doing everything you can to ensure that our homeland remains
secure.
Mr. Bilirakis. Thank you, sir.
I now recognize Dr. Fagbuyi for 5 minutes.
Welcome, sir. Thank you.
STATEMENT OF DANIEL B. FAGBUYI, MEDICAL DIRECTOR, DISASTER
PREPAREDNESS AND EMERGENCY MANAGEMENT, CHILDREN'S NATIONAL
MEDICAL CENTER
Dr. Fagbuyi. Good afternoon, Chairman Bilirakis and Ranking
Member Richardson. Thank you for holding today's hearing on
such an important topic, medical countermeasures.
My name is Dan Fagbuyi. I am representing the Academy of
Pediatrics, a nonprofit professional organization of more than
60,000 primary care pediatricians, pediatric medical
subspecialists, and pediatric subspecialists dedicated to the
health, safety, and well-being of children of all races.
I serve as the Academy Disaster Preparedness Advisory
Council member, and you have heard the saying that children are
not little adults. Why does this matter when it comes to
medical countermeasures and disaster preparedness? Well,
children are particularly vulnerable to aerosolized biological
or chemical agents because they breathe more times per minute
than do adults, meaning that they would be exposed to a larger
dose of an aerosolized substance.
Children are also more vulnerable to agents that act on or
are absorbed through the skin because their skin is thinner and
they have much larger skin-to-body surface ratio than adults.
They have immature immune systems which put them at risk for
CBRN-type agents and are more vulnerable to radiological agents
due to their more rapid metabolic and cellular growth rates.
So consider this: When children are critically ill or
injured their bodies respond differently than adults to similar
insults. Consequently, pediatric treatment needs are unique in
a number of ways, and I will start with children actually need
different doses and different formulizations of medicines than
adults because certain drugs and biologic agents have certain
safety and efficacy profiles that are different in developing
children.
Children also need different-sized equipment and other
medical devices than adults. In fact, our day-to-day emergency
readiness requires the presence of many different sizes of key
resuscitation equipment in infants--for infants, for preschool
children, school-aged children, and adolescents. From needles
and tubing to oxygen and ventilator masks, all these are
different in children. Children also display unique
developmental and psychological responses to acute injury and
illness, and also, as well, to mass casualty events, and are at
greater risk for post-traumatic stress disorder and acute-
traumatic stress disorder.
While we have a lot of work ahead of us to adequately plan
and prepare for children in disastrous situations there are
several programs that have really moved the needle, one of
which is emergency medical services for children, EMSC, which
has played a crucial role in driving a significant amount of
improvement in pediatric emergency care, including disaster
preparedness.
Despite a modest appropriation of slightly more than $20
million for EMSC, EMSC has managed to affect changes by
providing pediatric emergency care initiatives in every State,
territory, and the District of Columbia, as well as National
improvement programs and protocols that will be critical in an
event of National emergency.
In the area of medical therapeutics there are two laws--the
BPCA, Best Pharmaceuticals for Children Act, and PREA--have
incentivized and required drugs to be studied in children.
These studies have identified safety issues, altered dosing,
have led to new indications and have shown some drugs even lack
efficacy in children. Nearly 400 drugs have been labeled for
children as a result.
When it comes to medical countermeasures, progress has been
made to improve the availability of pediatric countermeasures
but much more work needs to be done. Most recently, pediatric
labeling was added to pralidoxime for the treatment of nerve
agent poisoning. However, labeling took 7 years, during which
time no new data was presented.
It is hard to understand why that took so long. Pediatric
labeling was the first step. HHS and BARDA need to support the
manufacture and purchase of child-specific auto-injector so
that pralidoxime can be forward deployed and administered in
the field.
In the event of a radioactive release such as what we
experienced in--was experienced in Japan, children should be
administered potassium iodide, as our Ranking Member had
mentioned, as quickly as possible, and to be appropriate in
dosage and treatment to prevent the long-term consequences. The
big question, if a liquid formulation of potassium iodide
exists and is safe and effective but if the Federal Government
and State governments do not purchase this to be stockpiled in
the Strategic National Stockpile in the event of a radiation
exposure and in sufficient quantities to treat our Nation's
children, how secure are we really?
In other policy recommendations, the Academy of Pediatrics
has specific recommendations for policymakers, and there are
many that I listed in my written testimony but I will just
highlight one. The medical countermeasure enterprise led by the
Federal Government should set a goal to achieve parity between
adult and child medical countermeasures developed and included
in the Strategic National Stockpile and other Federally funded
caches.
This includes amending the PAHPA Act to require that the
HHS Secretary, acting through BARDA, prioritize children.
Children should be distinguished as a separate population from
the broader at-risk category currently at the Health and Human
Services.
These also preposition medical countermeasures as a crucial
piece and it needs to be in locations where children gather,
such as schools and in child care facilities. They must not be
an afterthought.
In conclusion, the Academy of Pediatrics thanks this
committee for the opportunity to testify on this important
issue of medical countermeasures. Children are our future.
Finally, I want to give you a recent poll which was
conducted at the Academy of Pediatrics and the Children's
Health Fund: 76 percent of Americans agree that if resources
are limited children should be given a higher priority for
lifesaving treatments; 75 percent believe that if tough
decisions must be made lifesaving treatments should be provided
to children rather than adults with the same medical condition;
and 92 percent agree that if there were a terrorist attack our
country should have the same medical treatments readily
available for children as are now available for adults.
When disaster strikes, we as a Nation must be prepared with
the medical countermeasures to keep our children healthy and
ensure that we have and they have an opportunity to achieve
optimal health outcomes. As a pediatrician and a father of
three, I look forward to your questions. Thank you.
[The statement of Dr. Fagbuyi follows:]
Prepared Statement of Daniel B. Fagbuyi
April 13, 2011
Chairman Bilirakis and Ranking Member Richardson, thank you for
holding today's hearing on such an important topic, medical
countermeasures. My name is Dan Fagbuyi, MD FAAP, and I am representing
the American Academy of Pediatrics, a non-profit professional
organization of more than 60,000 primary care pediatricians, pediatric
medical sub-specialists, and pediatric surgical specialists dedicated
to the health, safety, and well-being of infants, children,
adolescents, and young adults. For more than a decade, the Academy has
engaged in a broad range of activities related to disaster
preparedness, including policy statements on clinical care and tools
for pediatricians in crisis situations.
I am currently the Medical Director of Disaster Preparedness and
Emergency Management at Children's National Medical Center in
Washington, DC. I am an Assistant Professor of Pediatrics and Emergency
Medicine at The George Washington University School of Medicine with
board certification in both Pediatrics and Pediatric Emergency
Medicine. I have the distinct honor of recently being appointed by the
U.S. Secretary of Health and Human Services, Kathleen Sebelius, to
serve on the National Biodefense Science Board. As a Major in U.S.
Army, I was involved in combat and civil military operations, serving
as a battalion surgeon on the front lines and caring for more than 800
soldiers while deployed for Operation Iraqi Freedom with the U.S.
Army's 101st Airborne Division.
Recent events in Japan make today's hearing especially timely and
critical. The Academy strongly supports the Federal Government's
response to the Japanese government and its people. We have been in
touch with our pediatrician colleagues through the Japan Pediatric
Society to offer the Academy's assistance and, as of today, we have
raised $51,519 in gifts and pledges for Disaster Relief for Japan
through the AAP Friends of Children Disaster Relief Fund.
The recovery and relief efforts in Japan will take time and for
countless families, especially those who lost loved ones, life will
never be the same. Recovery for the most vulnerable citizens, children,
may present several unique challenges and it is important that we as
Americans look within our own borders to assess whether our planning
and exercises our Government and communities engage in, our medical
capabilities, the training of our first responders, and the
preparedness of our Nation's hospitals, Federal, State, and local
governments, and families, adequately account for the needs of children
should a disaster strike.
Unfortunately, today, the reality is that none of those systems are
fully prepared to address the needs of nearly 25 percent of the
population, children. We need to work to change this realty.
children are more vulnerable than adults
You've heard the saying that children are not little adults. Why is
that and, more importantly, why does that matter when it comes to
medical countermeasures and disaster preparedness?
Children are particularly vulnerable to aerosolized
biological or chemical agents because they normally breathe
more times per minute than do adults, meaning they would be
exposed to larger doses of an aerosolized substance in the same
period of time. Also, because such agents (e.g. sarin and
chlorine) are heavier than air, they accumulate close to the
ground--right in the breathing zone of children.
Children are also much more vulnerable to agents that act on
or are absorbed through the skin because their skin is thinner
and they have a much larger skin surface-to-body mass ratio
than adults.
Children are more vulnerable to the effects of agents that
produce vomiting or diarrhea because they have smaller body
fluid reserves than adults, increasing the risk of rapid
progression to dehydration or shock.\1\
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\1\ Committee on Environmental Health and Committee on Infectious
Disease. Chemical-Biological Terrorism and Its Impact on Children: A
Subject Review. Pediatrics, Vol. 105 No. 3 March 2000. (update
scheduled for publication in Pediatrics September 2006.)
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Children have much smaller circulating blood volumes than
adults, so without timely intervention, relatively small
amounts of blood loss can quickly tip the physiological scale
from reversible shock to profound, irreversible shock or death.
An infant or small child can literally bleed to death from a
large scalp laceration.
Children have significant developmental vulnerabilities not
shared by adults. Infants, toddlers, and young children may not
have the motor skills to escape from the site of a hazard or
disaster. Even if they are able to walk, young children may not
have the cognitive ability to know when to flee from danger, or
when to follow directions from strangers such as in an
evacuation, or to cooperate with decontamination.\2\ As we all
learned from Katrina, children are also notably vulnerable when
they are separated from their parents or guardians.
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\2\ American Academy of Pediatrics. Children, Terrorism & Disasters
Toolkit. The Youngest Victims: Disaster Preparedness to Meet Children's
Needs. http://www.aap.org/terrorism/topics/PhysiciansSheet.pdf
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Children have immature immune systems that make them more
susceptible to biological, chemical, radiological agents.
Children are also more vulnerable to radiological agents due
to their more rapid metabolic and cellular growth rates.
children have unique treatment needs
When children are critically ill or injured, their bodies respond
differently than adults exposed to similar insults. Consequently,
pediatric treatment needs are unique in a number of ways:
Children need different dosages and formulations of medicine
than adults--not only because they are smaller, but also
because certain drugs and biological agents may have adverse
effects in developing children that are not of concern for
adults.
Children need different-sized equipment and other medical
devices than adults. In fact, our day-to-day emergency
readiness requires the presence of many different sizes of key
resuscitation equipment for infants, pre-school and school-aged
children, and adolescents. From needles and tubing, to oxygen
masks and ventilators, to imaging equipment and laboratory
technology, children need equipment that has been specifically
designed for their size.
Children demand special consideration during decontamination
efforts. Because children lose body heat more quickly than
adults, mass decontamination systems that may be safe for
adults can cause hypothermia in young children unless special
heating precautions or other warming equipment is provided.\3\
Hypothermia can have a profoundly detrimental impact on a
child's survival from illness or injury.
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\3\ American Academy of Pediatrics. Children, Terrorism & Disasters
Toolkit. The Youngest Victims: Disaster Preparedness to Meet Children's
Needs. http://www.aap.org/terrorism/topics/PhysiciansSheet.pdf
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Children display unique developmental and psychological
responses to acute illness and injury, as well as to mass
casualty events. Compared to adults, children appear to be at
greater risk for acute- and post-traumatic stress disorders.
The identification and optimal management of these disorders in
children requires professionals with expertise in pediatric
mental health.\4\ When disaster strikes and these professionals
are not readily available, it may fall to the responsibility of
first responders who need to be adequately prepared, trained,
and equipped for children.
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\4\ Hagan, J and the Committee on Psychosocial Aspects of Child and
Family Health and the Task Force on Terrorism. Psychosocial
Implications of Disaster or Terrorism on Children: A Guide for the
Pediatrician. Pediatrics, Vol. 116, No. 3, September 2005.
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Children may be developmentally unable to communicate their
needs with health care providers. The medical treatment of
children is optimized with the presence of parents and/or
family members. Timely reunification of children with parents
and family-centered care should be a priority for all levels of
emergency care. In a 2008 survey of hospital preparedness by
the Centers for Disease Control and Prevention (CDC), only 42.6
percent of hospitals had a tracking system for accompanied and
unaccompanied children, about 34 percent of hospitals had plans
for reunification of children with families, and 31.1 percent
for protocols to identify and protect displaced children.\5\
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\5\ Niska R and Shimizu I. Hospital Preparedness for Emergency
Response: United States, 2008. National Health Statistics Reports, No.
37, March 24, 2011.
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children need care from providers trained to meet their unique needs
Because children respond differently than adults in a medical
crisis, it is critical that all health care workers be able to
recognize the unique signs and symptoms in children that may indicate a
life-threatening situation, and then possess the experience and skill
to intervene accordingly.\6\ As already noted, a child's condition can
rapidly deteriorate from stable to life-threatening as they have less
blood and fluid reserves, are more sensitive to changes in body
temperature, and have faster metabolisms. Once cardio-pulmonary arrest
has occurred, the prognosis is particularly dismal in children, with
less than 20% surviving the event, and with 75% of the survivors
sustaining permanent disability.
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\6\ Markenson D, Reynolds S, Committee on Pediatric Emergency and
Medicine and Task Force on Terrorism. The Pediatrician and Disaster
Preparedness. Pediatrics, Vol. 117 No. 2 February 2006.
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Therefore, the goal in pediatric emergency care is to recognize
pre-cardiopulmonary arrest conditions and intervene before they occur.
While children represent 25 to 30% of all emergency department visits
in the United States, and 5 to 10% of all EMS ambulance patients, the
number of these children who require this advanced level of emergency
and critical care, and use of the associated cognitive and technical
abilities, is quite small. This creates a special problem for pre-
hospital and hospital-based emergency care providers, as they have
limited exposure and opportunities to maintain their pediatric
assessment and resuscitation skills. Fifty percent of U.S. Emergency
Departments (EDs) provide care for fewer than 10 children per day.\7\
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\7\ Gausche-Hill M, Schmitz C, Lewis RJ. Pediatric preparedness of
United States emergency departments: a 2003 survey. Pediatrics.
2007;120(6):1229-1237.
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This committee is no doubt familiar with ED overcrowding as a day-
to-day reality. Imagine layering on top of the current situation, a
widespread mass care or mass casualty event involving children,
including children with special health care needs. The experience is
much like what my institution saw with H1N1.\8\ Large volumes of
patients and their families seeking medical care; having to educate
pharmacies on how to constitute Oseltamivir for the pediatric
population with cherry syrup; creating innovative strategies to address
the surge of patients on top of the baseline patients; engaging the
community and demystifying vaccine concerns; ensuring that media
message was consistent and accurate and medically sound, ensuring
infection control and so on. Fortunately for all of us, the overall
morbidity of H1N1 was less than expected, though children were
disproportionately impacted by the pandemic.
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\8\ Fagbuyi DB, et al. A Rapid Medical Screening Process Improves
Emergency Department Patient Flow During Surge Associated With Novel
H1N1 Influenza Virus. Annals of Emergency Medicine, Vol. 57, No. 1,
January 2011.
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The science of ED surge remains relatively undeveloped.\9\ What we
do know is that when it comes to pediatrics, less than one-third (32.4
percent) of hospitals have guidelines for increasing pediatric surge
capacity. In the face of a disaster, all hospitals will need to
increase their capacity.
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\9\ Nager AL, Khanna K. Emergency department surge: models and
practical implications. J Trauma. 2009;67(2 Suppl):S96-99.
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The vital clinical ability to recognize and respond to the needs of
an ill or injured child must be present at all levels of care--from the
pre-hospital setting, to emergency department care, to definitive
inpatient medical and surgical care. The outcome for the most severely
ill or injured children, and for the rapidly growing number of special
needs children with chronic medical conditions, is optimized in centers
that offer pediatric critical care and trauma services and pediatric
medical and surgical subspecialty care. As it is not feasible to
provide this level of expertise in all hospital settings, existing
emergency and trauma care systems and State and Federal disaster plans
need to address regionalization of pediatric emergency and critical
care within and across State lines, leveraging inter-facility transport
as a means to maximize the outcome of the most severely ill and injured
children.
Children with special health care needs\10\ are the fastest growing
subset of children, representing 15 to 20% of the pediatric
population.\11\ These children pose unique emergency and disaster care
challenges well beyond those of otherwise healthy children. Our
emergency medical services systems, and our disaster response plans,
must consider and meet the needs of this group of children.
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\10\ MacPherson M et.al. A New Definition of Children with Special
Health Care Needs. Pediatrics, Vol. 102, No. 1, July 1998.
\11\ Van Dyck P et.al. Prevalence and Characteristics of Children
With Special Health Care Needs. Arch Pediatr Adolesc Med, Vol. 158, No.
9, September 2004.
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emergency medical services for children
The Emergency Medical Services for Children (EMSC) program has
played a crucial role in driving significant improvements in pediatric
emergency care, including disaster preparedness. Despite a modest
appropriation of slightly more than $20 million, EMSC has managed to
effect these changes despite the lack of pediatric emphasis in other
related Government programs. EMSC has funded pediatric emergency care
improvement initiatives in every State, territory, and the District of
Columbia, as well as National improvement programs. These include the
development of equipment lists for ambulances, guidelines for hospital
emergency preparedness, pediatric treatment protocols, and handbooks
for school nurses and other providers that would be critical in the
event of an emergency. EMSC supports training for emergency medical
technicians and paramedics who often have little background in caring
for children, and has underwritten the development of vital educational
materials and treatment guidelines. In the 21 years since the program
was established, child injury death rates have dropped by 40 percent.
national commission on children and disasters
Recognizing how far children lagged behind in disaster
preparedness, response, and recovery, Congress saw fit to create the
National Commission on Children and Disasters in 2008. The Commission
produced two reports, the most recent in October 2010, in which it
makes comprehensive recommendations aimed at the Federal Government and
policymakers, some of whom are testifying at today's hearing. The
Commission also called on the President to develop and present to
Congress a National Strategy on Children and Disasters. Such a National
strategy from the President would serve as a clarion call to
Government, the private sector, communities, and families to engage one
another in setting and achieving goals and priorities for children.
Of note to this committee given the subject of today's hearing, the
Commission recommended that Congress, HHS, and DHS/FEMA should ensure
availability of and access to pediatric medical countermeasures at the
Federal, State, and local levels for chemical, biological,
radiological, nuclear, and explosive threats.\12\ The Commission offers
several proposals to carry out this recommendation which include
amendments to the Emergency Use Authorization authority to allow the
FDA to authorize pediatric indications of medical countermeasures for
emergency use before an emergency is known or imminent as well as
funding and grant guidance for the development, acquisition, and
stockpiling of medical countermeasures for children. The Academy
strongly supports this recommendation.
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\12\ National Commission on Children and Disasters. 2010 Report to
the President and Congress. AHRQ Publication No. 10-M037. Rockville,
MD: Agency for Healthcare Research and Quality. October 2010.
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I am saddened to report that the Commission officially terminated
on April 4, pursuant to the statute that established it. The Academy
opposes the termination of the Commission and will continue to urge
Congress to move quickly to reconstitute the Commission. I had the
pleasure of partaking in the discussions of the medical care
subcommittee of the Commission and the achievements this Commission
made with its Federal partners, professional organizations, and the
public have been tremendous.
The Academy supported the creation of the Commission and we are
committed to helping carry on the work of implementing the Commission's
outstanding recommendations. It is unacceptable to us, and it should be
to Congress as well, to allow the Commission's recommendations to
simply sit on a shelf and gather dust.
medical products for children
In 1977, AAP experts first published a policy statement saying that
not only was it ethical to study drugs in children, it was unethical
not to. Since that time, the Academy has advocated strongly that
children deserve the same standards of therapeutic evidence as adults.
The first step forward in public policy solutions to the lack of
pediatric drug research came in 1997 when Congress passed the Food and
Drug Administration Modernization Act. This law contained the first
authorization of pediatric exclusivity, an incentive to study drugs in
children. This program was reauthorized as the Best Pharmaceuticals for
Children Act (BPCA) in 2002. In 2003, the Pediatric Research Equity Act
(PREA), a requirement for pediatric studies, was passed after the
Pediatric Rule was struck down. Finally in 2007, BPCA and PREA were
reauthorized together, creating an integrated system for pediatric
research incentives and requirements.
The uniqueness of pediatric therapeutics has been proven over and
over again by surprising and unexpected results. BPCA and PREA studies
have revealed safety issues, altered dosing, led to new indications,
and have shown some drugs to lack efficacy in children. In total,
nearly 400 drugs have been labeled for children as a result of BPCA and
PREA. These laws have also served as a model for international advances
in pediatric therapeutics, including the development of a parallel
pediatric program used by the European Medicines Agency (EMEA). We can
say unequivocally that BPCA and PREA have dramatically improved
pediatric practice.
There are real opportunities to harness the experience of these
programs and the strong leadership of the Food and Drug Administration
with BARDA and their industry partners to improve pediatric labeling
for medical countermeasure. There are opportunities for collaborations
with the National Institutes of Health (NIH) as well. Within the last
week, NIH released the 2011 BPCA Priority List of Needs in Pediatric
Therapeutics and among the drugs identified by the NIH are several in
the biodefense arena. The Academy looks forward to working with
Congress to reauthorize and strengthen BPCA and PREA, two laws that
have done so much to improve children's health.
medical countermeasures for children
Progress has been made to improve the availability of pediatric
countermeasures but much more work needs to be done. Most recently,
pediatric labeling was added to pralidoxime for the treatment of nerve
agent poisoning. However, that labeling took 7 years during which time
no new data was presented. It is hard to understand why it took that
long. Pediatric labeling was the first step. HHS/BARDA needs to support
the manufacture and purchase of a child-specific auto-injector so that
pralidoxime can be forward deployed and administered in the field.
In the event of a radioactive release much like we saw in Japan,
children must be administered potassium iodide as quickly as possible,
ideally within 2 hours, and in an appropriate form and dosage to
prevent long-term health effects.\13\ The liquid formulation of
potassium iodide exists and is safe and effective but if Federal and
State governments do not purchase it to be stockpiled in the event of
radiation exposure and in sufficient quantities to treat all of our
Nation's children, how secure are we really?
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\13\ Committee on Environmental Health. Radiation Disasters and
Children. Pediatrics, Vol. 111, No. 6, June 2003.
---------------------------------------------------------------------------
The Academy looks forward to the approval of pediatric labeling for
midazolam to treat nerve gas exposure. Those studies are well underway
at NIH and the Academy hopes that NIH and FDA are closely coordinating
their efforts in order to expedite the approval of pediatric labeling.
other policy recommendations
The American Academy of Pediatrics has specific recommendations for
all policymakers regarding children and medical countermeasures:
The medical countermeasure enterprise, led by the Federal
Government, should set a goal to achieve parity between adult
and child medical countermeasures developed and included in the
Strategic National Stockpile (SNS) and all other Federally-
funded caches.
The Pandemic and All-Hazards Preparedness Act should be
amended to require that the Secretary, acting through BARDA,
prioritize children.
Children must be distinguished as a separate population from
the broader ``at-risk'' individuals' category and the HHS
Secretary should create an Office of Preparedness and Response
for Children to be headed by a Director who reports to the
Secretary.
The Federal Government should conduct a comprehensive review
of the contents of the SNS and all other Federally-funded
caches to assess how many products have pediatric labeling and,
for those that don't, the Government should create a plan by
which pediatric labeling can be added.
The Emergency Use Authorization process should be amended to
allow the FDA to authorize pediatric indications of medical
countermeasures for emergency use before an emergency is known
or imminent.
The Federal Government must give guidance to States that
ensures they purchase adequate supplies of countermeasures for
children, especially liquid potassium iodide in States with or
near nuclear facilities. And, there must be accountability for
States' plans for maintenance and distribution of medical
countermeasures for children.
Prepositioning of medical countermeasures is critical. All
prepositioning strategies must include locations where children
gather, e.g. schools and child care facilities and they must
include plans for children with special health care needs.
Because ``children'' encompass individuals from birth
through adolescence, it is often insufficient to have a single
size device to serve all children. In the case of respiratory
masks, for example, different sizes are needed for infants,
young children, and teenagers. Both individual facilities and
the SNS must take this into account and provide for these
needs. Similarly, drugs must be available in appropriate
formulations and dosages for children. Infants cannot be
expected to take pills. Needles must be provided in smaller
sizes. In many cases, dosages for children should be determined
not by age but by weight.
Utilize pediatric subject matter expertise in identifying
gaps, setting priorities, planning, and exercising all-hazard
disaster response capabilities.
Federal agencies such as FDA, BARDA, and NIH must coordinate
their efforts with the goal of prioritizing pediatric medical
countermeasures.
conclusion
The American Academy of Pediatrics thanks the committee for this
opportunity to testify on the important issue of medical
countermeasures. America's children represent the future of our Nation,
our most precious National resource. They must not be an afterthought
in medical countermeasures and disaster planning. The Academy looks
forward to working with you to protect and promote the health and well-
being of all children, especially in emergency and disaster
preparedness. We would like to offer the children and disasters website
of the Academy as a resource to you as you work on disaster
preparedness issues. It can be found at www.aap.org/disasters.
Finally, we would like to leave you with the findings of recent
public opinion polling conducted by the AAP in partnership with
Children's Health Fund on the use of resources related to disaster
planning and response specific to children's issues. The poll found:
76% of Americans agree that if resources are limited,
children should be given a higher priority for life-saving
treatments;
75% believe that if tough decisions must be made, life-
saving treatments should be provided to children rather than
adults with the same medical condition; and
92% agree that if there were a terrorist attack, our country
should have the same medical treatments readily available for
children as are now available for adults
You represent fathers, mothers, grandparents, uncles, and aunts;
our children deserve better. When disaster strikes, we as a Nation must
be better prepared with the medical countermeasures to keep our
children healthy and ensure they have the opportunity to achieve
optimal health outcomes. As a pediatrician and a father of three, I
look forward to your questions and to working with you to address the
preparedness needs of all children.
Mr. Bilirakis. Thank you, Doctor. Appreciate it very much.
I recognize myself for 5 minutes.
To the doctor, we appreciate your testimony describing how
children are a particularly vulnerable population when it comes
to CBRN threats. Many would argue that our preparedness and
ability to deal with children and other vulnerable populations
in a disaster lags behind our preparedness for adults. I know
you mentioned this, so I am going to give you an opportunity to
elaborate.
Can you please elaborate on your comments about potassium
iodide for children if you have more to say? That is my first
question.
Dr. Fagbuyi. Thank you.
The issue with regards to potassium iodide, it is a
countermeasure. It is safe and effective; the FDA has
recommended it. It should be stockpiled. It should not be
allowed to expire if it does exist in the stockpile.
The stockpile actually should be evaluated to ensure that
there are pediatric countermeasures in the stockpile sufficient
enough to address the same needs that would be appropriate for
a threat that would affect adults. That is something that is
important and should be evaluated.
With regards to KI, you can talk about amount, and what is
the zone, and how far it should be deployed out, and who should
have it, but if States and Federal Governments don't stockpile
it and if we don't actually have enough in quantity then it
doesn't matter if it is 10 miles, 20 miles, 30 miles. If you
don't have enough you don't have enough.
Mr. Bilirakis. Okay. I would like to follow up with you
after the hearing as well on this issue.
Mr. Clerici, your testimony indicates that the main
challenge we face in this enterprise is not one of authority
but one of culture. As a contracts lawyer it is your perception
that many of the flaws in the system--in other words, is it
your perception that many of the flaws in the system could be
fixed if it would simply make better use of existing
authorities, of the other transaction authority, of allowable
transactions with industry under the FARR, of getting out RFPs
and contracts quickly instead of waiting for years? So my
question is: What needs to change to fix this and how can
Congress help?
Mr. Clerici. Thank you, Mr. Chairman. You clearly point
out, it goes beyond just interactions with the procurement. It
is the BioShield legislation itself.
The vision of BioShield was actually to anticipate that
Government has to act differently with respect to these non-
Governmental contractors, and there are special authorities in
the BioShield legislation other than--beyond the other
transactions authority that you mentioned on the last panel
that have not been used at all, let alone to their fullest. It
is a frustrating problem because here you have, in my view--the
funding is available, which as we sit here today, as you vote
on the continuing resolution of the budget, that is a rare
benefit that you don't really see in these times.
The leadership is actually very strong as well. I think Dr.
Robinson and his team are very, very accessible to industry. It
is what happens after that, after you have talked to that team
down below where the problems seem to arise.
The program has morphed into much more, at the Department
of Defense, acquisition program based upon a very long timeline
rather than the sense of urgency imparted upon the legislation
with Project BioShield. The frustrating part, Mr. Chairman, is
I am not sure what Congress can do. It has given them all the
authority; it has given them all the tools and they actually do
have strong leadership.
You know, your oversight authority is certainly an
important way to follow this, as well as kind of just reminding
them that the legislation was meant to convey that sense of
urgency of the events of 9/11 and after that has been somewhat
lost as we move further and further away from the event.
Mr. Bilirakis. Thank you.
My next question is for Ms. Arthur. In your opinion is the
Government working with industry to develop sufficient broad
spectrum technologies thereby getting away from the one bug,
one drug problem? This seems like just the type of challenge
that biotechnology companies would be poised to tackle.
Ms. Arthur. So actually, thank you for your question. I
think that BARDA and the DOD both are working in concert with
industry to try to maximize these multiplatform, multiuse
opportunities. I think that one of the things that we face is
actually what is the regulatory process for those products
going forward?
So in the end it is still true that the FDA approves a
product for a specific indication. They don't approve the idea
of how you might use this for multiple products, so it is very
important, as we stress, that the agencies work together with
the FDA to think through how we move these new platforms that
have dual use through the regulatory process with clarity.
Hopefully I answered your question.
Mr. Bilirakis. Thank you.
Mr. Clerici, can you please elaborate on your statement
that HHS was unresponsive to industry offers to help provide
products that would mitigate the radiological crisis in Japan?
Why do you think that BARDA has not been proactive in this
regard, second? Then the last question is, further, what needs
to happen to ensure that the United States has stockpiled the
countermeasures it would need to respond to a rad-nuc incident
of its own?
Mr. Clerici. Yes, Mr. Chairman. So in my experience there
are three or four products out there that are licensed, FDA-
approved for other indications that are related to what would
occur or what has occurred in Japan. Those companies are very
well aware of BARDA and vice-versa. BARDA's leadership, again,
has done, I think, an outstanding job of making an outreach to
those teams.
Based upon my understanding, since the events in Japan
there has been very little interaction to understand how many
of those products are on hand, what are the protocols that
would be used during an event such as Japan if Japan asked for
them, or what sort of file could be done to make sure the data
that comes from where these products are actually used can go
to license these products here in the United States for the
nuclear indication.
Why I think that has happened is a couple reasons, Mr.
Chairman. First, I think that there is sensitivity to the
Japanese. They have not asked for our help; we certainly can't
offer it in the abstract. However, there is nothing wrong with
being prepared for them to ask us those questions, and even
that exercise alone I think would be very important.
The second problem, I think, goes back to the procurement
problem. I think that there is sensitivity among the program
folks who very much want to have these exchanges with industry
but they might be viewed as favoring industry or somehow
endorsing them along the way. This is the time, essentially, to
kind of act very proactively and I think we are missing it.
The last one is a high level of sensitivity around
endorsing a product for an unapproved use. We are very
sensitive about offering a promotion and everything that goes
along with that. But by definition these products that are FDA-
approved are a little bit different than a product that is
earlier in development, and particularly those products that
have already been used in nuclear events outside the country in
South America and others.
Seems there should be a little less sensitivity on that
issue that I am not actually seeing.
Mr. Bilirakis. One last question for Ms. Arthur.
Ms. Arthur, you mentioned in the testimony that the Federal
Government must provide an MCM market that is sustainable and
therefore of interest to industry. Was the 10-year advance
appropriation for BioShield a reasonable model? If not, what do
you suggest now that the funds are nearing their expiration
date?
Ms. Arthur. Thank you. That is a good question.
So, there have actually been several suggestions of what
number would be the best number to put in BioShield to really
serve as the right size for the marketplace that required all
of these products--as the doctor pointed out, you don't just
want products that treat adults; you want products to treat
pediatrics, geriatrics, immunocompromised persons, and each of
those indications is its own development process.
So I think that the Weapons of Mass Destruction Commission
actually suggested a number that was order of magnitude higher
than $5.6 billion, and I would have to get back to the
committee with the correct number, but there are some published
data that show that the number would need to be bigger in order
to actually prove a marketplace size big enough to give you all
of the countermeasures that would be required for the--to
fulfill all the needs. I hope I answered your question.
Mr. Bilirakis. Get back to us on that.
Ms. Arthur. We absolutely will.
Mr. Bilirakis. I am sure the Ranking Member would be
interested as well. Thank you.
Okay, Ms. Richardson, you are recognized for 5 minutes or
so.
Ms. Richardson. Thank you, Mr. Chairman.
Let me start off my first question with Mr. Clerici. From
your perspective, which research and development works better,
DOD's or HHS?
Mr. Clerici. There are certain aspects of the DOD model,
particularly in the program that Dr. Parker mentioned, the
Transformation Medical Technologies program, that I think have
been very strong. In fact, BARDA has actually adopted some of
those practices--two-stage procurement, where you submit a very
short white paper and then you are screened out and don't have
to spend the time to go through a full proposal. That has been
very positive.
I have also seen examples that have been fairly public that
DOD has been more aggressive. There is one example of a
influenza therapeutic that was discussed in a recent
publication after the H1N1 pandemic arose where DOD acted very
aggressively. So in that respect I think that is a positive
light.
BARDA faces a lot greater challenges than DOD, quite
frankly. You talked about the population differences. Generally
speaking, the military is buying products for the warfighter,
18- to, you know, 35-year-old healthy people. BARDA has to
address the entire population.
The other struggle that BARDA faces, which is kind of
counterintuitive, is BARDA actually has the authority to use
products that aren't FDA-approved; DOD does not. DOD must
develop a product all the way through licensure before it can
be used in a military setting. That creates challenges because
of the Animal Rule and kind of the expectations around what
BARDA's mission is.
So I think I would have to say that in many respects DOD
has been faster and better; in other respects I understand that
BARDA has a much bigger challenge on its hands. But there are
lessons that can be learned.
Ms. Richardson. Okay.
Ms. Arthur, will changes described in the August 2010
PHEMCE review fix all of the problems with HHS's process in
developing medical countermeasures? What is missing from those
recommendations? Which of the recommendations should not be
implemented?
Ms. Arthur. Well, now, thank you.
I think that a great--the review actually did touch on
several of the most important issues that would go a long way
to increasing industry involvement. Certainly the FDA
investment is the most important and the most--the biggest
hurdle that industry faces today.
I think that in addition what might be missing is the
opportunity to have more transparency of a longer-range plan.
To discuss these products takes anywhere from 8 to 12 years to
develop and that actually means that this annual procurement
process and appropriations process does not necessarily allow
companies to have their security that their investors are
planning where they will be in the process and how they will be
leveraging their funds and hitting their milestones over the
long term.
So the ability to do a more long-range plan that can be
shared transparently with stakeholders would be added benefit
to industry.
I think there are several provisions inside the review that
industry is still looking at--the strategic investor and the
flexible manufacturing. I want to make sure that we work with
BARDA and the DOD to understand exactly how those would be
implemented and to make sure that there are no--or as few
negative implications for commercialization of some of these
dual-use products as possible.
So while everything in the review was certainly meant to
increase the incentive for industry to be involved, a few of
the proposals might need to be finessed and worked on with
industry and partnership.
Ms. Richardson. Okay. Thank you.
Doctor, since you are the director of disaster preparedness
and emergency management at the Children's National Medical
Center, to your knowledge--I don't know if you were in the room
when I asked the question about stockpiling--to your knowledge
is there an adequate stockpiling of children-related vaccines
and so on?
Dr. Fagbuyi. Thank you, ma'am. I do not know that. I am not
privy to that.
However, from the lessons that we learned from H1N1, for
example, I will give--Oseltamivir is a drug we used that was
the medical countermeasure at least that the population was--
was distributed to the population. That was a logistical
nightmare trying to get that to different hospitals and other
end-users, the patients themselves.
In addition, pharmacies didn't even know how to constitute
it right for a pediatric patient. There was an issue of cherry
syrup shortage. What is going to happen with cherry syrup? What
is that about? Well, that is how you mix it for it to be more
palatable, and to constitute it right for the dosing for the
pediatric patient.
So that is a preview. That gives me an opportunity to say,
well, I question the rest of the things then with that. That is
where the Academy stands at. We need to actually look back into
the stockpile, see what is actually there. What is in there?
Does it have pediatric indications and can it be used in a
patient? Does it have pediatric instructions that are clear so
that people make sure they are using the right dose?
People should engage with the pediatric experts who do this
often to be able to make sure that that is changed. I hope that
answers your question, ma'am.
Ms. Richardson. Absolutely.
Thank you. I yield back.
Mr. Bilirakis. Thank you very much.
I want to thank the witnesses for their valuable testimony,
thank my Ranking Member for her great questions, and I am sure
you will agree this is a very timely hearing and hopefully this
will bring the issues to the forefront because these are so
very important.
The Members of the committee may have some additional
questions for you and we ask you to respond in writing please.
The hearing record will be held open for 10 days.
Without objection, the subcommittee stands adjourned. Thank
you.
[Whereupon, at 4:31 p.m., the subcommittee was adjourned.]
A P P E N D I X
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Questions From Chairman Gus M. Bilirakis for Cynthia A. Bascetta
Question 1. Medical countermeasures aren't just about vaccines and
antibiotics, but also include appropriate diagnostic measures to
determine who is actually exposed. We have no rapid diagnostic tools
stockpiled for any of the material threats. In your opinion, is the
civilian medical countermeasures program developing appropriate
diagnostics to meet the material threat determinations?
Answer. Our current work is examining HHS's chemical, biological,
rediological, and nuclear (CBRN) medical countermeasure development and
acquisition activities, and the Department has a stated interest in
developing and acquiring vaccines, antibiotics, diagnostic devices, and
other countermeasures. As we reported in our testimony, the Federal
Government faces a variety of challenges in developing and acquiring
these countermeasures, such as the high failure rate in research and
development and difficulties meeting regulatory requirements. These
challenges apply to diagnostic devices as well as vaccines and
antibiotics. However, we have not reviewed issues specific to the
development of diagnostics, but we agree that diagnostics are an
important component of response to certain types of threats.
Question 2. Do you believe that the distribution of funds for
medical countermeasures is appropriate? That is, is the way the funds
are spent actually resulting in enough and useful countermeasures?
Answer. Our current work is examining how much HHS has invested in
CBRN medical countermeasure research, development, and acquisition and
its progress in these activities. However, we are unable to make a
determination as to whether HHS is spending its funds appropriately. As
we reported in our testimony, countermeasure research and development
is a lengthy and complex process. In addition, given the high failure
rates and other challenges, it is also an expensive process, especially
in the advanced research and development stages. HHS is making some
changes to its countermeasure enterprise and processes intended to
improve countermeasure development and acquisition, which we are also
examining in our current work. While it is too early to determine how
some of these changes will affect countermeasure development and
acquisition, our work will include a review of how investments in
countermeasure development have been guided by threat and risk
assessments.
Questions From Ranking Member Laura Richardson for Richard J. Hatchett
Question 1. Does HHS support the goal of achieving parity within
the SNS between countermeasures for children and those available for
adults?
Answer. The Department of Health and Human Services (HHS) supports
the goal of achieving parity within the Strategic National Stockpile
(SNS) between medical countermeasures (MCMs) available for children and
those for adults. HHS inventories the SNS on a yearly basis to assess
and rectify MCM gaps, and there has been a specific focus on pediatric
MCM requirements and gaps in the 2010 SNS Annual Review [relates to QFR
No. 2 below] that will be reviewed and prioritized by the Enterprise
Senior Council.
In many cases, a gap exists because either a pediatric formulation
of a countermeasure has not been developed or an existing
countermeasure has not been approved by the Food and Drug
Administration (FDA) for use in pediatric populations. HHS is working
diligently to overcome the challenges to obtaining FDA approval for
pediatric MCM. Because pediatric MCM research must be conducted in
accordance with 21 CFR Part 50, Subpart D (50.50-50.56): ``Additional
Safeguards for Children in Clinical Investigations,'' and with 45 CFR
Part 46, Subpart D, ``Additional Protections for Children Involved as
Subjects in Research,'' as relevant, the ability to conduct studies is
limited and consequently the opportunity to collect sufficient data on
the safety and efficacy of MCMs in pediatric populations is limited.
Furthermore, the ethics and feasibility of collecting data on the use
of MCMs against CBRN threats in children are particularly challenging.
HHS is working to stimulate pediatric MCM development by
integrating considerations for pediatric populations in every stage of
development, including requirements setting, research, and program
management. The National Institutes of Health (NIH) is spearheading
clinical trials to obtain the data necessary for FDA approval of
pediatric MCMs, such as midazolam to treat seizures resulting from
nerve agent exposure. Since 2004, HHS's Biomedical Advanced Research
and Development Authority (BARDA) has invested over $2 billion to
support MCM development in healthy and special populations including
pediatric populations. This includes MCMs for anthrax vaccines and
therapeutics; heptavalent botulinum antitoxin; Smallpox vaccine for
immunocompromised persons; and a number of products intended for use
after radiological or nuclear events. Additionally, HHS is putting in
place new mechanisms, such as a working group focused specifically on
the issues of developing and dispensing MCMs to pediatric and obstetric
populations, to improve the development and acquisition of safe and
effective countermeasures for children.
Question 2. Will the ASPR conduct a comprehensive review of the
contents of the SNS and provide this committee and the public a report
on how many have pediatric labeling?
Answer. An annual review of the SNS formulary is mandated by
Homeland Security Presidential Directive 21: Public Health and Medical
Preparedness (HSPD-21) and Section 319F-2(a)(1) of the Public Health
Service (PHS) Act, as added by Section 102(c) of the Pandemic and All
Hazards Preparedness Act (PAHPA), Public Law 109-417.\1\
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\1\ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=50- &showFR=1&subpartNode=21:1.0.1.1.19.4.
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PAHPA directs the SNS Annual Review to address medical
countermeasure assets for at-risk individuals, including pediatric
populations. To enhance preparedness planning for pediatric
populations, the 2010 SNS Annual Review process specifically examined
the medical countermeasure requirements needed to cover the U.S.
pediatric population (defined as individuals aged 0-21 years).\2\ The
HHS-led working groups that contribute input into formulary decisions
have accounted for pediatric medications, formulations (some of which
are also appropriate for persons unable to swallow pills), and dosages
where available. This ensures that SNS requirements will include
medical countermeasures appropriate for pediatrics wherever possible.
The overall quantitative gaps were examined, while also pinpointing
areas where existing medical countermeasures are insufficient to meet
the specific needs of pediatric populations. The results of this Review
will be available in 2012, as required under HSPD-21.
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\2\ The 0-21 year age range is consistent with the definition
generally used by the practicing community of pediatricians and
pediatric stakeholder groups. An estimated 30% of the U.S. population
is included in this age range. There are diverse medical countermeasure
formulation requirements within this range however (e.g. suspension
formulations are designated for children 0-9 years of age (14% of the
U.S. population)).
---------------------------------------------------------------------------
The issue of pediatric labeling of MCMs is very important to HHS.
This is a complex subject that presents challenges beyond its impact on
medical countermeasures stockpiled in the SNS, as the majority of
medications on the market today have not undergone clinical studies in
children. The FDA maintains an informative web page that addresses the
challenge of identifying safe pediatric uses for existing MCM that have
not been tested and labeled for children (http://www.fda.gov/Drugs/
ResourcesForYou/Consumers/ucm143565.htm).
The ability to use the medical countermeasures provided by SNS
during an incident depends on necessary mechanisms that allow for
deployment, dispensing, and utilization of those assets. In order to
treat individuals at the State and local level with medical
countermeasures that have not been approved, licensed, or cleared by
FDA for their intended uses (e.g., off-label pediatric applications),
Emergency Use Authorization (EUA) or Investigational New Drug protocols
must be in place for each product for the intended purpose. CDC also
continues to prepare for potential deployment and use of medical
countermeasures by preparing pre-EUA documents and working with FDA to
streamline the process for obtaining an EUA at the time of an incident.
Question 3. In light of recent events in Japan, is the
administration currently considering changing the policy to limit the
availability of potassium iodide (KI) to just 10 miles around nuclear
power plant facilities?
Answer. The Nuclear Regulatory Commission (NRC) has principal
Federal responsibility for policy recommendations regarding the use of
potassium iodide (KI) in proximity to nuclear power plant facilities.
Consequently, this question is more appropriately suited for the NRC to
address. It should also be noted that the final authority to make any
determinations regarding implementation of KI distribution beyond 10
miles of nuclear power stations resides with States, which have to
develop preparedness plans and submit them to the Federal Emergency
Management Agency (FEMA), Department of Homeland Security, for review.
Question 4a. At present, is there enough liquid KI in the SNS for
all children, especially children living in States with or near nuclear
facilities?
Question 4b. If not, what is being done to ensure liquid
formulation KI will be available for all children?
Answer. The Nuclear Regulatory Commission currently implements the
program for providing KI to the States that have populations living in
the Emergency Planning Zones (EPZ) surrounding nuclear power plants in
the United States. Following the decision not to distribute KI in the
10-20 mile radius of nuclear power stations, the KI tablets originally
purchased for the SNS to carry out this requirement were turned over to
the NRC for the purpose of supporting these populations, and the KI
liquid solution was offered to the States by HHS and SNS to address
their childhood populations; however, it was declined by nearly all
States due to the logistical issues and cost associated with accepting,
stockpiling, and distributing this product to communities within 20
miles of a nuclear power station.
While KI liquid solution does reside in the SNS and could cover the
childhood populations in many scenarios of potential radioiodine
release from a nuclear power station, it is expiring and there is no
operational requirement to maintain it in the SNS formulary. KI should
be administered for risk of exposure, or within of 4-6 hours or less of
exposure, to be effective, and thus National stockpiling of KI would
not appear to be an effective strategy that allows for utilization in a
timely manner.
The quantities of bottles of liquid KI held in SNS inventory are
treated as Controlled Unclassified Information, but HHS would be happy
to provide this information in another manner that permits appropriate
safeguards. Due to the packaging of KI liquid solution, it would be
expected that one bottle would be provided per family with one or more
children even though there are multiple doses in each bottle. Thus, the
number of children that could be treated for prophylaxis with KI liquid
solution following a release of radioactive iodine is, at a minimum,
equal to the number of available bottles.
The amount of excess KI liquid solution currently held in the SNS
would be insufficient to treat the total pediatric population of the
United States, if the entire Nation was at risk. HHS does not currently
have information on the size and demographic breakdown of populations
surrounding U.S. nuclear power plants to calculate the requirement for
KI liquid solution to treat the entire pediatric population in those
areas.
The Office of the Assistant Secretary for Preparedness and Response
is leading an interagency effort to evaluate the need for a National
stockpile of KI that could include the liquid formulation of KI. We
would welcome the opportunity to provide an update to the subcommittee
when this review is complete.
Question 5. Please describe how BARDA coordinates with
pharmaceutical companies developing MCMs--specifically MCMs for
anthrax.
Answer. BARDA coordinates with large and small pharmaceutical and
biotechnology companies through many different venues and mechanisms.
Companies that have been awarded contracts by BARDA for the development
of anthrax countermeasures are in constant communication with relevant
program managers, project officers, and contracting officers and
specialists. As warranted, companies with active contracts participate
in interagency ``In-process Reviews'' to discuss progress toward
project milestones or deviations of cost, schedule, or performance.
BARDA senior leaders participate in and present BARDA plans and
priorities at National and international biodefense, pharmaceutical,
and biotechnology meetings. Subject matter experts from BARDA
participate in a myriad of scientific and product development
conferences throughout the world, broadening the understanding of
BARDA's mission in the private sector.
BARDA also supports public meetings that bring together scientists
and pharmaceutical companies. BARDA, as mandated in PAHPA, convenes
meetings with representatives from relevant industries, academia, other
Federal agencies, international agencies as appropriate, and other
interested persons at least once per year, providing an opportunity for
the private sector to interact with USG staff and ask questions related
to BARDA's mission, planning, priorities, and requirements. The next
BARDA Industry Day will be conducted June 7-9 in San Diego, CA, with a
similar meeting planned for Boston in October. Representatives of the
Office of Acquisition Management, Contracts, and Grants within ASPR
will also participate in and jointly sponsor both of these conferences.
BARDA also has an open electronic portal
(medicalcountermeasures.gov) for industry to request a meeting with the
USG, and find information related to: (1) Procurement and grant
opportunities, (2) public meetings and conferences, (3) specific
product guidance, (4) available resources, and (5) PHEMCE and BARDA
strategic and implementation plans and reports.
Lastly, BARDA has a solicitation (Broad Agency Announcement; BAA)
open year-round for product developers to engage BARDA through product
development proposals. This solicitation allows private industry the
ability to present ideas and projects to BARDA under an expedited
review process. Although the solicitation calls for proposals based on
all chemical, biological, radiological, and nuclear MCMs, BARDA has
also issued Specific Instructions under the solicitation for anthrax
countermeasures. Collectively, these activities are broadening BARDA's
portfolio of anthrax medical countermeasure candidates and making it
more feasible that these products will be available for future
procurements.
Questions From Chairman Gus M. Bilirakis for Gerald W. Parker
Question 1. In your testimony, you indicated that DOD is integrated
with other agencies through the National Biosurveillance Integration
System (NBIS). Can you please expand on this comment, by describing the
ways in which DOD participates (through information exchange, liaison
officers, etc.)? Please also describe any memoranda of agreement,
memoranda of understanding, etc. that have been signed, and how these
have facilitated information sharing.
Answer. Biosurveillance includes the process of data gathering and
monitoring of potentially valuable information sources for tracking
both naturally-occurring and man-made emerging epidemics. The ability
to detect an outbreak early, investigate and verify the biological
threat, and determine the extent of the outbreak all aid in responding
to and mitigating the consequences of the outbreak. The Global Emerging
Infections Surveillance and Response System (GEIS), operated by the
Armed Forces Health Surveillance Center (AFHSC) through a network of
U.S. and overseas laboratories, creates a centralized coordination and
communication hub to help organize DoD resources and link U.S. and
international efforts.
DoD has entered into a Memorandum of Understanding (MOU) with the
Department of Homeland Security, the Department of Agriculture, the
Department of Health and Human Services, the Department of the
Interior, the Department of State, and other agencies to participate in
the establishment of the National Biological Integration System (NBIS).
NBIS focuses on biosurveillance and early recognition and notification
of hazards.
This MOU has removed bureaucratic hurdles and clarified roles and
requirements for DoD to share GEIS information with the Centers for
Disease Control and Prevention and NBIS for integration into an overall
National pattern. In particular, it allows DoD to participate in
quarterly sessions of the NBIS Interagency Working Group and the NBIS
Interagency Oversight Council. Moreover, DoD is involved in NBIS
Protocol Activations, as needed (e.g., E. Coli outbreak in Germany).
The NBIS representatives also participate in the DoD Joint
Biosurveillance Working Group, contributing to discussions across the
community that fields the necessary tools for operational users to
gather data from environmental sensors, diagnostic results, or open
source communications. The possibility exists for an MOU with DHS to
allow DoD to place a military liaison with NBIS. In connection with the
above, DoD's efforts are designed to capture all relevant
biosurveillance information in a central location for better
coordination with NBIS and other interagency and international
partners.
Question 2. The Department of Defense's Transformational Medical
Technologies Initiative targets development of countermeasures that are
broad spectrum, that is, effective against an array of threat agents.
The civilian enterprise is also attempting a similar effort. Can you
please provide the subcommittee with insights and best practices into
how to advance this challenging, but necessary, endeavor in the
civilian sector?
Answer. Transformational Medical Technologies (TMT) investments are
focused on broad-spectrum medical countermeasure (MCM) solutions,
either individual MCMs that target conserved pathogen- or host-based
targets or MCMs that are based on an adaptable platform technology that
may be tailored to a new or emerging pathogen. These efforts attempt to
mitigate the risk associated with both engineered and naturally evolved
resistance in the pathogen.
All medical countermeasure development toward licensure must adhere
to Food and Drug Administration (FDA) regulations to demonstrate
efficacy and to protect their respective populations, the general
population and the warfighter, from unsafe drugs. The traditional FDA
approval process presumes one indication per drug and one drug per
target. The key breakthrough TMT seeks is a safe FDA approval process
for a platform and not merely a product. In this regard, TMT has
advanced further than the civilian sector. TMT New Drug Application
submissions to FDA for approval consideration are the first examples
under a new ``fast-track'' FDA process, still being developed.
All products must comply with, and progress through, appropriate
FDA regulatory processes governing their development and ultimate
approval and use. Any civilian effort addressing MCMs should include
working directly, and often, with the FDA and other organizations to
promote and support new approaches to regulatory science.
Civilian investments in broad-spectrum countermeasures should
carefully consider the risks and benefits of a relabeling approach and
assess whether relabeling or new discoveries will address their needs
and gaps. Existing FDA-approved MCMs, and candidates under development
by the civilian sector, are primarily pathogen-directed and well-
characterized. FDA-approved products could be (and are being) relabeled
for additional indications. Consideration must include additional costs
to license any subsequent indication necessary to reach broad-spectrum
status with the FDA. The cost estimates should reflect the approximate
cost to achieve FDA approval for the first indication, and the
additional costs for new indications. Alternatives include designing
MCMs against broadly conserved targets not easily subverted because
they have a critical and necessary role in the pathogenesis of the
infectious agent.
To enable MCM discovery, TMT has invested in both in silico and in
vitro platforms that enable rapid screening of candidates for off-
target effects, such as toxicity and drug-to-drug interactions. TMT
supports development of computational tools that provide rapid analysis
of potential targets, based on genomic sequence data. To enable MCM
development under the FDA Animal Rule, TMT is investing in a range of
tools to make drug testing in animals more predictive of the human
experience. Collectively, these tools will improve the confidence for
using data extrapolated from animal models for MCM evaluation. Broad-
spectrum investments should include enabling technologies to support
this critical but original effort.
TAKING MEASURE OF COUNTERMEASURES (PART II): A REVIEW OF EFFORTS TO
PROTECT THE HOMELAND THROUGH DISTRIBUTION AND DISPENSING OF CHEMICAL,
BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES
----------
Thursday, May 12, 2011
U.S. House of Representatives,
Subcommittee on Emergency Preparedness, Response,
and Communications,
Committee on Homeland Security,
Washington, DC.
The subcommittee met, pursuant to call, at 1:00 p.m., in
Room 311, Cannon House Office Building, Hon. Gus M. Bilirakis
[Chairman of the subcommittee] presiding.
Present: Representatives Bilirakis, Marino, and Richardson.
Mr. Bilirakis. The Subcommittee on Emergency Preparedness,
Response, and Communications will come to order.
The subcommittee is meeting today to receive testimony on
Federal, State, and local efforts to distribute and dispense
medical countermeasures in the event of a CBRN attack,
pandemic, or other emergency.
I now recognize myself for an opening statement.
At the outset, I would like to thank our witnesses for
their flexibility on the timing of today's hearing. Thank you
very much. Appreciate it.
This hearing is the second in a series considering medical
countermeasures. Last month, the subcommittee received
testimony on Federal efforts to work with industry to research,
develop, and acquire medical countermeasures. Today, the
subcommittee will focus on efforts to get those medications,
diagnostics, and other medical supplies to individuals who need
them in the event of a CBRN attack, pandemic, or other
emergency.
Our enemies have made no secret of their desire to use
weapons of mass destruction to attack the United States. Last
year, the Committee on Homeland Security received testimony
from former Senators Graham and Talent, the commissioners of
the Commission on the Prevention of Weapons of Mass Destruction
Proliferation and Terrorism.
At the hearing, the commissioners noted that it is more
likely than not that there will be a weapon of mass destruction
used someplace on Earth by a terrorist group before the end of
the year 2013 and that it is more likely that the weapons will
be biological rather than nuclear.
This assessment, along with the anthrax attacks in 2001,
the H1N1 pandemic in 2009, and the disaster in Japan,
highlights the need for robust plans for countermeasure
distribution and dispensing.
The WMD commission issued a report card on U.S. Government
efforts to protect the Nation from WMD terrorism last year.
Sadly, the Government received a grade of ``F'' on its efforts
to enhance the Nation's capabilities for rapid response to
prevent biological attacks from inflicting mass casualties. Of
course we can and must do better.
I look forward to hearing from our Federal witnesses about
whether we have made strides in this area since January 2010,
since the report card was issued. What lessons have we learned
from the response to the H1N1 pandemic that can help us enhance
our preparedness and response?
I would also like their opinion on whether the Federal
Government is investing adequate resources in the Strategic
National Stockpile to ensure that we have appropriate
quantities of the right drugs, diagnostics, and supplies. In
light of the radiological emergency in Japan, we must not
squander this opportunity to assess our own preparedness for a
radiological or nuclear disaster, which I fear is, as I said,
substantially inadequate.
I am interested in hearing from all of our witnesses,
especially our State and local witnesses on the second panel,
on their view of the various distribution models and where we
need to be today to respond to any event that may happen
tomorrow. Which models are the most promising to reach the
largest population as expeditiously as possible? What
innovative efforts are being implemented at the local level to
ensure prompt dispensing?
Last, we must consider how effectively the Federal
Government is interfacing with States and localities to ensure
that resources and guidance are provided and that planning is
coordinated. We must ensure that the public is appropriately
informed of the threats they face and that the first responders
who treat them have the guidance and opportunities for pre-
event vaccination that they deserve.
With that, I welcome our witnesses, and I look forward to
their testimony.
Right on time, I will recognize the Ranking Member for her
statement. Thank you. You are recognized.
Ms. Richardson. Thank you, Mr. Chairman. Thank you for
convening this very important hearing about our Nation's
readiness for distributing and dispensing medical
countermeasures.
I would also like to express my gratitude to those of you
who have served on our behalf. We are very grateful for that,
and thank you.
As a representative of the 37th Congressional District, I
understand the critical importance of developing effective
nuclear biological and radiological and chemical
countermeasures. The Port of Long Beach and other critical
infrastructure is throughout my entire district, not to mention
the large population that Los Angeles County faces, us being
the largest county in the entire United States.
We must ensure that the Federal, State, and local efforts
are coordinated to ensure a seamless and expeditious
distribution and dispensing process to respond to bioterror,
pandemic events, or emergencies caused by a natural disaster.
There have been major improvements to the Nation's public
health infrastructure over the last decade, especially since
the anthrax attacks that we had and even faced here in
Washington, DC. Most importantly, however, our State and local
health departments, who serve as the backbone of our
distribution and dispensing efforts, have made great progress
in planning and navigating through complex logistical
challenges.
However, we must ensure that the Federal efforts support
State and local health departments, who, under law, have the
primary responsibility for the health of our citizens.
Therefore, when we consider the Federal efforts that should be
taken, unfortunately a decade of gains to our State and local
public health departments are endangered based upon the budget
cuts, or the proposed budget cuts.
According to a December 2010 study by the Trust for
America's Health, entitled, ``Ready or Not? Protecting the
Public's Health from Diseases, Disasters, and Bioterrorism,''
33 States and Washington, DC, have cut funding for public
health since 2008. Also, since fiscal year 2005, Federal
support for public health preparedness has also been cut by 27
percent. Funds for public health allocated during the 2009
pandemic flu response and through the Recovery Act helped to
provide some support but did not address the need to build a
sustainable capacity for a large-scale response.
The erosion of the State and local public health
infrastructure and workforce leaves us at risk of not being
adequately prepared to have the basic capabilities to meet
time-sensitive goals of dispensing medical countermeasures.
I look forward to hearing specific effects that you might
feel would be impacting your area based upon the cuts that have
been proposed. We, in Congress, must assure you and provide the
support you deserve to address these health challenges.
Inadequate emergency health preparedness puts our Nation at
risk, and we must be resolved now, prior to being tested by
another large-scale emergency.
In addition to funding issues, I would like to hear about
the lessons learned from the 2009 H1N1 response and what is
being done to protect our at-most-risk populations, especially
children in schools and daycare centers.
Again, I thank you for being here today, and I look forward
to your testimony.
Mr. Bilirakis. Thank you very much.
Others Members of the subcommittee are reminded that
opening statements may be submitted for the record.
Before I introduce our first panel, I ask unanimous consent
to insert in the record a statement from the National
Association of Chain Drug Stores.
Without objection, so ordered.
[The information follows:]
Statement of The National Association of Chain Drug Stores
May 12, 2011
NACDS thanks the committee for the opportunity to submit a
statement for the hearing on ``Taking Measure of Countermeasures: A
Review of Efforts to Protect the Homeland Through Distribution and
Dispensing of CBRN Medical Countermeasures.'' Rapid access to medical
countermeasures is critical for preventing and treating illness caused
by public health emergencies. As the Institute of Medicine reported,
public health cannot do this job alone--collaboration from the private
sector will be necessary to reach large numbers of people in the
community. NACDS, its member companies, and the 120,000 dedicated
pharmacists who work in community pharmacies are uniquely equipped and
stand ready to assist policymakers and public health officials at all
levels of government in ensuring convenient access to countermeasures
in a medically-relevant time frame following an emergency.
The National Association of Chain Drug Stores (NACDS) represents
traditional drug stores, supermarkets, and mass merchants with
pharmacies--from regional chains with four stores to National
companies. Chains operate 39,000 pharmacies, and employ more than 2.7
million employees, including 118,000 full-time pharmacists. They fill
nearly 2.6 billion prescriptions annually, which is more than 72
percent of annual prescriptions in the United States. The total
economic impact of all retail stores with pharmacies transcends their
$830 billion in annual sales. Every $1 spent in these stores creates a
ripple effect of $1.96 in other industries, for a total economic impact
of $1.57 trillion, equal to 11 percent of GDP. NACDS represents 137
chains that operate these pharmacies in neighborhoods across America,
and NACDS members also include more than 900 pharmacy and consumer
packaged goods suppliers and service providers, and over 60
international members from 23 countries. For more information about
NACDS, visit www.NACDS.org.
engage the private sector in countermeasure dispensing
Experts in emergency preparedness have reported that most
communities lack adequate mechanisms and capacity in public health to
expeditiously dispense countermeasures to all of the target populations
following a public health emergency. Various dispensing modalities have
been discussed, including home delivery by the U.S. Postal Service, the
development of Points of Dispensing (PODs) and pre-positioning of
medications in households, among others.
Policymakers should be encouraged to engage the Nation's community
pharmacies as primary PODs to help extend the reach of public health.
Put simply, dispensing is a normal pharmacy function; nearly 2.6
billion prescriptions are filled in community pharmacies annually.
Pharmacists are among the most accessible health providers, and most
Americans live within 5 miles of a community pharmacy. In a July 2009
PriceWaterhouseCoopers survey, respondents reported the least amount of
difficulty in accessing care from pharmacists. In addition, pharmacists
are highly trusted health care professionals, and have rated in the top
three in each of the past 8 years in Gallup's survey of integrity
across professions. Pharmacists also have the advantage of being able
to administer vaccinations in all 50 States. More than 100,000
pharmacists Nation-wide are qualified to administer vaccinations.
pharmacies: extending the reach of public health
The value of community pharmacies in extending the reach of public
health has clearly been recognized by Federal officials and State
public health officials following their active participation in the
response following Hurricane Katrina and during the 2009 H1N1 influenza
pandemic. Pharmacists have performed a range of services to targeted
patient populations following emergencies, including dispensing
countermeasures, administering vaccines, patient screening and triage,
education of the public, and monitoring for adverse events. Pharmacies
have existing technological infrastructures that can be leveraged to
triage patients, have lot space to accommodate surges in patient
demand, and sell personal protective equipment and medical supplies
that may also be important in preventing or treating CBRN threats. An
increasing percentage of pharmacies have drive-through windows that can
augment patient throughput and assist with social distancing to prevent
infectious exposure.
Pharmacy Engagement During H1N1 Influenza Pandemic
The 2009 H1N1 vaccination campaign was the largest such undertaking
in history, requiring broad coordination across the entire health care
continuum to increase the number of vaccine providers. NACDS and its
members were actively engaged in the planning and execution of public
health H1N1 influenza response. NACDS convened a stakeholder workgroup
meeting that produced the Operational Framework for Partnering with
Pharmacies for the Administration of 2009 H1N1 Vaccine, published by
the Association of State and Territorial Health Officials, which served
as guidance for the relationship between community pharmacies and State
public health planners. The Framework included a template ``provider
agreement'' between public health and community pharmacies, and a
template ``executive order'' proposing emergency amendments to expand
State-level use of community pharmacies in H1N1 vaccination programs.
As a result of the framework, community pharmacies enrolled broadly in
State vaccine provider networks. Several States also issued emergency
orders to expand the ability of pharmacists to administer H1N1 vaccine,
by lowering age limits and streamlining vaccination protocols. While
the vaccine was first available in October 2009, many pharmacies did
not start receiving them from State and local health departments until
November or December.
In December 2009, the Centers for Disease Control and Prevention
(CDC) launched the H1N1 Vaccine Retail Initiative to supplement State
and local public health vaccination efforts. Through this program, CDC
partnered with retail pharmacies and retail clinics to directly provide
H1N1 vaccine. Ten retail pharmacy chains participated, totaling 10,700
retail locations served. These pharmacies received over 5.4 million
doses of 2009 H1N1 vaccine directly from CDC. All told, 10% of 2009
H1N1 influenza vaccinations were provided in a community pharmacy
location.
Pharmacies were also the primary provider of countermeasures to
H1N1 influenza, including Tamiflu and Relenza. The shortage of
commercially manufactured Tamiflu oral suspension--an important
treatment for high-priority pediatric patients--necessitated that
trained pharmacy personnel compound the product with guidance from the
Food and Drug Administration (FDA) and CDC. The unique skill set of
pharmacists make them well-prepared to compound countermeasures into a
formulation that can be used by the most vulnerable populations.
Preserving Adherence to Chronic Medications
In addition to rapid access of countermeasures, it is critical that
patients continue to access life-sustaining medicines for chronic
conditions such as diabetes, high blood pressure, or respiratory
disorders during public health emergencies. This problem, known as poor
``medication adherence'' is a well-documented, enduring challenge to
achieving positive outcomes in patients with chronic disease. The New
England Healthcare Institute (NEHI) estimated that poor medication
adherence in all its manifestations costs the Nation $290 billion
annually--13% of total health care expenditures--resulting from a
worsening of disease, avoidable hospitalizations, and emergency room
visits. Preserving patient medication adherence can mitigate patient
surges at hospitals and emergency rooms, which may free up these venues
to focus on the most at-risk patients. Utilizing pharmacies as PODs may
reinforce the message that patients must continue the safe and
appropriate use of their chronic medications during public health
emergencies.
maximizing pharmacy participation in public health efforts
Community pharmacy support of public health programs has led to
partnerships that have significantly improved patient care, but also
has involved on-going challenges. During the H1N1 influenza pandemic,
the wide variety of State and local processes and restrictions added
complexity to community pharmacy support and we would recommend a more
uniform process in the future. Aligning processes in and across States
for ordering products, claims process, reimbursement, inventory
monitoring, vaccine regulations, and reverse distribution would serve
to enhance the ability of pharmacies to participate in public health
campaigns. Policymakers must also address liability issues related to
employing rapid countermeasure dispensing models. To enhance
preparedness and response to any CBRN attack, it is critical that any
National medical countermeasure dispensing strategy actively engage
private sector partners--including community pharmacies--to address
these issues prior to an attack.
conclusion
NACDS thanks the committee for consideration of our comments on
efforts to engage pharmacies in countermeasure dispensing. As the face
of neighborhood health care, community pharmacies remain committed to
assist public health efforts to protect our citizens through convenient
access to countermeasures. We look forward to working with Congress and
the public health community to ensure the Nation's community pharmacies
are used to the greatest extent possible.
Mr. Bilirakis. I am pleased to welcome our witnesses.
Our first witness is Dr. Alexander Garza. Dr. Garza is the
Assistant Secretary for Health Affairs and Chief Medical
Officer of the Department of Homeland Security. He manages the
Department's medical and health security matters, oversees the
health aspects of contingency planning for all chemical,
biological, radiological, and nuclear hazards, and leads a
coordinated effort to ensure that the Department is prepared to
respond to biological and chemical weapons of mass destruction.
Prior to joining the Department in August 2009, Dr. Garza
spent 13 years as a practicing physician and medical educator.
He most recently served as the Director of Military Programs at
the ER One Institute at the Washington Hospital Center and has
served as the Associate Medical Director of Emergency Medical
Services for the State of New Mexico and Director of EMS for
the Kansas City, Missouri, Health Department.
Dr. Garza holds a medical degree from the University of
Missouri Columbia School of Medicine, a master's of public
health from the St. Louis University School of Public Health,
and a bachelor's degree of science and biology from the
University of Missouri-Kansas City.
Prior to earning his medical degree, he served as a
paramedic and an emergency medical technician. He is a fellow
of the American College of Emergency Physicians and a member of
the American Public Health Association.
Welcome, Dr. Garza.
Our next witness is Rear Admiral Ali Khan. Dr. Khan is the
Assistant Surgeon General and Director of the Centers for
Disease Control and Prevention's Office of Public Health
Preparedness and Response, a position he assumed in August
2010. In his capacity, Dr. Khan leads the CDC's efforts to
prepare for and respond to public health threats and manages
the Strategic National Stockpile.
Dr. Khan joined CDC and the U.S. Public Health Service
Commission Corps in 1991. Over the course of his career, Dr.
Khan has focused on bioterrorism, global health, and emerging
infectious diseases and serves as one of the main architects of
the CDC's Public Health Bioterrorism Preparedness Program.
Dr. Khan received his medical degree from Downstate Medical
Center in Brooklyn, New York, and completed a joint residency
in internal medicine and pediatrics at the University of
Michigan--Ann Arbor. He has a master's of public health from
Emory University, where he also serves as an adjunct professor.
Welcome.
Your entire written statements will appear in the record. I
ask that you each summarize your testimony for 5 minutes.
We will start with Dr. Garza. Thank you.
STATEMENTS OF ALEXANDER G. GARZA, MD, MPH, ASSISTANT SECRETARY
FOR HEALTH AFFAIRS, CHIEF MEDICAL OFFICER, DEPARTMENT OF
HOMELAND SECURITY
Dr. Garza. Thank you, sir.
Good afternoon, Chairman Bilirakis, Ranking Member
Richardson, and distinguished Members of the subcommittee.
Thank you for inviting me to testify before you today. It is an
honor to be here to discuss the Office of Health Affairs
programs that support the Department of Homeland Security's
efforts in medical countermeasures.
Today I will discuss a number of OHA initiatives that help
to mitigate biological threats and help prepare the Nation to
detect and respond to a biological incident. I will also speak
about how DHS coordinates with State and local governments, how
our activities were related to the Executive Order No. 13527,
and how we worked to ensure to a resilient DHS workforce.
OHA supports and coordinates with our Federal partners,
especially the Centers for Disease Control and Prevention and
the Food and Drug Administration, on medical countermeasure
issues. OHA works closely with the DHS Science and Technology
Directorate to assess current and emerging chemical,
biological, radiological, and nuclear risks to the United
States population.
The threat of an attack using a biological agent is real
and requires vigilance. A wide-area attack using Bacillus
anthracis is one of the most serious biological threats facing
the United States. However, even a small, well-coordinated
biological attack will have significant consequences.
The Federal Government has recognized that, in order to
minimize the effects of such an attack, two critical
capabilities must be in place: First, the Nation must be able
to rapidly determine that an attack has occurred before people
become ill. Second, we must have the capability to rapidly
distribute medical countermeasures to the affected population.
Through early detection via our BioWatch system, OHA works
to mitigate the consequences of a biological incident. BioWatch
is a Nation-wide environmental surveillance system that detects
the release of selected aerosolized biological agents of
concern. Early detection give decision-makers the capability to
act to protect their communities by providing medical
countermeasures in a timely fashion, with the goal of saving
lives.
Through the BioWatch program, we have essentially built
local biodefense capability by expanding public health
participation in, and coordination with, the National network
of BioWatch jurisdictional advisory committees as well as local
fusion centers.
In addition, OHA provides health and medical expertise in
planning and exercise efforts that advance National
preparedness and response capabilities. In 2009, Secretary
Napolitano directed OHA to develop the Anthrax Response
Exercise Series. These were comprehensive anthrax response
exercises that have been conducted in each of the 10 FEMA
regions in coordination with State and local governments. OHA
has also led efforts to provide our State and local partners
with guidance for the protection of personnel responding to a
wide-area anthrax attack.
On December 30, 2009, President Obama signed Executive
Order 13527 establishing Federal capability for the timely
provision of medical countermeasures following a biological
attack. OHA participated in all aspects of the response for DHS
to this Executive Order and is the lead office for the
Department's efforts on section 4, which directs Federal
agencies to establish mechanisms for the provision of medical
countermeasures to personnel to ensure the continuity of
mission-essential functions.
In addition, the Department and HHS have the responsibility
to develop a plan to provide medical countermeasures to
mission-essential personnel to ensure the continuity of
operations. We lead this efforts for DHS, and we set the stage
for the Federal interagency.
The Department builds National resilience by ensuring the
protection of our workforce. Due to the nature of our
workforce's security mission, DHS personnel could be exposed
during response activities or in their interactions with the
millions of people they meet every day at airports, ports of
entry, to name a few.
As previously discussed, individuals exposed to anthrax
spores must be protected in a timely manner. Added to this is
the understanding that a biological attack is an act of
terrorism. These issues underlie the importance of the
Department's plans to preposition medical countermeasures in
caches across the country for our workforce.
We have spearheaded the MCM strategy and oversee the
purchase and storage of our countermeasures for our workforce.
This strategy includes all of our employees and personnel, as
well as those in care and custody of DHS. We collaborate with
offices across the Department to assure the Department-wide
strategy is met.
We are following the Secretary's directive to lead by
example and continue to work on developing strategies to make
sure countermeasures are available to support our mission-
critical functions.
I thank you again for the opportunity to testify today, and
I look forward to any questions that you may have. Thank you.
[The statement of Dr. Garza follows:]
Prepared Statement of Alexander G. Garza
May 12, 2011
Good afternoon, Chairman Bilirakis, Ranking Member Richardson, and
distinguished Members of the subcommittee. Thank you for inviting me to
testify before you today. It is an honor to be here to discuss the
Office of Health Affairs' (OHA) programs that support the Department of
Homeland Security's efforts in medical countermeasures (MCM)
distribution and dispensing.
Today I will discuss a number of OHA initiatives that help to
mitigate biological threats and help prepare the Nation to quickly
detect and respond to a biological attack. I will also speak about how
DHS assists and coordinates with State and local governments, our
activities relating to Executive Order (E.O.) 13527, and how we work
every day to ensure a resilient Nation and DHS workforce.
OHA Initiatives That Help Mitigate Biological Threats and Help Prepare
the Nation to Quickly Detect and Respond to Biological Events
OHA supports and coordinates routinely with our Federal partners,
especially the Department of Health and Human Services (HHS), including
the Assistant Secretary for Preparedness and Response (ASPR), the
Centers for Disease Control and Prevention (CDC), and the Food and Drug
Administration (FDA), on medical countermeasures issues. OHA and the
DHS Science and Technology Directorate (S&T) represent DHS as ex
officio members of the HHS-led interagency Public Health Emergency
Medical Countermeasures Enterprise Senior Council, which is the primary
conduit for communication among entities involved in the MCM mission.
OHA also works closely with S&T, which has the DHS lead to assess
current and emerging threats that occur naturally or are chemical,
biological, radiological, or nuclear agents, and to determine which
agents present a significant threat to the U.S. population. S&T
produces the Bioterrorism Risk Assessment (BTRA), a strategic
assessment of bioterrorism risk, updated biennially, that integrates
the findings of the intelligence and law enforcement communities with
input from the scientific, medical, and public health communities. OHA
provides subject matter expertise to S&T in developing the BTRA, and
has worked closely with the BTRA program managers to develop tailored
assessments designed to address specific knowledge gaps or areas of
uncertainty identified within OHA programs. OHA applies these
assessments when operating, managing, and supporting the Department's
biodefense programs.
The threat of an attack using a biological agent is real and
requires that we remain vigilant. A wide-area attack using aerosolized
Bacillus anthracis, the bacteria that causes anthrax, is one of the
most serious mass casualty biological threats facing the United States.
An anthrax attack could potentially encompass hundreds of square miles,
expose hundreds of thousands of people, and cause illness, death, fear,
societal disruption, and economic damage. If untreated, the disease is
nearly 100 percent fatal, which means that those exposed must receive
life-saving MCM as soon as possible.
The Federal Government recognizes two critical capabilities must be
in place in order to minimize the effects of a biological attack.
First, the Nation must be able to rapidly determine that an attack has
occurred. Second, we must have the capability to quickly distribute MCM
to the entire affected population before clinical symptoms appear.
Through early detection, OHA works to mitigate the consequences of
a biological incident. OHA's Biowatch program is a Federally managed,
locally operated, Nation-wide environmental surveillance system that
detects the release of certain aerosolized biological agents before
exposed individuals develop symptoms of illness. This ``detect to
treat'' approach provides the public health community with an
opportunity to respond to a release of a biological agent as quickly as
possible in order to mitigate the potentially catastrophic impact on
the population. Early detection allows communities to provide medical
countermeasures to affected persons in a timely manner in order to save
more lives.
For this reason, OHA is investing in the development of advanced
detection technology that aims to significantly reduce the time between
a release of a biothreat agent and confirmation of the release by
Biowatch technology. The transition to an automated detection system,
called ``Generation 3'', is intended to confirm a release within 4 to 6
hours in the locations that Biowatch covers. Reducing the time it takes
to properly detect and confirm a release is critical because earlier
detection allows for earlier distribution of lifesaving MCM to
effectively protect the exposed population.
DHS Assists and Coordinates with State and Local Governments
OHA works directly with State and local leaders to develop
capabilities to respond to health threats. We have done this by
expanding local public health participation in, and coordination with,
the National network of BioWatch jurisdictional advisory committees as
well as State and urban area fusion centers.
Furthermore, OHA provides health and medical expertise to planning
and exercise efforts that advance National preparedness and response
capabilities. To increase preparedness for and resilience to biological
threats, Secretary Napolitano initiated the Anthrax Response Exercise
Series (ARES) exercises, which are comprehensive anthrax response
exercises conducted in each of the 10 Federal Emergency Management
Agency (FEMA) regions in coordination with State and local governments.
Completed in fall 2010, the ARES series was valuable to State, local,
and regional stakeholders for a number of reasons. It increased
awareness in the areas of biodetection, notification, and early
response protocols. It also provided the opportunity to combine
exercise program requirements (biodetection strategies, including
BioWatch and State exercise plans) while engaging both large and small
metropolitan areas throughout the United States.
ARES successfully provided an opportunity for Federal, State,
local, and regional partners to come together and better understand
their roles and responsibilities supporting biodetection, notification,
and response. ARES created an opportunity for all levels of government
to define and refine their MCM programs and plans. We plan to continue
to build on the success of ARES by conducting workshops in additional
cities for 2011 and 2012.
In addition to ARES and other exercise activities that allow State
and local governments to strengthen their National response
capabilities, OHA also provides our State and local partners with
guidance for protection of personnel responding to a wide-area anthrax
attack. Through the Federal interagency process, OHA led the effort to
develop consensus guidance regarding appropriate protective measures
for responders in the immediate post-attack environment of an
aerosolized anthrax attack. The guidance reflects the most current
understanding of the unique environment that would exist after a wide-
area anthrax release. The guidance is a prudent step to provide to
first responders the best information on protective measures currently
available. The responder community had requested guidance in this area,
and DHS and Federal partners are committed to continually updating the
guidance to ensure that it reflects the best science.
Executive Order 13527: Establishing Federal Capability for the Timely
Provision of Medical Countermeasures Following a Biological
Attack
In addition to assisting and coordinating with State and local
governments, OHA also actively engages in Federal interagency efforts
to strengthen the Nation's ability to prepare for, respond to, and
recover from natural disasters and terrorist attacks. On December 30,
2009, President Obama signed Executive Order (E.O.) 13527,
``Establishing Federal Capability for the Timely Provision of Medical
Countermeasures Following a Biological Attack.'' The E.O. seeks to
mitigate illness and prevent death, sustain critical infrastructure,
and complement State, local, territorial, and Tribal government MCM
distribution capacity.
Section 2 of the E.O. directs the development of a National United
States Postal Service (USPS) MCM dispensing model for U.S. cities to
respond to a large-scale biological attack. This model has the capacity
for rapid residential delivery of MCM for self administration across
all U.S. communities. In collaboration with the Departments of Justice,
Defense, HHS, and USPS, DHS supported the development of the USPS
model. Upon request, DHS will assist State and local governments
through Emergency Support Function (ESF)-13 to provide required law
enforcement support for the U.S. Postal model in those jurisdictions
considering this modality of distributing MCM.
Section 3 of the E.O. directs the development of a Federal rapid
response capacity to supplement State and local governments and the
private sector's capabilities to deploy MCM. This effort is being co-
led by FEMA and ASPR, and OHA has provided subject matter expertise.
Section 4 of the E.O. directs Federal agencies to establish
mechanisms for the provision of MCM to personnel to ensure that the
mission essential functions of the Executive branch departments and
agencies continue to be performed following a biological attack. In
addition, the Department and HHS have the responsibility to develop a
plan to provide MCM directly to mission-essential personnel to ensure
continuity of operations. OHA leads this effort for DHS. We are pleased
to say that DHS is among the first Federal agencies to have met this
requirement of the E.O.
In April 2010, DHS established the Anthrax Preparedness and
Response Steering Committee to develop specific products to improve
preparedness and response efforts that include the activities mandated
in the E.O. The Steering Committee leads the Department's efforts in
enhancing readiness and immediate response in the event of wide-area
aerosolized anthrax attack and includes senior leaders from across the
Department.
DHS Workforce and Health Protection OHA works each day to build
resilience across the country and within the Department. We do so by
leading and strengthening our Nation's collective efforts to secure our
country from the threats we face. We also build resilience by ensuring
the protection of our workforce, as mandated in Section 4 of the E.O.
In Section 4, the President ordered the Federal Government to
establish mechanisms for the provision of MCM to personnel performing
mission-essential functions. Secretary Napolitano further directed the
Department to develop a plan and seek funding for a capacity to provide
emergency antibiotics to all DHS employees in an attacked area, not
just those who are mission-essential.
The DHS workforce includes a wide variety of mission-essential
personnel who work in varying geographical locations throughout the
United States and internationally. Due to the nature of DHS workforce's
security mission, some DHS personnel could be exposed during response
activities or in their interactions with millions of people each day at
airports and ports of entry.
As previously discussed, individuals exposed to anthrax spores can
survive if they take antibiotics quickly, underlining the importance of
the Department's plans to pre-position MCM in caches across the country
for employees. In the event of an anthrax attack, all affected DHS
personnel and their families will also have access to MCM through
existing community MCM dispensing plans.
OHA spearheaded an MCM strategy for DHS employees and oversees the
purchase and storage of MCM for the DHS workforce. This includes all
employees and personnel and individuals in the custody and care of DHS.
The MCM strategy and implementation plan is a multi-year, multi-layered
approach which consists of four phases, each building upon the previous
and is subjected to the availability of funding to achieve its goal of
covering the entire DHS workforce. This scalable approach will ensure
the sustainability of the program.
The goal of the first phase is to protect and mitigate the effect
of an anthrax exposure by delivering MCMs post-event to employees. This
phase is currently underway. We purchased courses of MCM that are
stored at a central location and at regional locations to cover Federal
employees and those in DHS's care and custody. OHA, in coordination
with DHS components, identified accessible and secure facilities for
storage of MCM. Additional cache locations will be identified over time
to improve coverage and proximity to employees. OHA also builds points
of dispensing capability to dispense MCM as needed by providing
training to appropriate personnel.
Leading by example and pushing forward the Federal interagency
effort for MCM dispensing and distribution, OHA collaborates routinely
with various offices within DHS to ensure synergistic efforts in
implementing this Department-wide strategy. OHA provided guidance and
comprehensive planning information to DHS components through the
Anthrax Operations Plans Department Guidance Statement (DGS). We also
provide medical guidance and logistical and operational support to DHS
component offices as they finalize their MCM plans. To supplement the
DGS, OHA has also provided medical guidance in the form of Standard
Operating Procedures, including for storage of MCM, administration of
MCM for anthrax spore exposure, non-medical points of dispensing for
MCM, and working and service animal anthrax spore exposure. OHA is now
in the process of credentialing DHS personnel who will provide the
medical oversight of MCM storage and dispensing.
Among the first departments to fulfill the mandates required by the
E.O., OHA is also sharing lessons learned and coordinating with the
interagency process to ensure the consistency of plans across the
Federal Government, including our partners at HHS, CDC, and FDA. Along
with ASPR, we co-chair a working group to protect mission-essential
employees of Executive branch departments and agencies in the event of
a wide-area aerosol anthrax attack.
Conclusion
OHA manages and oversees the DHS MCM program and works to mitigate
biological threats by preparing the Nation to quickly detect and
respond to a biological attack through early detection and rapid
distribution of MCM. DHS leads and strengthens our Nation's collective
efforts to secure our country from threats, assisting and coordinating
with State and local governments, and helping to ensure a resilient DHS
workforce. Thank you again for the opportunity to testify today. I look
forward to any questions that you may have.
Mr. Bilirakis. Thank you.
Dr. Khan, welcome, sir.
STATEMENT OF REAR ADMIRAL ALI S. KHAN, MD, MPH, DIRECTOR,
OFFICER OF PUBLIC HEALTH PREPAREDNESS AND RESPONSE, CENTERS FOR
DISEASE CONTROL AND PREVENTION
Dr. Khan. Good afternoon. Thank you for the invitation to
address the subcommittee today. My remarks will focus on the
role of the medical countermeasures, including the CDC's
Strategic National Stockpile, to protect the public's health
and, ultimately, our Nation's security.
I would like you all to imagine a 5-pound bag of sugar.
Instead of sugar, let's imagine that it is full of anthrax
spores. Now, while the anthrax bacterium is a naturally
occurring organism, there is nothing natural about well-
produced anthrax spores. In 2001, these anthrax spores were
mailed to news reporters and U.S. Senators, and you know better
than most of the world about anthrax and the risk of anthrax
and how real it is. I had the opportunity and privilege to
serve here for 3 months during those attacks in Washington, DC.
Now, these attacks involved letters which held just one
gram of powdered spores, about the amount in a sugar packet.
Yet, 22 people were infected and 5 died. In comparison, an
equivalent of this 5-pound bag that I mentioned earlier could
infect 100,000 people or more.
If that were to occur, every hour of delay in pretreating
these people with antibiotics will lead to not just increased
illness and death but also social, political, and economic
disruption, as we saw with the limited attack in 2001. Given
this, it is quite clear that this is a National health security
issue.
That is why the Strategic National Stockpile is such a
vital resource for us here in the United States for the
American people. Fortunately for us, CDC, DHS, and Federal,
State, and local partners are working diligently to make sure
that, if such an attack would ever occur, our Nation would be
ready to minimize disease and loss of life--ready to rapidly
detect and identify disease in our communities, ready to
quickly deploy these lifesaving countermeasures from CDC's
Strategic National Stockpile, ready to mitigate the attack, and
ready to assess the effectiveness and safety of our public
health interventions.
Now, to be ready, we require an entire public health system
to use these medical countermeasures for the people who need
them most. This public health system includes public health
nurses, disease detectives, lab workers, who are essentially
helping protect health every day from threats.
During an emergency, CDC also must be able to provide
clinical guidance, track these medical countermeasures and how
they are used, and monitor adverse events. Thus, to protect our
National health security, CDC goes beyond stockpiling and
delivering medical countermeasures. We support our State and
local partners to help them build their capabilities and
abilities to distribute, dispense, and utilize those assets,
recognizing that all response is essentially local. We provide
approximately $600 million in funding and technical assistance
to our State and local partners to help them develop tests to
improve their public health preparedness capability, including
this distribution and dispensing of medical countermeasures.
In my visit to States, including the States represented by
the two of you, I have seen really visible, measurable
improvements in preparedness in multiple areas, specifically
incident management, laboratory capabilities, and risk
communications. Throughout the Nation, we have seen the value
of this investment in public health in how much better we were
able to respond to H1N1 than if we had not made that
investment.
Now, public health preparedness is a dynamic process, and
we must remain responsive to both the changing threats out
there and the environment. To do this, we work very closely
with our Federal partners. DHS is one of our strongest
partners. We work together on deciding the best medical
countermeasures to have ready, developing new lab tests,
including for BioWatch that you just heard, and improving our
ability to utilize medical countermeasures better than we
currently do.
Now, it is important for us to be very innovative in this
time, to make sure that we have rapid, efficient, and cost-
effective ways to protect our National health security. Since--
you referenced--the meeting in January 2010, we are
reconsidering the number of SNS storage sites to have drugs
more available to people rapidly; we are phasing out legacy
perhaps for more efficient programs; we are continuing to
examine the formulary of the SNS, specifically for drug-
resistant anthrax; and we are thinking about stretching the
amount of countermeasures we have by using various studies to
look at using different amounts of those existing
countermeasures.
So, in the end, let me say, we cannot control when or where
an outbreak pandemic or natural disaster, terrorist attack may
occur to threaten the public's health, but we can control how
we respond to it. This is an issue of National health security
for us.
I thank you again for the invitation to testify before you
today, and I will be happy to answer any questions you may
have.
[The statement of Dr. Khan follows:]
Prepared Statement of Ali S. Khan
May 12, 2011
introduction
Good afternoon, Chairman Bilirakis, Ranking Member Richardson, and
Members of the subcommittee. I am Dr. Ali Khan, an Assistant Surgeon
General and Director of the Office of Public Health Preparedness and
Response, at the Centers for Disease Control and Prevention (CDC).
Thank you for the invitation to address the subcommittee today. My
remarks will discuss the role of medical countermeasures (MCM),
including the CDC Strategic National Stockpile (SNS), in strengthening
our Nation's public health preparedness and response, and ultimately
our Nation's health security.
background
Threats to the public's health are always present. These threats
can range from a local food-borne disease outbreak to the tornadoes
that devastated the southeastern United States 2 weeks ago to the
anthrax attacks in the fall of 2001. We cannot control when or where an
outbreak, pandemic, natural disaster, nuclear incident, or terrorist
attack may occur and threaten the public's health, but we can control
how we respond to it. Threats to public health are threats to the
Nation's health security.
Because of its unique abilities to respond to infectious,
occupational, or environmental incidents, CDC plays a pivotal role in
ensuring that State and local public health systems are prepared for
public health emergencies. CDC provides funding and technical
assistance for State, local, Tribal, and territorial public health
departments through the Public Health Emergency Preparedness (PHEP)
cooperative agreement. PHEP cooperative agreement funding provides
approximately $700 million annually to 50 States, four localities, and
eight U.S. territories and freely associated States for building and
strengthening their abilities to respond to public health threats.
The same systems that we use to meet everyday public health needs
are at the core of public health preparedness and response for
unforeseen and unpredictable public health threats. State and local
surveillance and epidemiologic investigations allow us to detect an
emerging health threat and assess its scope, and laboratories identify
and characterize the biological, chemical, or radiological agent
causing it. The public health workforce at the State, local, and
Federal levels uses information from these resources to make decisions
about how to respond to a public health emergency. In some cases,
responding involves the use of MCM to protect or treat people who have
been exposed, infected, or injured, or to protect the health care
workers and others responding to the incident such as first responders
and critical infrastructure personnel.
The SNS is a National repository of MCM. It contains antibiotics,
antiviral drugs, chemical antidotes, antitoxins, vaccines, life-
supporting medications, and medical supplies that are available to
State and local health departments during a public health emergency and
when local supplies are depleted or unavailable. The specific MCM in
the SNS formulary for response to CBRN events are based largely on
assessments by HHS of the need for MCM to address material threats to
National security identified by Department of Homeland Security (DHS).
The SNS is a vital and valuable resource for protecting the
American people. Many threats against the public health component of
National security are from chemical, biological, radiological, or
nuclear (CBRN) agents for which there are few, if any, commercially
available life-saving MCM. The SNS is, in many cases, the only viable
purchaser and holder of necessary quantities of these scarce materials
which are vital for a successful response to many incidents.
As important as the National capability to obtain and hold these
MCM is, the success of health security interventions of the SNS depends
on several factors. These include the detection and characterization of
an event to the timely delivery of these assets to the site of an
incident to the local plans for receiving, distributing, and dispensing
them in the communities. The SNS has developed, tested, and used
pathways to accomplish these goals. CDC's job is not finished, and the
SNS continues to work towards more rapid, efficient, and cost-effective
ways to accomplish this mission.
importance of state and local partnerships
CDC is working to continually improve our capability to deliver SNS
assets to affected areas during a public health emergency. This work
has led to the recent reformulation of the 12-hour push packages--
assets designed to provide a broad spectrum of potentially beneficial
interventions in the early hours of an emergency when we do not have
complete information--that expanded the capability of each 12-hour push
package for use in response to a biological incident, such as an
anthrax release. CDC has also increased the number of storage locations
to allow for better and faster distribution across the country. The
result is that the SNS can deliver large amounts of MCM anywhere in the
United States and the U.S. territories in a very short window of time,
and CDC continues to work to decrease that time window even further.
Getting these products to the people who need them during an
emergency depends on sufficient infrastructure and planning at the
State and local levels. CDC goes beyond stockpiling and delivering SNS
MCM assets to supporting our partners at the State and local levels to
develop and refine their abilities to effectively receive and utilize
MCM delivered from the SNS. CDC is also exploring innovative ways to
dispense them to communities by cultivating strong collaborative
partnerships among planners, emergency responders, and businesses at
the State and local levels. CDC supports these partners by providing
funding through the PHEP cooperative agreement, technical assistance,
distribution plans, and performance measurement consultation.
CDC provides technical assistance to State and local health
departments on receiving and dispensing SNS and other medical assets.
This assistance includes written guidance, on-site and video
teleconference consultations, training and exercise support (e.g.,
workshops, National training summit, tools to design and test response
plans), and direct assistance of CDC personnel at State health
departments. Just as the nature and contents of the SNS have evolved
over time, the guidance, assistance, and support CDC offers to States
have also adapted to changing needs. SNS Program Services Consultants
(Consultants) are CDC employees available to support States and
localities that receive PHEP cooperative agreement funding to engage
the SNS. SNS Consultants regularly provide direct, on-site technical
assistance to State and local personnel on interpreting guidance,
developing and refining plans, conducting training and exercises, and
evaluating capabilities and performance. SNS Consultants are backed up
by dedicated training, exercise, and response teams from CDC that
conduct regular training in Atlanta and provide on-site training and
exercise support to States.
State and local public health responders depend on the
implementation of emergency contracts and, in some cases, mobilization
of volunteer workforces to distribute MCM during an event. CDC
recognizes that volunteers are critical to the final dispensing of MCM
and sponsors grant-funded pilot studies of innovative means to recruit
volunteers. All of these functions feed into the on-going development
of the capabilities critical to the effective dispensing of MCM to the
communities of each State.
Every State maintains plans to receive, distribute, and dispense
MCM received from the SNS. These plans are all unique and account for
the local infrastructure and supporting Government and commercial
partnerships at the State and local levels. These plans are evaluated
and exercised by the SNS coordinators at the State and local levels and
reviewed by the SNS Consultants as part of annual reviews. To
facilitate the improvement of plans and aid in the development of new
capabilities, CDC maintains several forums to actively share promising
practices and innovative concepts and foster discussions among SNS
Consultants and State and local staff. CDC has also developed several
modeling tools that facilitate planning at the Federal, State, and
local levels, providing officials with ways to evaluate plans without
resource-intensive drills or exercises.
To evaluate the effectiveness of each State's plans to use MCM, SNS
Consultants conduct regular Technical Assistance Reviews (TARs) at
least annually to ensure continued readiness. These reviews use an
objective, quantitative scoring framework to assess plans for
receiving, distributing, and dispensing SNS assets. CDC conducts these
reviews at the State, local, and territorial levels and provides each
level with a tool to help them identify gaps in their plans.
The purpose of this technical assistance and performance
measurement consultation is to ensure that each State and local health
department has the ability to utilize SNS MCM assets during the window
where it would make a difference from a public health standpoint.
Because different incidents require different modes of dispensing and
different timelines for effective treatment, CDC has established a
flexible framework for the delivery of MCM from the SNS, through
partnerships with air and ground transportation providers, from a
network of storage locations. Within this framework, CDC staff can
ensure the best combination of location and method of transportation to
support the delivery of MCM within the required time frame.
During the 2009 H1N1 influenza pandemic response (April 2009 to
spring 2010), there was a clear need to provide antiviral drugs and
personal protective equipment to minimize illness and death. The SNS
distribution planning and MCM holdings helped CDC to rapidly deploy
large quantities of key medical assets, including 11 million regimens
of antiviral drugs as part of the deployment of 25% of pro rata
allocations of pandemic influenza MCM, including personal protective
equipment to all U.S. States and territories. CDC also released 300,000
bottles of Tamiflu oral suspension for pediatric use to fill
production gaps and meet increasing demand. Later, SNS distributed
234,000 additional bottles of the suspension to all U.S. States and
territories. HHS also authorized the release of 59.5 million N95
respirators from the SNS to all U.S. States and territories that
requested them. The SNS achieved all planned timelines for this
distribution.
Lessons learned from real-world events such as the 2009 H1N1
influenza pandemic response and on-going work with the SNS have been
applied to a broad range of public health problems. For example,
California relied on its extensive public health preparedness,
planning, and training to distribute and dispense MCM to respond to an
outbreak of pertussis, or whooping cough, in 2010.\1\ Surveillance
systems first brought the increase in the number of cases among
pediatric hospital patients to the attention of the California
Department of Public Health (CDPH) in early 2010. To prevent
transmission of pertussis to vulnerable infants, CDPH offered free
vaccine and encouraged hospitals and local health departments to
support vaccination of new mothers and newborn caregivers. County
public health departments across California applied elements of SNS
planning and public health preparedness to develop and disseminate
educational materials and clinical guidance, raise community awareness,
and set up accessible and innovative vaccine dispensing points, from
mobile clinics to grocery stores, to reach their communities. The
success of this response can be attributed to not only prior SNS
planning among CDC, State, local, and private partners, but also the
capability of the public health workforce in counties across California
to receive and administer the vaccine in a timely manner.
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\1\ CDC. Notes from the Field: Pertussis--California, January--June
2010. MMWR June 9, 2010; 59(26):817.
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federal partner collaboration
CDC collaborates with Federal partners on several MCM efforts. The
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is
a coordinated interagency effort to define and prioritize public health
emergency MCM requirements, focus research, development, and
procurement activities for identified requirements, and establish
deployment and use strategies for MCM in the SNS. PHEMCE is led by the
HHS Office of the Assistant Secretary for Preparedness and Response
(ASPR) and includes key Federal interagency partners, including DHS.
Together, the PHEMCE partners work to optimize our preparedness for
public health emergencies with respect to the creation, stockpiling,
and use of MCM.
CDC also collaborates with ASPR and other Federal partners on the
interagency implementation of Executive Order 13527, ``Establishing
Federal Capability for the Timely Provision of Medical Countermeasures
Following a Biological Attack.'' CDC is currently looking at ways to
further reduce the time required to deploy assets at the Federal level
and to better understand the costs associated with these changes,
particularly at the State and local levels, where resources are
limited. CDC subject matter experts have participated in DHS- and ASPR-
led interagency working groups to generate the planning documents
required by the Executive Order. Through these working group
interactions, CDC is addressing the public health issues associated
with the implementation of the Executive Order. These collaborative
efforts with DHS have resulted in plans to respond that will better
protect the public's health.
CDC is also working with Federal partners to optimize the use of
MCM. For example, CDC is collaborating with DHS and the Food and Drug
Administration (FDA) to establish a process to validate laboratory
methods that will enable the public health community to respond
effectively and appropriately. This process will be used in the
Laboratory Response Network, which is managed by CDC. CDC is also
working with the Biomedical Advanced Research and Development Authority
(BARDA) to enhance our abilities to rapidly test clinical specimens and
determine who has been exposed to a biological agent in order to
provide effective post-exposure prophylaxis. DHS and CDC are also
working to develop rapid antimicrobial resistance testing to quickly
identify agents that may be resistant to first-line MCM in the SNS,
conduct anthrax-related exercises, and develop risk assessments for
CBRN threats.
phemce recommendations guide sns procurements
The contents of the SNS are determined by the PHEMCE, which
assesses the SNS' formulary and makes recommendations based on current
scientific evidence about future procurements. PHEMCE provides
priorities to guide the allocation of funds to the most critical MCM
requirements and the recommended MCM are added to the SNS as resources
allow.
The current PHEMCE process for identifying MCM requirements
includes activities to identify and assess CBRN threats through DHS
threat prioritization; assess medical and public health consequences
for a given threat scenario and use of MCM for each threat agent
through HHS public health modeling; and consult with subject matter
experts. ASPR then assesses MCM requirements by incorporating the DHS
threat prioritization and medical and public health consequence
assessments with evaluations of current levels of preparedness,
concepts of utilization, and product specifications.
Maintaining the inventory of the SNS poses a significant challenge.
All MCM stockpiled in the SNS are subject to FDA regulations. These
regulations include a requirement to label products with expiration
dates that are intended to protect the public from ineffective
products. While some of these FDA-approved MCM are included in the FDA
Shelf Life Extension Program, extension is not an option for the
majority of MCM, and so all of the MCM will eventually expire. SNS
appropriations must be used not only to procure new MCM, but also to
replace items that have expired. Therefore, there are many resource
demands for expanding capabilities to meet PHEMCE requirements.
Innovation is critical to ensuring that public health preparedness
remains dynamic and responsive to changing needs. For example, we
continue to examine the formulary to address new threats like multi-
drug resistant anthrax. CDC is also seeking innovative ways to use the
existing, limited supply of MCM in the SNS. For example, CDC is
providing technical support to the National Institutes of Health (NIH)
and BARDA to conduct anthrax vaccine dose sparing studies to explore
the effectiveness of using smaller doses of anthrax vaccine for each
person to potentially use the current product in the SNS to treat more
individuals.
optimizing the use of mcm in the sns
In addition to the previously mentioned Federal partnership
activities to optimize the use of MCM, CDC's ability to use the MCM
provided by SNS during an event depends on the necessary regulatory
mechanisms that allow for deployment, dispensing, and utilization of
SNS MCM assets. In order to treat individuals at the State and local
level with MCM that have not been approved, licensed, or cleared by FDA
for their intended uses, Emergency Use Authorization (EUA) or
Investigational New Drug protocols must be in place for each product
for the intended purpose. CDC also continues to prepare for potential
deployment and use of MCM by preparing pre-EUA documents and working
with FDA to streamline the process for obtaining an EUA at the time of
an incident. For example, at the request of DHS and with FDA, CDC is
assisting in the development of an EUA for certain MCM that could be
pre-authorized, rather than waiting until an emergency occurs. This
supports continuity of operations planning through implementation of
Executive Order 13527 and would allow Federal agencies to store and
forward place caches of MCM to treat mission-essential personnel,
thereby shortening the time frame in which MCM would be made available
for use and ensuring continuity of operations.
In addition, during an emergency, CDC must be able to provide
clinical guidance for public health and medical professionals.
Difficult allocation decisions should also be made in advance of an
emergency to the extent possible. For example, prioritization policies
are needed to identify populations at highest risk of exposure
following an incident because the need for certain limited MCM would
likely exceed supply. CDC is currently beginning the process of
developing an anthrax vaccine policy that would provide guidance on
priority populations for vaccination as well as those who should not be
vaccinated, much like we do annually for influenza.
CDC is also working with State and local partners to identify ways
and develop systems to better track MCM supply during a public health
emergency response. During the 2009 H1N1 influenza pandemic, the
Federal Government was able to distribute antiviral drugs and other MCM
to the States, in accordance with pandemic influenza response plans.
This activity ensured the availability of MCM at the State level.
However, there was no standard mechanism to track distribution at the
local level. While State and local partners cooperated in CDC's efforts
to establish this level of visibility as the response progressed, the
lack of detailed, accurate inventory tracking information was
challenging for the decision-making process for further SNS
deployments. CDC is applying lessons learned from the response to
understand the most effective and efficient means to distribute and
track antiviral drugs during a pandemic.
The optimal use of MCM also requires rapid feedback on how well
drugs and other interventions are working and how effectively
individuals are able to use public health information to protect
themselves and their families. As with other drugs, monitoring for
adverse events related to the use of MCM is important to guide future
recommendations. Providing decisionmakers and public health authorities
with adverse event data is useful not only for identifying new
concerns, but also for demonstrating that safety monitoring is a vital
part of any emergency response.
challenges to maintaining a strong, flexible system
We have been successful in expanding CDC and public health
resources for preparedness through Federal interagency support and
strong State and local collaboration, but there is still much work to
do.
CDC staff and the interagency participants in PHEMCE diligently
evaluate the SNS to ensure that the public receives the best value for
the funding invested, and that the holdings of the SNS are
scientifically reviewed and prioritized.
The result of this decoupled system for determining requirements
and budgets is that CDC prioritizes the use of funds to meet the
requirements.
Other challenges include professional shortages in State and local
workforce and limited subject matter expert capacity for MCM data
review. In addition, limited safety and efficacy data is available for
many MCM for special populations such as children and pregnant women.
CDC is working with HHS, FDA, and NIH to seek innovative ways to obtain
critical data to improve the evidence base for use in these
populations.
conclusions
The SNS is a unique Federal asset. Effectively using the SNS
requires a collaborative effort by State, local, Tribal, territorial,
and Federal partners on everything from MCM development to development
of diagnostics to detection of an event to distribution and dispensing
of MCM. CDC is seeking ways to ensure appropriate use of resources in
the current fiscal environment. We see examples every day across the
Nation of how public health preparedness and planning to use MCM from
the SNS are being incorporated into everyday public health systems.
CDC continues to work with Federal partners, including DHS, to
integrate Federal capabilities in the overall effort to identify,
develop, acquire, distribute, and dispense MCM--with the ultimate goal
of getting MCM to the people who need them. Being prepared to protect
the public's health is ultimately an issue of health security.
I thank you again for the invitation to testify before you today. I
will be happy to answer any questions you may have.
Mr. Bilirakis. Thank you. Thank you, Dr. Khan. I appreciate
it.
Thank you, Dr. Garza.
We are in the middle of votes now, and we expect it to be a
pretty long series of votes. So we are going to submit our
questions for the record, if that is okay.
I appreciate that. We will reconvene with the second panel
following the last vote, as soon as we get a quorum.
So thank you very much. We should be back in roughly 1
hour, but we want to dismiss the first panel. Thank you.
Ms. Richardson. Thank you very much. I will not return. We
are meeting with the President this afternoon. Thank you very
much.
Dr. Khan. Thank you very much.
[Recess.]
Mr. Bilirakis. I want to welcome our second panel. Thanks
for being so patient with us.
I have Mr. McHargue--I believe that is how you pronounce
it--and he is the Director of Emergency Operations for the
Florida Department of Health.
Welcome, sir.
Next we have Mr. David Starr, and he is the Director of the
Countermeasures Response Unit within the Office of Emergency
Preparedness and Response at the New York City Department of
Health and Mental Hygiene.
Then we have Chief Lawrence Tan. If you could tell where
you are from, as well.
I believe we have one more witness. I believe there is one
more. Dr. Levi--excuse me--and he is the Executive Director of
the Trust for America's Health.
So why don't we go ahead and start, begin testimony with
Mr. McHargue.
I have a markup. I know that the Member over here, Mr.
Marino, also has, I think, an intelligence classified briefing.
But let's get in as much as we possibly can. We look forward to
asking you questions and your responses. Thank you.
We will go ahead and start with Mr. McHargue. Thank you.
STATEMENT OF MIKE MC HARGUE, DIRECTOR OF EMERGENCY OPERATIONS,
DIVISION OF EMERGENCY MEDICAL OPERATIONS, FLORIDA DEPARTMENT OF
HEALTH
Mr. McHargue. Thank you, Chairman Bilirakis and
distinguished Members of the committee. On behalf of Dr. Frank
Farmer, State surgeon general, we thank you for allowing us to
be here today to speak on this most important matter.
Consistent with the National Response Framework, we plan
under the assumption that CBRN incidents will produce
catastrophic impact and will overwhelm local resources,
requiring immediate and sustained State and Federal support.
The ability to quickly assess and meet local needs for medical
supplies and search capability, including pharmaceuticals, is
vital to stabilize the impacted community. This simply cannot
be accomplished in a vacuum and without effective partnerships,
defined through plans and honed by training and exercises.
At the State level, we rely heavily on partnerships with
the Federal agencies charged with developing strategies, plans,
and stockpiles through the Public Health Emergency Medical
Countermeasures Enterprise and the array of programs and
initiatives it sponsors. It is through these efforts that
States have mechanisms to rapidly surge medical countermeasures
in the face of CBRN threats.
The contribution by our Federal partners through the
regional medical coordinators and other medical countermeasure
program staff are invaluable. To be effective, we must work
together at all levels to be prepared to address the
potentially devastating consequences of such incidents. The
stakes are high, the challenges are real, and our commitment to
meet them, like yours, is unwavering.
In Florida, preparedness is operationalized in three
overlapping structures: Public health, emergency management,
and domestic security. Our preparedness and response strategy
is built upon the 37 National target capabilities. The
Department of Health coordinates an integrated public health
system with a network of county health departments. The
structure enhances the integration and coordination between
other local and State entities, such as emergency management
and domestic security.
Chapter 252, Florida statute, establishes the comprehensive
emergency management plan and provides the framework for
responses to all hazards. Also, as a member State with FEMA
Region 4, our partnerships fully engage Federal agencies and
assets.
Florida's domestic security structure is an
interdisciplinary one that is implemented through a framework
of seven regional domestic security task forces involving
disciplines at all levels. Florida's strategy is dependent upon
first-responder input to recommend what needs to be done, how
do we do it, and what resources are required.
Through a variety of Federally-sponsored or -recognized
programs, Florida has an on-going and robust capability to
identify the characteristics of a variety of chemical,
biological, and radiological agents and their effects on
populations. These programs integrate with Federal partners at
every touchpoint.
We also learn from every incident. In the 2010 H1N1
pandemic, a series of advisory groups was used to provide
clinical guidance on our State strategies and response. This
has developed into the establishment of a standing medical
advisory group to assist the department and the State emergency
response team with several things, such as: Recommendations on
protective actions for the public; providing protection for
first responders; evaluation of contraindications in a mass
prophylaxis incident; and, of course, with SNS or managed
inventory, the allocation and apportionment to impacted
populations.
Further, the State has broadened that capability through
demonstrated partnership with the Poison Control System to
rapidly identify both the conditions within the State as well
as serve as the key contact point for adverse reactions
reported by citizens.
As we talk about points of dispensing and their
effectiveness, the Florida strategy provides that points of
dispensing would be utilized for countermeasure dispensing in
every county of our State. These PODs can be used to dispense
medications into the community for virtually any disease
outbreak or CBRN threat. This includes dispensing material from
the Strategic National Stockpile or its managed inventory.
The State has deployed medical countermeasures during real-
world events, things like antivirals and antibiotics; the
anthrax event in Palm Beach in 2001; vaccines for H1N1; and
PPE, personal protective equipment, to hospitals, county school
systems, and other partners.
Florida caches pharmaceuticals locally to be dispensed to
the responders at the onset of an incident, with the Strategic
National Stockpile and managed inventory stockpiles then being
apportioned to meet the civilian need. We are pleased to say
that just today, sir, our plan just received a score of 100
percent from the CDC technical assistance review that was
conducted in January of this year. We believe our plan is
effective.
Since the development of the first three Federal programs--
SNS, CHEMPACK, and the Cities Readiness Initiative--Florida has
continued to develop its program to best manage the logistics
efforts to maximize the time windows to move this important
product. The SNS capability provided, we feel, is the most
significant partner asset we have utilized to date to meet the
needs of citizens impacted by CBRN incidents.
The State uses an on-line training program that has trained
over 3,000 Florida Department of Health staff, volunteers, and
partner agencies on the operations and management of the SNS
program. This is available on-line and should be of interest to
the committee and partners.
In closing, the determination of the scope of the
distribution of medical countermeasures is one best determined
by the collective guidance of State and Federal subject-matter
experts, our partners. Once we receive the guidance, it is our
mission to provide the appropriate countermeasure to the
affected population and to do so quickly and effectively. Given
the recent events that affect the Nation, with influenza to the
broad range of services required for Nationally-occurring
events, I feel that we have developed an appropriate structure
to meet the demand.
I thank you for your time, and I am open to your questions.
[The statement of Mr. McHargue follows:]
Prepared Statement of Mike McHargue
May 12, 2011
Good afternoon, Chairman Bilirakis, and distinguished Members of
the subcommittee. On behalf of Dr. Frank Farmer, State Surgeon General,
I want to thank you for allowing me to represent the Florida Department
of Health on this most important matter here today. My name is Michael
McHargue, Director of Public Health and Medical Planning and Response
for the Bureau of Preparedness and Response of the Florida Department
of Health. My role is the Emergency Coordinating Officer and lead for
Emergency Support Function 8, Public Health and Medical, of the State
of Florida. I work in concert with the State Emergency Response Team
(SERT), which functions at the behest of Governor Rick Scott. As the
lead for ESF8, I coordinate Health and Medical resources and
capabilities as one of 18 Emergency Support Functions of the Florida
State Emergency Response Team. Integrated planning and response is
critical to achieving successful outcomes. Though important, the health
and medical countermeasures that are of interest to this committee are
but one part of the total response required to address a threat of this
type. The medical logistics structure, partnership, and process are the
lifeblood of public protection.
Over the next few minutes, I hope to provide you with an overview
of Florida's on-going efforts in meeting the broad array of challenges
that either impact the State on a regular basis, or that we sincerely
hope to not have to confront.
state level overview
Preparedness is founded on the principle of incremental, integrated
and, simultaneous planning across all disciplines and layers of
government--local, State, and Federal--for all types of hazards, and is
accomplished in a continuous cycle of planning, equipping, training,
and exercising, underpinned by evaluation at each phase. In Florida,
preparedness is operationalized in three overlapping structures: Public
health, emergency management, and domestic security. As stated above,
our preparedness is heavily reliant on the local, State, and Federal
partnerships necessary to span jurisdictions and to provide resources
for incidents that might be deemed as catastrophic. Public health and
medical preparedness is essential to ensuring that the Florida
Department of Health's mission of protecting the health and safety of
all residents and visitors to our State is achieved. Facilitating
collaboration among the State's health care partners, including pre-
hospital, hospital, and medical practitioners, is critical in order to
respond as a system of care. Florida's Public Health and Health Care
Preparedness Strategic Plan 2011-2013 goals, objectives, and strategies
unifies the principles of the three structures and provides the
direction for preparing the State's public health and medical system.
This strategy is built upon the 37 National Target Capabilities.
public health system
Public Health Preparedness is essential to achieving the Florida
Department of Health's mission of protecting the health and safety of
all residents and visitors to our State. Facilitating collaboration
among the State's health care partners, including pre-hospital,
hospital, and medical practitioners, is critical to responding as a
health care system. The Department of Health is structured as an
integrated public health system with the county health departments
being statutory entities under the direction of the State Department of
Health. This structure enhances the integration and coordination
between other local and State entities such as emergency management and
domestic security. Emergency Management Structure Chapter 252, Florida
Statutes, establishes the Comprehensive Emergency Management Plan, and
provides the framework through which the State of Florida prepares for,
responds to, recovers from, and mitigates the impact of a wide variety
of disasters that could adversely affect the health, safety, and/or
general welfare of residents and visitors to the State. It also
provides guidance to State and local officials on procedures,
organizational structure and responsibilities, and serves as a
blueprint for an integrated and coordinated local, State, and Federal
response. As a member State within FEMA Region IV, our plans and
partnerships fully engage Federal partners and assets. Domestic
Security Structure Florida has a dynamic interdisciplinary domestic
security strategy which is founded on five goals:
1. Prepare for all hazards, natural or man-made, to include
terrorism.
2. Prevent, preempt, and deter acts of terrorism.
3. Protect Florida's citizens, visitors, and critical
infrastructure.
4. Respond in an immediate, effective, and coordinated manner,
focused on the victims of the attack.
5. Recover quickly and restore our way of life following a
terrorist act.
The framework for Florida's strategy is seven Regional Domestic
Security Task Forces. From its inception, Florida's strategy has
depended on the first responders to recommend what is needed and to
prioritize implementation of planning, training, and equipment projects
through the domestic security structure.
monitoring and detection of the threat
The State has an on-going and robust capability to identify the
characteristics of a variety of chemical, biological, and radiological
agents and their effects on the population. The ESSENCE syndromic
surveillance system is operational in three-fourths of all hospitals
throughout the State, covering approximately 85% of all emergency
department visits. This system is coupled real-time with regional
epidemiologists working in disease control, as well as food and
waterborne investigations.
Constant updating of the health care system occurs through the use
of the Florida Department of Health Emergency Notification System
(FDENS), as well as the EpiCom system, a State reporting and messaging
board built along the structure of Epi-X, the CDC notification and
update system for a variety of threats to our subject matter experts.
This system, coupled with local surveillance within the county health
department structure, provides an on-going framework for the response.
To aid in the rapid identification of the threat agent, the State
Laboratory Response Network (LRN) laboratory capability is available,
coupled with a laboratory surge structure that utilizes both hospital
and academic laboratory capability.
populations affected
Due to the on-going activities the State faces with natural
disasters, the on-going analysis of all populations, including
vulnerable populations, has been a yearly activity since the storms of
2004. Every county has a profile developed that analyzes the age, race,
indigence, medical status, and birth rates for the community. These
data are coupled with environmental factors that may impact the
community in any event. Florida possesses the capability to rapidly
access, compile, and depict these data using sophisticated GIS mapping,
and can share the results of same using web-based communication, as
well as, redundant mobile communications systems.
evaluations and recommendations for countermeasures
In the 2010 H1N1 pandemic, a series of advisory groups was used to
provide clinical guidance on various aspects our State strategies and
response. This has developed into the establishment of a Medical
Advisory Group to assist both the Department and the SERT in:
Evaluating CDC guidance for appropriateness to the State
situation.
Evaluation of contraindications in a mass prophylaxis event.
Other issues as needed. In an event such as BioWatch, for
example, the group would be evaluating the allocation and
apportionment strategy.
Provide both protective actions and the medical protocols.
Make recommendations to protect first responders.
The State has broadened that capability by developing a key rapport
with the Poison Control system to rapidly identify both the conditions
within the State, as well as, serve as the key contact point for
adverse reactions reported by the citizens.
information management branch
During the response deployments for H1N1, Haiti, then Deepwater
Horizon, there was an increasing and diverse need for information. The
proliferation of rumors and the expanding role of social media
necessitated the development of this Branch in the Operations section
of the Incident Management Structure. The Branch is assigned all of the
messaging for the Department of Health and functions within the Joint
Information Center (JIC) established by the State Emergency Response
Team (SERT). As stated previously, the SERT is the vehicle that ensures
the coordinated input and output of public information for Florida's
citizens.
points of dispensing (pod) strategy
The Florida strategy provides that Points of Dispensing (POD) would
be utilized for countermeasure dispensing in every county in the State.
Local PODs have been established in both open and closed environments.
Adaptation of the POD for issues related to radiation, for example, are
incorporated into the current planning for the incident. Most recently,
the H1N1 pandemic provided an opportunity to demonstrate Florida's POD
Strategy State-wide.
The H1N1 campaign highlighted two successes for the Florida plan.
Forty-three of the 67 counties provided school-based immunization
clinics for students (an example of a closed POD). One of Florida's
counties received a National award for the vaccine strategy within its
school system. The second success was incorporating major
pharmaceutical chains to dispense antiviral medication during the early
days of the pandemic. This partnership, combined with distribution
within the county health department system, led to increased access and
availability.
logistics annex
The Florida Department of Health's Emergency Operations Plan
Logistics Support Annex integrates with the State Unified Logistics
Plan to ensure that the flow of medical supplies, equipment,
pharmaceuticals, and auxiliary personnel is performed in a unified
manner in cooperation with other State of Florida emergency response
elements. Effective public health and medical logistics management
ensures that all functions are executed in a unified manner in order to
reduce costs and ensure the appropriate support actions are
accomplished in a timely manner.
The scope of the Logistics Support Annex is to develop and
coordinate a FDOH State-wide strategy including operational objectives
and tactical standard operating procedures for the procurement,
receipt, storage, distribution, dispensing, and recovery of
pharmaceuticals, medical supplies, and equipment in support of State-
wide response activities.
Florida strategy for delivery systems incorporates a hub and spoke
concept for delivery. The Department uses two main warehousing
facilities, coupled with Receive, Stage, and Store (RSS) sites
strategically located throughout the State. The present format is being
developed to establish a single drop point within the county and then
redistribution to the POD sites. Given the unique nature of Florida's
structure and communities, the apportionment of countermeasures will be
a highly dynamic event.
Florida has provided personal protective equipment (PPE) to
Advanced Life Support Pre-Hospital Emergency Medical Services (EMS)
providers and acute care hospitals. A pre-defined standard PPE package
was allocated based on the number of licensed vehicles for EMS
providers and number of licensed beds for hospitals. Allocation to the
agency level was determined through an assessment of current capacity
and prioritized by the Regional Domestic Security Task Force, Health
and Medical Committees. A minimum standard level of PPE has been
established by the State Working Group for Preparedness, Health,
Medical, Hospital, EMS Committee's Hospital Equipment Task Team. The
current focus of PPE provision is on the sustainment and maintenance of
PPE and the training required for using the PPE.
The State has deployed medical countermeasures during events such
as antivirals, antibiotics (anthrax event in Palm Beach), vaccines, and
PPE to the hospital and county school systems. Caches of ventilators
and a concurrent strategy for them is part of the overall response
continuum. Other key items presently part of the core distribution
strategy include PPE and other protective measures from responders.
In terms of the pharmaceutical strategy, the caches held by the
State are designed to be dispensed to the responders at the outset of
the event, with the Strategic National Stockpile and Managed Inventory
stockpiles then being apportioned to meet the civilian need.
strategic national stockpile (sns)
CDC's Strategic National Stockpile (SNS) is a National repository
of antibiotics, chemical antidotes, antitoxins, vaccines, and other
life-saving medications. During a public health emergency, State and
local public health systems may be overwhelmed. SNS is designed to
supplement and re-supply State and local public health agencies in the
event of such an emergency.
Florida has a robust State-wide SNS program with an emphasis on
maintaining a ready Receipt, Staging & Storage (RSS) infrastructure
which includes enhancement of current State plans and supporting
documentation for receipt of SNS assets, development and conduct of
training and exercise activities for State and Federal partners.
The State has an on-line training program which allows Florida
Department of Health staff, volunteers, and partner agencies an
opportunity to learn the operations and management of the SNS program.
The program, Florida's Introduction to Strategic National Stockpile and
Mass Dispensing, http://www.doh.state.fl.us/demo/php/
FL_Mass_Dispensing.html has trained over 3,000 people. The objectives
of this course are: The scope and purpose of Florida's Strategic
National Stockpile Program, the community's mass dispensing roles and
responsibilities, the two primary methods of distributing and
dispensing supplies, and how mass dispensing incidents are managed.
cities readiness initiative (cri)
The Cities Readiness Initiative is a Federal funding mechanism
targeted at major U.S. cities to assist with preparedness activities
related to the achievement of State and county SNS program goals.
Florida's CRI program includes providing consistent
guidance, feedback, and evaluation to 14 CRI counties and 53
non-CRI counties via multiple venues.
Provide technical assistance to 67 counties for planning
development/refinement, training, and exercise related to the
SNS/CRI programs.
Perform program monitoring, tracking, and presenting project
funding, program deliverables, and performance measures.
chempack
CHEMPACK is a joint Federal-State program designed to implement the
forward placement of chemical nerve agent antidotes to State/local
areas in order to reduce treatment response times. Placement of 108
CHEMPACK containers in the State of Florida was completed in November,
2007. The program is currently in sustainment phase.
In closing, the determination of the scope of the distribution of
medical countermeasures is one best determined by the collective
guidance of State and Federal subject matter experts. Once we receive
this guidance, it is our mission to frame the structure to provide the
appropriate countermeasure to the affected population. Given the recent
events that affected the Nation with influenza, to the broad range of
services required for naturally occurring events, I feel that we have
developed an appropriate structure to meet the demand. I thank you for
your time and will now hopefully be able to answer any questions you
might have.
Mr. Bilirakis. Thank you very much.
Mr. Starr, you are recognized.
I failed to say, the entire statement will be entered into
the record.
You are recognized for 5 minutes, sir.
STATEMENT OF DAVID STARR, DIRECTOR, COUNTERMEASURES RESPONSE
UNIT, EMERGENCY PREPAREDNESS AND RESPONSE, NEW YORK CITY
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Mr. Starr. Good afternoon, Chairman Bilirakis and Members--
Member--of the committee. Thank you for inviting me here today
to testify on New York City's efforts to prepare for the rapid
distribution of dispensing of medical countermeasures in the
event of a public health emergency. My name is David Starr, and
I am the director of countermeasures response at the New York
City Department of Health and Mental Hygiene.
In New York City, our goals are simple: To maximize the
speed and efficacy of distribution operations and to increase
access to countermeasures by the general public. New York City
has worked hard to develop robust plans for the receipt of the
Strategic National Stockpile assets and their distribution
dispensing to the public. Currently, two warehouses stand ready
to receive and distribute SNS assets, and we have identified
close to 200 facilities city-wide that could be used as points
of dispensing, or PODs.
PODs, of course, are temporary dispensing sites set up at
the time of an emergency, and each is designed to dispense oral
medications to approximately 40,000 people in less than 48
hours. We have trained more than 1,500 city employees as POD
managers.
We have developed our capacity to provide critical supplies
and medication to hospitals and primary-care centers after the
initial 72 hours and have reviewed plans for these facilities
to dispense medication to their staff and patients. We maintain
a local cache of medications for our first responders.
In response to the emergence of H1N1 influenza in 2009, we
had an opportunity to implement existing emergency plans. Our
ability to mobilize quickly was proven when the SNS notified us
of inbound assets at approximately 1:00 a.m. on Monday, April
27, and our receiving warehouse was ready as the first trucks
arrived around 5:00 a.m.
That fall, New York City implemented an ambitious school-
based vaccination program and the largest POD operation in
recent history. We directed the receipt, repackaging, and
delivery of more than 1,800 orders of vaccine and supplies to
schools, providing more than 200,000 flu vaccinations to
children across the city.
We mobilized several thousand city employees and volunteers
for POD operations in 29 sites over 5 weekends, vaccinating
close to 50,000 more New Yorkers. At one site, almost 6,000
people were vaccinated over 2 days. The response from the
public at this site, even from those who waited an hour in a
cold rain, was overwhelmingly positive.
Even these experiences did not reach the threshold we set
for ourselves for a city-wide dispensing effort. Though we are
pleased with our accomplishments, complacency is the greatest
enemy to progress. Preparedness is a continuum that must be
nurtured with constant attention, creativity, and predictable
financial support.
When terrorism or a potentially deadly influenza outbreak
is in the news, Federal resources increase. However, once the
threat dims, interest and resources dwindle.
In 2004, Cities Readiness Initiative funding was provided
to prepare 21 high-risk U.S. cities and metropolitan areas to
effectively respond to a large-scale bioterrorist attack. In
the following years, the number of CRI cities increased to 72,
but, without additional resources, many of the highest-risk
cities experienced a decrease in support. In 2008, New York
City's CRI grant was cut by 25 percent and has remained at that
level since.
Since 2002, New York City has also experienced a decrease
of about 26 percent in overall public health emergency
preparedness, or PHEP, P-H-E-P, financial support. The
administration's fiscal year 2012 budget request includes
another cut to this funding. On a per capita basis, New York
City, despite its obvious high risk, ranks 13 out of the 18
jurisdictions awarded a new risk-based funding allocation in
this year's proposed CDC grant. Even that is partially offset
by a cut in our basic program grant.
Stable Federal funding is absolutely necessary for State
and local responders to increase and maintain current levels of
preparedness. If preparedness funds continue to decline, New
York City's ability to sustain its preparedness infrastructure,
so carefully constructed over the last decade, will be in
jeopardy.
There are also operational issues that need attention. We
continue to work for the prepositioning of countermeasures in
local warehouses and the relaxation of the terms of the FDA's
emergency use authorization for the legal dispensing of
countermeasures in the first hours of an emergency.
There is also a need to better align the requirements,
timelines, and deliverables of the different funding streams.
The PHEP grant from the CDC, the Hospital Preparedness Grant
from the Office of the Assistant Secretary for Preparedness and
Response, and the Urban Areas Security Initiative Grant from
the Department of Homeland Security all have unique reporting
and administrative requirements. Any effort to align these
requirements would reduce administrative costs and improve
efficiency. Fortunately, our Federal partners are willing to
listen, and we are making progress on these and other issues.
We very much appreciate the work of Chairman King, Chairman
Bilirakis, and the other Members of this committee. Thank you
for your support of our efforts to protect our citizens and for
the opportunity to speak to you today.
[The statement of Mr. Starr follows:]
Prepared Statement of David Starr
May 12, 2011
Good afternoon Chairman Bilirakis, Ranking Member Richardson, and
Members of the subcommittee. Thank you for inviting me here today to
testify on New York City's efforts to prepare for the rapid
distribution and dispensing of medical countermeasures in the event of
a public health emergency. My name is David Starr and I serve as the
Director of Countermeasures Response in the Office of Emergency
Preparedness and Response at the NYC Department of Health and Mental
Hygiene. I have been privileged to be involved in NYC's emergency
medical countermeasure planning for more than 5 years. I currently
supervise operational planning for the receipt and distribution of
Strategic National Stockpile (SNS) assets and the opening of emergency
dispensing sites city-wide, development of emergency staffing plans to
support such an operation--including the expansion of New York City's
Medical Reserve Corps (MRC)--and special projects to supplement current
dispensing plans. Our goals remain consistent: To maximize the speed
and efficacy of distribution and dispensing operations and to increase
access to countermeasures by the general public.
Over the last decade, New York City has worked hard to develop
robust plans for the receipt of SNS assets and their further
distribution and dispensing to the public. Currently, two receiving
warehouses stand ready to receive and distribute SNS assets within
hours of notification. We are linked to the two sites with a state-of-
the-art warehouse management system, enabling us to both monitor and
direct warehouse operations remotely. We have identified close to 200
facilities city-wide that could be used as ``Points of Dispensing'' or
PODs--temporary dispensing sites set up at the time of an emergency.
Each POD is designed to dispense oral medications to approximately
40,000 people in less than 48 hours. Setting up and running these PODs
would present enormous logistical challenges.
We are working hard to overcome the challenges. In New York City,
each POD is operated with pre-trained leadership teams of 6 and about
90 additional staff who receive ``Just-in-Time'' training. If NYC were
to open all PODs for a city-wide emergency dispensing operation, we
would need approximately 1,200 leadership staff and 20,000 general
staff for the first shift. To support the leadership staffing needs of
such an operation, we have trained over 1,500 city employees as
potential POD leadership team members. We continue to build that number
by identifying and training additional staff. For general staff, NYC
plans include accessing the city's substantial workforce of nearly
300,000 individuals, and engaging volunteers from various organizations
to respond. The New York City Medical Reserve Corps is another source
of staff for PODs, and consists of more than 9,000 pre-credentialed and
pre-registered health care professionals who have volunteered their
services during emergencies.
We have also developed our capacity to provide critical supplies
and medication to hospitals and primary care centers after the initial
72 hours, and we have reviewed plans for these health care facilities
to dispense medication to their staff and patients. We maintain a local
cache of medications for our first responders, whose agencies maintain
internal plans for dispensing these medications to their own employees.
Admittedly, these plans and protocols are merely words and ideas
until implemented in exercises and real-life responses. The response to
the H1N1 influenza outbreak in 2009 allowed us to put into practice
many of our plans and protocols. Within days of its emergence in a
Queens high school, New York City received antiviral medications and
respirators from the SNS. Our ability to mobilize quickly was proven
when the SNS notified our staff of inbound assets at approximately 1:00
a.m. on Monday, April 27 and our receiving warehouse was ready as the
first trucks arrived around 5:00 a.m. As the response in the fall
unfolded, our operational capacity was further tested. New York City
planned an ambitious school-based vaccination program, as well as the
largest POD operation in recent history. Our warehouse quickly set up a
parallel vaccine distribution operation, expanding their refrigerated
vaccine processing area, purchasing additional vaccine supplies and
training select staff on vaccine handling. New York City then directed
the receipt, repackaging, and delivery of more than 1,800 orders of
vaccine and supplies to schools--at the peak, making 90 deliveries per
day, including 15 priority deliveries before 9:00 a.m. Through this
emergency school-based vaccination program, we provided an estimated
202,000 flu vaccinations to children across the city.
In addition, New York City mobilized several thousand city
employees and Medical Reserve Core volunteers for POD operations in 29
sites over five weekends. The vast majority of these employees were
trained ``Just in Time'' per our current protocols. We vaccinated close
to 50,000 New Yorkers in these PODs, and in one site on the Upper East
Side, almost 6,000 people were vaccinated within 2 days. The response
from the public at this site--even from those who waited an hour in a
cold rain--was overwhelmingly positive. However, even the valuable H1N1
experience did not reach the threshold we set for ourselves for a city-
wide dispensing effort.
These operations allowed us to test our distribution and dispensing
site selection, staffing, command and control, and training protocols
and a substantial number of changes to existing plans resulted from
this experience. We have altered our process for selecting POD sites to
assure selected sites are most suitable to support the operation and we
made selection criteria more stringent. In addition, we have conducted
population-density analysis to achieve optimal coverage among our
selected sites. We have revamped our training program and are
conducting drills to test these new protocols. We know that we must not
stop with these accomplishments. Opening 200 temporary sites across an
urban area the size, density, and diversity of New York City is fraught
with obstacles, and while we attempt to identify and mitigate these
obstacles, we are constantly seeking innovative solutions to maximize
dispensing speed and increase access to needed countermeasures.
The greatest danger to our efforts is complacency; the hard work
doesn't end. The Federal Government has worked to define target
capabilities and benchmarks relative to countermeasure distribution and
dispensing, and we meet and exceed those that have been defined.
However, in the absence of a real-life catastrophic incident, the
operational success of our plans is extremely difficult to predict. We
don't have a textbook we can open, or a workbook or checklist to
complete that tells us if we are truly prepared or not. Preparedness is
not a binary concept, you are not either prepared or not prepared, it's
a continuum that must be nurtured with constant attention, creativity,
and predictable financial support. However, I can say with assuredness
that in the arena of countermeasure distribution and dispensing, we are
far more prepared than we were a decade ago, or even 3 years ago.
Maintaining these achievements and continuing our progress requires
constant vigilance.
When terrorism, or H5N1, or H1N1 is in the news, Federal resources
increase. However, once the threat dims, interest and resources dwindle
as well. After 9/11, everyone was a New Yorker, and there was no debate
about the increased threat faced by New Yorkers and other urban areas.
In 2004, Cities Readiness Initiative (CRI) funding in the Public Health
Emergency Preparedness grant was provided to prepare major U.S. cities
and metropolitan areas to effectively respond to a large-scale
bioterrorist event by building capacity to dispense antibiotics to
their entire identified population within 48 hours.
New York City initially received $5.1 million in 2004 as one of 21
cities in the country considered at highest risk. In the following
years, the number of CRI cities increased to 72. The Cities Readiness
Initiative became everybody's readiness initiative, but without
additional resources, many of the highest-risk cities saw a decrease in
support. In 2008, New York City's CRI grant was cut by 25%, and has
remained at that level since.
New York City has also experienced decreases in overall Public
Health Emergency Preparedness (PHEP) grant funding as well--
approximately 26% since 2002; the administration's budget for fiscal
year 2012 proposes another cut in funding for PHEP State and Local
Capacity. While the Center for Disease Control has developed a pilot
risk-based funding pool for fiscal year 2011, this additional funding
for New York City is--in current proposals--partly offset by a 4% cut
in our basic grant. Furthermore, we have been informed that current
proposals are not final, and levels are expected to decrease even more.
In regard to the new risk-based funding, on a per capita basis, New
York City, despite its obvious high risk, ranks 13th out the 18
jurisdictions to be awarded risk funding. Although we have long
supported risk-based funding, we are also concerned that the
uncertainty of continuation of this funding stream and the large cut in
program funding would leave us with a much larger overall funding gap
in fiscal year 2012 and beyond.
Stable Federal funding is absolutely necessary for State and local
responders to increase and maintain levels of preparedness. As we
undertake new initiatives and maintain our state of readiness, there is
a cost. We pay contingency fees to various private partners to build
operational capacity and integrate response planning. We pay to
identify, survey, and map POD sites. We pay for modeling and other
scientific analyses to improve our plan elements. We pay for
transportation redundancy to deliver countermeasures to our citizens.
We pay to maintain a robust warehouse management system, and for
climate monitoring systems that operate in all sites where we store
pharmaceuticals. We pay for the annual training of POD leadership
staff. We continually strive to identify gaps, holes, and weaknesses in
our plans and often pay to fill, patch, and reinforce them. Most of
all, we pay for essential staff, including the highly dedicated
individuals in public health that help to build and maintain our
preparedness. Simply put, if preparedness funds continue to decline,
our city's ability to sustain its preparedness infrastructure will be
jeopardized.
There are also many operational issues that need additional
attention--as we have communicated to the various Federal agencies we
depend on for guidance and support. We continue to push for the pre-
positioning of a limited quantity of Federal countermeasures in local
warehouses to speed the opening of the first PODs to the public. We
have advocated for the relaxation of the terms of the Emergency Use
Authorization that the FDA will require for the legal dispensing of
countermeasures in an emergency. And while our plans center primarily
on the rapid dispensing of oral medications, we are moving forward with
planning for the dispensing of the additional days of antibiotics
needed by an exposed population following a widespread anthrax attack,
as well as the administration of the three-dose course of anthrax
vaccine as recommended by the CDC. There is great need for more
guidance in regard to these matters, and we continue to push for
clarity.
The structure of our funding is also confusing and sometimes
encourages duplication of effort. We continue to use, to the best of
our ability, funds from many different sources including the PHEP grant
from CDC, the hospital preparedness grant from the office of Assistant
Secretary for Preparedness and Response/HHS and the UASI grant from
Department of Homeland Security. However, each of these funding streams
has unique characteristics and requirements. We understand that a
perfect synergy may not be possible, but some effort to align
requirements, timelines, and deliverables could significantly reduce
the administrative burden that draws resources from efforts to improve
public health preparedness.
Fortunately, we benefit from having Federal partners that are
willing to listen, and there has been marked improvement over the
years. We've seen our Federal partners consider options to speed the
initial delivery of countermeasures to our warehouses, and a
willingness to entertain different models of Emergency Use
Authorizations that would help States and local jurisdictions dispense
countermeasures legally in the first hours of an emergency.
We are also grateful for the continued interest of Congress and the
work of Chairman King and this committee. Thank you for your support of
our efforts to protect our citizens, and for the opportunity to comment
today.
Mr. Bilirakis. Thank you very much.
Now, Mr. Lawrence Tan, Chief Tan, you are recognized for 5
minutes.
STATEMENT OF LAWRENCE E. TAN, EMERGENCY MEDICAL SERVICES
DIVISION, DEPARTMENT OF PUBLIC SAFETY, NEW CASTLE COUNTY,
DELAWARE
Mr. Tan. Thank you, Chairman Bilirakis and Members of the
subcommittee. Thank you for giving me this opportunity to
discuss the issue of medical countermeasures' development and
distribution from the perspective of the emergency services
sector.
I am Lawrence Tan, Chief of Emergency Medical Services for
New Castle County, Delaware, and here representing the
Emergency Services Sector Coalition on Medical Countermeasures.
I am also the current president of the International
Association of Emergency Medical Service Chiefs, a professional
organization that represents the leadership of EMS agencies
that performed over 3.3 million emergency responses and
transported over 2.78 million patients in America.
Recent events underscore the importance of these hearings
and the responsibilities of subcommittee in developing policies
that prepare the Nation and ensure our resilience. Given the
recent events and the impending anniversary of September 11, it
is clear that we may yet face another terrorist attack in the
coming months.
The events of 9/11 demonstrated the potential for long-term
health effects and unforeseen costs resulting from terrorism on
unprotected populations. The anthrax attacks of 2001
demonstrated the vulnerability of the United States to
intentional threats from chemical, biological, radiological,
and nuclear incidents. More recently, the earthquake and
resulting tsunami in Japan and implosion of the Fukushima
nuclear plant have dramatically heightened awareness about the
fragility of response capability and capacity and have focused
international awareness on the potential impact of
unintentional radiological exposure.
A biological attack on an unprepared nation has significant
potential to disrupt our Nation's security, hospitals, public
health services, and critical infrastructure, to include the
emergency services sector.
As the Chair cited in his opening statement, the Graham-
Talent Commission has stated, ``It is more likely than not that
a weapon of mass destruction, and most likely a biological
weapon, will be used in a terrorist attack sometime in the
world by the end of 2013.''
The issue the terrorism aside, our society operates with
the potential for a hazardous-material disaster each day.
Accidental chemical and biological incidents can occur anytime
and could have significant detrimental effect on our local
communities.
The current methods of distributing medical countermeasures
have not proven capable of meeting our National goals--in
particular, the protection of the emergency services sector.
New approaches are needed to ensure that those on the front
lines of the response community and their families are
protected.
Several exercises and reports have described that the
stockpiling and distribution practices are currently inadequate
in many parts of the Nation to protect the population against
an intentional anthrax attack. The prospect of critical
infrastructure failure is real and will be compounded by lack
of a National strategy to protect first responders. Ensuring
our first responders' capability and capacity must be a
priority in any National medical countermeasure strategy.
We have examples of when the Nation has shown it is not
prepared to protect emergency services personnel, such as
during the H1N1 pandemic, when determinations about the
protective value of masks were inconsistent with the
operational needs. Additionally, changes in prioritization of
vaccine distribution were made without consulting local
incident commanders.
The emergency services sector is, by definition, the tip of
the spear during a domestic response within the United States
and its territories. Emergency services personnel are likely to
be among the first exposed in an event and need the earliest
possible access to medical countermeasures.
History has demonstrated there is no front line in the
global war on terrorism and that all parts of the world,
including our local communities, are potential targets.
Protecting those who we depend on to respond during these
crises is essential for our community response, resilience, and
recovery and, thus, our Nation's security. This includes
planning with, by, and for the emergency services sector a
medical countermeasure program that protects these personnel
and their families.
As an emergency medical services chief, I have a
responsibility not only for the community for which I am
charged to provide critical lifesaving services but for the
safety and welfare of the personnel that deliver that care each
and every day. We ask these personnel to rise to the needs of
the community during a chemical, biological, radiological, or
nuclear incident. Imagine the potential stressors on that
individual responder being asked to handle the community's
needs during a catastrophic event, all the while wondering if
the needs of their own family members are being fulfilled.
It is imperative that we include the families of the
emergency services sector personnel in the planning for any
medical countermeasures. The effective continuity of operations
of the emergency services sector as a fundamental component of
the Nation's critical infrastructure may well depend on these
personnel having timely access to medical countermeasures both
for themselves and their families.
The time is right to provide emergency service sector
personnel with emergency caches of prepositioned, personal, and
institutional medical countermeasures.
A more fundamental review of the medical countermeasure
enterprise is warranted if we, as a Nation, want a medical
countermeasure system that will protect us through the threats
of the 21st Century. The alphabet soup of programs--the Cities
Readiness Initiative, the Metropolitan Medical Response System,
the Biological Advance Research Development Authority--were
conceived separately and remained uncoordinated.
The Medical Countermeasure Enterprise Review provides the
emergency services sector and the Federal agencies an
opportunity to improve our Nation's protective posture. But the
medical countermeasure enterprise must maintain a larger
perspective than just the Federal Government and must evolve to
include an end-user's point of view.
Many of the emergency services sector professional
associations have joined together to form a new coalition on
medical countermeasures to assist with this effort and provide
a single voice in these important issues for the Nation and
ensure that the evolving National policy protects our response
personnel and their families. We offer the following
recommendations for your consideration:
First, develop an advisory board comprising emergency
services representative to engage in defining end-user
requirements, similar to battlefield medicine practices, and to
advise on the effective distribution practices.
Second, develop a medical countermeasures strategy that
enhances National resilience by protecting the protectors of
our Nation's critical infrastructure.
Third, develop pilot projects to position medical
countermeasures for emergency services personnel and their
families.
Fourth, ensure the continuity of the CHEMPACK program,
including pilot programs to expand the formulary and examine
local pharmaceutical control.
We thank you for your time and attention. We realize that
you certainly have my complete remarks already entered in the
record. I sincerely appreciate the opportunity to come before
you this afternoon to present a perspective from the emergency
response community on this vital subject.
I would certainly welcome any feedback or questions from
the Chairman.
[The statement of Mr. Tan follows:]
Prepared Statement of Lawrence E. Tan
May 12, 2011
introduction
Chairman Bilirakis, Ranking Member Richardson, and Members of the
subcommittee, thank you for giving me this opportunity to discuss the
issue of medical countermeasures development and distribution from the
perspective of the emergency services sector. I am Lawrence E. Tan,
Chief of Emergency Medical Services for New Castle County, Delaware,
and here representing the Emergency Services Sector Coalition on
Medical Countermeasures. I am also the current President of the
International Association of Emergency Medical Service Chiefs, a
professional organization that represents the leadership of emergency
medical services agencies that performed over 3.3 million emergency
responses and transported over 2.78 million patients in America.
Recent events underscore the importance of these hearings and the
responsibilities of the subcommittee in developing policies that
prepare the Nation and ensure our resilience. Given the recent events
and the impending anniversary of September 11 it is clear that we may
yet face another terrorist attack in the coming months.
The events of 9/11 demonstrated the potential for long-term health
effects and unforeseen costs resulting from terrorism on unprotected
populations. The anthrax attacks of 2001 demonstrated the vulnerability
of the United States to intentional threats from chemical, biological,
radiological, and nuclear incidents. More recently, the earthquake and
resulting tsunami in Japan and implosion of the Fukushima nuclear plant
have dramatically heightened awareness about the fragility of response
capability and capacity, and have focused international awareness on
the potential impact of unintentional radiation exposure.
A biological attack on an unprepared nation has significant
potential to disrupt our Nation's security, hospitals, public health
services, critical infrastructure to include the emergency services
sector (ESS). The Graham-Talent Commission on the Prevention of Weapons
of Mass Destruction Proliferation and Terrorism stated ``it is more
likely than not that a weapon of mass destruction [most likely a
biological weapon] will be used in a terrorist attack somewhere in the
world by the end of 2013.'' The issue of terrorism aside, our society
operates with the potential for a hazardous materials disaster each
day. Accidental chemical and biological incidents can occur anytime and
could have significant detrimental effect on our local communities.
The current methods of distributing medical countermeasures have
not proven capable of meeting our National goals, in particular the
protection of the emergency services sector. New approaches are needed
to ensure that those on the front lines of the response community and
their families are protected. Several exercises and reports have
described that the stockpiling and distribution practices are currently
inadequate in many parts of the Nation to protect the population
against an intentional anthrax attack.
The prospect of critical infrastructure failure is real, and would
be compounded by a lack of a National strategy to protect first
responders. Ensuring first responder's capability and capacity must be
a priority in any National medical countermeasure strategy. There are
examples when the Nation has shown it is not prepared to protect
emergency services personnel: During the H1N1 pandemic, determinations
about the protective value of masks were inconsistent with operational
needs. Additionally, changes in prioritization of vaccine distribution
were made without consulting local incident commanders.
The emergency services sector is, by definition the tip of the
spear during a domestic response within the United States and its
territories. Emergency services personnel are likely to be among the
first exposed in an event, and need the earliest possible access to
medical countermeasures. History has demonstrated there is no ``front
line'' in the Global War on Terrorism, and that all parts of the world,
including our local communities, are potential targets. Protecting
those who we depend on to respond during these crises, is essential for
our community response, resilience, and recovery, and thus our Nation's
security. This includes planning with, by and for the emergency
services sector a medical countermeasure program that protects these
personnel and their families. As an emergency medical services chief, I
have a responsibility not only for the community for which I am charged
to provide critical lifesaving services, but for the safety and welfare
of the personnel that deliver that care each and every day. We ask
these personnel to rise to the needs of their communities during a
chemical, biological, radiological, or nuclear incident. Imagine the
potential stressors on an individual responder being asked to handle
the community's needs during a catastrophic event, while wondering if
the needs of their own family members are being fulfilled. It is
imperative that we include the families of the emergency services
sector personnel in the planning for any medical countermeasures. The
effective continuity of operations of the emergency services sector as
a fundamental component of the Nation's critical infrastructure, may
well depend on these very personnel having timely access to medical
countermeasures for both themselves and their families.
The time is right to provide emergency service sector personnel
with emergency caches of pre-positioned personal and institutional
medical countermeasures. The existing processes developed since 2004 to
distribute ``medkits'' to postal workers could be extended to include
the protection of our fire service, law enforcement, emergency medical
services, public works, emergency health care, public health providers,
and other components of our critical infrastructure or in short--the
Emergency Services Sector.
In an age of asymmetrical threats, where the ``battlefield''
extends far from foreign fields into our local communities, we must
take advantage of our strengths, in this case our innovations in
medical protection and stockpiling. The Graham-Talent commission
clearly identified our lack of preparedness to ensure the continuity of
government and civil society in the event of a biological attack. Given
the already identified gaps in preparedness; innovation and new methods
will be needed to address these shortfalls.
The recent Public Health Emergency Medical Counter-measure
Enterprise (PHEMCE) review, which was reported to this subcommittee
last month, took important steps towards improving the process of
developing medical countermeasures in our private and military labs.
The recommendations from the review, as were previously reported are:
the establishment of a Concept Acceleration Program at the
National Institutes of Health to identify promising scientific
discoveries;
the establishment of a strategic investment corporation to
spur innovation;
the establishment of a Center for Innovation in Advanced
Development and Manufacturing; and
a major investment in regulatory sciences and review
capabilities at the Food & Drug Administration.
Each recommendation is important; however the review did not
address the crucial issues of distribution and dissemination of
currently stockpiled countermeasures. The review also failed to
substantially engage the emergency services sector either as end-users
of the countermeasures or in their role within the incident command
component of a response. The medical countermeasure enterprise is not
exclusively a public health mission separate and singular from the
response to a large-scale incident. Medical counter-measure dispensing
is one part of an overall response that includes resource allocation,
security, and public information. It is important to note that even
with the existing Federally stockpiled assets, the overall response
will likely be coordinated through local emergency management
resources.
A more fundamental review of the medical countermeasure enterprise
is warranted if we as a Nation want a medical counter-measure system
that will protect us through the potential threats of the 21st Century.
The alphabet soup of programs (Citizen Ready Initiative, Metropolitan
Medical Response System, Biological Advance Research Development
Authority) were conceived separately and remain uncoordinated. The
PHEMCE review provides the emergency services sector and the Federal
agencies an opportunity to improve our Nation's protective posture. But
the PHEMCE must maintain a perspective larger than the Federal
Government and must evolve to include an end user's point-of-view.
Many of the emergency services sector professional associations
have joined together to form a new Coalition on Medical Countermeasures
to assist with this effort and provide a single voice on these
important issues for the Nation, and to insure that the evolving
National policy protects both our response personnel and their
families.
We offer the following recommendations for your consideration:
develop an advisory board comprising emergency services
representatives to engage in defining end-user requirements
similar to battlefield medicine practices, and to advise on
effective distribution practices;
develop a medical countermeasure strategy that enhances
National resilience by protecting the protectors of our
Nation's critical infrastructure;
develop pilot projects (in at least the Tier 1 Urban Area
Security Initiative ``UASI'' cities) to position medical
countermeasures for emergency services personnel and their
families;
ensure the continuity of the Chempack program, including
pilot programs to expand the formulary and examine local
pharmaceutical control.
The Strategic National Stockpile, the Biological Advanced
Development and Research Authority, and the Metropolitan Medical
Response System are all mature systems which in cooperation with each
other, are capable of devising a new level of protection for the
Nation, and ensuring the protection of the emergency services sector.
A medical countermeasure program that does not effectively protect
the emergency services sector as the first group likely to be exposed
during the performance of their duties, is insufficient. It would seem
logical to include those we depend on to respond to the needs of our
communities during these catastrophic incidents, and have the most to
lose during a chemical, biological, radiological, or nuclear event, in
the development of an effective medical countermeasure program.
Protecting America's emergency responders will not only contribute to
our National resilience, but it's the right thing to do. The axiom of
``form follows function'' leads us to urge the policymakers to verify
the inclusion of the first response community at the beginning, and
throughout the development of any medical countermeasure system.
Thank you for your time and attention. I sincerely appreciate the
opportunity to come before you this afternoon to present a perspective
from the emergency response community on this vital subject. I would
welcome any feedback or questions.
Mr. Bilirakis. Thank you, sir.
Dr. Levi, you are recognized for 5 minutes.
STATEMENT OF JEFFREY LEVI, PH.D., EXECUTIVE DIRECTOR, TRUST FOR
AMERICA'S HEALTH
Mr. Levi. Thank you, Mr. Chairman. Thank you, Mr. Marino. I
am delighted to be testifying here on behalf of Trust for
America's Health, a non-profit, non-partisan organization
dedicated to saving lives by protecting the health of every
community and working to make disease prevention a National
priority.
I have two major points to make in my testimony today.
First, our Nation faces continuing natural and manmade threats
that require an on-going commitment to public health
preparedness. This is a National security threat as direct as
any we face abroad. Second, if we are to achieve the goal of
rapid distribution and dispensing of CBRN medical
countermeasures, we must fund public health preparedness with
the same level of commitment as we have made to other National
security priorities.
As you know, research and development of medical
countermeasures are only half of the battle in our capacity to
quickly respond to a public health disaster. These medicines,
diagnostics, vaccines, and devices must also reach the
potential victims. That is why we need a well-staffed, well-
trained, and well-funded public health system to ensure these
drugs reach the mouths or arms of every impacted individual.
This means we must assure reliable, predictable funding for
public health preparedness, in contrast to the 27 percent
decline faced over the last several years. We must also assure
that State and local health departments are given flexibility
to use all employees, supported with Federal funds, during an
emergency and not be hamstrung by categorical restrictions. We
must fully embrace the spirit of all-hazards in the Pandemic
and All-Hazards Preparedness Act by recognizing that almost
every public health program contributes to preparedness.
Since 2003, Trust for America's Health has been tracking
our Nation's progress and improving our preparedness through
our annual report, entitled, ``Ready or Not? Protecting the
Public's Health from Diseases, Disasters, and Bioterrorism.''
In our 2010 report, we found that States had made enormous
progress since the events of 2001 in planning for and
responding to disasters. The public health emergency
preparedness and hospital preparedness programs, Federal,
State, and local attention to the role of public health in
emergency preparedness, and local attention to the role of
public health in emergency preparedness, and real-world
experiences, such as the H1N1 outbreak, have helped us bring
preparedness to the next level.
However, the report also found that the economic crisis is
putting almost a decade of gain at serious risk. While
emergency H1N1 and stimulus funds may have helped States
weather the storm of the pandemic, we cannot continue to fund
preparedness on a disaster-by-disaster basis.
Our report laid out several remaining public health gaps
that need to be addressed, each of which affects our ability to
distribute and dispense medical countermeasures. We have a
workforce and infrastructure gap, a surge capacity gap, a
surveillance gap, and also a gap in community resiliency
support, and, finally, gaps in medical countermeasure
development.
My written testimony details these issues, but let me focus
on just a few key points now.
The economy recession has led to cuts in public health
staffing and eroded the basic capabilities of State and local
health departments. Our report found that 33 States and the
District of Columbia cut public health funding between fiscal
years 2009 and 2010, with 18 of these States cutting funding
for the second year in a row. If we took another snapshot
today, I fear to say that almost every State would have cut
public health funding.
In addition, Federal support for public health preparedness
has dropped by 27 percent between fiscal 2005 and 2010, when
you adjust for inflation. We are fully expecting further cuts
to the public health preparedness programs in fiscal 2011 and
2012.
The National Association of County and City Health
Officials reports that we have lost 19 percent of the local
health department workforce since 2008. This poses a growing
threat to our response capacity.
Surge capacity--the ability of the medical system to care
for a massive influx of patients--requires on-going planning,
funding, and coordination across health care, public health,
first responders, and the private sector. The medical system
will be an integral partner in distributing countermeasures, as
we saw during H1N1, so we must prepare them to triage and
identify targeted recipients. We believe efforts currently
under way to build regional collaboration into the Hospital
Preparedness Program are essential to leveraging the capacity
of the inpatient and ambulatory care health-care systems for
medical asset dispensing.
Finally, the Nation still lacks an integrated National
approach to biosurveillance, the gathering and analysis of data
related to threats to human health, to achieve early-warning
detection and situational awareness. An interoperable,
coordinated National biosurveillance system would significantly
improve the country's capability to quickly detect an outbreak
or attack and, thus, target our medical countermeasures
appropriately.
The lack of an overarching Federal biosurveillance strategy
has led to fragmentation, multiple separate surveillance
systems, and barriers to relevant agencies' prioritizing and
synthesizing data. We urge HHS to lead the development of a
National strategy, which should examine means to achieve
interoperability and transparency among the various
surveillance systems.
Thank you for this opportunity to weigh in with this
subcommittee as you consider the end-to-end realities of a
medical response to a disaster. I look forward to your
questions.
[The statement of Mr. Levi follows:]
Prepared Statement of Jeffrey Levi
Chairman Bilirakis, Ranking Member Richardson, and Members of the
subcommittee: My name is Jeffrey Levi, and I am Executive Director of
Trust for America's Health (TFAH), a nonprofit, nonpartisan
organization dedicated to saving lives by protecting the health of
every community and working to make disease prevention a National
priority. I am grateful for the opportunity to testify before the
subcommittee today on the distribution and dispensing of medical
countermeasures (MCM) for chemical, biological, radiological, and
nuclear (CBRN) threats.
I have two major points to make in my testimony today:
First, our Nation faces continuing natural and man-made threats
that require an on-going commitment to public health preparedness. This
is a National security threat--as direct as any we face abroad. The
death of Osama bin Laden does not erase that threat; there are still
very creative terrorists out there and our guard cannot be let down.
Second, we must fund public health preparedness with the same level
of commitment as we have made to other National security priorities.
This means: (a) We must assure reliable, predictable funding for public
health preparedness, in contrast to the 27 percent decline faced over
the last several years; (b) we must assure that State and local health
departments are given flexibility to use all employees supported with
Federal funds during an emergency and not be hamstrung by categorical
restrictions; (c) and we must fully embrace the spirit of ``all
hazards'' in the Pandemic and All-Hazards Preparedness Act (PAHPA) by
recognizing that almost every public health program contributes to
preparedness. As our health care system modernizes--especially with
regard to health information technology--we must be sure public health
programs, such as biosurveillance, adapt as well, including by
leveraging existing resources in more creative ways.
As you know, research and development of medical countermeasures
are only half of the battle in our capacity to quickly respond to a
public health disaster. These medicines, diagnostics, vaccines, and
devices must also reach the potential victims. That is why we need a
well-staffed, well-trained, and well-funded public health system to
ensure these drugs reach the mouths or arms of every impacted
individual.
The public health system has always been integral in our response
to natural disasters and terrorist attacks. Public health was on the
frontlines of the response to 9/11 and to the anthrax attacks. It is as
fundamental to the Nation's security as our military and as fundamental
to local protection as fire and rescue. Passage of PAHPA codified and
expanded the Federal Government's support for this role. As a result of
this legislation, and the investments that followed, our Nation is more
prepared than ever. We saw this in the response to the H1N1 outbreak in
2009, when nearly every State and jurisdiction implemented its pandemic
influenza plan in response to the H1N1 outbreak, with activities
including disease surveillance, on-going communication updates,
carrying out vaccination campaigns and the coordination of response
efforts with partners.\1\
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\1\ Centers for Disease Control and Prevention, Public Health
Preparedness: Strengthening the Nation's Emergency Response State by
State, September 2010. Available from: http://emergency.cdc.gov/
publications/2010phprep/pdf/complete_PHPREP_report.pdf.
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Since 2003 TFAH has been tracking our Nation's progress in
improving our preparedness through our annual report entitled Ready or
Not: Protecting the Public's Health from Diseases, Disasters, and
Bioterrorism. In our 2010 report, we found that States had made
enormous progress since the events of 2001 in planning for and
responding to disasters. The Public Health Emergency Preparedness and
Hospital Preparedness Programs, Federal, State, and local attention to
the role of public health in emergency preparedness, and real-world
experiences such as the H1N1 outbreak have helped us bring preparedness
to the next level. However, the report also found that the economic
crisis is putting almost a decade of gains at serious risk. While
emergency H1N1 and stimulus funds may have helped States weather the
storm of the pandemic, we cannot continue to fund preparedness on a
disaster-by-disaster basis.
Our report laid out several remaining public health gaps that need
to be addressed, each of which impacts our ability to distribute and
dispense medical countermeasures: A workforce and infrastructure gap, a
surge capacity gap, a surveillance gap, a gap in community resiliency
support, and gaps in medical countermeasure development. I'll address
these in turn.
Workforce and Infrastructure Gap.--The economic recession has led
to cuts in public health staffing and eroded the basic capabilities of
State and local health departments. Our report found that 33 States and
the District of Columbia cut public health funding from fiscal years
2008-09 to 2009-10, with 18 of these States cutting funding for the
second year in a row. In addition, Federal support for public health
preparedness was cut by 27 percent between fiscal year 2005 and fiscal
year 2010 (adjusted for inflation). We also expect to see major cuts to
Federal public health preparedness programs in both fiscal year 2011
and 2012. The National Association of County and City Health Officials
reports that we have lost roughly 19 percent of the local health
department workforce since 2008. This loss of experience has a
staggering impact on preparedness, as workers cannot simply be hired
and trained once a disaster strikes. Strengthening the public health
preparedness infrastructure is critical to ensuring the health
protection of our Nation through distribution and dispensing of medical
material. It also requires adequate funding and human resources to
recruit and train personnel, stockpile life-saving countermeasures,
develop and exercise plans to distribute assets, and identify and
engage partners to support the public health mission. The resources
required to truly modernize public health systems must be made
available to bring public health into the 21st Century and improve
preparedness.
During the 2009-2010 H1N1 influenza outbreak, State and local
health departments were on the front lines responding to the pandemic,
though many were limited in their efforts as a result of Federal and
State budget cuts, particularly those that have occurred over the past
5 years. These budget crises demonstrated, among other things, the need
to build in mechanisms to allow more flexibility in how staff, funded
by Federal grant programs, are used during emergencies. In the H1N1
influenza response, the ability to re-assign staff from other funded
projects in health departments could have improved the financial and
human resource efficiencies of that agency's response to the influenza
pandemic, especially during the earlier response phases when additional
funding was not yet available and jurisdictions needed to mobilize
``all hands on deck.''
The Department of Health and Human Services (HHS) and Department of
Homeland Security (DHS) have been working to align grant programs that
aim to build our Nation's emergency preparedness capacity, including
the Public Health Emergency Preparedness (PHEP) grants, Hospital
Preparedness Program (HPP), and FEMA grants. Currently the PHEP and HPP
grants, both of which are often distributed through public health
departments, have separate application and reporting requirements,
overarching goals, and in some cases conflicting performance metrics.
We believe the alignment process should include coordinating grant
priorities and goals, grant cycles, and streamlining application and
reporting mechanisms to achieve maximum efficiency. We hope this
committee works with your counterparts in Energy & Commerce to ensure
the alignment process continues.
Surge Capacity Gap.--Surge capacity, the ability of the medical
system to care for a massive influx of patients, requires on-going
planning, funding, and coordination across health care, public health,
first responder, and private sectors. The medical system will be an
integral partner in distributing medical countermeasures, as we saw
during H1N1, so we must prepare them to triage and identify targeted
recipients. We believe efforts currently underway to build regional
collaboration into the Hospital Preparedness Program are essential to
leverage the capacity of the inpatient and ambulatory health care
system for medical asset dispensing.
Surge planning must also take into account the important role of
volunteers in mass dispensing. The Medical Reserve Corps (MRC) is a
National network of community-based groups which include volunteers
from public health, medicine, nursing, and non-medical support fields.
During the H1N1 outbreak, MRC units across the country participated in
2,500 response activities, including vaccination clinics, significantly
augmenting the capacity of local public health to implement the
immunization strategy.\2\ However, in a survey conducted during the
outbreak, MRC units reported that fear of liability was a significant
barrier to full participation.\3\ HHS has also acknowledged that a
patchwork of Federal liability laws is confusing and frustrating to
other health care providers.\4\ HHS should clarify Federal volunteer
liability laws to implement one, blanket liability that applies to all
volunteer health professionals and entities volunteering under a
Nationally-declared public health emergency or disaster. There should
also be Federal Tort Claims Act protection for MRC volunteers year-
round, as these personnel participate in public health drills and
training during times of non-disaster.
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\2\ Office of the Civilian Medical Reserve Corps, ``Report on the
Medical Reserve Corps Response to the H1N1 Influenza Pandemic April--
December 2009.'' http://www.medicalreservecorps.gov/file/PandemicFlu/
MRC-H1N1-2009-final.pdf.
\3\ Office of the Civilian Medical Reserve Corps, ``Medical Reserve
Corps Units and H1N1 Influenza Related Activities: September 2009.''
http://www.medicalreservecorps.gov/file/SwineFlu/
MRC_Units_H1N1_Flu_Activities.pdf.
\4\ DHHS, Office of the General Counsel, ``Public Health
Emergencies and Federal Health Law.'' Presentation at 2010 Public
Health Preparedness Summit, February 2010. http://www.phprep.org/2010/
Agenda/upload/Interactive-145.pdf.
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Surveillance Gap.--The Nation still lacks an integrated, National
approach to biosurveillance, the gathering and analysis of data related
to threats to human health to achieve early warning, detection, and
situational awareness.\5\ An interoperable, coordinated National
biosurveillance system would significantly improve the country's
capability to quickly detect an outbreak or attack and thus target our
medical countermeasures appropriately. The lack of an overarching
Federal biosurveillance strategy has led to fragmentation, multiple
separate surveillance systems, and barriers to relevant agencies
prioritizing and synthesizing data.\6\, \7\ We urge HHS to lead the
development of a National strategy, which should examine means to
achieve interoperability and transparency among various surveillance
systems.\8\
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\5\ Centers for Disease Control and Prevention, ``Biosurveillance:
A Definition, Scope, and Description of Current Capability for a
National Strategy,'' Presentation before International Society for
Disease Surveillance, 2008. http://www.syndromic.org/conference/2008/
presentations/Track%203/
ISDS%20Presentation_Fleischauer_Biosurveillance_2008.ppt.
\6\ Nuzzo, Jennifer, Center for Biosecurity of UPMC. ``Developing a
National Biosurveillance Program,'' Biosecurity and Bioterrorism.
Volume 7, Number 1, 2009. http://www.upmc-biosecurity.org/website/
resources/publications/2009/biomemo/2009-03-27-
develop_natl_biosurveillance.html.
\7\ Vinter, S. et al, Trust for America's Health, Ready or Not?
2009: Protecting the Public's Health from Diseases, Disasters, and
Bioterrorism. December, 2009. http://healthyamericans.org/reports/
bioterror09/pdf/TFAHReadyorNot200906.pdf.
\8\ Nuzzo, 2009.
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The National strategy should also call for leveraging of new
epidemiological data that may become available as a result of the
development of health information technology (IT) and electronic health
records (EHRs). There is no overarching coordination between public
health surveillance efforts at HHS and the work of the Office of the
National Coordinator (ONC). For example, as ONC develops new standards
for meaningful use of health IT, it should incorporate the preparedness
and biosurveillance implications of such technologies. Interoperability
between public health and EHRs could not only help with early detection
of an emerging disease outbreak or bioterror attack, but could also
help with identification of targeted populations or geographic regions
to receive medical countermeasures and tracking the post-dispensing
impact of medical interventions.
Community Resiliency Support Gap.--We continue to face challenges
in preparing communities to recover from a disaster, especially at-risk
people. Without an ability to reach these populations, such as home-
bound individuals or those with limited-English proficiency, we face
significant barriers in distributing medical countermeasures to them.
Public health must work with the private sector, community-based and
faith-based organizations, health care organizations, and community
leaders to develop trust and communication with at-risk communities
before a disaster occurs. We also must address on-going vaccine access
issues during times of non-disaster, especially in high-risk
communities. For example, according to 2008 data, 70 percent of older
non-Hispanic whites received the seasonal influenza vaccination,
compared to only 51 percent and 56 percent of older African-Americans
and Hispanics, respectively.\9\ This indicates a systemic problem with
access, acceptance, and education that must be addressed before the
next mass-dispensing campaign occurs.
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\9\ HHS Office of Minority Health, Immunizations Data/Statistics,
April 20, 2010. http://minorityhealth.hhs.gov/templates/
browse.aspx?lvl=3&lvlid=60.
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Gaps in Medical Countermeasure Enterprise.--As you explored in your
April hearing, although we are miles ahead of where we were during the
2001 anthrax outbreak, our ability to spur innovation in limited-use
technologies has been hampered by a lack of stable funding and some
breakdowns in program administration. As the Nation revamps its
approach to research and development of vaccines, medicines,
diagnostics and equipment to respond to emerging public health threats,
policymakers must ensure public health is involved throughout the
process, from initial investment through distribution and dispensing.
We believe a Federal MCM strategy should lead to: (1) Increased
coordination between all of the involved agencies within HHS, DHS, and
State and local public health, from initial investment through
dispensing; (2) improved transparency of the development and
distribution process; and (3) an end-to-end approach--not just focused
on initial investments, but on advance development, procurement,
distribution, and surveillance.
There should also be a plan for stocking the Strategic National
Stockpile (SNS) and for on-going replacement of expiring product,
especially vaccines,\10\ pediatric doses of antimicrobials, antivirals,
and other products, and restocking materiel used as a result of the
H1N1 outbreak. This plan should also include a professional judgment
budget for replacing product expiring over the next several years.
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\10\ Testimony of Robert Kadlec Before House Homeland Security
Subcommittee on Emerging Threats, Cybersecurity, and Science and
Technology. June 15, 2010. http://hsc.house.gov/SiteDocuments/
20100615131640-79968.pdf.
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Success at Risk: The Urban-Rural Experience.--Urban and rural areas
face very different challenges in capacity to distribute and dispense
medical countermeasures. For all jurisdictions, adequate workforce and
resources are a continuing obstacle to effective dispensing.
The Cities Readiness Initiative (CRI) is a Federal program that
directly funds the largest metropolitan statistical areas (MSA) and
provides technical assistance to develop capacity to receive and
distribute medical countermeasures. Fifty percent of the U.S.
population is covered by the 72 jurisdictions in the CRI program.\11\
The program requires each area to demonstrate plans to be able to
distribute antibiotics to the entire population within 48 hours. An
analysis by RAND in 2009 found that CRI had helped cities develop the
workforce, partnerships, planning, and purchasing capacity to dispense
medical assets, but evaluation of the real capacity of cities to carry
out these plans was limited due to the nature of the data
collected.\12\ We hope CDC continues to refine these measures to enable
evaluation of the actual capacity and capabilities of each
jurisdiction, rather than just the adequacy of plans, and we urge CDC
to release this data at the local level.
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\11\ Centers for Disease Control and Prevention, ``Cities Readiness
Initiative,'' May 20, 2010. http://www.bt.cdc.gov/cri/.
\12\ Willis, H.H., et al. RAND Corp, Initial Evaluation of the
Cities Readiness Initiative, 2009. http://www.rand.org/content/dam/
rand/pubs/technical_reports/2009/RAND_TR640.pdf.
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The impact of CRI in urban areas was demonstrated during the H1N1
outbreak. In Los Angeles County, for example, 200,000 people received
free H1N1 vaccines at 109 points-of-dispensing (PODs) in a 6-week
period.\13\ And the county has in place plans to distribute medical
assets to 10 million people within 48 hours, as required by CRI. Los
Angeles is also in the process of developing partnerships with schools
and child care facilities to serve as alternative dispensing sites.
These kinds of partnerships are key to achieving coverage of an at-risk
population (during H1N1, children), and ensuring that income, language,
and transportation are not barriers to receipt of the product.
---------------------------------------------------------------------------
\13\ Plough, A. et al, ``Pandemics and Health Equity: Lessons
Learned From the H1N1 Response in Los Angeles County,'' Journal of
Public Health Management & Practice: January/February 2011--Volume 17--
Issue 1--p. 20-27.
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The rural perspective varies based on whether the area is part of a
CRI. Those rural areas within a CRI's MSA have the benefit of
additional resources and technical assistance from the Federal program,
with fewer people to serve. However, in truly rural areas, additional
creativity is required. For example, one rural Virginia health
department pursued agreements with fast-food establishments and banks
to serve as drive-thru PODs.\14\ Rural areas also face different
challenges due to the limitations of communications. In many areas,
land-lines are the only consistent form of telecommunication, while
cities can depend more reliably on internet and cell phone use.\15\
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\14\ McMorrow, Julie, National Association of County and City
Health Officials, personal communication, May 10, 2011.
\15\ Ibid.
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In both rural and urban areas, local health departments have had to
rely on public-private partnerships to achieve maximum coverage of
dispensing planning. During H1N1, health departments depended on big
box stores, retail pharmacies, schools, and private physician offices
to serve as distribution points. These partnerships are an
acknowledgement that public health does not have the personnel to reach
everyone in a community, but also demonstrates that the private sector
and other community-level organizations often have better access to the
population. Federal assistance, both before and during an emergency,
should embrace and grow these partnerships. This is one of the reasons
we support expansion of the mission of the Hospital Preparedness
Program to include the entire medical system of a region.
Thank you for this opportunity to weigh in as the subcommittee
considers the end-to-end realities of a medical response to a disaster.
I look forward to your questions.
Mr. Bilirakis. Thank you, Dr. Levi.
I want to thank all of you for being so flexible with the
schedule today. You know, initially, the meeting was scheduled
in the morning, but to accommodate the minority party, we--in
the afternoon, we did not anticipate votes. So I apologize for
that.
I would like to recognize Mr. Marino, because I know he has
an important meeting to go to, for 5 minutes or so.
Sir, you are recognized.
Mr. Marino. Thank you, Mr. Chairman.
This meeting here is just as important to me; it is just
that we have to be in three different places at one time
anymore.
Gentlemen, I was a district attorney for 12 years and very
active in my community and in my region with emergency
services. I am going to pose a scenario to you and ask you to
respond to it. I may interrupt politely to expand on it,
bearing in mind that we only have about 5 minutes.
We will start with the doctor, if you don't mind, sir.
Let's assume that the money that you have been budgeted
last year will be cut by 50 percent. What do we do
collectively--and I know people come in and say, money is the
issue, money is the issue. But let's just assume the bottom
line is cut 50 percent. What do we do, and how do we use it
most efficiently?
I know that is a tough one, so you have a moment to think
about it, but not too much. And I say ``we'' collectively.
Mr. Levi. Right, right. So, you know, that is obviously a
very difficult question. I mean, I think the first thing is
that one would have to be honest with the American people and
say, if we make cuts of this magnitude, you cannot expect the
level of protection that you have assumed exists for you today.
Mr. Marino. Okay, then where would you start? What are the
priorities with that 50 percent cut?
Mr. Levi. I think my priorities probably would be, to a
large degree, the focus of this panel, making sure that State
and local health departments had a true emergency response
capacity. What I would be looking at are some of the things you
heard from some of the other witnesses as well: Making sure we
are eliminating duplication, making sure that the existing
programs are as efficiently managed as possible.
I will be honest with you, I don't think that we can
sustain a 50 percent cut. So it is very hard for me to even
imagine what we would focus on. I think we would have to make--
and I wouldn't feel comfortable doing this on the spot--would
have to make some decisions. There are some threats that we
just couldn't prepare for.
Mr. Marino. Okay.
Mr. Levi. You know, I don't think that is an acceptable
approach to, you know, the most vital Government function,
which is protecting us from threats over which we have no
control.
Mr. Marino. Okay.
Chief, do you want to add something to that?
Mr. Tan. I think one of the first things you would have to
look at is, do we have sufficient information to determine what
our greatest threats are?
From an EMS standpoint, one of the biggest gaps that we
find is there is no lead Federal agency with responsibility for
EMS to help coordinate what is the emerging threat for the
emergency services sector so that we can focus what remaining
funding we have left, in your scenario, on what is the greatest
threat that is going to do the greatest amount of good for the
greatest number of people.
The other is early detection and preparedness, that if we
can take the intelligence and the information that is available
on where our greatest gaps and threats are, push that
information out to the response community so that there is
preparedness activities rather than consequence management,
that may leverage some greater savings, from the perspective of
minimizing potential exposure rather than having to deal with
the aftereffect.
Mr. Marino. Mr. Starr, do you want to add anything
different to that?
Mr. Starr. Not really. I would just like to concur with Dr.
Levi. I think that you would--we couldn't fathom that kind of
cut to our programs. I think that it would be a tangible and
real decrease in the ability for us to function and for us to
protect our population.
I don't think--our ability to cooperate with the Federal
Government, to fulfill the mandates that we receive from the
Federal Government under our current grant programs would be
severely impacted. I mean, I doubt we could fulfill the
mandates that we are getting from our Federal partners.
Mr. Marino. Okay.
Mr. McHargue, I am going to change the question a little
bit. How much of a stockpile do we need and how much notice
would the pharmaceutical industry need if we avoided
inventories for great periods of time for medications that you
would have to dispense? Do you understand my question? You look
a little perplexed.
Mr. McHargue. I am. Are you speaking, sir, about the
National stockpile in concert with local?
Mr. Marino. Yes.
Mr. McHargue. Well, those numbers are a moving target, I
will admit that. I don't know how much testimony you want in
terms of actual figures, because the strategic placement of a
lot of those materials and the ability for them to be exploited
or used against us, or eliminated in the case of a threat,
but----
Mr. Marino. Let me rephrase that a little bit. Say you
need--I am just going to take penicillin just as an example.
How long would it take, in your opinion, for you to have enough
to start distribution if--how much time if you need to contact
the pharmaceutical that, ``Hey, we need this, and we need it
now. How much can you give us?''
Mr. McHargue. Well, according to the Strategic National
Stockpile Plan, those assets would be rolled immediately and on
the ground within 12 hours. Then it becomes our responsibility
to receive, break those packages down, and distribute them into
the community.
Mr. Marino. Now, you are saying they are already produced,
though, correct?
Mr. McHargue. Well, that assumes availability, yes, sir.
Mr. Levi. Right. The whole assumption of the Strategic
National Stockpile is that these are things that we would need
so quickly that you couldn't go to a manufacturer and say, you
know, ``Start producing a large quantity now.'' The whole
principle of the Strategic National Stockpile is that we have
to be able to respond immediately.
Mr. Marino. Thank you.
Mr. Tan. Mr.----
Mr. Marino. I have gone over my time. Please, Chief--is
that all right, Chairman?
Chief, do you want to respond?
Mr. Tan. Just, I mean, in looking at medical
countermeasures, one of the things that I would just offer is
the fact that sometimes the cost of these medical
countermeasures is prohibitive of local government being able
to sufficiently have supplies that would protect the
population.
A good example is the Cyanokits that are used as a medical
countermeasure against cyanide. It is $700 a kit. When you
start looking at trying to protect the local population, local
government, local emergency response agencies would have a
tremendously difficult time, in your scenario, trying to
adequately prepare not only their own personnel but respond to
the population, as well.
Mr. Marino. Gentlemen, thank you very much. Thank you for
waiting. I apologize for that.
Mr. Bilirakis. Thank you, Mr. Marino. Appreciate it. That
first question was hypothetical, correct?
Mr. Marino. Yes.
Mr. Bilirakis. Yes, I figured that. Just getting that on
the record.
All right. My first question is to Mr. McHargue.
The Council on State and Territorial Epidemiologists
conducted a survey last year to assess State-level preparedness
for a radiological or nuclear event, exclusive of a nuclear
plant emergency.
Can you please describe Florida's planning efforts with
regard to stockpiling, distribution, and dispensing of medical
countermeasures that can be used to respond to a radiological
dirty bomb or nuclear attack?
Mr. McHargue. Okay, I can to a limited degree, sir.
We have three nuclear power facilities in Florida that you
are very familiar with, being from that State. We work very
closely with the National Regulatory Commission, the State
Emergency Response Team, through regular drills and exercises
to test the safety of the response plans.
The caching of pharmaceuticals are limited, at best,
locally. We are aware--I don't know the numbers, but in the
communities surrounding the nuclear power plants, it is our
understanding that there are limited quantities of KI, for
example, or like drugs. I cannot, at this moment, tell you the
quantities, but I will be glad to report off-line following the
hearing.
Mr. Bilirakis. Yeah, we would appreciate that very much.
Mr. McHargue. I would be glad to do it.
Mr. Bilirakis. Thank you.
Mr. Starr, I am concerned about your comments regarding the
considerable need for more Federal guidance and more action on
matters such as prepositioning of Federal emergency medical
countermeasures and some relaxation of the emergency use
authorizations. I know that some locales would also like to see
local implementation of the Federal Shelf-Life Extension
Program for expiring countermeasures.
Two questions: Who in the Federal Government have you
worked with to address these issues? Is it FDA or DHS?
Mr. Starr. It is actually, particularly in the first case,
it is the CDC we have been working with about the
prepositioning of medical countermeasures and the relaxation of
the FDA's emergency use authorization. It is not really our
place, being a recipient of CDC funds, to go past the CDC to
contact the FDA.
If you remember some of Dr. Khan's comments from the first
panel, they have made--and this is one of the things that is
very heartening to us--they have made advances on that. I don't
have details on how far they have gotten. I think that is a
question for them.
The guidance, really, that we were looking for is in regard
to the follow-on 50 days of antibiotics needed for anthrax
exposure after the 10 days of initial distribution, as well as
the three-dose regimen of vaccine that is necessary to an
exposed population. Again, they have convened work groups to
identify some of the issues surrounding these and provide
further guidance.
So, again, we push for this type of guidance, and we are
lucky enough to have partners, I think, at the Federal level
that are responding as best they can.
Mr. Bilirakis. Thank you.
This is for Chief Tan. Anyone else who wants to chime in,
you are perfectly welcome.
Your coalition was established to provide a forum for the
first responder medical countermeasures policy issues. Why do
you think the emergency services sector, which is one of the 18
critical infrastructure sectors, has been left out of important
policy discussions surrounding review of our MCM enterprise and
promulgation of guidance for response to WMDs?
Mr. Tan. I think part of the dilemma is that there is a
disconnect between the public health portion and the actual
response community. It is likely that when the public health
community was looking at the medical countermeasures, they
weren't necessarily looking at it from an emergency response
perspective. They were probably looking at it more from a
global population perspective.
As you prioritize these types of responses, one of the
things that the coalition is looking at is, who are the people
on the front lines that are going to be potentially the first
to be exposed in these types of events? As I indicated during
my remarks, the emergency services personnel, the emergency
services sector, which is, as you indicated, part of the
critical infrastructure, is going to be at the front lines and
potentially exposed to any one of these CBRNE types of events
and also is most likely living within the impact area of these
types of events, so their families are going to be involved, as
well.
What we are hoping to do through the coalition is to raise
awareness regarding the needs of the emergency services sector
to have, as a part of the planning for medical countermeasures,
prepositioned caches for those personnel.
Mr. Bilirakis. Thank you.
Anyone else want to add anything on that? Okay.
Mr. McHargue, in your testimony, you spoke of your
successes in dispensing the flu vaccine during the H1N1
pandemic in 2009. In particular, you mentioned that Florida's
planning incorporated major pharmaceutical chains to dispense
antivirals in the early days of the pandemic.
To what extent do your State plans leverage the capacity of
the private sector to dispense the CBRN medical
countermeasures?
Mr. McHargue. We learned through that experience with H1N1,
and with the encouragement of our Governor, Rick Scott, that
private enterprise is an expansion of local or public
capability. Through contracts with some nationally-known
pharmacies, we were able to secure and administer a lot of the
H1N1 vaccines through pharmacy locations in neighborhoods where
people typically go to buy their other medications, their
trusted deliverers of that service.
We have not fully exploited other partnerships for the
provision of the wider range of CBRN medications, but we are in
the process of continuing those expanded partnerships, sir.
Mr. Bilirakis. Thank you.
Anyone else want to add to that?
Mr. Levi. I guess what I would add is that, particularly in
rural communities, having those public-private partnerships is
going to be incredibly important. You know, in large cities,
you have a relatively large infrastructure of the public health
system that is able to respond. In rural communities, your
health department may be one or two people serving a very large
geographic community. Without those public-private
partnerships, we just will not reach lots and lots of people.
Mr. Bilirakis. Okay, Mr. Levi, certain Federally-funded
initiatives, such as the Cities Readiness Initiative, the
Metropolitan Medical Response System program, and other grant
programs, have a key impact at the local level with regard to
preparedness and response.
In your experience examining State readiness, have you
found that the States are taking full advantage of these
programs? Do you think that these separate but related efforts
are well-coordinated?
Mr. Levi. Coordination could always be better, but I think
we found over time that the partnerships have improved and that
State preparedness programs and their counterparts in the
Cities Readiness Initiative have been working more closely
together. I think that is--you know, certainly, making sure
that those are well-coordinated is a responsibility for the
CDC.
I think the larger coordination issue is less a State-local
issue and more of what Mr. Starr was referring to, which is
these multiple grant mechanisms from multiple Federal agencies
coming into either a State or into a city with different
requirements, different timelines, multiple application
processes, all ultimately serving the same goal. If those could
be rationalized, coordinated, integrated in a more effective
way, I think we would find people spending less time on
administration and applying for grants and more time on
actually doing the preparedness work.
Mr. Bilirakis. How many States would you say take advantage
of these programs?
Mr. Levi. Well, every State is a recipient of the Public
Health Emergency Preparedness Program, as well as the Hospital
Preparedness Program, which are sort of the core programs.
Mr. Bilirakis. Anyone else?
Okay. Well, thank you.
I have a little time. We don't have Members on the panel.
Does anybody else want to maybe expand on their testimony on
any particular issues since you are here?
Mr. Starr. I just wanted to say----
Mr. Bilirakis. Sure, please. You are recognized. Please.
Mr. Starr. Thank you.
I just wanted to add one point about Mr. Marino's earlier
comment about the use of the private sector. New York City, and
particularly the pharmaceutical supply chain, if the stockpile
was eliminated--if I am not mistaken, his question was, if the
stockpile was eliminated, how fast could the private
pharmaceutical supply chain swing into action to supply the
needed countermeasures in a public health emergency, and
specific to anthrax and other extremely short-timelined
incidents. It is too long. It would be far too long, and there
is absolutely no way.
I have some experience with the pharmaceutical supply
chain, at least around my region. Without any kind of Federal
intervention or any kind of interaction with us, it would be
too long for the private supply chain to swing into action at
the level that we would need to in the timeline that we would
need. I think I speak for the rest of the panel on that.
Mr. Bilirakis. Anyone else want to add to that?
Okay, well, thank you. I do have a markup, but I want to
thank the witnesses for their valuable testimony and the
Members for their questions.
The Members of the subcommittee may have some additional
questions--I am sure they will, because, as I said, the
Minority party is at the White House at this particular time--
but we ask you to respond in writing, please. The hearing
record will be open for 10 days.
Without objection, the subcommittee stands adjourned.
Thank you, folks. Appreciate it very much.
[Whereupon, at 3:35 p.m., the subcommittee was adjourned.]
A P P E N D I X
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Questions From Chairman Gus M. Bilirakis for Alexander G. Garza
Question 1. What is the Department of Homeland Security's strategy
for relaying imminent threat information to the public? I am not just
speaking of the new National Terrorism Advisory System, but also about
the need for detailed information for the public on whether to shelter
in place or evacuate, and on health information like what
countermeasures are appropriate and where to get them.
How will DHS get this information out in real time to local
authorities and/or the public?
Answer. Thank you for the opportunity to provide information
pertaining to how we disseminate information to the public and the
coordination that is required with State and local governments, and
with the Department of Health and Human Services (HHS), which has the
Federal lead on public health communications.
The public information response to a wide-area aerosolized anthrax
attack would require significant participation of many Government
agencies, non-profit organizations, and the private sector. The
information provided to the public about the nature of the threat, the
attack, and the response would require parallel communication efforts
through various channels. Different audiences will need difference
pieces of the overall flow of information. It is first important to
recognize that the responsibility and authority to provide detailed
information to the public on immediate public health and safety matters
such as shelter-in-place, evacuation, or appropriate medical
countermeasures is held at the local level under a State's police
powers. DHS will work with local authorities to ensure they have the
most up-to-date and comprehensive information available.
The audience of those not immediately affected by the attack will
require different information, particularly since identification of an
anthrax attack will likely occur well after thousands have traveled
across a State, the Nation, and even other parts of the world. As
characterization of the event becomes better understood, DHS will be
coordinating with these communities and States affected but not
necessarily targeted in the attack itself; therefore, the information
and strategy to provide information to those audiences will involve
less details about immediate response efforts and more information
about what we know about the nature of the threat (i.e. potential for
multiple attacks) and the need to work closely with HHS's CDC on
education (i.e. why the SNS isn't being deployed to other cities,
personal protective measures to take and not to take, etc.).
Communication and coordination with this group will be essential to a
National response and recovery in the early stages so that limited
resources are not misallocated and local officials and their
constituents are educated about the decisions that are being made and
why.
strategy
White House Communications will provide strategic communications
direction following a terrorist attack. In addition, the U.S. Domestic
Communications Strategy (DCS), developed by the DHS Office of Public
Affairs and Federal interagency, was designed to counter the intended
consequences of terrorism against the United States. The DCS details a
comprehensive set of pre-identified counterterrorism communications
options that each agency could and likely would take following a
terrorist attack.
Because the DCS is a broad-based strategy to meet counterterrorism
objectives for all terrorist attacks, the DHS Office of Public Affairs
has also developed an anthrax specific communications coordination
plan. HHS and CDC will retain the Federal lead on public health
communications, including providing technical assistance to State and
local governments to improve their planning for emergency public
information and warning. DHS's responsibilities in both operations and
public communications under Homeland Security Presidential Directive--5
are to coordinate those response efforts. For this reason, DHS has
developed a draft communications coordination plan that lays out roles
and responsibilities within the Federal Government and the mechanism
the Department will use to coordinate public communications activities
across State, local, Federal, international, and private sector
partners following an anthrax attack. The mechanisms include the
National Incident Communications Conference Line (NICCL) and the State
Incident Communications Coordination Line (SICCL). The NICCL and SICCL
are managed once DHS stands up the National Joint Information Center
(NJIC) and are used to coordinate Federal and State communications,
respectively. A similar private sector coordination capability also
exists through the NJIC. Coordination is essential to a successful
response to an incident of the magnitude of a wide-area aerosolized
anthrax attack, and DHS will use all of the communications channels
(print and broadcast media, internet, social media, etc.) and its
proven ability to coordinate large-scale incidents to provide
information the public will seek during such a high-profile National
incident. These communication channels include new media, such as
blogs, Twitter, and other on-line publications, as well as traditional
media sources.
Finally, under the National Response Framework, DHS Public Affairs
is responsible for Emergency Support Function (ESF) 15--External
Affairs. ESF-15 is the standard operating procedure for how the U.S.
Government will conduct the external affairs response to a National-
level incident requiring a large coordinated Federal response. There is
intentional overlap between the anthrax planning process and the ESF-15
standard operating procedure. ESF-15 largely addresses the efforts for
a large on-scene Federal communications presence.
Question 2a. OHA released draft guidance in 2009 for protecting
first responders immediately after an anthrax attack.
Can you please provide a status update on when that guidance will
be finalized for use by first responders? The guidance has been with
OMB for sign-off for a long time.
Answer. OMB and NSS staff has been working with DHS/OHA to ensure
the document is responsive to the concerns raised by Federal
departments and agencies that will be our partners in implementing this
guidance. OHA is now finalizing the guidance for approval and
publication. It is important to note that in the interim, the draft
guidance that was initially published for public comment in 2009 should
guide first responders; no major changes to that guidance are being
contemplated.
Question 2b. Can you please address whether the final guidance will
recommend pre-event vaccination for first responders, and how would OHA
help to implement such a program?
Answer. The draft guidance provides information for consideration
by the responder community. It provides specific planning and program
considerations if such a pre-event vaccination program is desired. In
that regard, OHA and others are evaluating strategies for making some
portion of the vaccine in the Strategic National Stockpile (SNS) that
would otherwise go unused available to this community.
Question 3. We've heard from different avenues that it can be
confusing to State and local governments to work with so many different
grant programs, many of which have related guidance, and that this can
encourage duplication of efforts. I know that some work has been
undertaken to address this problem.
Can you please provide a description and update of DHS' work with
HHS to align related grants?
Answer. The Department of Health and Human Services (HHS), Office
of the Assistant Secretary for Preparedness and Response (ASPR) is
leading an interagency effort to align public health and medical
preparedness grants having separate authorizations, appropriations,
applications, reporting, and measurement requirements. One of the main
goals is to standardize the grant process--a large portion of that
process includes streamlining the application submission process for
the States as they respond to multiple Federal Government funding
opportunities. The core interagency partners critical to the success of
this endeavor are HHS/ASPR; HHS/Centers for Disease Control and
Prevention (CDC); HHS/Health Resources and Services Administration;
Department of Homeland Security (DHS), Federal Emergency Management
Agency (FEMA); and Department of Transportation (DoT), National Highway
Traffic Safety Agency (NHTSA).
The Department of Homeland Security's Office of Health Affairs has
been actively engaged in the DHS/HHS Coordinating Committee. In this
role, DHS along with our partners are working to align emergency
preparedness grant programs throughout the Federal Government to
support National preparedness strategies for end users at the State,
local, Tribal, and territorial level. These funding opportunities, and
related alignment activities, need to be coordinated in the most cost-
effective manner possible, consistent with the applicable laws and
missions of the respective agencies. This collaboration and integration
is essential for establishing an effective and coordinated response
between all levels of government during a public health emergency.
Question 4. In response to President Obama's Executive Order on
countermeasure distribution, I understand that your office has taken
the lead for DHS on the conops plan for mission-essential personnel of
the Executive branch. OHA has also spearheaded an MCM strategy for DHS
employees, and oversees the purchase and storage of MCMs for the DHS
workforce.
Can you please provide us with an update on the status of the
conops plan?
What is your approach to stockpiling, distributing, and dispensing
countermeasures within DHS?
Answer. Per Section 4 of President Obama's Executive Order 13527,
the Department of Homeland Security (DHS) Office of Health Affairs
(OHA) and the Department of Health and Human Services (HHS) have formed
a joint task force in order to plan a common path forward for
continuity of operations among Federal agency mission-essential
functions (MEF), inclusive of Executive branch departments and
agencies.
OHA and DHS Operations Coordination and Planning (OPS) have
coordinated in ensuring that plans are in place across all of the DHS
Components. Per the Department Guidance Statement (DGS) developed by
OPS and approved by the Secretary of DHS, each of the DHS Components
has developed its own Anthrax Operation Plan, which is a requirement of
each Component outlined as part of this DGS. These plans identify how
each Component will protect its personnel by ensuring each DHS employee
will be able to receive medical countermeasures (MCM). OHA is engaged
in meetings with Federal partners outside of DHS to discuss planning
and coordination to improve our MCM capabilities, and is able to offer
assistance, make recommendations, and share existing training and
educational resources and reference materials.
Focusing specifically on stockpiling, distributing, and dispensing
MCM within DHS, OHA has developed a DHS MCM Program at the direction of
Secretary Napolitano to provide MCM to DHS employees in an attacked
area. Currently, OHA has over 6 million tablets of antibiotic and
antiviral MCM purchased and stored in a pharmaceutical logistics center
ready for rapid deployment, to protect DHS employees and individuals
under DHS care and custody. OHA has identified two dozen medical
storage locations for local MCM stockpiles, or ``caches,'' and has pre-
positioned MCM in these storage caches around the Nation. OHA has
entered into an inter-agency agreement partnership with the HHS Supply
Service Center (SSC) to provide MCM supply chain management support,
including sourcing, bottling/repackaging, labeling, storage, and
distribution services.
In preparation for activation of Points of Dispensing (POD) for DHS
employees utilizing these stockpiled MCM, OHA has established POD
training material to assist all DHS Components in selecting their
appropriate POD locations and POD staff members. POD training includes
the roles and responsibilities for DHS POD staff members to
successfully stand-up, implement, and close-down a POD for DHS
employees and those under DHS care and custody. OHA has worked with
each of the DHS Components to exercise their POD implementation and OHA
created POD demonstration videos to assist Components in educating
their personnel. OHA is also working with the DHS Office of the Chief
Learning Officer to develop and disseminate training on-line for the
DHS workforce with regards to Anthrax and MCM POD education.
Question From Chairman Gus M. Bilirakis for Mike McHargue
Question. The Council on State and Territorial Epidemiologists
conducted a survey last year to assess State-level preparedness for a
radiological or nuclear exclusive of a nuclear power plant emergency.
Can you please describe Florida's planning efforts with regard to
stockpiling, distribution, and dispensing of medical countermeasures
that can be used to respond to a radiological dirty bomb or nuclear
attack?
Answer. The Florida Department of Health maintains primary caches
of Potassium Iodide (KI) at three County Health Departments in the
State. The Health Departments have primary response capability for the
nuclear reactors located in their jurisdictions. To meet this need,
there are 1.615 million total doses of KI at these sites. An additional
300,000 doses are maintained in Tallahassee by the bureau of Pharmacy
for a cache of approximately 2 million doses.
In addition, the State has four radiological countermeasure kits
that are controlled by the State pharmacy. These kits total 2,000 doses
and are designed for treat emergency responders and victims in an
emergency. Each kit contains KI, Prussian blue, Zn-DTPA and Ca-DTPA.
The kit also contains the appropriate medical supplies for
administration. The distribution capability of this product is covered
under the Logistics Support Annex and utilizes the response deadlines
established for SNS level events.
In an event, the State has developed a Medical Advisory Group to
evaluate an allocation and apportionment methodology of both these
caches as well as the use of the SNS or Vendor Inventory. Once the
apportionment is made, the Health Departments, using their all-hazards
approach, activate their Points of Dispensing protocols that are
developed to utilize a 48-hour window to a longer more extensive
delivery needs.
Questions From Chairman Gus M. Bilirakis for Ali S. Khan
Question 1a. The Nuclear Regulatory Commission is responsible for
stockpiling and distributing potassium iodide in the 10-mile zone
around nuclear reactors. But I am concerned about our preparedness for
a radiation/nuclear terrorist event.
Can you please describe the role of your office and of the SNS in
the event of a radiological or nuclear attack?
Answer. I share your concern about the Nation's preparedness for a
radiation event, whether it is an accidental release or a radiological
or nuclear attack. During such an event, the Centers for Disease
Control and Prevention (CDC) and the Agency for Toxic Substances and
Disease Registry (ATSDR), stand ready to assist State, local, and
territorial authorities in protecting people's health by providing
technical assistance and science-based advice on steps people can take
to reduce their exposure to radiation. During a radiation incident,
CDC/ATSDR focuses on its public health strengths, which include:
Laboratory and epidemiological detection and
characterization of event;
Technical assistance to States upon request;
Clinical and self-help guidance;
Medical countermeasures (where appropriate) to mitigate
morbidity and mortality;
Risk communication with stakeholders and the public;
Linkage across the health system from local to State,
National, and even international levels to ensure an integrated
health system response; and
Participation in interagency radiation response systems
including the Federal Radiological Monitoring and Assessment
Center and the Advisory Team for Environment, Food, and Health.
Many systems that we use to meet everyday public health needs are
at the core of public health preparedness and response for unforeseen
and unpredictable public health threats.
Within CDC, the Office of Public Health Preparedness and Response
(PHPR) leads CDC's preparedness and response activities by providing
strategic direction, support, and coordination for activities across
CDC as well as with public health emergency response partners. When a
disaster occurs, CDC must respond effectively and support
international, National, State, local, Tribal, territorial, and private
sector public health emergency response partners. A critical component
of CDC's work during an incident is to coordinate public health
response activities and provide resources to State and local public
health departments. PHPR manages CDC's Emergency Operations Center
(EOC), which serves as the command center for monitoring and
coordinating CDC's emergency response to public health threats in the
United States and abroad. Staffed around the clock, the EOC serves as
CDC's central point of contact for reporting public health threats and
supports the Department of Health and Human Services (HHS) Secretary's
Operations Center. The EOC organizes CDC scientific experts in one
location during an emergency response to analyze, validate, and
efficiently exchange information as well as connect with public health
emergency response partners.
PHPR also manages the Strategic National Stockpile (SNS), a
National repository of large quantities of medicine, vaccines, and
other medical supplies stored in strategic locations around the Nation.
SNS assets, when combined with Federal, State, and local technical
expertise to manage and distribute them efficiently, help ensure that
key medical supplies are available during emergencies.
Question 1b. Are we stockpiling radiation/nuclear countermeasures,
and if so, which countermeasures, and do we have a workable plan to
distribute them?
Answer. The SNS includes radiation countermeasures which may be
used to mitigate health effects from radiation exposure. In addition,
the SNS maintains inventories of medical supplies that can be used for
burn and blast injuries and other trauma such as those resulting from
large-scale events such as an improvised nuclear detonation. Complete
listings of the contents and quantities of materials held in the SNS
are considered sensitive but unclassified information, and distribution
of this information is limited to guard against exploitation of gaps
that could be identified through a review of SNS holdings. We will
happily provide an opportunity for you to review additional information
in hard copy at your convenience.
The SNS has proven plans for distribution of these products to the
States. State and local authorities are then responsible for
distribution to local areas and dispensing to the affected population.
CDC guidance and technical assistance have assisted the States and
major cities in developing their plans to receive, distribute, and
dispense SNS assets. These plans have been exercised and were used to
guide implementation of their core capabilities for providing SNS
assets to their populations during the 2009 H1N1 influenza pandemic.
Question 1c. What countermeasures (including preventives,
treatments, and diagnostics) are missing from our arsenal?
Answer. Requirements for medical countermeasures against chemical,
biological, radiological, and nuclear threats are established by the
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). In
July 2006, HHS established the PHEMCE, creating a coordinated framework
as we advanced an ``end-to-end'' approach in the development,
procurement, and use of medical countermeasures. The HHS Office of the
Assistant Secretary for Preparedness and Response (ASPR) leads the
PHEMCE, which includes principal representatives from CDC, the U.S.
Food and Drug Administration (FDA), and the National Institutes of
Health (NIH) as well as key interagency partners from the Department of
Defense (DoD), the Department of Homeland Security (DHS), the
Department of Veterans Affairs (VA), and the Department of Agriculture.
The overarching mission of the PHEMCE is to define and prioritize
requirements for public health emergency medical countermeasures;
coordinate research, early and late stage product development, and
procurement activities addressing these requirements; and set
deployment and use strategies for medical countermeasures held in the
SNS. The PHEMCE also conducts an annual review of the SNS, which allows
for a thorough accounting of the SNS contents each year, and an
evaluation of those contents against the current medical
countermeasures requirements.
As the statutorily designated entity for this activity, DHS has
identified 13 specific material threats to prepare and respond to
biological, radiological, and nuclear hazards. In response, HHS has
taken the lead through a coordinated strategic approach--led by the
PHEMCE--to maximize our preparedness to the range of threats we face
while also ensuring the most efficient use of limited taxpayer dollars.
Under the leadership of the ASPR, we have improved the Nation's
preparedness through the development of new medical countermeasure
products and procurements.
The available, existing countermeasures to hasten the body's
excretion of radionuclides (chelation) cover only a limited number of
radioactive isotopes, but the SNS continues to work towards stockpiling
the existing radiation countermeasures to meet the current PHEMCE-
established goals.
There currently are very few licensed pharmaceuticals that reduce
the risk of radiation-related illness following severe radiation
exposure. The PHEMCE has established goals for the development of such
medical countermeasures, and BARDA and NIH, in collaboration with
partners at the DoD, are supporting research towards those goals.
To date there have been no PHEMCE requirements or resources
available for procurement of diagnostics for the SNS. However,
radionuclide diagnostics are essential for diagnosing which
radionuclides people have been exposed to, and at what levels, as well
as the overall level of radiation exposure. Results of these
diagnostics indicate which medical countermeasures should be delivered
and for how long based on the exposure dose. Current U.S. radionuclide
exposure diagnostic capability is provided by CDC's National Center for
Environmental Health, in the Environmental Health Laboratory. At this
time, CDC's Environmental Health Laboratory can test for only half of
the priority threat radionuclides for a large-scale emergency incident,
a gap that can only be filled by additional research and development.
In addition, this laboratory is the only U.S. facility that can rapidly
diagnose radionuclide internal contamination in people. This limits
National surge capacity.
Finally, the Nation does not have the capability to rapidly conduct
external monitoring of people who may have been contaminated by fallout
or other sources of airborne release of radionuclides. CDC has
developed guidance for State and local health departments on how to
conduct a population monitoring program, but most health departments
lack equipment and trained human resources to implement such a program
Question 2a. I understand that funding for the Cities Readiness
Initiative comes out of HHS' Public Health Emergency Preparedness fund.
The budget for that program has been steadily decreasing.
In a time of continued risk, can you please explain your rationale
for that decrease?
Answer. CDC is continually evaluating what we do and constantly
looking at ways to efficiently utilize existing resources to maximize
health impact. Without the dedicated Cities Readiness Initiative (CRI)
funding, awardees are still able to use PHEP funding for CRI-related
activities within their jurisdictions. The PHEP program is structured
so that awardees assess their current capabilities against the targeted
public health preparedness capabilities and plan their activities to
meet those targeted capabilities. Awardees that prioritize medical
countermeasure dispensing may apply their PHEP funding to improving
those related capabilities within their jurisdictions.
Funds for the CRI are provided through a carve-out from the total
dollars appropriated annually for the Public Health Emergency
Preparedness (PHEP) cooperative agreement. The distribution of PHEP
funds is calculated using a formula established by statute that
includes a base amount for each awardee, as determined by the
Secretary, plus population-based funding. Funding also is awarded for
specific preparedness activities, including CRI. Fiscal year 2011 funds
for the CRI ($54 million), Chemical Laboratories ($10 million), and
Risk-Based Projects ($10 million) are provided through a carve-out from
the total dollars appropriated for the PHEP cooperative agreement.
Dedicated funding for CRI has decreased as overall PHEP funding has
declined. The fiscal year 2011 PHEP funding level is $613,610,342,
which represents a 12% ($84.6 million) reduction from fiscal year 2010
when about $698 million was awarded. CRI funding for fiscal year 2011
accounts for 8.85% of the total PHEP funding and is consistent with CRI
funding levels in prior years. For instance, CRI funding was 8.87% of
the total PHEP funding in fiscal year 2010, 8.50% in fiscal year 2009,
and 9.1% in fiscal year 2008.
The fiscal year 2011 PHEP reductions were proportionally allocated
in an effort to preserve core PHEP funding used in support of other
critical preparedness activities and systems which ultimately also
impact response capability for medical countermeasure use. The base
portion of the PHEP funding is used by States for activities that
support both CRI and non-CRI jurisdictions.
Question 2b. Can you also please explain how that drop in funding
will impact the Cities Readiness Initiative? I understand you are
considering a risk-based funding scheme for this program, and I would
appreciate further clarity in what that means for funding distribution.
Answer. At this point, it is too early to have a full appreciation
of the impact of the fiscal year 2011 reductions in PHEP funding on CRI
as the funding will not be awarded until August 2011. However,
anecdotal evidence received by our staff as the States prepare their
cooperative agreement applications and budgets suggests that both State
and local jobs may be in jeopardy of being lost. Furthermore, our State
and local partners have identified their inability to sustain minimal
program requirements, including the maintenance of plans, the need to
preserve critical response resources, and their ability to recruit,
train, and drill/exercise staff and volunteers. The success of CRI is
largely contingent on plans and people. With a fiscal impact to both,
the ability to sustain an effective medical countermeasure distribution
and dispensing infrastructure is diminished and may result in fewer
individuals adequately protected from disease and death following a
public health threat.
In addition to CRI, CDC intends to direct a portion of the fiscal
year 2011 PHEP funds to 10 major urban areas (including 14 States and
the four directly-funded localities) for an all-hazards public health
risk reduction funding initiative. This risk-based funding scheme is a
pilot intended to promote and accelerate the development of strategies
that mitigate the public health risks associated with higher population
areas.
The jurisdictions selected for this initiative include the 10 Tier
1 urban areas in the U.S. Department of Homeland Security's Urban Area
Security Initiative (UASI) grant program for fiscal year 2010. However,
the purpose of the CDC funding is for all-hazards public health risk
reduction and is not restricted to terrorism preparedness.
A total of $10 million will be awarded for this project, with
funding to be directed to the following 10 urban areas: Boston;
Chicago; Dallas/Fort Worth/Arlington; Houston; Jersey City/Newark; Los
Angeles/Long Beach; New York City; Philadelphia; San Francisco; and the
National Capitol Region (Washington DC).
CDC may elect to extend and/or expand the project in future years
based on available funding and a review of how well initial strategies
developed during the pilot may demonstrate evidence of mitigating
public health, medical, and mental/behavioral health system risks
associated with hazards that may be more likely to affect higher
population areas.
Question 3a. HHS' budget request for the Strategic National
Stockpile is $655 million, a $59 million increase over fiscal year 2010
levels. These funds will be used to replace expiring countermeasures in
high-priority categories.
Can you discuss what these high-priority categories are, or at
least explain how you prioritize funds for replacement countermeasures?
Answer. Requirements for medical countermeasures are set by the
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).
The PHEMCE establishes goals based on analyses of scenarios that lead
to the numbers of persons likely to require medical countermeasures.
Priorities for purchase of replacement and new medical countermeasures
are established by this group through a documented, robust governance
process. The current high priorities include medical countermeasures
for anthrax, smallpox, and other bacterial threats, as well as
maintaining current levels of inventory.
To inform this decision process, CDC has built a capacity for on-
going life-cycle analysis, which it uses to make recommendations on
replacement and shelf-life extension decisions, as well as to
accurately cost long-range projections of the fiscal needs relating to
various products in the SNS inventory.
CDC has used these more accurate and robust cost figures in its
annual budget requests to give decisionmakers at the agency,
Departmental, and Congressional levels the most convincing possible
notion of the true financial requirement for maintaining this National
security asset.
Question 3b. Will your requirements for replacement funding
increase as the Biomedical Advance Research and Development Authority
(BARDA) add new countermeasures to the stockpile?
Answer. BARDA-purchased medical countermeasures are funded from the
Project BioShield Special Reserve Fund for which there is no authority
to provide funding for storage, management, or replacement of the
medical countermeasures by the SNS. As a result, any replacement of
BARDA-procured countermeasures would likely be funded by the SNS.
Question 4a. In its fiscal year 2012 budget request, HHS stated
that the SNS will continue to explore non-traditional methods of
distribution and dispensing of countermeasures within 48 hours,
including public-private collaborations and the implementation of the
closed point of dispensing (POD) concept.
Can you please describe the ``closed POD'' concept in greater
detail?
Answer. Closed points of dispensing (PODs) will be important during
a large-scale public health emergency that requires the provision of
medical countermeasures, as health care providers and open or public
PODs will likely be overwhelmed. A closed or private POD refers to an
organization-specific POD operated by a large employer, university, or
other organization with a significant employee/student/resident
population that, in collaboration with its local health department,
develops plans to provide medical countermeasures to its employees,
contractors, students, residents, and their families. The goal of a
closed POD is to use the resources of the partnering organization to
take care of itself by rapidly dispensing medical countermeasures.
Doing so protects its constituency and associated families and reduces
the number of people that would need to go to the open PODs. Benefits
of closed PODs include ease of access to life-saving medications; quick
dispensing to employees and their families; enhanced business
continuity plans; and the potential for increased numbers of volunteers
to support open PODs, since in some cases, organizations participating
as closed PODs have agreed to provide their staff as volunteers. In all
cases, operation of closed PODs by other than State and local public
health organizations has the effect of increasing the numbers of people
who could rapidly receive medical countermeasures. Some examples
include, but are not limited to employer-specific closed PODs,
homeowners-association closed PODs, community-organization closed PODs,
and hotel-based closed PODS.
Question 4b. Operationally, how does a closed POD like a school
differ from an open POD?
Answer. Open and closed PODs differ in the size and scope of their
dispensing operation because they serve different populations. Open, or
public, PODs are available to the general public and are the
cornerstone of all jurisdictional plans. Open PODs are often located in
large community facilities known to the population, accessible by
common modes of transportation, and capable of accommodating many
persons at one time. They also allow for efficient dispensing to the
public. Open PODs are generally staffed by State and local public
health personnel, other State and local personnel, or volunteers.
Closed PODs are characterized by their focus on dispensing to a
pre-defined population rather than the general public, e.g., the
employees of a private company. Closed PODs are generally staffed by
qualified personnel who are members of the organization operating the
closed POD rather than by those persons who operate open PODs. This
arrangement effectively increases available resources to dispense
medical countermeasures without adversely impacting staff at open PODS.
Question 4c. Which POD modalities have you found to be the most
successful?
Answer. The experience of developing and testing these varying POD
modalities in public health communities allows for the selection and
implementation of the most complementary array of planned modalities to
reach a given population.
Ultimately, the most successful dispensing modalities employed
depend on the community. Each community is unique and has its own
challenges, resources, and capabilities. No one modality or prescribed
combination will work for all communities. A large-scale public health
event in any community will require a layered system of dispensing
using modalities that match and maximize the available resources and
infrastructure.
However, if success is measured in terms of the percentage of
population covered, then the most successful modality is the
traditional large-scale public health-run open POD, which is typically
situated at a school, auditorium, or sports arena. This modality is the
cornerstone for mass dispensing for most jurisdictions. An open POD is
scalable and can easily be expanded or retracted to meet the complexity
of an event. Open POD operations have also been modified to include
drive-through PODs, mobile PODs (using trailers to take PODs to remote
locations), and household delivery of medical countermeasures by home
health care nurses, Meals on Wheels, or other community-based
organizations. Targeted home delivery strategies, complemented by
additional strategies such as closed PODs, combine to help reduce the
volume pressure on traditional open PODs.
Question 5a. What other dispensing models is CDC considering, and
are guidance and funding provided to State and local governments so
they can establish the modality that best fits the needs of their
jurisdiction? Some of modalities would need to be Federally-driven,
such as pre-deployment of medkits to peoples' homes. I am also
wondering to what extent your dispensing activities are driven by a
formal National dispensing strategy.
Answer. CDC has worked with State and local jurisdictions since
2002 to help them develop their plans to receive, store, distribute,
and dispense medical countermeasures. CDC has provided numerous
guidance documents, tools, and technical assistance opportunities to
assist and assess State and local medical countermeasure distribution
and dispensing plans. As noted previously, the ultimate decision of
what works best is up to the individual States and localities. Listed
below are some examples of dispensing modalities developed by State and
local health departments.
General examples of innovative dispensing:
Closed PODs (such as private business, faith-based
organizations, military installations, homeowners
associations),
Drive-through PODs (see variations listed below),
Mega PODs to facilitate mass dispensing in highly congested
areas that are conducive to traffic gridlock,
Mobile POD trailers,
Tiered POD system (where the most-needed and highest
population PODs open first),
Civic groups for delivery of medication during an event,
Community Emergency Response Team (CERT) for door-to-door
delivery,
Unusual dispensing locations such as grocery stores, long-
term care facility pharmacies, mass transit stations, private
physicians' offices, retail pharmacies,
School bus delivery,
Tele-pharmacy dispensing operations,
U.S. Postal Service (USPS) dispensing.
Examples of variations of drive-through countermeasure dispensing:
Omaha, Nebraska (in conjunction with the Nebraska Department
of Roads and the Nebraska State Patrol): A highway closed to
through traffic and with ``pit stops'' spaced along the
highway. The car pulls into the ``pit stop'' and dispensing
staff come to the car to conduct full-service prophylaxis
dispensing. The car re-enters the highway upon completion.
Seattle, Washington: Trailers cached throughout the county
to allow almost immediate setup of multiple countermeasure
dispensing locations with the ability to be mobile as needed.
Cabell-Wayne Counties, West Virginia: Mobile countermeasure
dispensing units reach rural populations. This is achieved with
a 9-County ``bundle team'' to form a Threat Preparedness
Planning Region along with the Homeland Security Committee and
the local emergency planning committee.
The USPS mode of delivery is currently operational in only one
city, Minneapolis, Minnesota. Other communities have shown an interest,
but are unable to rally the necessary numbers of law enforcement
personnel to support the 1:1 escort of volunteer postal carriers as
required by the USPS unions.
The MedKit at this point is a concept product only. It is not a
licensed or commercially available product. The feasibility and
commercial interest in developing the product is under further
investigation by the PHEMCE.
Question 5b. BARDA published a requirement for smallpox that
includes sufficient second generation smallpox vaccine to treat the 66
million people for whom the traditional smallpox vaccine is
contraindicated. Enough vaccine for dispensing to 10 million people (20
million doses) is due to be delivered to the Strategic National
Stockpile in 2013.
Will BioShield exercise its contract option to purchase an
additional 60 million doses?
Answer. HHS is committed to ensuring that the Nation is able to
respond to known threats, such as that posed by smallpox. A decision on
whether to exercise the option will be made upon completion of product
delivery in the base contract and after appropriate consultation with
the Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE).
Question 5c. Why does the pre-Emergency Use Authorization (EUA) for
this pharmaceutical apply only to individuals with HIV? This population
is much smaller than the 66 million stated in the BARDA requirement.
Will CDC work with FDA to expand the EUA, therefore aligning it with
the BARDA requirement? Does CDC have a response plan for how it would
actually use this drug?
Answer. The determination of product use under an EUA is made by
the FDA based on the totality of available scientific information.
Based on the FDA's review of IMVAMUNE (or MVA, a third-generation
investigational smallpox vaccine) data from clinical studies conducted
by Bavarian Nordic (BN), FDA has communicated to CDC that the only
eligible individuals for MVA vaccination under a potential EUA during a
smallpox post-event emergency are HIV-positive individuals (18 years of
age or older) with CD4 counts greater than 200 cells/ul who have not
received a diagnosis that their condition has progressed to AIDS. FDA
has stated that the eligible population for MVA under an EUA must
correspond to those in which the vaccine has been studied. Therefore,
at this time, only HIV-positive individuals could be vaccinated with
IMVAMUNE (MVA) if an EUA were issued at this time.). Any updates to
proposed product use, including additional eligible populations, will
be made to the pre-EUA in accordance with FDA review determination as
additional scientific information becomes available.
The PHEMCE has estimated that approximately 66.5 million
individuals have relative contraindications to receiving a live-virus
vaccine. This population includes those with a variety of conditions
that impair the immune system such as cancer, HIV, and transplant
patients. As described previously, the determination of eligible
populations for IMVAMUNE (MVA) will be made by the FDA based on its
review determination of the available data in the target populations
and/or extrapolated from existing data. CDC is aware of BN's submission
of clinical data from its study of MVA in adult subjects (18-40 years)
with diagnosed atopic dermatitis to FDA. Currently, the FDA's review
determination is pending; however, CDC will include any expanded use(s)
of MVA under pre-EUA in accordance with FDA's review determination and
in concert with the overarching post-event smallpox vaccine utilization
policy/strategy.
ASPR is currently forming an interagency Smallpox Vaccine Strategy
Working Group to begin initial discussion in July 2011 to determine a
National smallpox vaccine strategy that considers all stockpiled
smallpox vaccines, including MVA.
Question 5d. Can you please explain what an ``Integrated Project
Team'' is, who sits on it, and to whom they report?
Answer. The PHEMCE is an interagency effort coordinated by the HHS
Office of the Assistant Secretary for Preparedness and Response (ASPR).
The PHEMCE includes three HHS internal agencies: CDC, FDA, and NIH.
DHS, DoD, USDA, and VA have been supporting members of the PHEMCE. An
Integrated Program Team (IPT) is formed for a specific threat. IPT
memberships represent different Federal agencies, and composition may
vary. At a minimum, membership includes CDC, FDA, NIH, BARDA, and DoD.
IPTs are chaired by personnel from the ASPR. IPT chairs report to the
Enterprise Executive Committee of the PHEMCE.
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