Homeland Security

Bush Plans Protections Against Chemical, Biological Weapons

(Project BioShield will develop medical countermeasures) (1280)
President Bush outlined details of a new government initiative to
accelerate the development of drugs and vaccines to protect and treat
the U.S. population in the event of a chemical or biological weapons
attack.
The following terms are used in the text:
NIH:  National Institutes of Health
FDA:  Food and Drug Administration
Billion: 1,000 million
Following is the White House fact sheet on Project BioShield
(begin fact sheet)
FACT SHEET
The White House
Office of the Press Secretary
February 3, 2003
Project BioShield
TODAY'S PRESIDENTIAL ACTION
In his State of the Union Address, President Bush announced Project
BioShield -- a comprehensive effort to develop and make available
modern, effective drugs and vaccines to protect against attack by
biological and chemical weapons or other dangerous pathogens. Project
BioShield will:
-- Ensure that resources are available to pay for "next-generation"
medical countermeasures. Project BioShield will allow the government
to buy improved vaccines or drugs for smallpox, anthrax, and botulinum
toxin. Use of this authority is currently estimated to be $6 billion
over ten years. Funds would also be available to buy countermeasures
to protect against other dangerous pathogens, such as Ebola and
plague, as soon as scientists verify the safety and effectiveness of
these products.
-- Strengthen NIH development capabilities by speeding research and
development on medical countermeasures based on the most promising
recent scientific discoveries; and
-- Give FDA the ability to make promising treatments quickly available
in emergency situations - this tightly controlled new authority can
make the newest treatments widely available to patients who need it in
a crisis.
PROJECT BIOSHIELD - AN OVERVIEW
Today, the country is better prepared than ever to meet the threat of
terrorist attack with a biological, chemical, radiological or nuclear
agent. The national stockpile of medical countermeasures is more
extensive and can be accessed more rapidly than ever, and additional
diagnostic tests, drugs, and vaccines are under development.
But, the possibility of the intentional use of biological or other
dangerous pathogens represents a threat to our society. Unfortunately,
the medical treatments available for some types of terrorist attacks
have improved little in decades, while there has been tremendous and
rapid progress in the treatment of many serious naturally-occurring
diseases.
-- The smallpox vaccines available today are not much different than
those last used by the public in the 1960s. Some treatments for
radiation and chemical exposure have not changed much since the 1970s.
-- In contrast, since the 1960s, the treatment of the vast majority of
naturally-occurring illnesses has changed dramatically as a result of
ongoing innovations from biomedical research and development. Heart
attacks were often fatal in the 1970s, but they are much less so
today. Better detection and therapeutic options have significantly
increased survival rates for many kinds of cancer over the last 20
years.
The President believes that, by bringing researchers, medical experts,
and the biomedical industry together in a new and focused way, our
Nation can achieve the same kind of treatment breakthroughs for
bio-terrorism and other threats that have significantly reduced the
threat of heart disease, cancer, and many other serious illnesses. The
President's Project BioShield has three major components:
1. Spending Authority for the Delivery of Next-Generation Medical
Countermeasures. The President proposed the creation of a permanent
indefinite funding authority to spur development of medical
countermeasures. This authority will enable the government to purchase
vaccines and other therapies as soon as experts believe that they can
be made safe and effective, ensuring that the private sector devotes
efforts to developing the countermeasures.
-- The Secretary of Homeland Security and the Secretary of Health and
Human Services will collaborate in identifying critical medical
countermeasures by evaluating likely threats, new opportunities in
biomedical research and development, and public health considerations.
2. New NIH Programs to Speed Research and Development on Medical
Countermeasures. The President proposed to give the NIH new
authorities to speed research and development in promising areas of
medical countermeasure development. NIH's usual methods for supporting
research and development on conventional diseases have been extremely
effective in those areas but may not always be suited to meet the
urgent demands posed by the risk of terrorism. The new authorities
would apply only to support research and development on bioterrorism
threat agents and include the following features:
-- The Director of the National Institute of Allergy and Infectious
Diseases would have increased authority and flexibility to award
contracts and grants for research and development of medical
countermeasures. Funding awards would remain subject to rigorous
scientific peer review, but expedited peer review procedures could be
used when appropriate.
-- This authority would also permit more rapid hiring of technical
experts, and would allow NIH to quickly procure items necessary for
research.
3. New FDA Emergency Use Authorization for Promising Medical
Countermeasures Under Development. Some of the most promising
treatments for a terrorist agent may still be under formal FDA review
when an attack occurs. The President proposed an emergency use
authorization to permit the effective use of such treatments in an
emergency, if alternative treatments are not available. This will
improve access to a potentially beneficial treatment in an emergency
situation, when it is most likely to save lives, even if it has not
yet been proven to be suitable for routine general use or has not
completed the formal process for full FDA licensure.
-- The thorough process required for FDA licensure has protected the
American people and provided a supply of safe and effective drugs. The
administration fully supports the thorough review FDA requires before
licensing a product.
-- These new authorities seek to supplement the traditional FDA
licensing process to ensure that we could respond effectively in a
crisis to use a medical countermeasure that experts judged to be safe
and effective, but just had not completed the formal FDA process. This
authority is very narrowly focused and targeted - only drugs under the
direct control of the US government could be used, they could only be
used after certain certifications had been made, and all civilian use
would be voluntary.
-- Current use of a drug prior to licensure - a so-called
Investigational New Drug - has many safeguards built into it,
including informed consent and extensive follow-up monitoring. These
are important provisions, but in a crisis they could prevent the drug
from being made available in a timely fashion to all the citizens who
need it.
-- The emergency use authorization would require a finding by the
Secretary of Health and Human Services, based on expert analysis by
FDA, that the treatment in question was expected to have benefits in
the emergency situation that outweighed its expected risks.
-- Unlike typical medical product approvals, the emergency use
authorization may be limited to particular types of medical providers,
patients, and conditions of use. Thus, the authorization would allow
greater flexibility in the FDA review process to meet the
circumstances of specific terrorist threats.
-- The emergency use authorization would remain in effect no more than
one year, unless the specific terrorist threat justifies extension of
the authorization and the available evidence indicates that the
countermeasure is providing important expected benefits.
Scientific breakthroughs such as recombinant DNA technology,
immunology, molecular structural engineering, genomics, and proteomics
that are now protecting our health from many conventional diseases
hold considerable promise against the diseases of terrorism as well.
This same innovation can be applied to the challenge of protecting
America by identifying the new treatments that are most needed, and
providing meaningful and consistent rewards for innovators who bring
these products to the American public. And, the breakthroughs
resulting from Project BioShield are likely to have important
spillover benefits in diagnosing and treating other diseases, and in
strengthening our overall biotechnology infrastructure.
(end fact sheet)
(Distributed by the Office of International Information Programs, U.S.
Department of State. Web site: http://usinfo.state.gov)