The White House
Office of the Press Secretary
For Immediate
Release
February 3, 2003
Project BioShield
TODAYS PRESIDENTIAL ACTION
X 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:
o 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. o Strengthen
NIH development capabilities by speeding research and development on
medical countermeasures based on the most promising recent scientific
discoveries; and o 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
X 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.
X 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.
o 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. o 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.
X 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 Presidents
Project BioShield has three major components:
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. o 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.
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. NIHs 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:
o 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. o This authority would also permit more rapid hiring
of technical experts, and would allow NIH to quickly procure items
necessary for research.
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.
o 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. o 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. o 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.
o 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. o 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.
o 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.
X 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.
For more information on the Presidents initiatives, please visit
www.whitehouse.gov