For Immediate Release
Office of the Press Secretary
February 3, 2003
President Details Project BioShield
TODAYS 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
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
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.