Fact Sheet
FOR IMMEDIATE RELEASE Wednesday, July 21, 2004 |
Contact: HHS Press Office (202) 690-6343
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HHS Fact Sheet--Project Bioshield
President Bush today signed into law Project BioShield, which
provides new tools to improve medical countermeasures protecting
Americans against a chemical, biological, radiological or nuclear
(CBRN) attack.
The President first proposed Project BioShield in his 2003 State of
the Union address and Congress approved it last week.
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Project BioShield is a comprehensive effort overseen jointly by
Secretary Thompson and Secretary Ridge, and involving other Federal
agencies as appropriate, to develop and make available modern,
effective drugs and vaccines to protect against attack by CBRN
weapons. Project BioShield will:
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Ensure that resources are available to pay for
“next-generation” medical countermeasures.
Project BioShield will allow the government to buy improved
vaccines or drugs. The fiscal year 2004 appropriation for the
Department of Homeland Security included $5.6 billion over 10 years
for the purchase of next generation countermeasures against anthrax
and smallpox as well as other CBRN agents.
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Expedite the conduct of NIH research and development on
medical countermeasures based on the most promising recent
scientific discoveries.
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Give FDA the ability to make promising treatments quickly
available in emergency situations – this tightly
controlled new authority will enable access to the best available
treatments in the event of a crisis.
As the result of the Project BioShield legislation, the
administration has already begun the process of acquiring
several new medical countermeasures:
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75 million doses of a second generation anthrax vaccine to become
available for stockpiling beginning next year.
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New medical treatments for anthrax directed at neutralizing the
effects of anthrax toxin.
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Polyvalent botulinum antitoxin,
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A safer second generation smallpox vaccine.
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Initial evaluation of treatments for radiation and chemical weapons
exposure.
Secretary Thompson has also directed the FDA to prepare
guidelines and procedures for implementing the emergency use
authorization included in the legislation should it be needed.
The administration will start taking new steps today -- armed with
these new authorities -- to swiftly focus research on the most
vexing problems and ensure rapid translation of laboratory findings
into new CBRN medical countermeasures. Today Secretary
Thompson will direct NIH to:
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Launch a multi-year initiative for Project BioShield
Treatments for Biological Agents. While most
vaccines provide protection prior to exposure to the biological
agent, therapeutics offer protection after exposure and hence
are particularly important in the homeland security
context. This initiative will be focused on the most
dangerous biological pathogens and the toxins they produce.
Launch a multi-year initiative to create Project BioShield
Treatments for Radiation Poisoning. This
initiative will focus on practical methods to vastly improve
current treatments for radiation poisoning from exposure to a
nuclear or radiological attack.
Expedite Grant Proposals and Awards. Before BioShield,
the grant process associated with biodefense medical research took
18 to 24 months. With the new authorities provided by
BioShield, HHS estimates this process will take about 6 months.
Today, Secretary Thompson will also direct the use of BioShield
authorities to create several new positions to assure that basic
scientific discoveries are translated as swiftly as possible into
usable products to protect Americans. Secretary Thompson will
create senior positions for countermeasure product development in
the National Institute of Allergy and Infectious Diseases (NIAID),
the lead Institute for Project BioShield implementation at the
National Institutes of Health (NIH). The NIH is the
nation’s premier biomedical research institution.
Complementing this scientific excellence with individuals
experienced in product development will ensure that the nation
secures rapid benefit from its investments in bioterrorism-related
R&D. Project BioShield enables hiring this needed
expertise quickly, compressing the usual hiring process for 12 to
18 months to about 6 months.
The new authorities also will be used to reduce the time to acquire
critical materials and services for NIAID research programs,
including the program on medical countermeasures against botulism
toxin, a potentially deadly pathogen, particularly when put into
food. The BioShield authorities will speed the development of
countermeasures by reducing procurement time from 18 to 24 months
to 4 to 6 months.
A BROAD RECORD OF PROGRESS
Project BioShield builds on remarkable progress across the board to
strengthen the nation’s protections against a CBRN
attack. The administration has:
Greatly increased the current generation medical countermeasures
stockpiled for use against CBRN attack.
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Increased the size of the Strategic National Stockpile five-fold
since 2001, including increasing the amount of antibiotics able to
treat exposure to anthrax, securing enough smallpox vaccine for
every individual in the United States, as well as increasing the
number of treatments available for radiation poisoning, chemical
agent exposure and a variety of other biological pathogens.
Greatly strengthened the nation’s ability to use these
countermeasures swiftly and effectively.
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Initiated the Cities Readiness Initiative to work with 21
metropolitan areas to increase their ability to deliver
antibiotics effectively; began forward deploying chemical
antidote kits under the ChemPack program, with the objective of
placing 2,300 kits across all 50 states by January 2006; ensured
that initial stockpile materials could be anywhere in the United
States within 12 hours, with additional materials following
within 36 hours, and required that every state outline their
plans to receive and distribute the materials swiftly.
Vastly increased the R&D monies devoted to developing
cutting-edge medical countermeasures.
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Biodefense medical research and development at the NIH has been
funded at more than $1.5 billion per year since fiscal year 2003,
30 times the investment in fiscal year 2001. NIH researchers
are developing and evaluating new and improved treatments and
vaccines against smallpox, anthrax, and, for the first time, Ebola,
as well as other dangerous pathogens. This funding will
cultivate and sustain a national network of researchers including
the eight new Regional Centers of Excellence for Biodefense and
Emerging Infectious Diseases Research (RCE).
Moved swiftly to harvest the best research advances, develop
improved products aaand get them into the stockpile.
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HHS in coordination with DHS will contract for the production and
stockpiling of 75 million doses of a second generation anthrax
vaccine. This vaccine, made by recombinant technology, high volume
fermentation and modern protein purification methods will become
available for stockpiling beginning next year.
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Within the next month, HHS will request proposals for the
acquisition of new medical treatments for anthrax directed at
neutralizing the effects of anthrax toxin. These new treatments
when used in conjunction with antibiotics are expected to reduce
the mortality from inhalation anthrax.
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Actions are being taken to apply Project BioShield funds to the
production and stockpiling of polyvalent botulinum antitoxin, a
safer second generation smallpox vaccine, and treatments for
radiation exposure and exposure to chemical weapons.
Greatly strengthened the nation’s ability to detect a
bioattack through the first-ever wide scale deployment of
environmental detectors, under the Biowatch program.
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These surveillance activities would be further strengthened with
approval of the Biosurveillance Initiative, which seeks $274
million in the President’s fiscal year 2005 budget
request. The initiative extends Biowatch detector coverage
and extends and expands human, plant and animal health and disease
surveillance capabilities in the Departments of Health and Human
Services, Agriculture and Homeland Security, to provide the
earliest possible warning and characterization of a
bioattack.
Greatly strengthened links between expert science and the
intelligence and law enforcement communities.
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The Department of Homeland Security has created the National
Biodefense Analysis and Countermeasure Center to systematically
apply, for the first time, cutting edge science to the study of
classified intelligence about foreign weapons programs and develop
first-class forensics in support of law enforcement investigations
of biological crimes like the 2001 anthrax letters attack.
Initiated new agriculture and food programs to defend against
disease, pest, or poisonous agents that could be intentionally
delivered by acts of terrorism and cause catastrophic health and
economic effects.
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The President’s fiscal year 2005 budget contains $567
million (an increase of $372 million) to secure and defend our
agriculture and food systems.
BIOSHIELD IS PART OF A STRATEGIC NATIONAL PLAN
President Bush recently signed Biodefense for the
21st Century, a presidential directive that provides
a comprehensive framework for biodefense, that specifies roles and
responsibilities, and that also fully integrates the programs and
efforts of various Federal communities – national security,
medical, public health, intelligence, diplomatic, agricultural and
law enforcement – into a sustained and focused national
effort against biological weapons threats.
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The framework provides specific directives to cabinet officers to
further strengthen the significant gains put in place over the past
three years. It will, for example, spur new progress in
improving our intelligence capabilities against foreign biological
weapons programs and strengthening our defenses against novel or
genetically modified agents.
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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
Last Revised: July 21, 2004
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