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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. 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.

From U.S. HHS:
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.

* 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:
* 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.
* Expedite the conduct of NIH research and development on medical countermeasures based on the most promising recent scientific discoveries.
* 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:

* 75 million doses of a second generation anthrax vaccine to become available for stockpiling beginning next year.
* New medical treatments for anthrax directed at neutralizing the effects of anthrax toxin.
* Polyvalent botulinum antitoxin,
* A safer second generation smallpox vaccine.
* 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:

* 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.

* 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.

* 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.

* 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.

* 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.
* 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.
* 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.

* 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.

* 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.

* 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.

* 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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