Project Bioshield Act of 2004

PROJECT BIOSHIELD ACT OF 2004 -- (Extensions of Remarks - July 16, 2004)

SPEECH OF
HON. MIKE ROGERS
OF MICHIGAN
IN THE HOUSE OF REPRESENTATIVES
WEDNESDAY, JULY 14, 2004

Mr. ROGERS of Michigan. Mr. Speaker, I rise in strong support of the House-Senate negotiated substitute amendment and final passage of the Project BioShield Act of 2004. This legislation will greatly strengthen our nation's capabilities to protect our military, first responders and U.S. citizens from the threat of biological, chemical, radiological and nuclear weapons of mass destruction.

I am extremely pleased that the final language that recently passed the Senate incorporates the expanded definition of eligible countermeasures for which BioShield funds can be designated. This expanded definition would permit BioShield funding and procurement for certain FDA-licensed vaccines and other medical countermeasures in addition to experimental products for inclusion in the Strategic National Stockpile.

It is important to note that while BioShield was intended to stimulate and accelerate the development of new countermeasures, existing safe and effective FDA-licensed vaccines and medicines may have new unlicensed applications that may also contribute to our nation's preparedness. These new product applications must be tested and licensed by the FDA and made available for the stockpile. For example, the only FDA-licensed anthrax vaccine is manufactured in my home state by BioPort Corporation. BioThrax

These existing products, like BioThrax

I am especially pleased that during the Senate debate, the Senate managers of the BioShield legislation also clarified their understanding of discussions with the Administration regarding the use of BioShield funds under new section 319F-2©(9) of the Public Health Service Act. The bill's managers agreed that BioShield allows for the future procurement of vaccines already being purchased under government contract at the time of enactment of BioShield. Further, clarification in the Senate allows for their procurement under new or existing contracts. Under this interpretation, the President and BioShield procuring agencies will have the flexibility to use BioShield funds for the purchase of additional doses of FDA-licensed anthrax vaccine for inclusion in the stockpile for post-exposure use with antibiotics. This would be in addition to those previously contracted doses currently funded from discretionary appropriations and available to the Departments of Defense, Homeland Security and Health and Human Services.

The consensus panel published in the Journal of the American Medical Association and the CDC Advisory Committee on Immunization Practices have already recommended the FDA-licensed anthrax vaccine for post-exposure use in combination with antibiotics. The Institute of Medicine of the National Academy of Sciences agreed with the FDA that the FDA-licensed anthrax vaccine is safe and effective for the prevention of anthrax in those at-risk of exposure to anthrax, including against inhalation anthrax. Since 1998, more than 1.1 million military and civilian personnel have been safely vaccinated with more than 4 million doses of the vaccine. Indeed, these statistics also include both the pre- and post-exposure vaccinations of many of our own Congressional colleagues, staff members and decontamination workers before and following the October 2001 anthrax attacks.

Mr. Speaker, I urge the Departments of Homeland Security and Health and Human Services to consider the immediate procurement of millions of additional doses of the FDA-licensed anthrax vaccine, as well as additional doses of antibiotics for the Strategic National Stockpile. These doses are essential to improving our capability to respond to another potential anthrax attack. This is the same method used by these agencies for the stockpiling of both licensed and experimental smallpox vaccines.

Mr. Speaker, I also urge my colleagues to follow the lead of the Senate by unanimously clearing this legislation for signature by the President. This will send a strong message to the world that our nation is serious about protecting our citizens and first responders from deadly terrorist threats with tested and proven medical countermeasures.