[Congressional Record (Bound Edition), Volume 150 (2004), Part 12]
[Extensions of Remarks]
[Pages 16074-16075]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     PROJECT BIOSHIELD ACT OF 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. BioThraxTM vaccine is 
licensed for pre-exposure vaccination of the military and other 
civilians at risk of exposure to anthrax. Though it is recommended by 
the CDC for post-exposure use in conjunction with antibiotics for 
protecting those who may have been exposed to this deadly biological 
agent, it is not yet licensed for this use.
  These existing products, like BioThraxTM vaccine, will 
provide our nation with an insurance policy to strengthen its immediate 
bioterrorism preparedness capability, while supplementing other 
experimental vaccines and medicines currently in development, though 
many years away from FDA-approval.
  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(c)(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

[[Page 16075]]

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.

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