Project Bioshield
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Project Bioshield II
Senators Joseph Lieberman (D-Conn.) and Orrin Hatch (R-Utah) introduced
the "Project BioShield II Act of 2005" (S. 975) on April
29, 2005. The bill builds upon the first BioShield bill, which was
signed into law on July 21, 2004, and authorized $5.6 billion over
10 years to encourage pharmaceutical and biotechnology companies
to develop bioterrorism countermeasures. Bioshield II would provide
additional liability protections for firms creating vaccines or
drugs that could cause injuries. No action has been scheduled on
the bill yet.
Senate Bioterrorism and Public Health Preparedness Subcommittee
Chair Richard Burr (R-N.C.) introduced the Biodefense and Pandemic
Vaccine and Drug Development Act (S. 1873) on October 17. It also
seeks to build upon the Project Bioshield program. The bill would
create the Biomedical Advanced Research and Development Agency (BARDA)
within the Department of Health and Human Services to coordinate
bioterrorism countermeasure development. Although the Senate Health,
Education, Labor and Pensions Committee approved the bill on October
18, there remained outstanding issues to be resolved, including
liability protections for manufacturers and first responders and
compensation for people injured by vaccines and other drugs.
Senator Edward Kennedy (D-Mass.) introduced the National Biodefense
and Pandemic Preparedness Act (S. 1880) on October 17. His version
includes some provisions similar to Senator Burr's but curbs the
liability protections and patent extensions, while including compensation
for those injured by vaccines or other drugs. The Protecting America
in the War on Terror Act of 2005 (S. 3) and Bioterror and Pandemic
Preparedness Protection Act (S. 1437), introduced by Senator Judd
Gregg (R-N.H.) also include provisions that seek to enhance liability
protections for bioterrorism countermeasure manufacturers.
Project Bioshield
The President signed the Project Bioshield Act (P.L. 108-276) into
law on July 21, following final approval by the House on July 14.
The legislation authorizes funds to encourage pharmaceutical and
biotechnology companies to develop bioterrorism countermeasures.
First proposed in the 2003 State of the Union address, Project
Bioshield provides $5.6 billion over ten years. The final bill guarantees
this funding cannot be diverted for other purposes, but Congress
retains discretion over the program's annual appropriations, such
as the $890 million approved for FY 2004.
Provided under the proposed Department of Homeland Security FY
2005 budget is $2.5 billion for Project Bioshield, three times the
$890 million provided by Congress in FY 2004. The conference report
of the FY 2004 Homeland Security Appropriations bill was signed
by the President October 1 (P.L.
108-90) and included $890 million for Project BioShield.
"Project BioShield," first announced in the President's
State of the Union address in January, is designed to expand and
speed up the availability of vaccines and treatments to combat potential
bioterrorism agents. Under the plan, the federal government would
provide $6 billion over 10 years to create and produce vaccines
and treatments and would guarantee drug companies a buyer for these
products. In addition, the Food and Drug Administration would have
the authority to expedite the approval process for vaccines and
treatments and approve their use, prior to formal approval, in the
event of a bioterrorist attack.
Contact
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Office of Governmental Relations
efroyd@aamc.org
(202) 828-0525
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