Project Bioshield Act

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Project BioShield Act of 2004

Long title	An Act To amend the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health contracting flexibility, infrastructure improvements, and expediting the scientific peer review process, and streamlining the Food and Drug Administration approval process of countermeasures
Enacted by	the 108th United States Congress
Citations
Public law	108-276
Statutes at Large	118 Stat. 835–864
Codification
Titles amended	42: Public Health and Social Welfare
U.S.C. sections amended	Chapter 6A § 201
Legislative history
Introduced in the Senate as S. 15 by Judd Gregg (R-NH) on March 11, 2003 Committee consideration by Senate HELP Passed the Senate on May 19, 2004 (99-0) Passed the House on July 14, 2004 (414–2) Signed into law by President George W. Bush on July 21, 2004

The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack.^[1] This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.^[2]

Since the 2001 terrorist attacks, the United States government has allocated nearly $50 billion to address the threat of biological weapons. U.S. funding for bioweapons-related activities focuses primarily on research for and acquisition of medicines for defense. Funding also goes toward stockpiling protective equipment, increased surveillance and detection of biological agents, and improving state and hospital preparedness. The increase in this type of funding is mainly for Project BioShield. Significant funding also goes to Biomedical Advanced Research and Development Authority (BARDA), part of HHS. Funding for activities aimed at prevention has more than doubled 2007 and is distributed to 11 federal agencies.^[3] Efforts toward cooperative international action are part of the project.