Project Bioshield Act
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| Enacted by the | 108th United States Congress |
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| Citations | |
| Public Law | Pub.L. 108–276 |
| Stat. | 118 Stat. 835–864 |
| Legislative history | |
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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 these agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated. In these cases efficacy 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. Biodefense 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 this 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.
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Acquired vaccines [edit]
In September 2012, BioPrepWatch reported that the BARDA annual report shows that the number of supplies of countermeasures for combating terrorist attacks is growing.[4]
According to the report, BARDA has acquired:[5]
- 107,000 doses of an antitoxin for Clostridium botulinum (a decrease from the full 200,000 doses ordered in 2006).
- 57,102 doses of the monoclonal antibody Raxibacumab, which treats anthrax, from Human Genome Sciences in 2011. This included 20,000 doses under a 2005 contact and 37,102 doses of the 45,000 ordered in a 2009 contract option. At the end of 2010, there was a total supply of 36,102 doses of Raxibacumab.
- 10,000 doses of Anthrax Immune Globulin from Cangene, which also treats anthrax. By 2010, the supply was down to 7,327 doses, with spending on Raxibacumab and AIG coming to $478 million.
- 28.75 million doses of the anthrax vaccine BioThrax from Emergent BioSolutions.
- Botulism treatments, as well, including 107,560 doses of Botulinum Antitoxin Therapeutic from Cangene. It ordered 200,000 doses. At the end of 2010, the supply was at 97,000 doses.
Related legislation [edit]
Section 401 of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress) reauthorized the BioShield Project.[6] More specifically, it reauthorizes the Project BioShield Special Reserve Fund (SRF), originally established in 2004.[7]
References [edit]
- ^ "President Bush Signs Project Bioshield Act of 2004". White House. July 21, 2004. Retrieved 2008-08-01. "Project BioShield will transform our ability to defend the nation in three essential ways. First, Project BioShield authorizes $5.6 billion over 10 years for the government to purchase and stockpile vaccines and drugs to fight anthrax, smallpox and other potential agents of bioterror. The Department of Health and Human Services has already taken steps to purchase 75 million doses of an improved anthrax vaccine for the Strategic National Stockpile. Under Project BioShield, HHS is moving forward with plans to acquire a safer, second generation smallpox vaccine, an antidote to botulinum toxin, and better treatments for exposure to chemical and radiological weapons."
- ^ Gibbs, W. Wayt (October 2004), "An Uncertain Defense", Scientific American (Scientific American, Inc.) 291 (4): 20–24, ISSN 0036-8733, OCLC 1775222
- ^ Federal Funding for Bioweapons Prevention and Defense, by Agency, 2001-2009
- ^ Kellen Alexander "U.S. grows its biodefense stockpile", BioPrepWatch, 18 Sep 2012
- ^ Kellen Alexander "U.S. grows its biodefense stockpile", BioPrepWatch, 18 Sep 2012
- ^ "H.R. 307". United States Congress. Retrieved 10 April 2013.
- ^ "H.R. 307 - Legislative Digest". House Republicans. Retrieved 10 April 2013.
See also [edit]
- Biodefense and Pandemic Vaccine and Drug Development Act of 2005, nicknamed "Bioshield Two"
- Biomedical Advanced Research and Development Authority (BARDA)
- Vaccines for the New Millennium Act
- Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress)
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