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Summary:
Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack available countermeasures. In 2003, President Bush proposed Project BioShield to address this need. The 108th Congress passed the Project BioShield Act of 2004, and President Bush signed it into law on July 21, 2004 (P.L. 108-276). The main provisions of this law include (1) relaxing procedures for some CBRN terrorism-related spending, including hiring and awarding research grants; (2) guaranteeing a federal government market for new medical countermeasures; and (3) permitting emergency use of unapproved countermeasures. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS used expedited review authorities to approve grants relating to developing treatments for radiation exposure. The HHS used the authority to guarantee a government market to obligate approximately $2.3 billion to acquire countermeasures against anthrax, botulism, radiation, and smallpox. In response to the 2009 influenza A (H1N1) swine flu outbreak, HHS has used the emergency use authority to ease the distribution of two antiviral medications and to allow their use in children younger than the ages for which the drugs are currently approved. Certain respirators and a diagnostic test were also approved for emergency use against this outbreak. HHS Project BioShield countermeasure procurement funding comes from the Department of Homeland Security Appropriations Act, 2004 (P.L. 108-90), which appropriated $5.593 billion for FY2004 to FY2013. Congress subsequently removed $25 million from this account through rescissions in FY2004 and FY2005. In the Omnibus Appropriations Act, 2009 (P.L. 111-8), Congress transferred $412 million from this account to other programs to support countermeasure advanced research and development and pandemic influenza preparedness and response. Since passing the Project BioShield Act, subsequent congresses have considered several additional measures to further encourage countermeasure development. The 109th Congress passed the Pandemic and All-Hazard Preparedness Act (P.L. 109-417) to create the Biomedical Advanced Research and Development Authority (BARDA) in the Department of Health and Human Services. Questions remain regarding the impact BARDA will have on countermeasure development, the continuing implementation of Project BioShield, and whether additional legislation would further encourage countermeasure development.
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