Download Locations

• Open CRS (User submitted)

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 Project BioShield Act became law in July 2004 (P.L. 108-276). This law has three main provisions: (1) relaxing procedures for some CBRN terrorism-related spending, including hiring and awarding research grants; (2) guaranteeing a federal government market for new CBRN 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 and used the authority to guarantee a government market to obligate approximately $2.3 billion to acquire countermeasures against anthrax, botulism, radiation, and smallpox. The HHS has also employed the emergency use authority several times including allowing young children with H1N1 swine flu to receive specific antiviral drugs. The Department of Homeland Security Appropriations Act, 2004 (P.L. 108-90) advance-appropriated $5.593 billion for FY2004 to FY2013 for Project BioShield. In addition to the approximately $2.3 billion used for countermeasure procurement, Congress has decreased the available amount in the BioShield account. In FY2004 and FY2005, Congress removed approximately a total of $25 million through rescissions. In the Omnibus Appropriations Act, 2009 (P.L. 111-8), Congress transferred $412 million to other programs to support countermeasure advanced research and development and pandemic influenza preparedness and response. President Obama has proposed transferring an additional $305 million in FY2010 to support countermeasure advanced research and development. The administration also seeks to transfer management of this account from the Department of Homeland Security to HHS. The President has also requested that the type of countermeasures that could be procured using these funds be expanded from solely CBRN to include countermeasures against pandemic influenza. Such an action would likely decrease the amount of BioShield money that would be available for CBRN countermeasures. Since passing the Project BioShield Act, subsequent congresses have considered additional measures to further encourage countermeasure development. The 109th Congress passed the Pandemic and All-Hazard Preparedness Act (P.L. 109-417) which created the Biomedical Advanced Research and Development Authority (BARDA) in HHS. This office oversees all of HHS Project BioShield activities, amongst other duties. The Pandemic and All-Hazard Preparedness Act also modified the Project BioShield procurement process. Questions remain regarding whether these changes have sufficiently improved countermeasure development and procurement. The 111th Congress faces several challenging policy decisions. Primary among them is assessing whether Project BioShield is successfully encouraging medical countermeasure development. A second issue is whether to allow additional diversions of Project BioShield appropriations, a key element of the governments market guarantee, to support other activities. A third is whether to broaden what has been a CBRN countermeasure mandate in the face of other threats such as pandemic influenza.

XML