Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress

Following the terrorist attacks of 2001, the federal government determined that it would need new medical countermeasures such as diagnostic tests, drugs, vaccines, and other treatments to respond to an attack using chemical, biological, radiological, or nuclear CBRN agents. Representatives of the pharmaceutical industry attributed the paucity of CBRN agent countermeasures to the lack of a significant commercial market. They argued that because these diseases and conditions occur infrequently, the private sector perceived little economic incentive to invest the millions of dollars required to bring treatments to market. In 2004, Congress passed the Project BioShield Act P.L. 108-276 to encourage the development of CBRN medical countermeasures. The 108th Congress also appropriated 5.6 billion to acquire countermeasures through Project BioShield for FY2004 through FY2013. Subsequent congresses have evaluated implementation of Project BioShield. In response to perceived problems with Project BioShield countermeasure procurement, the 109th Congress created the Biodefense Advanced Research and Development Authority BARDA and the position of Assistant Secretary for Preparedness and Response in the Department of Health and Human Services HHS through the Pandemic and All-Hazards Preparedness Act P.L. 109-417. The 111th Congress continues to address several Project BioShield-related policy issues. These include whether to continue diverting Project BioShield acquisition funding to other purposes whether to change the countermeasure development and acquisition process how to replace stockpiled countermeasures as they expire and whether to alter federal efforts to encourage the development of broad-spectrum countermeasures.