Critical Mission for Biodefense
On July 21, 2004, Project BioShield Act of 2004 (Project BioShield) was signed into law as part of a broader strategy to defend America against the threat of weapons of mass destruction. Project Bioshield was designed to provide additional and more flexible authorities and funding to financially support and expedite the development and procurement of medical countermeasures against chemical, biological, radiological, and nuclear threats. BARDA was also designed to streamline the approval process of such countermeasures, and provide the government with the authority to quickly authorize their use during public health emergencies.
Funding and Types of Contracts
Project BioShield institutes a secure funding source for the purchase of critical medical countermeasures, such as vaccines, therapeutics, and diagnostics. Project BioShield authorizes $5.6 billion in funding over 10 years for the advanced development and purchase of priority medical countermeasures. This Special Reserve Fund was provided in the FY2004 Department of Homeland Security Appropriations Act and becomes available to the Secretary of Health and Human Services (HHS) for procurements following interagency and White House approval. Within HHS, the Office of the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) has the procurement authority for Project BioShield acquisitions utilizing the Special Reserve Fund.
Contracts awarded using the Special Reserve Fund are primarily of the Fixed Priced variety. These contracts may have cost reimbursable elements to support FDA product licensure requirements. Since the passage of the Project BioShield legislation in 2004, BARDA has awarded 9 contracts for development and acquisition of CBRN medical countermeasures valued at over $2 billion, and has successfully stockpiled 17 medical countermeasure products against 6 CBRN threats.