BioterrorismCongress may modify the amount, manner by which Project BioShield procurements are funded
In 2004, Congress passed the Project BioShield Act to provide the federal government with new authorities related to the development, procurement, and use of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents. Among other things, the authority allows the government to guarantee a market for CBRN medical countermeasures. Under this provision, the secretary of Health and Human Services (HHS) may obligate funds to purchase countermeasures that still need up to ten more years of development. Since 2004, HHS has obligated approximately $3.309 billion to guarantee a government market for countermeasures against anthrax, smallpox, botulism, radiation, and nerve agents. Another provision established a process through which the HHS secretary may temporarily allow the emergency use of countermeasures which lack Food and Drug Administration (FDA) approval. The 113th Congress may also consider modifying the amount and manner by which it funds Project BioShield procurements.
In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to provide the federal government with new authorities related to the development, procurement, and use of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents.
The government, however, still lacks countermeasures against many of the CBRN terrorism agents determined by the government to pose the greatest threat. Congress is likely to consider whether modifications of these authorities or new authorities would help address remaining gaps.
A CRS report notes that the authority generally referred to as Project BioShield allows the government to guarantee a market for CBRN medical countermeasures. Under this provision, the secretary of Health and Human Services (HHS) may obligate funds to purchase countermeasures that still need up to ten more years of development. Since 2004, HHS has obligated approximately $3.309 billion to guarantee a government market for countermeasures against anthrax, smallpox, botulism, radiation, and nerve agents.
Another provision of the Project BioShield Ac t established a process through which the HHS secretary may temporarily allow the emergency use of countermeasures which lack Food and Drug Administration (FDA) approval. The HHS has used this authority to allow the emergency use of unapproved products several times.
The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance appropriated $5.593 billion to acquire CBRN countermeasures through Project BioShield between FY2004 and FY2013. Subsequent Congresses rescinded or transferred $2.291 billion, more than one-third, from this advance appropriation. The transfers from this account supported CBRN medical countermeasure advanced development, pandemic influenza preparedness and response, and basic biomedical research. The Consolidated Appropriations Act, 2014 (P.L. 113-76) provides $255 million for Project BioShield procurements to remain available until expended. For FY2015, the president requests $415 million.
Since passage of the Project BioShield Act, Congress has considered additional measures further to encourage countermeasure development. The Pandemic and All-Hazards Preparedness Act (P.L. 109-417) created the Biomedical Advanced Research and Development Authority (BARDA) in HHS and modified the Project BioShield procurement process. Among other duties, BARDA oversees all of HHS’s Project BioShield procurements. The Pandemic and All-Hazards Preparedness Reauthorization Act (P.L. 113-5) authorized Project BioShield appropriations of $2.8 billion for FY2014 through FY2018 and modified some Project BioShield-related authorities.
The CRS report says that the 113th Congress may also consider modifying the amount and manner by which it funds Project BioShield procurements. Additionally, Congress may consider whether HHS is optimally using its CBRN-related authorities to close remaining countermeasure gaps and appropriately planning for long-term costs associated with maintaining a countermeasure stockpile.
— Read more in Frank Gottron, The Project BioShield Act: Issues for the 113th Congress (Congressional Research Service, 18 June 2014)
