Frank
Gottron
Specialist in Science and Technology Policy
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. As the
expiration of some of these authorities approaches, Congress is considering
whether these authorities have sufficiently contributed to national
preparedness to merit extension.
The Project BioShield Act provides three main authorities: (1) guaranteeing a
federal market for new CBRN medical countermeasures, (2) permitting
emergency use of countermeasures that are either unapproved or have not
been approved for the intended emergency use, and (3) relaxing regulatory
requirements for some CBRN terrorism-related spending. The Department of Health and
Human Services (HHS) has used each of these authorities. The HHS obligated
approximately $2.5 billion to guarantee a government market for countermeasures
against anthrax, botulism, radiation, and smallpox. The HHS allowed the
emergency use of several unapproved products, including during the 2009
H1N1 influenza pandemic. The HHS used expedited review authorities to
approve contracts and grants related to CBRN countermeasure research and
development.
The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L.
108-90) advanceappropriated $5.593 billion to acquire CBRN countermeasures
through Project BioShield for FY2004-FY2013. Through FY2012, subsequent
Congresses have removed $1.876 billion from this account through
rescissions and transfers, more than one-third of the advance appropriation. The
transfers from this account supported CBRN medical countermeasure advanced development,
pandemic influenza preparedness and response, and basic biomedical research.
Since passing the Project BioShield Act, subsequent Congresses have considered
additional measures to further 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 112th Congress is considering several Project BioShield-related policy
questions. One question is whether the Project BioShield acquisition
mechanism has sufficiently improved national preparedness relative to its
costs to merit extension. If so, congressional policymakers may consider
whether changes to the funding levels or how Congress provides Project
BioShield funds would improve the program’s efficiency or performance. Additionally,
congressional policymakers are considering whether the federal government
sufficiently plans and coordinates its CBRN countermeasure efforts from
basic research to distribution. Finally, Congress is considering whether
changes to the emergency use authority will improve preparedness and planning.
Three bills in the 112th Congress address some of these Project
BioShield-related issues, H.R. 2356, H.R. 2405, and S. 1855.
Date of Report: June 15, 2012
Number of Pages: 21
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