To encourage the development of new CBRN countermeasures, President Bush proposed Project BioShield in his 2003 State of the Union address. The 108th Congress considered this proposal and passed the Project BioShield Act of 2004 (P.L. 108-276, signed into law July 21, 2004).3 This act has three main provisions.
It provides the Department of Health and Human Services (HHS) expedited procedures for CBRN terrorism-related spending including procuring products, hiring experts, and awarding research grants.
The act creates a government-market guarantee by allowing the HHS Secretary to obligate funds to purchase countermeasures while they still have several more years of development.
The act also authorizes the HHS Secretary to temporarily allow the emergency use of countermeasures that lack Food and Drug Administration (FDA) approval.
1 For additional information and analysis of the procurement provisions of Project BioShield, see CRS Report RL33907, Project BioShield: Appropriations, Acquisitions, and Policy implementation Issues for Congress, by Frank Gottron.
2 Alan Pemberton, Pharmaceutical Research and manufacturers of America, Testimony before the U.S. House of Representatives Select Committee on Homeland Security, May 15, 2003.
3 For a detailed comparison of the legislative proposals, see CRS Report RL32549, Project BioShield: Legislative History and Side-by-Side Comparison of H.R. 2122, S. 15, and S. 1504, by Frank Gottron and Eric A. Fischer.