RS21507
Project BioShield
July 23, 2003

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Federation of American Scientists

Summary:

Many potential biological terrorism agents lack available countermeasures. President Bush proposed Project BioShield to encourage companies to develop new bioterror countermeasures. The main provisions of that proposal include: (1) relaxing procedures for bioterrorism-related procurement and peer review; (2) guaranteeing a market through contract authority granted to the Secretary of Health and Human Services (HHS) to buy countermeasures following Presidential approval, funded by a permanent, indefinite appropriation; and (3) allowing the Secretary of HHS to permit the emergency use of unapproved countermeasures. S. 15 (Gregg) incorporates these proposals. H. R. 2122 (Tauzin) is similar to S. 15. The largest difference is rather than creating a permanent, indefinite appropriation, H. R. 2122 establishes a special fund and authorizes the subsequent appropriation of up to $5.593 billion for the purchase of countermeasures through FY2013. Some provisions of Project BioShield are controversial. Some critics suggest that biotechnology and pharmaceutical companies will require even more incentives than contained in these proposals. Additional incentives being considered by the 108th Congress include protection from litigation because of adverse reactions to the countermeasures, and tax and intellectual property incentives (S. 666, Lieberman). Other options include directly funding development or increasing the scope of existing federal programs designed to encourage technology commercialization. This report will be updated in response to legislative developments.