Project Bioshield: Actions Needed to Avoid Repeating Past Mistakes

The anthrax attacks in Sept. & Oct. 2001 highlighted the need to develop medical countermeasures. The Project BioShield Act of 2004 authorized the Dept. of Health & Human Services (HHS) to procure countermeasures for a Strategic Nat. Stockpile. However, in Dec. 2006, HHS terminated the contract for a recombinant protective antigen (rPA) anthrax vaccine because VaxGen failed to meet a critical contractual milestone. Also, supplies of the licensed BioThrax anthrax vaccine already in the stockpile will start expiring in 2008. This report identifies: (1) factors contributing to the failure of the rPA vaccine contract; & (2) issues associated with using the BioThrax in the stockpile. Includes recommendations. Charts & tables.

Witnesses: Jay Cohen, Under Sec. for Science and Technology, Dept. of Homeland Security; Gerald Parker, Principal Deputy Assistant Sec., Office of the Assistant Sec. for Preparedness and Response, Dept. of Health and Human Services; Keith Rhodes, Dir., Center for Technology and Engineering, Applied Research and Methods, GAO; Tara O¿Toole, Dir., Center for Biosecurity, Univ. of Pittsburgh Medical Center. Appendix: Slides submitted for the Record from Mr. Cohen; Questions and responses for the record from the witnesses; Report to Congressional Requesters, ¿Project Bioshield -- Actions Needed to Avoid Repeating Past Problems with Procuring New Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine,¿ Oct. 2007. Illustrations.

Key recent events ¿ the 2001 terrorist attacks, Hurricane Katrina, and the H1N1 influenza (¿flu¿) pandemic, among others ¿ sharpened congressional interest in the nation¿s ability to respond to health threats. For the response to health emergencies, most authority resides with state and local governments, and most capacity resides in the private sector. The federal government plays a key role, however, providing numerous forms of assistance for planning and preparedness, as well as for response and recovery. This report summarizes key issues in domestic public health and medical preparedness and response, and discusses selected federal programs. It discusses issues regarding government leadership, organization, and capacity; health system preparedness and response; the development, procurement, and use of countermeasures; and the defense against specific threats, including foodborne outbreaks and bioterrorism, among others. Figures. This is a print on demand report.

The federal government¿s efforts to address the perceived threat of bioterrorism span many different agencies and are organized and directed through several strategy and planning documents. These agencies have implemented numerous disparate actions and programs in their statutory areas to address the threat. Despite these efforts, many experts, including congressional commissions, non-governmental org., and industry rep., have highlighted weaknesses or flaws in the federal government¿s biodefense activities. Contents of this report: (1) Introduction; (2) Strategic Planning; (3) Risk Assessment; (4) Biosurveillance; (5) Medical Countermeasures: R&D; Procurement; (6) Conclusion.