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Project Bioshield: Actions Needed to Avoid Repeating Past Mistakes

GAO-08-208T Published: Oct 23, 2007. Publicly Released: Oct 23, 2007.
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Highlights

The anthrax attacks in September and October 2001 highlighted the need to develop medical countermeasures. The Project BioShield Act of 2004 authorized the Department of Health and Human Services (HHS) to procure countermeasures for a Strategic National Stockpile. However, in December 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. GAO was asked to testify on its report on Project BioShield, which is being released today. This testimony summarizes (1) factors contributing to the failure of the rPA vaccine contract and (2) issues associated with using the BioThrax in the stockpile. GAO interviewed agency and industry officials, reviewed documents, and consulted with biodefense experts.

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Topics

AccountabilityAnthraxBiotechnologyEmergency preparednessMedical researchPharmaceutical industryProcurementProcurement planningProduct evaluationRisk assessmentStrategic national stockpile