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Biosecurity Briefing
Senate Hearing and GAO Report Examine Anthrax Preparedness Efforts By Crystal Franco, October 26, 2007 On October 23, 2007, the U.S. Senate Committee on Homeland Security and Governmental Affairs held a hearing titled Six Years After Anthrax: Are We Better Prepared to Respond to Bioterrorism?1 The hearing addressed a U.S. Government Accountability Office (GAO) report (also released on October 23), which looks at Project BioShield and “actions needed to avoid repeating past problems with procuring new anthrax vaccine and managing the Stockpile of Licensed Vaccine.”2 The GAO report examines the conditions under which the Department of Health and Human Services’ (HHS) BioShield contract for procurement of recombinant protective antigen (rPA) anthrax vaccine from biopharmaceutical company VaxGen was terminated. According to the report, VaxGen was contracted to deliver 25 million doses of rPA (also known as second generation anthrax vaccine) to the U.S. Strategic National Stockpile (SNS) within 2 years. GAO found that this timeline “would have been unrealistic even for a larger manufacturer,” and that “VaxGen took unrealistic risks in accepting the contract terms.” However, according to representatives from VaxGen, the Food and Drug Administration (FDA) “requirements regarding the type of data and testing required for the rPA anthrax vaccine to be eligible for use in an emergency were not known at the outset of the procurement contract,” and the “anticipated use” of the vaccine was “not articulated [by HHS] to all parties clearly enough and evolved over time.”2 GAO found that HHS has not yet analyzed “lessons learned” from the failure of the VaxGen contract, and industry experts feel that “biotechnology companies…now question whether the government can clearly define future procurement contract requirements.”2 The GAO report further notes that the licensed and stockpiled first generation anthrax vaccine, BioThrax, will begin to expire in 2008, and HHS currently lacks “an effective strategy to minimize the waste of BioThrax.” GAO recommends that HHS work with the Department of Defense to develop a “single inventory system” for the vaccine.2 In an October 23 CongressDaily article about the hearing Senator Joseph Lieberman (I–CT) expressed frustration at the GAO’s findings, noting that the cancellation of the VaxGen contract is a “disappointing failure that has put us back at square one after years of work.” However, Dr. Gerald Parker, Principal Deputy Assistant Secretary for Preparedness and Response at HHS, testified that anthrax is just one of many efforts under BioShield, and Congressional passage of the President’s FY2008 budget request of $189 million for advanced drug development would “spur needed research.”3 Dr. Tara O’Toole, Director of the Center for Biosecurity of the University of Pittsburgh Medical Center, testified that there is a large gap between the government’s goals for Project BioShield and the funding provided. She concluded that "Five billion [dollars] is much less than we're going to need" for the program.3 Dr. O’Toole’s full testimony is available online at: http://www.upmc-biosecurity.org/website/resources/hearings/content/Hearings_2007/20071023-sixyearsafteranthrax.html. References
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