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Biosecurity Briefing
House Committee Concerned About Timeline for Acquisition of Anthrax Countermeasures By Shana R. Deitch, September 14, 2007 In a September 10, 2007, letter to Health and Human Services (HHS) Secretary Michael Leavitt, the House Committee on Homeland Security, chaired by Representative Bennie Thompson (D-MS), expressed disappointment regarding the pace with which the agency has moved toward the development and procurement of a recombinant protective antigen (rPA) anthrax vaccine.1 HHS released a pre-solicitation notice for rPA vaccine on May 14, 2007, which closed June 11, 2007. The notice, according to a September 11, 2007, Government Executive report, said that the agency expected a formal solicitation to be released in July, with proposals due in November, but HHS has yet to release the solicitation.2 The letter to Secretary Leavitt also expressed concern about timelines for acquisition of anthrax antitoxin laid out in the HHS Public Health Emergency Countermeasure Enterprise (PHEMCE) Implementation Plan which the agency released in April 2007.3,4 As per the implementation plan, acquisition of anthrax antitoxin, a countermeasure that could be used to treat multiple drug resistant anthrax and which HHS considers to be “top priority” is not slated to begin until what HHS defines as its “mid-term” acquisition period, or fiscal years 2009 to 2013.3 However, Chairman Thompson and other members of the Committee are urging the Secretary to quicken the pace of antitoxin development and acquisition “given the Department’s history of delays in essential procurements, and widely documented problems in communications and transparency.”1 The letter cites the termination of the Project BioShield contract with Vaxgen for 75 million doses of rPA vaccine, the related House hearing, and the announcement by Hollis Eden that it was vacating the biodefense countermeasures market as failure on the part of HHS to fulfill essential requirements for national preparedness and to effectively manage countermeasure contracts.1 “We remain concerned that this cancellation [of the VaxGen contract] impedes development work and sends the wrong signal to private sector companies who would seek contracts under BioShield.” The Committee is asking Secretary Leavitt to respond to its inquiries regarding the May 2007 rPA pre-solicitation notice and HHS’ expected release date for any related Requests for Information or Proposals (RFI, RFP). According to the HHS Office of the Biomedical Advanced Research and Development (BARDA) website, the office is currently reviewing pre-solicitation notices and anticipates releasing an RFP for anthrax rPA vaccine in fall 2007.5 An agency spokesperson told Government Executive that HHS anticipates releasing the RFP before year’s end.2 The story also reports that Emergent Biosolutions, a Michigan biopharmaceutical company, and Avecia, a British biotechnology firm, are developing anthrax rPA vaccines. The Strategic National Stockpile (SNS) currently contains 10 million doses of anthrax vaccine adsorbed (AVA). The rPA, or next-generation, anthrax vaccine is expected to require half the number of necessary doses per person than AVA, which the Department of Defense administers six times over an 18-month period. References
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