|
| ||||||||
| ||||||||
|
Biosecurity BriefingHHS Requests Proposals for Next Anthrax Vaccine By Kunal Rambhia, March 7, 2008 On March 3, 2008, CQ Politics reported that the U.S. Department of Health and Human Services (HHS) released a request for proposals (RFP) for development of a new anthrax vaccine. The RFP requires 25 million doses of a vaccine that can be administered in only three doses instead of the six needed for Biothrax, the current vaccine.1 The article explains that HHS also requires the contractor to “seek Food and Drug Administration licensure for both pre- and post-exposure prophylaxis, and to submit a plan to address licensure in pediatric and geriatric populations.”1 The final draft of the RFP includes industry input that was incorporated after a draft was posted one month ago. The article notes that Tracey Schmitt, of Emergent BioSolutions, believes that HHS should “proceed with development [of] contracts targeting multiple products based on alternative technologies” to minimize risk and increase the likelihood of producing a viable product.1 This RFP represents HHS’s first solicitation of a next-generation anthrax vaccine since its $877.5 million award to VaxGen in 2004. The VaxGen contract, which was the government’s first attempt “to procure a next-generation anthrax vaccine under the Project Bioshield law (PL 108-276),” required the manufacturer to produce 75 million doses of its recombinant protective antigen (rPA) vaccine.1 However, “production delays” caused HHS to terminate VaxGen’s contract in December 2006. According to the article, a Government Accountability Office (GAO) review of the contract breakdown noted that HHS’s “pushing for such a large project with such a small company on such an aggressive timeline” was impractical.1 To address the procurement problems that HHS experienced under Project BioShield, Congress enacted “an overhaul of the procurement system,” in the form of the Pandemic and All-Hazards Preparedness Act signed in December 2006.1 A key change was that the new law “allows payments of up to 50 percent of a contract’s amount before final delivery” of a product.1 The procurement process, under Project BioShield was criticized because it “required the government to pay the contractor only after a product was delivered … and if the product failed, a company would lose its investment.”1 Carol Linden, acting director of the Biomedical Advanced Research and Development Authority (BARDA) in HHS, believes that the new law is good “because it allows government to be in a more risk-sharing mode with the company.”1 Linden also stressed the need for the contractor and the FDA to work together “at the beginning of the process,” as “a lack of clarity about the FDA’s involvement in the process was one of the main contributing factors to the failure of the VaxGen contract.”1 References
|