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Lawmaker Calls for Inquiry into Vaccine Contract
U.S. Representative Mike Rogers (R-Mich.) has called for an investigation of the U.S. Health and Human Service Department’s contract with VaxGen Inc. to produce the next-generation anthrax vaccine, the Associated Press reported (see GSN, April 5). Rogers said VaxGen has exaggerated the vaccine’s benefits and failed to stay on schedule to deliver the drug, raising concerns over the national stockpile of vaccines. “I am very worried that this will leave America unprotected,” he said. The lawmaker is looking to conduct the investigation through the House Energy and Commerce oversight and investigation subcommittee. The company in 2004 received an $877.5 million contract under Project Bioshield to produce 75 million doses of the new anthrax vaccine. The company is six to nine months behind schedule on delivery of the first 25 million doses and has asked Health and Human Services to amend the contract to reflect the delay. Delivery of the first order is now expected to begin late this year and continue into 2007, AP reported. The Food and Drug Administration has also warned VaxGen about claims in sales material it distributed. VaxGen made “false and misleading claims” about how its vaccine compares to that produced by BioPort Corp. of Michigan, according to a warning letter from the agency. BioPort is in Rogers’ district and received a $122.7 million contract in May 2005 to produce 5 million doses of its vaccine. The order has been filled. The company produces the only vaccine licensed by the Food and Drug Administration. Rogers has asked Health and Human Services Secretary Michael Leavitt to put out a contract for another 5 million doses of anthrax vaccine. Leavitt said last month a new contract had been approved, but Rogers said BioPort had not received any new anthrax vaccine business from the government. HHS spokesman Bill Hall said he was not aware of Rogers’ request, but defended the VaxGen contract, saying the “highest level of care” is taken with the company. “With any type of program like that, delays are absolutely possible, and when they happen, they're not unexpected,” Hall said. Paul Laland, a spokesman for VaxGen, said an investigation is unwarranted, “but if there was one, we'd be happy to participate and we'd welcome the opportunity to testify.” “The procurement process was an open, competitive solicitation that received multiple bids. It was a very open procurement process and we believe wholeheartedly that the best company won and we stand by that,” he added (Ken Thomas, Associated Press/San Jose Mercury News, April 5). In a statement released yesterday, the company said it was surprised by the investigation request, as the solicitation process complied with all laws and regulations. “It is our understanding that during the solicitation process the HHS received multiple bids and that the agency undertook a robust technical and business evaluation of all bids,” the release said. “Upon completion of that evaluation, HHS negotiated a contract with VaxGen. We believe our bid was chosen based on technological, scientific and cost grounds.” “We also believe that we won this open and fair solicitation because we consistently met the demands of the previously awarded NIAID [National Institute of Allergy and Infectious Disease] contracts for the accelerated development of a modern anthrax vaccine,” the company said (VaxGen release, April 5).
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