GAO says formal plan for testing, sample collection needed; schedule for contract to develop vaccine is too stringent.
The federal government's method to detect anthrax in public places and its program to develop a vaccine for the deadly pathogen still have deficiencies, according to the Government Accountability Office.
Testifying Tuesday before a House Government Reform subcommittee, Keith Rhodes of GAO said the Homeland Security Department needs to develop a formal roadmap for how agencies responding to a suspected biological contamination can participate in a validated form of collecting samples for tests.
The agency recommended a formal, probability-based approach to sample collection, so that negative results are interpreted correctly and the complex geometry and surfaces of indoor environments are accounted for properly.
GAO had made those recommendations previously, but DHS at first said establishing those methods was the job of the Environmental Protection Agency, before accepting responsibility recently, Rhodes said.
Rhodes also criticized elements of the $877.5 million contract the Health and Human Services Department awarded in 2004 to anthrax vaccine manufacturer VaxGen. The agreement calls for 75 million doses of the company's next generation vaccine, but Rhodes said the procurement came before the vaccine had completed safety and immunogenicity tests; the contract has little room for delays in schedule, despite an accelerated delivery timeline; and the payment-on-delivery structure places the financial burden solely on the contractor.
Since the VaxGen deal represents the first major procurement under Project BioShield, the federal government's $5.6 billion biodefense program, problems could dissuade other firms from doing business with the government, Rhodes argued.
"A contract schedule with no margin for error, especially for vaccine development, which is known to be risky, is not conducive to building confidence that a vaccine will be available for use within the arbitrarily defined time period," he said in prepared remarks. "While the government should be a tough negotiator when contracting for major procurements, it is important to understand the … rest of the biotechnology sector will be watching to see whether the industry and the U.S. government can make this partnership work."
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