Procurement pother

The US Congress refused to authorize $250 million intended to fund development of a second-generation anthrax vaccine this year because of a misunderstanding over the meaning of a single word, "procurement," according to Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases (NIAID).But the administration did not reduce the agency's responsibilities for developing that vaccine or for boosting bioterrorism research, Fauci says. That decision leaves NIAID scrambling for $250 million from somewhere else in its $3.7 billion budget to pay for the vaccine. "We may have to eat it," Fauci explains. Alternately, the Department of Health and Human Services (HHS) may extract the quarter billion from other HHS agencies, but that is unlikely, Fauci says. The new vaccine is needed because the only federally licensed anthrax vaccine may be unsafe for very young children, the elderly, and immunocompromised people, according to NIAID. Nevertheless, the Bush administration failed to convince Congress that the $250 million — about 14% of the agency's proposed $1.75 billion biodefense budget for fiscal year (FY) 2003 — would be used to develop the vaccine rather than to procure large supplies of it once it is completed, according to Fauci and to a congressional staffer knowledgeable about the decision by the House Subcommittee on Labor, Health and Human Services to withhold the proposed funding. The committee axed the anthrax budget mainly because a majority of members believe that procurement is not an NIAID function, according to the staffer, who spoke on condition of anonymity. "It really is a pretty unconventional use of NIH [National Institutes of Health] funds," the staff person says.Fauci maintains that NIAID always meant for Congress to fund $250 million of "advanced product development" necessary to license the already created vaccine. Unfortunately, the budget justification document HHS supplied to congressional appropriations committees last year states clearly, "In the FY2003 President's budget, $250 million is requested for anticipated procurement of anthrax vaccine, currently under development and testing."The misunderstanding over what "procurement" means is so subtle that Fauci resorted to defining "big-p Procurement" versus "little-p procurement" to explain it. Customarily, he says, pharmaceutical manufacturers develop vaccines and other drugs all the way to licensing. Then, when the government buys the licensed drug to provide vaccines for the public, that's little-p procurement. But NIAID is not authorized to do such little-p procurement; another federal agency does it.But since the federal government will be the only buyer of the new anthrax vaccine, some part of the Bush administration — Fauci says he doesn't know which — proposed last year that NIAID develop it all the way through licensing. That work inherently requires manufacturing small pilot lots of the vaccine to make sure they are all equally effective. This "advanced development part of Procurement [is] intimately connected with the actual delivery of the product into someone's hands," he says.However, the subcommittee understood that work to be customary little-p procurement, buying the final licensed product, and thus not the purview of NIH, according to the House staffer. Bush administration lobbyists could not persuade them otherwise. Other minor complications arose as well: the subcommittee did not specify from what part of the NIAID biodefense budget the $250 million should be cut. "Frankly," the House staffer explains, "I think the subcommittee…may have thought, 'OK, they're not ready to do procurement.' If we are simply silent on this issue, that's a pretty good way of resolving it."The budget dispute, an earlier 5-month delay in Congress' approving the 2003 federal budget, and another month's delay in the Office of Management and Budget have not slowed the anthrax vaccine research work, according to Fauci. Carole Heilman, NIAID's director of microbiology and infectious diseases, says that some approved but not-yet-funded grantees are continuing their research anyway, using temporary funding while they wait for their NIAID money. Depending upon how much the Bush administration restores, NIAID's effective biodefense budget for the year will wind up somewhere between $1.5 billion and $1.7 billion, more than six times last year's budget. Fauci calls the budget boost "the largest single increase of any discipline of any institute in the history of the NIH."

Procurement pother

A misunderstanding in Congress has clipped funding for new anthrax vaccine research.

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