NIAID's Pother Over Procurement

Brian Behnke, Illustration Works The US Congress refused to authorize $250 million (US) 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 Allergy 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," says Fauci. The Department of Health and Human Services 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, elderly people, and those who are immunocompromised, according to NIAID.1 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 2003) would be used to develop the vaccine rather than to procure large supplies of it once it is completed, according to Fauci and a congressional staffer who is knowledgeable about the House Subcommittee on Labor, Health, and Human Services' decision 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 [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."2 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 through the process to licensing. Then, when the government buys the licensed drug to provide vaccines for the public, that's considered little-p procurement. But NIAID is not authorized to do such little-p procurement; another federal agency does it. 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 to 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," Fauci says. However, the subcommittee understood that work to be customary little-p procurement, buying the final licensed product, and thus not the purview of NIAID according to the House staffer. Bush administration lobbyists could not persuade them otherwise, and 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 and an earlier five-month delay (from Oct. 1, 2002 to Feb. 25, 2003 ) 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 on how much of the budget 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." John Dudley Miller (johmiller@nasw.org) is a freelance writer in Cleveland, Ohio. References 1. "NIAID Biodefense Research Agenda for CDC Category A Agents," available online at www.niaid.nih.gov/biodefense/research/biotresearchagenda.pdf 2. Department of Health and Human Services, "Justification of estimates for appropriations committees, fiscal year 2003," Vol. I, Overview, 2002, pg. 26; available online at www4.od.nih.gov/officeofbudget/alternateformat/overview2003.pdf function sendData() { document.frm.pathName.value = location.pathname; result = false if (document.frm.score[0].checked) result = true; if (document.frm.score[1].checked) result = true; if (document.frm.score[2].checked) result = true; if (document.frm.score[3].checked) result = true; if (document.frm.score[4].checked) result = true; if (!result) alert("Please select") return result; } .myradio{background-color : #94bee5} Please indicate on a 1 - 5 scale how strongly you would recommend this article to your colleagues? Not recommended 1 2 3 4 5 Highly recommended Please register your vote

NIAID's Pother Over Procurement

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