http://www.biomedcentral.com/news/20030701/01

Procurement compromise possible

Anthrax vaccine standoff could be close to resolution in deal sparing non-biodefense research funds

By John Dudley Miller
 

The yearlong stalemate between the Bush administration and Congress over how and when to manufacture a safer second-generation anthrax vaccine may soon be resolved, The Scientist has learned. The White House Office of Management and Budget (OMB) is about to propose a deal to a US Senate subcommittee that would spare funds intended for other types of research, according to three sources close to the negotiations.

Although details may yet change and agreement is not certain, the broad outlines of the proposal require OMB to abandon its insistence that the National Institute of Allergy and Infectious Diseases (NIAID) procure up to 25 million doses of the new recombinant protective antigen (rPa) vaccine this year by scavenging $233 million intended for other NIAID research.

In return, the Senate Appropriations Committee's Subcommittee on Labor, Health and Human Services, and Education, which oversees NIAID, will allow the agency to divert about $60 million of that disputed money to pay for anthrax vaccine work this year, but only from its biodefense research budget, according to two of the sources, a Senate staffer and a lobbyist for research biologists. All three sources spoke on condition of anonymity.

"[The proposal] takes money away from either construction of biodefense facilities or within biodefense [research] itself," explained the Senate staffer, who took part in recent negotiations. "But it doesn't take money away from emerging infectious diseases or HIV/AIDS or the other activities that NIAID is in."

The redirected $60 million would pay to test the vaccine and scale up its manufacture, the staffer explained, probably through an existing NIAID plan to fund one or more companies this September to manufacture at least three million doses each and to complete phase II human testing. A new vaccine is necessary because the current one may be unsafe for young children, the elderly, and the immune-compromised.

Nevertheless, disagreement about how to fund its development erupted when the Bush administration's fiscal year 2003 (FY03) budget proposal directed NIAID to purchase the 25 million doses. The administration hoped to speed rPa vaccine development by simultaneously testing it on humans and scaling up manufacturing to millions of doses, rather than waiting for clinical trials to be completed.

In March 2003, Congress refused to authorize funds for the 25 million doses, arguing that procurement is not an NIH function.

A month later, OMB ordered NIAID to spend the money anyway out of funds intended for other researchers. Doing so would have delayed and perhaps nullified at least part of those grantees' and applicants' FY03 and FY04 funding.

On May 9, the subcommittee's leaders, chairman Arlen Specter (R-Pa.) and ranking member Tom Harkin (D-Iowa), wrote to OMB Director Mitch Daniels, warning him not to allow NIAID to spend any FY03 funds on procurement until the two sides talked.

OMB spokesman Trent Duffy told The Scientist late last week that his office would "very soon" send a letter in response detailing "a plan that accomplishes all the things that we need to do to get the vaccine moving forward."