Washington Editor

WASHINGTON - Next year’s proposed FDA budget came under scrutiny during a Senate hearing Tuesday, with Acting Commissioner Andrew von Eschenbach testifying before the Agriculture, Rural Development and Related Agencies Subcommittee.

"These funds are precious," he said of the nearly $2 billion budget proposal for the 2007 fiscal year. Of that total, about $1.5 billion is in the agency’s discretionary budget authority, and the remainder is to come from user fees paid by industries regulated by the FDA.

Notable is the budget’s focus on "emerging, urgent" public health concerns, von Eschenbach said, including $30.5 million for pandemic flu preparedness, $19.9 million for food defense, $4 million for human drug safety and $2.5 million for human tissue safety.

For biotech, $5.9 million is tabbed for the Critical Path Initiative, which von Eschenbach called "an essential investment" into the future of health care to ensure that the agency can guide the development of predictive and more cost-effective medicines. A vocal proponent of genetic- and molecular-based therapies, von Eschenbach, whom President Bush officially nominated Wednesday to permanently head the FDA, recently addressed members of the Personalized Medicine Coalition to extol such efforts.

An FDA "of the 21st century," he said at the Senate hearing, should be able to apply new discovery technologies to its regulatory and approval mechanisms.

The budget calls for the reassignment of $52 million, which concerned Subcommittee Chairman Robert Bennett (R-Utah). But von Eschenbach stressed that the redeployment would "not undermine or impair" the agency’s focus on public health and instead would eliminate wasteful spending in streamlining the agency’s business operations. Bennett also stressed that industry user fees should be used as funding supplements, not substitutes, for the programs they are intended to support.

The subcommittee’s ranking member, Sen. Herb Kohl (D-Wis.), focused on issues related to drug safety, and in particular, the FDA’s year-old Drug Safety Oversight Board that is housed within the Center for Drug Evaluation and Research. He expressed worry about the board’s transparency, given its lack of public representation and closed-door meetings, but von Eschenbach countered that the board’s membership of FDA, NIH and VA representatives allows it function without compromising conflicts-of-interest and confidentiality concerns. He argued that the oversight process is transparent in terms of its conduct, but the board’s actual discussions "are not appropriate to disclose in a public forum."

Another area causing unease among subcommittee members was the growing accumulation of generic drug applications awaiting FDA decisions. "Your budget doesn’t seem to make any effort to reduce that backlog," charged Kohl, noting that by some estimates, 800 generic drugs are in the queue.

Bennett agreed that it would be "helpful" if the issue were better addressed. Von Eschenbach countered that the agency is giving priority to the first generic application it receives for a particular drug class, ensuring that patients gain such an alternative "almost simultaneously" with the resolution of patent issues on pioneer drugs.

Sen. Tom Harkin (D-Iowa), noting the latest domestic case of mad cow disease that has surfaced in Alabama, used the hearing to question the FDA’s animal feed rules. Saying that poultry litter is incorporated into cattle food in the U.S., whereas such ingredients are prohibited elsewhere in the world, he was anxious about prion contamination because "they’re eating chicken crap."

Stephen Sundlof, who heads the FDA’s Center for Veterinary Medicine, tried to allay such worries and said the agency views risks from poultry litter to be "very low."

Overall, members of the subcommittee, which is part of the Senate Appropriations Committee, were largely supportive of the proposed budget. Other government health agency budgets also were reviewed on Capitol Hill in the past few days, including the National Institutes of Health and the Centers for Disease Control and Prevention.

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