FDA spending would increase 15 percent in fiscal 2010 under legislation approved by the House Appropriations Committee June 17, but if the agency receives new responsibilities - such as reviewing follow-on biologics applications or more drug and food safety authorities - the money may be eaten up quickly.

"It is very satisfying that everyone is on the right track" when it comes to giving FDA more resources to do its job, notes Steve Grossman, deputy executive director of the FDA Alliance.

But if the agency receives new authorities without provisions for funding them, "the monies that we have worked so hard to get to strengthen the agency may be drained by the need to fund new activities," he said.

In its report on the Department of Agriculture/FDA appropriations bill, the committee pledges to include language authorizing the collection and expenditure of fees to pay for a Center of Tobacco after the tobacco bill enacted by congress is signed by the president and becomes law.

But how and whether Congress will craft fees for other the possible new authorities remains to be seen, Grossman notes.

Tension On User Fees

FDA Commissioner Margaret Hamburg says fees in draft House legislation on food safety reform are insufficient for the proposed job (¹ Also see "House Food Safety Price Tag Exceeds Budget Request – Hamburg" - Pink Sheet, 8 June, 2009.).

The committee bill provides FDA with funding in line with the increase requested by the Obama administration - minus $141 million in proposed new user fees. The $2.9 billion agency budget would be $374 million higher than the agency's current spending allowance.

The panel notes the proposed user fees have not yet been authorized, but says it will consider them when they are. Among those assessments is $36 million in user fees for the Office of Generic Drugs, a fee that has faced congressional opposition in the past (² Also see "Generic Drug Fees In, DTC Fees Dropped, From Obama Budget Proposal" - Pink Sheet, 18 May, 2009.).

Iterating its interest in improving resources for OGD, the panel's bill calls for the office's budget to be $5 million above its fiscal 2009 level, which was $41.5 million. Last year, the generics office got a $6 million boost.

Rep. Rosa DeLauro, D-Conn., and her agriculture subcommittee indicated their opposition to user fees by killing a program to pay for FDA review of direct-to-consumer television ads in 2008 budget.

But user fees seem vital for the new programs under consideration since the sums needed for more food and drug inspections could total in the hundreds of millions of dollars.

The FDA budget includes $873.1 million for the Center for Drug Evaluation and Research and related field activities of the Office of Regulatory Affairs, and $305.2 million for the Office of Biologics Evaluation and Research and related ORA field operations.

Floor action on the USDA/FDA bill is slated to begin July 8 in a push by committee Chairman David Obey, D-Wis., to nail down funding before the new fiscal year begins Oct. 1.

Following House approval June 15 on a 226-202 vote, the Senate on June 17 approved by 91-5 the conference report on the supplemental appropriations package that includes $7.7 for pandemic flu preparedness (³ 'The Pink Sheet,' June 14, 2009).

-Cathy Dombrowski (c.dombrowski@elsevier.com)

FDA Resources Maintain Upward Trajectory In House Appropriations Committee Bill

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