The Food and Drug Administration (FDA) regulates more than $1 trillion worth of products annually. FDA's annual funding is provided in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill, and is handled by the corresponding appropriations subcommittees in the House and Senate. Not having completed the normal appropriations process, Congress acted in the final days of FY2008 to provide appropriations for the start of FY2009 as part of the larger Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 ( P.L. The annualized amount at this rate would provide FDA with $2.42 billion in total program level for all of FY2009. The FY2009 Request

The Administration's FY2009 budget request for FDA (FY2009 request) was $2.676 billion, an increase of $256 million (10.6%) over FY2008. The requested user fee amounts included $609 million in currently authorized fees. This included $14 million in new fees for the advisory review of direct-to-consumer (DTC) television advertisements, a program authorized in the FDA Amendments Act of 2007 (FDAAA, P.L. In addition to the authorized fees, the FY2009 request included $21 million in proposed new user fees for generic human and animal drugs, pending authorizing legislation. It described another $27 million in proposed fees for reinspections and food and animal feed certification, but did not include them in the budget request totals. The committee did not follow the agency's request for user fees: the Senate committee recommendations did not include the proposed human or animal generic drug user fee programs, or the FDAAA-authorized program to collect user fees for the advisory review of DTC television advertisements of prescription drugs. The Continuing Appropriations Resolution allowed agencies to spend, until March 6, 2009, at the rate of their FY2008 appropriations. It specified that, for FDA, this base would include the $150 million from the FY2008 supplemental.
Food and Drug Administration (FDA) funding for the first five months of FY2009 is provided in the Continuing Appropriations Resolution, 2009 (the CR), which is Division A of the Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 (P.L. 110-329). It allows most agencies to continue at the same rate of spending as set by the FY2008 appropriations. For FDA, the base includes the mid-year FY2008 supplemental. The CR carries through March 6, 2009. If Congress chooses to continue at that rate for the remainder of FY2009, FDA would receive $2.42 billion, 10.6% ($256 million) less than the Administration's FY2009 amended budget request of $2.676 billion.
The Administration FY2009 request (as amended), according to budget documents, would provide for expanded activities to ensure the safety of foods and drugs, enhance workforce development and recruitment, and accelerate the availability of new medical products. The request included $609 million in currently authorized user fees (including $14 million for the advisory review of direct-to-consumer [DTC] television prescription drug advertising) and $21 million in proposed user fees for the review of generic human and animal drugs. It described another $27 million in proposed fees for reinspections and food and animal feed certification, but did not include them in the budget request totals.
The Senate Committee on Appropriations, in S. 3289, recommended an FY2009 total of $2.646 billion for FDA. It did not include the requested user fees for generic drug review, reinspection and certification, or DTC advertising review. The full Senate did not consider S. 3289. There was no FY2009 agriculture appropriations action in the House committee.
Updates to this report will track legislative activity as the fiscal year continues.