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FDA's BUDGET REQUEST FOR FY 2002

The President's budget request for the Food and Drug Administration in fiscal year (FY) 2002 (10/1/2001-9/30/2002) totals $1.414 billion, an increase of $123 million or 9.5% over FY 2001. The budget request, which includes $204 million in industry-specific user fees, reflects FDA's commitment to continue strengthening the public health protection by focusing on urgent public health hazards and major performance goals emphasized by Congress. Here is the breakdown of the requested appropriations increase:

• $40 million to meet mandated cost-of-living and pay-related increases for FDA's employees. In the last eight years, FDA has had to absorb $284 million in unfunded pay raises and other inflationary costs.
• $15 million to protect consumers against the new variant Creutzfeldt-Jakob Disease, a fatal illness associated with consumption of meat from cows with Bovine Spongiform Encephalopathy (BSE). The request is earmarked for special measures to keep BSE, the "Mad Cow Disease," out of the United States.
• $25 million ($10.3 million in budget authority and $14.7 million in new import user fees) to prevent substandard food and health care products from reaching the U.S. market by increasing plant inspections and expanding surveillance of regulated imports;
• $10 million to safeguard patients against adverse events associated with the use of drugs, biological agents and medical devices by improving FDA's system for monitoring marketed products;
• $10 million to protect the human subjects and research data in clinical trials by increasing FDA's inspections.
• $14.7 million ($9.4 million in budget authority and $5.3 million in new user fees) to significantly upgrade food safety by expanding the highly successful Food Safety Initiative beyond microbiological contaminants to cover chemical and physical food hazards; and $17.3 million to enhance FDA's scientific potential and operational efficiency through infrastructure improvements. The request includes the development of an advanced financial management system, the completion of a new laboratory in Los Angeles, and the move of a FDA center to a new facility in a suburb of Washington, D.C.

FDA is also requesting new user fees -- $15 million for import activities and $5 million to provide certifications for food exporters -- and several increases in current user fees, including $12 million (of the total $162 million) requested for drug and biologic reviews under the Prescription Drug User Fee Act of 1992.

For further information, see the FDA Backgrounder on the budget request for FY 2002.

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