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FY 2004 PDUFA Financial Report

Letter to Congress

The Secretary Department of Health and Human Services
Washington, D.C. 20201

May 10, 2005

Honorable Richard Cheney
President of the Senate
United States Senate
Washington, D.C. 20510

Dear Mr. President:

Enclosed for your consideration is the annual financial report to Congress required by the Prescription Drug User Fee Act of 1992 (PDUFA), as amended. In FY 2002 Congress reauthorized PDUFA for five years (PDUFA III). This is the second financial report under PDUFA III. This report covers fiscal year (FY) 2004 and documents how the Food and Drug Administration (FDA) met each of the conditions specified in PDUFA, thereby allowing the Agency to continue to collect prescription drug user fees.

The report also presents the user fee revenues and related expenses for FY 2004 and comparative data for earlier periods, and details the amounts carried over at the end of each year that remain available. For FY 2004, FDA collected $246 million in user fees and spent $232 million. FDA spent almost 60 percent of the fee revenue for employee salaries and benefits. This infusion of human resources continues to be the single most critical factor enabling FDA to meet the challenging performance goals associated with PDUFA.

Sincerely,

/s/

Michael O. Leavitt

Enclosure

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