About FDA

FY 1999 PDUFA Financial Report

The Honorable Al Gore
President of the Senate
Washington, D.C. 20510


Dear Mr. President

Enclosed for your consideration is the annual report to Congress on the implementation of the authority and use of fees collected under the Prescription Drug User Fee Act of 1992 (PDUFA) as amended by the Food and Drug Administration Act of 1997. This financial report was prepared in accordance with section 104(b) of PDUFA and covers fiscal year (FY) 1999.

The report documents that each of the conditions specified in PDUFA for continued collection of user fees has been met and presents the user fee revenues and related obligations for 1999. Comparative data for for earlier periods is also provided. In FY 99, FDA collected $126.6 million in user fees. Of that amount $4.6 million was from previous fiscal years. FDA spent $122.5 million from PDUFA revenues, over 60 percent of which went for employee pay and benefits.

We are pleased with the success of the user fee program. Please be assured that we will continue to further strengthen and enhance our human drug application review process to expedite the availability of important medications to American consumers.



Donna E. Shalala



Identical Letters Sent to
Speaker of the House of Representatives
Chairman and Ranking Minority Member, Committee on Health, Education, Labor and Pensions,
United States Senate
Chairman and Ranking Minority Member, Committee on Commerce,
House of Represntatives


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