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FY 2003 PDUFA Financial Report

REQUIRED BY THE

PRESCRIPTION DRUG USER FEE
ACT OF 1992

AS AMENDED BY THE

FOOD AND DRUG ADMINISTRATION
MODERNIZATION ACT OF 1997

AND BY THE

PRESCRIPTION DRUG USER FEE
AMENDMENTS OF 2002

 

 

March 24, 2004

The 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 the Congress required by the Prescription Drug User Fee Act of 1992 (PDUFA), as amended. This is the first financial report under PDUFA III, which authorizes higher levels of fee revenue to support the drug approval process. This report covers fiscal year (FY) 2003, documenting how each of the conditions specified in PDUFA for continued collection of prescription drug user fees was met.

The report also presents the user fee revenues and related expenses for FY 2003 and comparative data for earlier periods, and details the amounts carried over at the end of each year that remain available. For FY 2003, FDA collected $210 million in user fees, and spent $200 million. Almost 60 percent of the fee revenue was spent for salaries and benefits. This infusion of human resources is the single most critical factor enabling FDA to meet the performance goals associated with PDUFA—goals that become increasingly more stringent each year.

Enclosure

 

Identical letters 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 Energy and Commerce, House of
Representatives

 


 

Content

Executive Summary

Background

Meeting the Legal Conditions for User Fees in FY 2003

User Fee Revenues

Obligation of User Fee Revenues

Carryover Balances

Total Costs of the Process for the Review of Human Drug Applications

Management Challenges for FY 2004

Appendices

Appendix A: Conditions for Assessment and Use of Fees

Appendix B: Exemptions and Waivers

Appendix C: Allowable and Excluded Costs for the Process for the Review of Human Drug Applications

Appendix D: Development of Costs for the Process for The Review of Human Drug Applications