FY 2000 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

January 19, 2001

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

Dear Mr. President:

Enclosed for your consideration is the annual financial report to the Congress required by the Prescription Drug User Fee Act (PDUFA) as amended (section 104(b)). This report covers fiscal year (FY) 2000, documenting how each of the conditions specified in PDUFA for continued collection of prescription drug user fees was met by the Food and Drug Administration (FDA).

The report also presents the user fee revenues and related expenses for FY 2000, comparative data for earlier periods, and details the amounts carried over at the end of each year that remain available. In FY 2000 FDA collected $137 million in user fees, and spent $147 million, including balances collected in earlier periods that remained available. Over 65% of the fees were spent for salaries and benefits, funding a total of 1009 staff years.

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. The resources PDUFA provides are essential to the vitality of FDA's program assuring the safety and quality of the nation's prescription drugs. One of the major challenges ahead is assuring the continuation of these resources, since PDUFA expires at the end of FY 2002. In assuring the continuation of these funds, we also need to reverse the erosion of FDA's core programs. This erosion has been caused by both increasing appropriations spent on drug review at the cost of other FDA programs, as required now by the PDUFA triggers, and the absorption of mandatory pay increases over many years.

Sincerely,
/s/
Donna E. Shalala

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 Commerce, House of
Representatives

Contents

Executive Summary

Background

Meeting the Legal Conditions for User Fees in FY 2000

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 2001

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