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U.S. Department of Health and Human Services

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FY 2000 PDUFA Financial Report: Executive Summary

Table of Contents

The law requires the Food and Drug Administration (FDA) to report annually on the financial aspects of its implementation of the Prescription Drug User Fee Act of 1992 (PDUFA), as amended and extended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This report covers fiscal year (FY) 2000.

The PDUFA, as amended, specifies that the following three conditions must be satisfied each year in order for FDA to collect and spend PDUFA fees:

  1. FDA's overall salaries and expenses appropriation, excluding fees, must exceed FDA's overall FY 1997 salaries and expenses appropriation (excluding fees and adjusted for inflation).
  2. Fee revenues collected must be specified in Appropriation Acts.
  3. FDA must spend at least as much from appropriated funds for the review of human drug applications as it spent in FY 1997, adjusted for inflation.

This report describes how those specific statutory conditions or "triggers" were met in FY 2000. The statements and tables included in this report also provide information on the user fee revenues and expenditures in FY 2000, and on the carryover balance. Comparative data for earlier periods are also provided.

In FY 2000, FDA collected $137.7 in fees and refunded $4.7 million, mostly from pre-1998 fees that exceeded limitations set in FDA's Appropriation Acts on the amount of fees FDA may keep and spend. Collections, net of these refunds, totaled $133.1 million. At the end of the year FDA also had receivables of $9.5 million.

In FY 2000, FDA spent $147.3 million from PDUFA revenues-$14.2 more than its net collections. This was possible using carryover balances from previous years, and is consistent with the PDUFA II Five-Year Plan published annually by FDA. Language allowing the PDUFA fees to be retained until expended has been included in each of the annual Appropriations Acts. Almost 65 percent of the FY 2000 expenditures went for employee pay and benefits. Throughout FY 2000, user fees financed 1009 more staff-years for the drug review process than in FY 1992 (before PDUFA was enacted), and 100 more than were financed from fees in FY 1999. This continued infusion of human resources is the single most important factor enabling FDA to meet the increasingly challenging performance goals associated with PDUFA.

The balance of the fee revenues spent in FY 2000 funded operating support for these additional employees and investments in FDA's infrastructure supporting the process for the review of human drug applications (including vital investments in the continued development of information technology capabilities).

Challenges facing FDA in FY 2001 include assuring the continuation these resources, since PDUFA expires at the end of FY 2002, and reversing, or at least halting, the erosion of FDA's core programs from both continued absorption of pay increases and the third PDUFA trigger described above

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