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FY 2004 PDUFA Financial Report

Executive Summary

The law requires the Food and Drug Administration (FDA or the Agency) to report annually on the financial aspects of its implementation of the Prescription Drug User Fee Act of 1992 (PDUFA), as amended. This report covers fiscal year (FY) 2004.

PDUFA 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, within certain tolerances.

This report describes how FDA met those specific statutory conditions or "triggers" during FY 2004. The statements and tables included in this report also provide information on the user fee revenues and expenditures in FY 2004, on the carryover balance, and on comparative data for earlier periods.

For FY 2004, FDA collected $246 million in fees. This is slightly more than the $241 million FDA projected at the beginning of the year when fees for FY 2004 were established. The higher revenues is attributable to receiving a greater than anticipated number of fee paying applications.

In FY 2004, FDA obligated $232 million from PDUFA revenues. This accounted for about 53 percent of all funds obligated in support of the process for the review of human drug applications. FDA obligated about $16 million less than net collections for the year, increasing the balance of funds collected and appropriated in previous years, and still available for obligation, to $51 million at the end of FY 2004.

Challenges facing FDA in FY 2005 include hiring, training and maintaining the staff to meet the PDUFA III goals and maintaining application review productivity while appropriated budget authority that supports drug review requires FDA to absorb the costs of pay increases and achieve significant administrative efficiencies.

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Table of Contents | FY 2004 PDUFA Financial Report

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