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FY 2002 PDUFA Financial Report: Total Costs of the Process for the Review of Human Drug Applications

Table of Contents

Previous Section: Carryover Balances

The following table presents the costs for the review of human drug applications for FY’s 2001 and 2002 by organization component. This presents the full cost of the process for the review of human drug applications, including costs paid both from appropriations and from user fee revenues. The amounts are based upon obligations recorded as of the end of each fiscal year. In the past, over 81 percent of amounts obligated are expended within one year, and 96 percent within two years. Thus, obligations represent an accurate measure of costs.


as of September 30, 2001 and 2002
FDA Component FY 2001 FY 2002
Center for Drug Evaluation and Research (CDER) $194,878,267 $209,823,215
Center for Biologics Evaluation and Research (CBER) $80,505,442 $90,039,433
Field Inspection and Investigation Costs (ORA) $22,247,719 $19,200,869
Agency General and Administrative Costs (OC) $25,773,229 $28,563,982
Total Process Costs $323,404,657 $347,627,499
Amount from Appropriations $162,691,657 $185,815,399
Amount from Fees $160,713,000 $161,812,100

The costs for all components except Field Inspection and Investigation rose slightly in FY 2002. This increase primarily reflects mandatory increases in pay rates for federal employees. The decrease in field inspection and investigation costs is due to the recent decrease in the number of applications submitted, and increased reliance on recently completed inspection reports, if they are satisfactory, instead of automatic new pre-approval inspections.

The Agency General and Administrative Costs, though up slightly from FY 2001 levels, have declined over the 5 years of PDUFA II as a percent of total spending on the drug review process. As reflected in Appendix D, the percent of drug review process costs devoted to agency general and administrative costs since 1998 has been reduced by 21 percent.

Next Section: Management Challenges for FY 2004