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

Back to Table of Contents:  FY 2009 PDUFA Financial Report 

The following table presents the costs for the review of human drug applications for FY 2008 and FY 2009 by organizational components.  It indicates 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 the obligations recorded at the end of each fiscal year.  In the past, over 81 percent of amounts obligated are expended within 1 year, and 96 percent within 2 years.  Thus, obligations represent an accurate measure of costs.

As of September 30, 2009

FDA Component

FY 2008

FY 2009

Center for Drug Evaluation and Research (CDER)



Center for Biologics Evaluation and Research (CBER)



Field Inspection and Investigation Costs (ORA)



Agency General and Administrative Costs (OC)



Total Process Costs



     Amount from Appropriations



     Amount from Fees



Of the total of $855,426,294 obligated in support of the process for the review of human drug applications as defined in PDUFA in FY 2009, about 60 percent came from PDUFA fees and about 40 percent came from appropriations.  The costs for all components increased in FY 2009.  The increases in expenditures primarily reflects the fact that in FY 2009 FDA used a total of 3,526 FTE for the process for the review of human drug applications, about 600 more FTE than the 2,926 FTE utilized by FDA in FY 2008.  Most of this increase reflected FDA’s success in hiring or reassigning employees to work in support of the process of the review of human drug applications.  A portion of the cost increase is due to mandatory pay increases for all Federal employees and increased employee benefit costs.

Next Section:  Management Challenges for FY 2010