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U.S. Department of Health and Human Services

For Industry

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Assumptions - Resources For The Human Drug Application Review Process Will Increase By About 16 Percent By The End Of PDUFA III

Table of Contents: PDUFA III Five-Year Plan

Previous Section : Assumptions - Human Resources May Be Acquired By Either Hiring Or Contracting

Over the five years covered by PDUFA III, spending on the process for the review of human drug applications is expected to increase to about $467 million, as reflected in the table below. This is an increase of about 34 percent, or $119 million, compared with $348 million spent in FY 2002, the last year of PDUFA II. This increase by itself may seem large. However, the impact of pay increases over the five years is about 18 percent—or a little over half of the increase. This means that, after accounting for inflation, and excluding the impact of any workload changes, the total resources available for drug review will increase by 16 percent by the end of PDUFA III—an increase of about $50 million. This is expected to add at least 376 more staff years to the drug review process than were spent by the end of PDUFA II—an increase of about 15 percent over the human resources available in FY 2002.

Projection of Total Spending for the Human Drug Review Process ($000)

Source of Funds FY 2003
Estimate
FY 2004
Estimate
FY 2005
Estimate
FY 2006
Estimate
FY 2007
Estimate
S&E Appropriations $166,062 $169,756 $174,000 $178,350 $182,809
Fees from Industry $208,040 $224,806 $255,249 $273,359 $284,512
Total Funds $374,102 $394,562 $429,249 $451,709 $467,321

Next Section : Assumptions - The Resources Are Allocated To Assure That The Performance Goals Are Met