Assumptions - Workload and Workload Adjustments
The statute also provides for annual adjustment of revenues each year after FY 2003 for increases in workload for the process of the review of human drug applications. This adjustment is new with PDUFA III and will be implemented for the first time when fees for FY 2004 are set in August of 2003.
The workload adjuster will use as its base the average number of various types of applications received for the five-year period from FY 1998 through FY 2002. It will compare those to the average number of applications of each type for the most recent five-year period, and assign a weighting factor to represent the portion of drug review workload represented by each type of application. If the workload for the most recent five years is higher than the five-year average for the base period, then revenues will be increased proportionately. The statute directs that the adjustment may not result in fee revenues for a fiscal year that are less than the inflation adjusted fee revenues for the fiscal year.
For the purpose of this initial five-year plan, FDA is assuming that workload over the course of PDUFA III will be stable. This assumption will change in future plans if, over time, our analyses reflect an increase in workload that causes us to adjust fee revenues.