FDA,FY 2001 Performance Report for the Prescription Drug User Fee Act of 1992,PDUFA Main Page

FY 2001 Performance Report to Congress

for the

Prescription Drug User Fee Act of 1992

as reauthorized and amended by the

Food and Drug Administration Modernization Act of 1997

Food and Drug Administration
Department of Health and Human Services

Executive Summary

In 1992, Congress enacted the Prescription Drug User Fee Act (PDUFA). PDUFA provided FDA with additional resources to hire more medical and scientific reviewers to conduct premarket re-views as well as support staff and field investigators to speed up the application review process for human drug and biological products. In 1997, after a successful first five years, Congress reauthorized the program for five additional years. With this reauthorization (PDUFA II) came higher expectations for reviews and additional goals intended to improve FDA's responsiveness to and communication with industry sponsors during the early years of drug development. FDA has been able to respond more rapidly to new drug and biologic applications without compro-mising review quality. For the consumer, this has meant more products available more quickly.

All of the original applications submitted during FY 2000 have been reviewed and acted upon, and final performance can now be reported. Only a preliminary performance assessment on ap-plications submitted during FY 2001 is possible at this time. FDA exceeded all the review per-formance goals for original and resubmitted new drug and biological applications and for efficacy and manufacturing supplements submitted in FY 2000. Although it is too early to report final results, the Agency appears to be meeting or exceeding all the review goals for FY 2001 submis-sions. The Agency also exceeded three of the six "procedural and processing" goals designed to improve its responsiveness to sponsors requests during the early phases of drug development (detailed results of performance on procedural and processing goals are on pages 16 and 17).

Notwithstanding these successes, the Agency has encountered challenges in trying to meet the PDUFA II goals. The fees the Agency has collected have been significantly less than expected due to the reduced number of new drug applications and the increased proportion of applications where fees are waived. Yet the number of goal-driven tasks for which the Agency collects no fees have increased substantially under PDUFA II.

The Agency will continue to work with the industry, the Congress, and all other stakeholders on a reauthorization of the PDUFA program that will continue to bring benefits to American consum-ers by bringing important new therapies to market quickly without compromising scientific re-view standards.