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Friday, March 1, 2013

Prescription Drug User Fee Act (PDUFA): 2012 Reauthorization as PDUFA V

Susan Thaul
Specialist in Drug Safety and Effectiveness

Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144) reauthorized the Prescription Drug User Fee Act (PDUFA) through September 30, 2017. Known as PDUFA V, this was the program’s fourth five-year reauthorization. The Prescription Drug User Fee Act (PDUFA), in 1992, gave the Food and Drug Administration (FDA) the authority to collect fees from the pharmaceutical industry and to use the revenue to support “the process for the review of human drug applications.”

PDUFA fees provided 52% of the Human Drugs Program funding for FY2012, accounting for more than 2,000 full-time equivalent employees. Therefore, as each reauthorization deadline approaches, FDA, industry groups, and most Members of Congress see PDUFA as must-pass legislation. Congress originally intended PDUFA to diminish the backlog of new drug applications at FDA and shorten the time from submission to decision. The general view is that PDUFA has succeeded. FDA has added review staff and reduced its review times. At each reauthorization, however, discussion returns to certain issues in the context of PDUFA that also reflect broader FDA concerns. The issues—and results—differ. PDUFA II expanded the user fee program’s scope to include activities related to the investigational phases of a new drug’s development, and to increase FDA communications with industry and consumer groups. PDUFA III again expanded the scope of activities that user fees could support to include both preclinical development and a three-year postapproval period. PDUFA IV concentrated on new measures concerning postmarket drug safety.

The PDUFA V statutory language does not differ much from PDUFA IV. The accompanying FDA-industry agreement on performance and goals and procedures for FY2013 through FY2017 includes revised communication procedures and timing goals during the application review process and addresses expanded FDA efforts in regulatory science, drug development, drug safety, and information technology.

In addition to PDUFA reauthorization, FDASIA included 10 other titles that reauthorized medical device user fees, established generic drug and biosimilar biological product user fees, and addressed pediatric drug research, medical device regulation, pharmaceutical supply chain security, antibiotic development incentives, expedited drug approval, drug shortages, and a set of miscellaneous provisions.

Date of Report: February 22, 2013
Number of Pages: 25
Order Number: R42366
Price: $29.95

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