	Introduction

The Prescription Drug User Fee Act (PDUFA I), in 1992, gave the Food and Drug Administration (FDA) the authority to collect fees from the pharmaceutical industry and use the revenue to support "the process for the review of human drug applications." 112-144 ); it extends the user fee program through September 30, 2017. The PDUFA reauthorization became Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144 ), whose other 10 titles covered reauthorization of medical device user fees, new authorities for generic drug and biosimilar biological product user fees, and other topics such as pediatric drug research, medical device regulation, pharmaceutical supply chain security, antibiotic development incentives, expedited drug approval, drug shortages, and a set of miscellaneous provisions. This report describes (1) the origin of prescription drug user fees; (2) current law; (3) the impact of PDUFA on FDA application review time and the agency's Human Drugs Program budget; and (4) the PDUFA V package (legislative language and the performance goals Agreement). Industry, consumer groups, and FDA agreed that the time from submission of a drug or biologics application to FDA's decision was unacceptably long. With each reauthorization, Congress has amended that definition to expand the scope of activities covered by PDUFA. PDUFA II expanded the range of activities for which FDA could use prescription drug user fee revenue to include those related to the clinical trial phases of a new drug's development (from the IND to submission of an NDA). PDUFA V maintained the PDUFA IV scope of activities that PDUFA fees could support. PDUFA II and III continued that procedure, again referring to the letter ("PDUFA Reauthorization Performance Goals and Procedures"). As described below, the changes address both communication and timing concerns about the review process, and support of a broader range of FDA activities to continue the development and use of regulatory science "[t]o enhance communications between FDA and sponsors during drug development and to meet the challenges of emerging science." Drug safety. Information technology and performance management. The urgency to pass PDUFA reauthorization stems from PDUFA revenue's accounting for more than half the FDA Human Drugs Program budget. The overall vehicle, FDASIA, included 10 other titles.
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.