Prescription Drug User Fee Act (PDUFA): Issues for Reauthorization (PDUFA V) in 2012

Susan Thaul
Specialist in Drug Safety and Effectiveness

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.” Because the current five-year authority expires October 1, 2012, the 112th Congress now turns to the law’s fourth reauthorization—referred to as PDUFA V.

PDUFA fees provide 52% of the Human Drugs Program funding for FY2012. If Congress were to allow the PDUFA authority to lapse, the program would lose 2,222 PDUFA-funded full-time equivalent employees. Congress originally intended PDUFA to diminish the backlog of new drug applications at FDA and increasingly 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 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 authorized activities to include both preclinical development and a three-year postapproval period. PDUFA IV concentrated on new measures concerning postmarket drug safety.

The Secretary of the Department of Health and Human Services (HHS), on January 13, 2012, submitted a PDUFA V package to Congress with proposed statutory language and the FDAindustry agreement on performance goals and procedures for FY2013 through FY2017 (the Agreement). The PDUFA V legislative proposal does not differ much from current law (PDUFA IV). The Agreement revises 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.

As Congress considers PDUFA V legislation, it is likely to also discuss a variety of related and unrelated issues. Those may include the Medical Device User Fee Act reauthorization, also set to expire on October 1, 2012; new proposals for a Generic Drug User Fee Act and a Biosimilars User Fee Act; and provisions concerning such topics as drug shortages, incentives for antibiotic makers, ways to better secure the pharmaceutical supply chain, less restrictive FDA advisory committee conflict-of-interest waiver policies, parity for foreign and domestic manufacturing inspections, and quicker approval of drugs to treat ultra orphan diseases.


Date of Report: February 16, 2012
Number of Pages: 27
Order Number: R42366
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