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Reauthorizing the Prescription Drug User Fee Act

The Prescription Drug User Fee Act (PDUFA) authorizes the Food and Drug Administration to collect fees from brand-name drug manufacturers that are dedicated primarily to reviewing new drug applications for human use. The law, first enacted in 1992 and twice reauthorized, will expire Sept. 30, 2007, unless Congress acts.

Although FDA has met its primary PDUFA goal of speeding the review of new products, questions about the law's impact on drug safety and funding dominate current debate. To inform that debate as reauthorization is considered, this paper (PDF) examines:

  • Current law and FDA's proposed revisions, which would enable the agency to collect more revenue; enhance premarket review; and revise the postmarket safety system.

  • The impact of PDUFA on the FDA's budget and on drug safety. The agency has shifted resources from research, training, field inspections and other activities in order to meet its commitment to timely drug reviews. Outside evaluations by the Institute of Medicine and others, coupled with several highly publicized safety problems, have raised questions about FDA's current approach to post-marketing surveillance.

  • Proposals to enhance drug safety. These include financing the FDA through federal revenues rather than industry fees; strengthening information technology; and developing risk-monitoring strategies at the time of approval.

Published by he Rapid Health Policy Response Project of the School of Public Health and Health Services at The George Washington University.

About the Rapid Health Policy Response Project
The Rapid Health Policy Response Project of the School of Public Health and Health Services at The George Washington University presents data and other background information on breaking public health stories. The goal is to educate the public, policymakers, legislators, health care providers, the media and others in order to promote informed decisionmaking. Karyn Feiden, an independent consultant who writes about public health and health care, provides editorial support for this project. Financial support comes from the Public Health and Policy Group of Pfizer Inc.