Reauthorizing the Prescription Drug User Fee Act:
How are PDUFA, the FDA Budget, and Drug Safety Related?
A new analysis from The George Washington University School of Public Health and Health Service examines the effect of the Prescription Drug User Fee Act on the availability and safety of pharmaceutical therapies. PDUFA, which allows the Food and Drug Administration (FDA) to collect fees from brand-name drug manufacturers that are dedicated primarily to reviewing new drug applications for human use, is set to expire on September 30, 2007 unless Congress acts.
Since it was enacted in 1992, FDA has met its primary PDUFA goal of speeding the review of new products - median review time for standard new drugs was 27 months in 1993 and 10.5 months in 2004. However, questions about the law's impact on drug safety and the agency's budget, and the FDA's capacity to identify adverse effects after a drug is approved, dominate current debate as Congress considers reauthorization.
This paper, Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA Budget, and Drug Safety Related?, is issued as part of the School's Rapid Public Health Policy Response Project (http://www.gwumc.edu/sphhs/about/rapidresponse/index.cfm). The paper examines:
- Current law and the revisions the FDA has proposed to Congress. The FDA proposals would enable the agency to collect more revenue; enhance premarket review; and revise the postmarket drug 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 from legislators, advocates and the industry 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.
For more information:
Susan Wood, PhD, Research Professor
Project on Scientific Knowledge and Public Policy
Department of Environmental and Occupational Health
School of Public Health and Health Services
The George Washington University
Washington, DC 20052
Phone: (202) 994-1734
Email:
eohsfw@gwumc.edu
Web site:
Rapid Public Health Policy Response Project 
