The Prescription Drug User Fee Act: Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?

May 2005

60 Food and Drug Law Journal 261-338 (2005).

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA I). This legislation called for the Food and Drug Administration (FDA) to charge the pharmaceutical industry for certain services and to allot the fee revenues to "performance goals" aimed at speeding up the drug approval process. This legislation was authorized for only five years. Praising PDUFA I's success but aware of its failures, Congress passed the Food and Drug Administration Modernization Act of 1997, Title I of which re-authorized an amended PDUFA bill for another five years (PDUFA II). Facing the same circumstances five years later, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Title V of which re-authorized a further-amended PDUFA bill for yet another five years (PDUFA III). This article traces the historical development of these three different versions of PDUFA, noting in particular how each one was amended to avoid its predecessor's failures. The article then critiques PDUFA III and argues that, while it fails to go far enough in attempting to avoid PDUFA II's failures, it goes too far in that it further entrenches FDA's dependence on the same industry that the agency is charged with regulating vigorously.


FDLI's policy regarding the Food and Drug Law Journal online is: Only the Table of Contents and article abstracts for each issue will be posted to our website. Those visitors wishing to obtain a full text version of a particular article, or a copy of an entire issue, may contact FDLI’s Customer Service Department by e-mail at Your purchase will be processed quickly, and at reasonable rates.

Any questions or concerns regarding this policy should be directed to Michael Levin-Epstein,
FDLI's Editor-in-Chief.