Number: RL31453
Title: The Prescription Drug User Fee Act: Structure and Reauthorization Issues
Authors: Donna U. Vogt and Blanchard Randall, IV, Domestic Social Policy Division 
Abstract: In general, FDA and the pharmaceutical industry feel that the user fee program has been a success. The program, however, has its share of critics. They argue that speeding up drug application review has come at the expense of safety. They also argue that the drug recalls soon after approval show the potentially hazardous consequences of faster approval. In response to some of these criticisms, Congress reauthorized PDUFA (PDUFA III), in the conference report of the bioterrorism bill, H.R. 3448. The new Act will authorize several post-market activities to ensure that FDA has more ability to monitor drug safety. In addition, it authorizes FDA to use funds from user fees to review adverse event reports; amends the FFDCA to ensure that if a drug company fails to complete a post-marketing study, FDA reports that failure on its web site, and requires drug sponsors who fail to complete required post-marketing studies, to notify health practitioners of that failure and of unanswered questions relating to clinical benefit and safety.
Pages: 23
Date: Updated October 7, 2002