Drug safety regulation and the Prescription Drug User Fee Act
The Washington, D.C., chapter heard a lively and informative panel discussion on the reauthorization of the Prescription Drug User Fee Act (PDUFA) on July 18, 2007.
PDUFA, which has been passed in different forms in both the House and the Senate, is currently in a Congressional conference committee. (Update, from Aug. 3) The law regulates how the Food and Drug Administration pays for reviews of new drug applications and addresses drug safety issues such as post-marketing reviews of new drugs and reviewing direct-to-consumer drug advertisements.
Panelists Caroline Loew, Ph.D., of the Pharmaceutical Research and Manufacturers Association; and Susan Wood, Ph.D., formerly of FDA and now at George Washington University, discussed whether the current system of "user fees" is really the best way to fund reviews of new drug applications, whether experts who have conflicts of interest (such as being on the speaker's bureau for a drug company) should be allowed to serve on FDA advisory committees, and whether PDUFA will help to prevent unsafe drugs from coming on the market.
The panel was moderated by chapter co-coordinator Jill Wechsler, Washington correspondent for Pharmaceutical Executive magazine.
More about the panelists:
Susan F. Wood, Ph.D., formerly of FDA and now with George Washington University. Dr. Wood has just written a paper entitled "Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA Budget, and Drug Safety Related?" Dr. Wood is the FDA official who resigned in protest over the Bush Administration's handling of the "Plan B" emergency contraceptive.
Caroline Loew, Ph.D., vice president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America. Dr. Loew recently testified before the House Energy and Commerce Health Subcommittee on the topic of drug safety regulation. She has a background in drug development and has worked at both AstraZeneca and at Abbott Laboratories.