D.C. chapter learns about drug safety regulation and the Prescription Drug User Fee Act

Washington, D.C., members gathered July 18 for a brown-bag lunch and panel discussion on drug safety regulation and the Prescription Drug User Fee Act (PDUFA), currently in conference committee in Congress. The panelists were Susan F. Wood, Ph.D., professor of environmental and occupational health at George Washington University and former director of FDA's Office of Women's Health; and Caroline Loew, Ph.D., senior vice president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America. Audio of this timely and informative discussion is available for download.

AUDIO

Download audio of the panel discussion about the Prescription Drug User Fee Act.

The Washington, D.C. chapter heard a lively 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. 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.