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Drug safety regulation and the Prescription Drug User Fee Act

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Download audio of the panel discussion (MP3 files):

Intro (1:52)
Introduction of speakers by moderator and chapter co-coordinator Jill Wechsler, Washington correspondent for Pharmaceutical Executive magazine

Part 1 (1:35)
Wechsler offers an overview of the drug safety issues in the legislation

Part 2 (11:29)
Caroline Loew, Ph.D., of the Pharmaceutical Research and Manufacturers Association, discusses which issues would have most impact on drug safety, the context and history of PDUFA, and what PhRMA supports.

Part 3 (13:38)
Susan Wood, Ph.D., formerly of FDA and now at George Washington University, offers background on the FDA's budget and Congress' lack of appropriations that she says have strapped the FDA. She refers to a white paper that GWU put out.

Part 4 (4:42)
A discussion of Risk Evaluation Mitgation Strategies (REMS) - will this be a facade and not have any teeth to it or will it be an effective tool? Loew sets out PhRMA's positions on REMS.

Part 5 - Q&A (33:46)
Discussions include:

• What are the risks of a major drug disaster in light of FDA's limited budget?

• Will this legislation help reduce risk?

• This legislation increases user fees even more than original negotiations. How does PhRMA feel about adding on more user fees?

• There have been a lot of problems getting post-marketing surveillance studies completed. Does this legislation address some of the issues with getting those studies completed?

• How well do companies/sponsors get the postmarketing studies done and are the provisions in the bill positive?

• What was the Durbin Amendment and how would it have limited financial conflicts of interest on FDA advisory committees? (Roll call of vote on Durbin Amendment)

• Timeline - When this will actually move forward?

Special thanks to Kathryn Foxhall for recording the panel discussion.

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.