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OTC NAPROXEN SWITCH REVIEW: COMMITTEE MEMBER "TROUBLED" BY PRESS COVERAGE

This article was originally published in The Tan Sheet

Executive Summary

OTC NAPROXEN SWITCH REVIEW: COMMITTEE MEMBER "TROUBLED" BY PRESS COVERAGE of the meeting prior to the event. Referring to a June 1 Wall Street Journal article which quoted one analyst as saying that "the FDA advisory committee will be quite happy to have this thing marketed," committee member Deborah Kredich, MD, Duke University, told the committee that she felt "troubled" by assumptions in the article. "I'm troubled that we are here listening to something that many people feel is a fait accompli," Kredich said. "Why did a lot of time and energy get put into a [review(BRACKET), if the decision has already been made? I resent [the efforts made by the committee members] if that is, in fact, true, and The Wall Street Journal is on target." Other committee members mentioned the amount of favorable press coverage the naproxen OTC switch review received in such papers as The Wall Street Journal, The New York Times, and The Washington Post. At the end of the one-and-a-half-day public review of Syntex' switch application, the joint OTC Drugs Advisory Committee and Arthritis Advisory Committee voted seven to four (with one abstention) against recommending approval of the naproxen OTC switch on June 2 ("The Tan Sheet" June 7, p. 1). Prior to a June 2 presentation by Syntex and the company's development and marketing partner Procter & Gamble (see previous story), Arthritis Committee member George Ehrlich, MD, University of Pennsylvania, told company representatives: "I realize [Syntex/P&G] is not responsible for another's mistake, but when I woke up this morning, [the newspapers] had already announced your approval, which of course you had nothing to do with. I don't know whether it's an overactive public relations person, or whether it's the press pressuring the firm, but I wanted to draw your attention to that." In his remarks to the committee, Syntex/P&G representative Mike Perry assured the joint committee that "certainly, there was no one from Syntex that announced any sort of approval in the press, and I just wanted that on the record."
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