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Rx-TO-OTC SWITCH ADVISORY CMTE. MEETINGS MAY BE EXTENDED TO TWO DAYS

This article was originally published in The Tan Sheet

Executive Summary

Rx-TO-OTC SWITCH ADVISORY CMTE. MEETINGS MAY BE EXTENDED TO TWO DAYS as opposed to the one-day-long reviews that have recently been held by the Nonprescription Drugs Advisory Committee and the applicable prescription drug advisory committee, FDA Monograph Review Staff Director William Gilbertson indicated at a Sept. 22 meeting on Rx-to-OTC switches sponsored by the Institute for International Research in Washington, D.C. Observing that joint advisory committee meetings considering switch drugs "are growing longer and more complex, just because of the physical size and the nature of these meetings," Gilbertson predicted that "there will most likely come the day when we'll have the manufacturer's" presentation day first and "second, the FDA day, or vice versa." Although the most recent joint committee review of an Rx-to-OTC switch NDA for SmithKline Beecham's Tagamet (cimetidine) was accomplished in one day ("The Tan Sheet" Sept. 13, p. 1), it is "quite difficult for the FDA to do that," Gilbertson noted. The past two switch drugs to come before joint advisory committee meetings -- cimetidine and Syntex' Anaprox (naproxen sodium) ("The Tan Sheet" June 7, p. 1) -- both failed to receive approval recommendations from the committees. These advisory committee determinations illustrate that the Rx-to-OTC switch process is growing "more complex, more sophisticated . . . as time goes on, and each switch application keeps getting a little bit harder for the next person," the FDAer said. A switch drug brought before a joint committee is sometimes mistakenly perceived as a "fait accompli," Gilbertson said. "That's not always the case, as evidenced by the last two switch public meetings" on cimetidine and naproxen sodium. "Neither of these drugs are switched, but it doesn't mean that these [drugs] will not eventually be switched. They most likely both will," he predicted. The naproxen sodium Rx-to-OTC switch application "is not dead at FDA," Gilbertson added, echoing comments made by Office of OTC Drug Evaluation Director Michael Weintraub to the OTC and arthritis advisory committees at a recent meeting ("The Tan Sheet" Sept. 13, p. 8). "FDA continues to look at the application," Gilbertson reported. "We have concerns raised by the panel that we continue to look at it, but the company has improved upon the labeling, the directions, and so forth." Regarding the review of OTC cimetidine, Gilbertson characterized advisory committee concerns as pertaining to efficacy of the lower OTC dose. cimetidine is "known quite well to be effective at the Rx dose -- it's the OTC dose that was not clear here," and "we needed a much lower dose to take this drug over-the-counter," he explained. SmithKline Beecham officials recently reported, however, that "there is a chance" that the cimetidine switch could be approved based on available data. Gilbertson concluded that "FDA is a referee; we're not the ultimate approval" in determining switches. "We allow you and the public to approve these things. We just sit in the background, because we get criticized many times when we do approve something," Gilbertson said. Referring to FDA's aborted attempt to unilaterally switch Boehringer Ingelheim's Alupent (metaproterenol) in the mid-1980s, Gilbertson added that the agency will not try to switch drugs on its own initiative in the future. Gilbertson indicated that the OTC office was interested in making the switch review process both more public and less rushed. The FDAer said that he was "trying to push for a system where [committee members] got more involved earlier on, before even the panel meeting, with questions." "Right now our panels are becoming involved in the eleventh hour," Gilbertson said. "That's been the focus of the advisory panel, and I think it might well be that we could get some of the members involved earlier on . . . that maybe some of the members could become involved with the data maybe . . . months before." In addition, the OTC office is "attempting to get more of these [switch] questions in the [Federal Register] ahead of the meeting," Gilbertson told the audience. "The more we get these kinds of things out prior to an actual advisory committee panel meeting, I think it makes it easier for all of us. But there are rules we must follow" under advisory committee procedures, he said. Asked if the OTC advisory committee would ever be solely responsible for review of Rx-to-OTC switches, Gilbertson answered that it would be "a considerable amount of time before that would ever happen." He noted that the OTC office is "still a small office" that has devoted approximately one-tenth of its time and resources to switch products, by his estimate. Should switches "be taken directly to NDAC," Gilbertson said, the committee would still require "some kind of concurrence . . . with our other colleagues on the prescription side." Responding to another question about the survival of the OTC committee under an executive order by the Clinton Administration that some federal advisory committees be eliminated, Gilbertson reported that at "last update," the OTC committee would not be cut. He added that the committee had already scheduled meetings in December and February 1994. "We were safe through October, the last I heard, and we're going ahead and planning for the upcoming meetings," he told the group. Gilbertson also reported that recent activities in the OTC office included the completion of an 80-page proposed rule on adverse event reporting for "old" or monographed drugs. The rule will include "new things" such as a suggestion to place a "1-800 number on the label." The adverse event reporting proposal is being held by FDA for collective publication with "other similar regulations," Gilbertson said, predicting that the document would be released before the end of 1993. Additionally, the OTC office has been working on a regulation addressing limits on alcohol levels in OTC systemic medications, Gilbertson said, and has completed a final rule on OTC topical antifungals and an amendment to the antacid monograph (see story, p. 17).
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