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

Executive Summary

Rx-TO-OTC SWITCH ADVISORY CMTE. MEETINGS MAY BE EXTENDED TO TWO DAYS as opposed to the one-day reviews that recently have 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 a switch NDA for SmithKline Beecham's cimetidine (Tagamet) was accomplished in one day, it is "quite difficult for the FDA to do that," Gilbertson said. The past two switch drugs to come before joint advisory committee meetings -- cimetidine and Syntex' Anaprox (naproxen sodium) ("The Pink Sheet" June 7, p. 6 and p. 8) -- 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," Gilbertson 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 said, echoing comments made by Office of OTC Drug Evaluation Director Michael Weintraub to the OTC and Arthritis advisory committees at a recent meeting ("The Pink Sheet" Sept. 13, p. 9). "FDA continues to look at the application," Gilbertson reported. "We have concerns raised by the the panel that we continue to look at, but the company has improved upon the labeling, the directions and so forth." In fact, there are recent indications that FDA's top management is taking a final look at the application, preparatory to approval within the month. 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," he said, characterizing the agency's role in 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." Referring to FDA's aborted attempt to 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] get 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, or six 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."
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