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This article was originally published in The Tan Sheet

Executive Summary

ORAL CONTRACEPTIVE SWITCH POTENTIAL IS STILL UNDER CONSIDERATION AT FDA and the agency plans to bring the issue before a joint session of the OTC Drug and Fertility & Maternal Health Advisory Committees before the end of the year, OTC Drug Policy Staff Director Michael Kennedy said March 24. Speaking at a Food and Drug Law Institute meeting in Washington, D.C., Kennedy predicted that a joint advisory committee meeting will "hopefully" be held "later this year dealing with the question of OTC OCs." A Fertility & Maternal Health Drugs Advisory Committee meeting to consider oral contraceptives as switch candidates initially was scheduled for Feb. 4-5. Members of the OTC Drugs Advisory Committee also had been encouraged to attend the meeting. But according to Kennedy, the committee meeting was cancelled because "there was a lot more interest than anybody thought and a decision was made that it had to wait a while [to] give a lot of groups" that are interested in the issue "the opportunity to get involved." In calling off the meeting on Jan. 28, FDA said it was "concerned that discussion of such a serious and far-reaching issue would require consultation with a broader range of groups inside and outside government than was originally planned." FDA's announcement of the meeting had appeared in the Federal Register on Jan. 21, less than two weeks before the scheduled date. In addition, the meeting was to have been partly sponsored by Johnson & Johnson's Ortho subsidiary, which had agreed to reimburse speakers for travel expenses and pay honoraria. Commenting on the general issue of who at FDA will have primary responsibility for Rx-to-OTC switches, Kennedy said "it hasn't yet been fully determined [who will oversee Rx-to-OTC switches]." He added that the agency was "not going to abruptly switch courses in mid-stream." Historically, FDA's prescription drug reviewing divisions have been responsible for OTC switch applications. OTC Monograph Review Staff Director William Gilbertson said the current thinking at FDA is to have the Office of OTC Drug Evaluation at some time in the future assume responsibility for being the primary reviewer of switch applications. However, Gilbertson noted that he has met with Center for Drug Evaluation and Research Director Carl Peck, MD, Office of Drug Evaluation I Director Robert Temple, MD, and "all the forces at FDA on this transition, and we pretty well agreed -- [and] no one is writing this down in stone -- that those divisions that have been involved actively in switch applications will continue to be the primary reviewer." But Gilbertson added that "[it] is hoped in the very near future, based on some additional resources [from] the user fees . . . that [the OTC Drug Office] will be the primary reviewer." He added: "That's . . . Dr. Peck's philosophy: that we will be the primary reviewer on switch applications, and our colleagues on the prescription side will be the secondary reviewer." Gilbertson also pointed out that the OTC Drugs Advisory Committee Chairman Randy Juhl was to have chaired the February advisory committee session on oral contraceptives as switch candidates. Gilbertson indicated that FDA will continue to try to schedule joint sessions with the OTC advisory committee and the relevant prescription drug reviewing committee when considering switch applications. Scheduling joint advisory committee sessions, Gilbertson noted, has become a potential problem. "The Rx panel and the OTC panel have set schedules for the year and set dates for meetings," he pointed out. "It's difficult at a late stage to try to change these important meetings to have them at the same time, so we're trying to phase in some kind of thing where we think there may be a switch coming up in the near future so that both panels will be available. Otherwise, we have to ask these people to come back twice within two weeks to participate in their own panel and then a switch one." "There are a couple of switches that are in the wind that are going to be considered in the near future and we are still trying to coordinate exactly what chairman is, in these cases, supposed to chair them," Gilbertson said. The Syntex/Procter & Gamble switch application for OTC naproxen (Naprosyn), filed a year ago, is a likely candidate for one of the first joint advisory committee sessions on a switch NDA. In the case of naproxen, the relevant advisory panel would be the Arthritis Drugs Advisory Committee. FDA's Kennedy also outlined some of the outstanding issues to be addressed by the Office of OTC Drug Evaluation in the future, including: Sodium labeling. "We haven't rushed to finalize [sodium labeling]; we were pressed with other business," Kennedy explained. But he said that the work that has thus far been done on the issue indicates that "basically the type of claims and the type of standards that will be used will make a dose of drug equal to a certain amount of food . . . if you have over 140 mg of sodium, it will be proposed that there will be a warning; under 140 mg down to 35 mg [labeling] will say 'low sodium'; 35 mg to 5 mg, [labeling will state] 'very low sodium'; and 5 mg and under will be considered to be 'sodium-free.'" Labeling "exclusivity" for NDAed OTCs. Kennedy said there would be "a regulation coming; I expect to see it out later this year . . . Basically, it will give the same type of labeling flexibility to an NDA product that is enjoyed by a monographed product." Print size and readability. Kennedy reported that the response to FDA's 1991 notice has "been far from plentiful." He also noted that FDA's request for comments on the Nonprescription Drug Manufacturers Association's voluntary guidelines "have also not been forthcoming." Kennedy added: "The more we get into it, the more complex it becomes. Whether this will end up a regulation, or stay a voluntary program, I can't predict at this time." Metrification. "Fortunately," Kennedy pointed out, "monographs have almost all been worked in metric terms, so metrification shouldn't be a problem. It's part of a whole series of congressional hand-downs for FDA."

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