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This article was originally published in The Tan Sheet

Executive Summary

FDA's OTC ADVISORY COMMITTEE EARLY 1994 MEETINGS TO FOCUS ON Rx-TO-OTC SWITCHES, according to the agency' s Nonprescription Drugs Advisory Committee Chairman Randy Juhl, PhD, University of Pittsburg. Speaking at a Dec. 15 session of the Food & Drug Law Institute's 37th Annual Educational Conference, Juhl predicted that "during the next six months, all of our meetings will be taken up by switch applications." As a result, Juhl said, OTC issues that were expected to be addressed by the advisory committee early in 1994, including pediatric dosing, common cold claims for antihistamines and labeling for OTC analgesics ("The Tan Sheet" Nov. 22, p. 1), "will have to wait until later this year to be reviewed." Earlier during the Dec. 15 session, FDA's OTC Monograph Review Staff Director William Gilbertson said that the pediatric dosing issue would be addressed by the advisory committee in May. FDA has tentatively set the first 1994 meeting of the Nonprescription Drugs Advisory Committee for Feb. 16-18. The first day of the meeting is slated to be a joint session with FDA's Dermatologic Drugs Advisory Committee, the second day will be a joint meeting with FDA's Antiviral Drugs Advisory Committee and the final day will be held in concert with FDA's Gastrointestinal Drugs Advisory Committee. Pending Rx-to-OTC switch applications in the antiviral area include Burroughs Wellcome's NDA for OTC Zovirax (acyclovir) as an orally administered treatment for recurrent genital herpes. In the gastrointestinal arena, NDAs pending at FDA include Rx-to-OTC switches for J&J/Merck's H[2] antagonist Pepcid (famotidine) and SmithKline Beecham's Tagamet (cimetidine). An Rx-to-OTC switch application for Tagamet was the subject of a Sept. 9 joint meeting of FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees, which determined that clinical trials for OTC cimetidine did not demonstrate the drug's efficacy in relieving heartburn symptoms ("The Tan Sheet" Sept. 13, p. 1). SmithKline has indicated that it is working with FDA to determine the best way to prove low-dose cimetidine's effectiveness for treating heartburn. Other tentative meeting dates over the next year for the Nonprescription Drugs Advisory Committee are May 18-19, with the second day being another joint meeting with the Antiviral Drugs Advisory Committee; July 28-29; and Sept. 22-23. During his presentation, Juhl attempted to dispel industry notions that "the committee is anti-switch" because it recommended against approval of "the first two switch applications that came before the committee" -- cimetidine and Syntex/P&G's naproxen sodium. "The committee is enthusiastic about the process of bringing meaningful drug products into the OTC market and promoting self care as a way of increasing the status of the health of the population in general," Juhl insisted. Juhl also offered suggestions "for true innovation in the OTC arena," such as over-the-counter migraine treatments and oral contraceptives. Other potential OTCs that "need to be examined," the advisory committee chairman said, are products for "male pattern baldness, stage fright, exercise-induced musculoskeletal pain, uncomplicated hypertension . . . strep throat, childhood immunizations, smoking cessation, nicotine maintenance, recurrent genital herpes" and cholesterol-lowering drugs. Juhl emphasized that, while he was not necessarily "suggesting that these are appropriate" candidates for OTC marketing, they are categories "that need to be reviewed and studied" for OTC use. These products would be "better ways for innovation to take place than with a number of 'me-too' drugs coming down the line," he asserted. "In the OTC world," Juhl added, "repackaging the same drug in a new box with a new name supported by millions of dollars of advertising has passed for innovation." The committee chairman also urged the industry to avoid using the advisory committee "as a marketing battleground or attempt to delay implementation [of FDA regulations] through transparent scientific objections." Juhl explained that some companies "occasionally will bring information to the committee about their competitor's product, hoping that the committee will make a decision that will . . . decrease the competitive position of their competitor." This "kind of activity," he complained, "consumes valuable resources" of FDA and the committee "that could be used in more valuable exercises."

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