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Executive Summary

FDA's OTC Drugs Advisory Committee will consider alcohol in systemic OTC drugs for adults at its inaugural meeting scheduled for Dec. 16-17, FDA OTC Drug Evaluation Monograph Review Staff Director William Gilbertson announced Nov. 13 at the Nonprescription Drugs Manufacturers Association Research & Scientific Development meeting in Washington, D.C. Noting that the agency tried to pick a topic that is "not too controversial" for the committee's first meeting, Gilbertson said: "We picked...the subject of OTCs and alcohol as our first agenda item. We are going to be discussing the types of products, the role of alcohol in them and possible alternatives," he said. Specifically, Gilbertson said, FDA is interested in alcohol- containing cough/cold products. In the agency's review of cough/cold products, Gilbertson noted that comments received from the American Academy of Pediatrics recommend that FDA "limit the amount of alcohol" in such products. Gilbertson said that FDA has asked NDMA to "identify the kinds of products [and] what kinds of alternatives might be available." NDMA Senior VP William Soller, PhD, reported that the association's task group on alcohol-containing OTC products will meet on Nov. 17 to discuss the issue. NDMA has surveyed its members, Soller said, in order to identify OTC products containing alcohol and alternatives to the ingredient. The association plans to "gather that information and bring it for a presentation" to the committee, Soller told the industry meeting. The role of alcohol in OTC products will be discussed on the second day of the advisory committee meeting. On the first day, FDA plans presentations on the history of OTCs, procedures, standards of safety and efficacy, and rules for Rx-to-OTC switches. The agency has 10-15 presentations scheduled for the morning session, Gilbertson said. In the afternoon, the committee will hear presentations from industry associations and medical groups. FDA Commissioner Kessler, Center for Drug Evaluation and Research Director Carl Peck, MD, and FDA's Office of OTC Drugs Directer-apparent Michael Weintraub, MD, (currently serving as an FDA consultant) are expected to attend the meeting. A brief closed session is scheduled for the late afternoon to discuss specific Rx-to-OTC switch candidates that are currently under review at the agency, Weintraub told the NDMA meeting. "We are going to try and [require] that, once the advisory committee is up and running,...all the switches come before" the committee, Weintraub said. Committee industry liaison representative and Clairol VP- Research Ed Marlowe, PhD, suggested that the committee would not engage in developing guidelines for switching prescription drugs to OTC. Rather than expect FDA to lay out criteria for product switches, Marlowe said, "I think we have to do our homework." Weintraub concurred, saying that the development of Rx-to-OTC guidelines would be an "unfair burden" on the agency. Gilbertson suggested that other future topics of the OTC advisory committee may include the question of whether to put ibuprofen in the monograph for internal analgesics. "That is the kind of question we might take to an advisory committee," he said. Another topic might be whether to relabel doxylamine- containing products to warn consumers about hepatocellular adenomas seen in animals, Gilbertson indicated. FDA proposed such a warning for doxylamine following recommendations made in June 1991 by FDA's Pulmonary-Allergy Drugs Advisory Committee ("The Pink Sheet" July 22, 1991, T&G-1). In a same-day "Talk Paper," FDA announced the names of the ten advisory committee members, the non-voting industry representative and two non-voting consultants (see following story). In its charter, the committee is allowed up to 15 voting members, in the event that members from other FDA advisory committees participate in the OTC Drugs Advisory Committee deliberations. The Talk Paper notes that committee members are appointed to four-year terms and that six of the first appointees will serve shorter terms "to allow for staggered replacement of members." Gilbertson said that in its operations the OTC advisory committee will follow the recommendations of the Institute of Medicine's soon-to-be released report on FDA advisory committees. Commissioned last year by FDA, the report is expected to be publicly available by Dec. 3. Referring to FDA's policy of discouraging communications between sponsors and advisory committee members before a meeting, Gilbertson reported that IOM "affirms the soundness of this policy." Reading from the executive summary of the report, Gilbertson quoted: "FDA takes the view that it is not obligated to share with sponsors or the general public its communications to advisory committee members before a meeting. The IOM committee, however, believes that it is appropriate for FDA to provide sponsors with copies of all information that it sends to advisory committees." The FDAer commented: "We agree with that and we intend to do that." Gilbertson also said FDA plans to conform to the IOM recommendation that questions to be discussed at an advisory committee meeting "should be sent to committee members and sponsors on the same schedule." The IOM committee also agrees with FDA's practice of releasing the committee questions to the public no earlier than the morning of the advisory committee meeting, Gilbertson noted. The advent of the OTC Drugs Advisory Committee and the Office of OTC Drug Evaluation have been long-awaited by industry members who feel that over-the-counter drugs have not received enough attention and priority at FDA. "The perception was that too often we saw our submissions placed in the bottom of the new drug medical reviewers pile," NDMA's Soller noted. The creation of an OTC Drugs office was one of the first initiatives undertaken by Kessler when he became commissioner in 1990. The OTC division was formally granted office status in November 1991 ("The Pink Sheet" Nov. 18, 1991, T&G-1). A Federal Register notice announcing the OTC advisory committee meeting is expected to appear the week of Nov. 16. The committee meeting will take place at the Bethesda Holiday Inn. While the committee is currently being referred to as the OTC Advisory Committee, Gilbertson noted that the name would probably be changed to the Nonprescription Drug Advisory Committee in the future. The second and third meetings of the committee have been tentatively scheduled for March and June. Gilbertson said that the committee will meet three to four times a year.

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