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Executive Summary

FDA may be ready to assemble an OTC advisory panel to review oral health care products, after almost two years of considering the project, the agency's OTC Evaluation Division Director William Gilbertson, PharmD, told the Sept. 14-16 annual meeting of the Regulatory Affairs Professional Society in Alexandria, Virginia. In preparation for the panel, Gilbertson said a Federal Register notice "soon" would call for data on plaque. The creation of a panel to review anti-plaque products was first mentioned over two years ago. At that time, Gilbertson cautioned that there was no assurance that the idea of bringing back a panel would be approved. FDA's establishment of a new advisory panel for oral health products would mark a significant milestone in the agency's approach to OTC regulatory questions. The agency has been pressed for a number of years to find a procedure for addressing OTC ingredient issues that have surfaced since the end of the active stage of the OTC Review. FDA recently called for data on sunscreen ratings as a first step to addressing that post-monograph issue ("The Pink Sheet" Sept. 7, T&G-10). However, the agency did not mention reconvening a panel for the sunscreen issue. The oral health panel could set a precedent for reconvening or recreating specific panels for classes of OTC products or special problems. Warner-Lambert Regulatory Affairs Director Robert Kerpitch noted the industry's interest in establishing procedures to handle OTC regulatory issues. "An area of major concern to the industry," Kerpitch said, "is the lack of an OTC drug advisory panel responsible directly to the division of OTC drug evaluation." At a Proprietary Association meeting last December, Gilbertson voiced his approval of a "standing OTC advisory panel" and said he had spoken with the commissioner on the subject. "FDA should establish such a committee comprised of individuals with knowledge of the OTC drug marketplace and with specific expertise on OTC drugs," Kerpitch urged. "Since there are numerous drug advisory panels already in existence, doesn't it seem reasonable to have at least one group of scientific experts to support the OTC drug industry?" he asked. Projecting a conclusion to the OTC Review project begun in 1972, Gilbertson said: "You can expect to see most of the final rules in place . . . by 1992." Furthermore, the division director said he "made a personal commitment with Commissioner Young in several private meetings over the last couple of months to get all the proposed rules out within the next 18 months." The agency has about 40% of the proposed rules (Tentative Final Monographs) still pending. The most recent final monograph, for OTC antitussive drug products, appeared in the Aug. 12 Federal Register ("The Pink Sheet" Aug. 17, p. 6). Gilbertson noted that most of the cough/cold monograph "is already in place." He added that the internal analgesic final rule, weighing in at about 450 pages, will be published within the next few months. "Ibuprofen will not be in it," he noted, but "we will be dealing with things like aspirin for heart attack." Within the next two months, final rules for the ophthalmic and first aid antibiotic drug classes can be expected, Gilbertson said. The expectorant and the nighttime sleep-aid final rules are also nearing completion. However, Gilbertson reported that final rules for weight control products, antiperspirants, and sunscreens are not expected in the immediate future. Gilbertson said he favors a "monograph supplement" system that "would allow for approval of a product, not an ingredient." A supplement system could be devised, Gilbertson said, that would provide some kind of exclusivity. "What we really need for all practical purposes is a mechanism in the future which is flexible -- something that's dynamic," he stressed. Warner-Lambert's Kerpitch stressed the importance of exclusive marketing rights, noting that OTC "drug manufacturers want to be rewarded for their research activities, whether it's a new dosage form, new product indication developed through clinical research, or an Rx-to-OTC switch product." In the beginning of the OTC drug review, Kerpitch reminded the RAPS group, "FDA encouraged manufacturers to pursue collaborative research to support the safety and efficacy of potential monograph drugs and submit the data in the form of a petition. While this was an acceptable practice for an ingredient used by the entire industry, it did not provide product exclusivity for an innovative formulation or new product claim." Noting that NDAs have been used to protect exclusive positions in the OTC area, Kerpitch pointed out that using the NDA approval procedures raises review difficulties. NDAs, he noted, "are traditionally reviewed by [FDA's] division of new drug evaluation, which has a different mind-set and works in a different time-frame than that which is required by the dynamics of the OTC drug marketplace." D.C. Attorney Greg Fisher (Royer, Shacknai & Mehle) also called for new procedures to handle OTC ingredients. "It seems to me," Fisher said, "that if the agency had an obligation to the public to review the ingredients that we use in OTC drugs, I think it also has an obligation to the public to keep some mechanism in place which would survey the population of prescription drugs . . . to determine on an ongoing basis whether some of them might not be appropriate for OTC use." The agency has switched 31 products from Fx to OTC status since 1972.

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