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FOREIGN MARKETING DATA TO SUPPORT OTC MONOGRAPH STATUS IS UNDER CONSIDERATION

This article was originally published in The Tan Sheet

Executive Summary

FOREIGN MARKETING DATA TO SUPPORT OTC MONOGRAPH STATUS IS UNDER CONSIDERATION at FDA in the form of a policy guideline, OTC Monograph Review Staff Director William Gilbertson reported at a May 19 Food and Drug Law Institute meeting. Gilbertson told the group that FDA has "a general . . . policy guideline that is under legal review now by counsel setting forth criteria" that would allow the agency to consider overseas marketing experience in petitions for monograph status. The guideline under consideration would revise FDA's current definition of an "old drug" that is used to determine OTC monograph eligibility. The agency currently interprets the FD&C Act to require that drugs be marketed for "a material time and a material extent" in the U.S. Under the guideline, FDA will define "'marketing experience' as marketing sales" and the agency will "require that there be a USP standard for these [ingredients] if it doesn't exist," Gilbertson explained. "More importantly, if we do allow this and make that kind of a substantial change in our policy, it would only apply to rulings that are complete and final, not to anything that's still under review," he added. Gilbertson noted that the concept FDA is considering would be based on the 1986 amendment to the Drug Export Act that lists 21 countries with drug regulation systems comparable to the U.S. FDA. The guideline would "use those countries as our basis and . . . only allow those countries to be considered in the monograph submissions or petitions," Gilbertson said. He indicated that the agency would like to see data from "three or four of them in case one country is slightly different in cultural uses and so forth." The FDAer characterized the policy guideline as "substantial" and pointed out that it would constitute a significant change in existing FDA policy. The guideline would respond in part to a July 1992 petition from the European American Phytomedicines Coalition, which proposed that FDA recognize data for products marketed in Europe for a "material time" and to a "material extent." The guideline also would affect "submissions and petitions from sunscreen manufacturers and anti-plaque makers [asking] the agency to allow . . . consideration [of their products] in the monograph system, instead of the NDA system, [based on] marketing experience in Europe," the FDAer said ("The Tan Sheet" March 29, p. 7). Gilbertson also reported that FDA will begin its anti-plaque review in August beginning with a meeting of the agency's new Dental Products Panel's plaque subcommittee. The anti-plaque ingredient review, Gilbertson explained, will "[look] at all the newly devised plaque products that are out there." He predicted that it will probably last several years. Referring to the recently published sunscreen TFM ("The Tan Sheet" May 17, pp. 10-20), Gilbertson told FDLI that FDA is already working on the issue of ultraviolet-A radiation blocking claims, which was discussed in the preamble to the proposed rule but not in the TFM. He noted that FDA "expects to have a UVA workshop sometime late this year, or early next year, dealing with the other . . . band of the spectrum," he said. Gilbertson also commented on the kaolin and attapulgite recommendations made by the joint OTC Drugs Advisory Committee and the Gastro-Intestinal Drugs Advisory Committee on April 9 ("The Tan Sheet" April 12, p. 1). "It looks like at this time that attapulgite will not be in the antidiarrheal final monograph; kaolin will, with limited claims," he commented. A proposed regulation on alcohol limits for systemic OTC products will appear "very soon," Gilbertson said. The first meeting of the OTC advisory committee last December recommended that alcohol limits be placed on systemic OTC products. Gilbertson said FDA will "recommend that the alcohol for OTC products be limited to 10% for those 12 years of age and over, 5% for [children aged] six to 12, and less than 5% or up to 5% for [children] under six," the FDA official said. More Rx-to-OTC switches will appear before the the agency's advisory body "probably by Labor Day," Gilbertson predicted. He added that "there are some good candidates, as you have all heard about, that are under consideration." Gilbertson also reported that FDA will publish "an updated ingredient status report in September for those interested in keeping track of the ingredients" in the monograph review. FDA also plans to publish a proposed benzoyl peroxide warning "in the very near future," Gilbertson said. He cited the April 1992 meeting of the Dermatological Drugs Advisory Committee, which suggested that benzoyl peroxide stay on the market despite its potential as a tumor promoter, provided that products containing the ingredient bear warnings. The agency will most likely propose "new labeling advising individuals that it is a tumor promoter, and they should avoid use of it in the presence of sunlight or else use it with a sunscreen if they have to go out in the sun," he noted. Another likely FDA proposal would require that labeling on aspirin-containing products feature "a statement advising consumers not to treat themselves for their heart or other diseases with aspirin without seeking professional advice," Gilbertson told FDLI. "We've tried over and over to write OTC labels to do that," he said, adding: "it's virtually impossible to write an OTC label for that." The OTC office's proposal on adverse drug event reporting is "really going very well" and will probably be out "sometime after Labor Day," Gilbertson predicted. He said the OTC reporting system will resemble the existing one for nonprescription drugs under the NDA system. "Manufacturers, packagers, distributors of non-NDA OTC products would have to comply with this," he explained. Companies will be expected to "report the information that you see about series of unexpected adverse experiences, maintain records of any of these, and permit access to any of these records by the FDA," Gilbertson said. Commenting on the progress of the OTC review, Gilbertson declared that "the logjam has apparently broken." He noted that FDA has published three OTC notices in the Federal Register in the past month. Although OTC monograph review staff has been criticized as slow-moving by such key Congressional figures as Rep. Henry Waxman (D-Calif.) ("The Tan Sheet" March 1, p. 3), Gilbertson said that his office has been "very busy." He said that the vaginal contraceptive TFM has already been completed, and that the OTC office expects to complete the laxative proposed rule sometime this year. Gilbertson also pointed out that there are "bundles" of proposed notices still at the Office of Management & Budget; they address almost one-quarter of the items in the monograph review, according to the FDAer. "They've been there a while," Gilbertson said, referring to 10 rules "including the antifungal labeling claims, smoking deterrents, hormones, nailbiting, thumbsucking . . . topical antifungals -- that would be athlete's foot -- ingrown toenail relief, boil treatments and so forth. There's a whole pile of them down there." In addition, Gilbertson said FDA hopes "later this year to get out the weight control PPA document," as well as to publish "a nasal decongestant PPA rule." To facilitate its work with industry, Gilbertson said that the OTC office is "very interested in trying out teleconferencing." He said that he and director-apparent Michael Weintraub "would like to have some kind of conference call via television and video. Telephone conferencing is now available at [FDA's] Parklawn Building, and we're very anxious to try it out." The FDAer told members of the FDLI audience that "if you want to have a conference with us, let's try to do the video thing."
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