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This article was originally published in The Tan Sheet

Executive Summary

OTC PEDICULICIDE FINAL RULE TO BE PUBLISHED BY FDA in "a couple of days," FDA's Monograph Review Staff Director William Gilbertson, PharmD, told a Nov. 19 session of the Nonprescription Drug Manufacturers Association's Research & Scientific Development Conference in Washington, D.C. Gilbertson noted that the document recently had been "cleared for publication" and that there are "no surprises" in the final monograph. The April 1989 tentative final monograph for OTC pediculicides classified nonaerosol forms of pyrethrins with piperonyl butoxide as Category I (safe and effective). Although FDA noted in the TFM that nonaerosol pyrethrins would not be included in the final monograph unless an appropriate composition standard is established, Gilbertson said at the NDMA meeting that "we're going to rely on" U.S. Pharmacopeia monograph standards for composition. The FDAer added that aerosol forms of pyrethrins are "not in the [final] monograph." In FDA's recent "unified regulatory agenda," the pediculicide final monograph is listed for publication in January. Gilbertson also updated the NDMA audience on the status of other monographs, including the antidiarrheal final monograph, which is expected to be issued "later this spring." The monograph review director noted that the antidiarrheal document "should be out of [the Office of OTC Drug Evaluation] very soon" and will "not include attapulgite," polycarbophil or calcium polycarbophil as Category I ingredients. Kaolin, which was Category III (data insufficient to permit classification) in the TFM, will be upgraded to Category I in the final monograph, Gilbertson said. Recently, FDA informed NDMA that there are no data to support the OTC use of polycarbophil and calcium polycarbophil for acute nonspecific diarrhea ("The Tan Sheet" Oct. 4, p. 3). Polycarbophil and calcium polycarbophil were both considered Category I ingredients in the antidiarrheal TFM, as was attapulgite, which was determined by FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees to be ineffective ("The Tan Sheet" April 12, p. 1). NDMA has been working on protocols for attapulgite efficacy studies, the results of which FDA said it would consider if they were submitted prior to the effective date of the final monograph ("The Tan Sheet" Oct. 4, p. 1). Regarding caffeine as an analgesic adjuvant, Gilbertson noted that the agency is "preparing a feedback letter to industry on upgrading [caffeine] to Category I." The options for dealing with caffeine, he said, are either to place it in the internal analgesics final monograph "and allow for some comment after the final rule is published or amend the tentative final [monograph] at this stage and add it to the final rule at a later time." Gilbertson also noted that FDA has "prepared an antihistamine amendment to the final rule that allows doxylamine in [the monograph] without the need to have [an] additional [warning] statement" that doxylamine has been found to be a rodent carcinogen. In June, FDA's Nonprescription Drugs Advisory Committee recommended that doxylamine remain on the market without such a warning ("The Tan Sheet" July 5, p. 5). Among other upcoming monograph documents is a TFM for "health care antiseptics," including surgical hand scrubs and personal hand care products, that will be issued "sometime in the spring," Gilbertson said. "There's nothing in Category I" in the health care antiseptics TFM, he noted, adding that "we're hoping somebody will do a study" on the efficacy of those products. Gilbertson also reported that FDA is continuing to receive industry comments on the sunscreen TFM, which was published in May. Gilbertson noted that the agency had received a letter from Sen. Joseph Lieberman (D-Conn.), criticizing FDA "for taking too long" with the proposal. Addressing OTC documents that are not tied to a specific monograph, Gilbertson predicted that the adverse drug reaction proposal for over-the-counter drugs would be issued "in April or May . . . at the earliest." The ADR reporting document, he said, is "in the final drafting stages" and has undergone numerous revisions. FDA's regulatory agenda had placed the release date for the ADR proposal in December. Commenting on whether an alcohol warning will be issued for OTC analgesics -- an issue that was addressed by the OTC advisory committee in June and revisited in September ("The Tan Sheet" Sept. 13, pp. 11-14) -- Gilbertson said that "we're developing labeling options" but "we don't know exactly where we're going to go yet . . . We may put a labeling statement into the final rule and ask for comments or we may . . . amend the tentative final analgesic [monograph] to include" warnings. In addition, a final rule on using interchangeable words for monographed products "will be published in the very near future," Gilbertson reported. Published in April, the proposal allowed the interchangability of words including doctor/physician in OTC product labeling ("The Tan Sheet" April 5, p. 9). Gilbertson noted that FDA has "made some revisions" to the proposal including allowing the interchangability of "indications/use, clean/cleanse [and] continue/persist." However, he added that "we disagreed" that "chronic" and "persistent" could be used interchangeably because "while chronic is always persistent, persistent is not necessarily chronic." Gilbertson told NDMA that, overall, "96% of the tentative final monographs are finished," with the remainder "awaiting publication." Approximately 60% of the final monographs have been published. However, while the OTC review "is winding down," Gilbertson said, OTC document "maintenance is growing." This trend "is evidenced by the 10 amendments to final rules that were done this year" that were "outside the scope of the OTC review [and] took time and resources from the office," he explained. Gilbertson concluded that it is "important to note that monographs are dynamic" documents that "are not etched in stone." They "will continue to be scrutinized as is the case with benzoyl peroxide and doxylamine."

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