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This article was originally published in The Tan Sheet

Executive Summary

DIGESTIVE AIDS OTC FEEDBACK MEETING EXPECTED IN JANUARY to discuss proposed protocols submitted by Requa and Kramer Labs studying the efficacy of activated charcoal for the relief of gastrointestinal distress. At a Dec. 15 session of the Food & Drug Law Institute's Educational Conference, FDA's OTC Monograph Review Staff Director William Gilbertson, PharmD, noted that "there will be feedback meetings on digestive aids . . . probably in January." FDA has not yet determined whether the two protocols will be discussed at separate feedback sessions or back-to-back at the same meeting. Both protocols were developed in response to FDA's final monograph on OTC digestive aids, which was published in October ("The Tan Sheet" Oct. 25, p. 15). The agency ruled that "although data and information were submitted on activated charcoal, they were not sufficient to support monograph conditions." The final monograph becomes effective on April 21. Requa asked FDA in November for a feedback meeting to discuss its activated charcoal protocol by the end of the year ("The Tan Sheet" Dec. 6, p. 7). The Requa protocol, a double-blind, randomized, placebo-controlled, parallel design study, would test the efficacy of the firm's CharcoCaps in alleviating gastrointestinal distress in 85 volunteers receiving activated charcoal and 85 subjects receiving placebo. Kramer Laboratories' counsel Akin, Gump, Strauss, Hauer & Feld also recently requested an OTC feedback meeting with FDA to discuss a protocol for an efficacy study involving Kramer's Charcoal Plus activated charcoal for the relief of gastrointestinal distress. In a Nov. 30 letter to the agency, Akin Gump noted that Kramer has recently completed a pilot study of activated charcoal "as a prelude to a larger, statistically valid investigation." The larger trial is expected to use essentially the same design as the pilot study and will enroll 80 subjects receiving Charcoal Plus and 80 receiving placebo. Kramer also requested a feedback meeting on its activated charcoal protocol before the end of 1993. Noting that the objective of the company is to complete the study before the monograph becomes effective in April, Akin Gump asserted that "to do so, it is essential that the clinical study commence immediately after the new year" and that "recruitment of subjects must begin in mid-December." If the study does not begin in time, Akin Gump said it envisions "requesting a stay of the final rule as it applies to Kramer's product." Gilbertson commented on the activated charcoal feedback meetings while providing an update to the FDLI audience on other OTC monograph issues. The anticaries products final rule is expected to be issued "within the next four to six months," Gilbertson predicted, pending the completion of ongoing work between FDA and the U.S. Pharmacopeia to develop "testing reference standards for the various anticaries formulations." One of the companies working with the agency, at FDA's request, is Church & Dwight. FDA informed Church & Dwight (in a September letter) that it was considering including sodium fluoride/sodium bicarbonate powder dentifrice formula in the final monograph for OTC anticaries products and asked the firm to act as supplier of the USP reference standard formula ("The Tan Sheet" Sept. 27, p. 18). Gilbertson also listed the OTC skin bleaching products proposal and the OTC nasal decongestants final rule among the monograph documents under active preparation in the OTC office. He noted that FDA plans to issue the nasal decongestants final rule without making a determination on the status of phenylpropanolamine, pending industry studies. The Nonprescription Drug Manufacturers Association is in the process of finalizing a protocol intended to determine whether PPA users have an increased risk of hemorrhagic stroke ("The Tan Sheet" Nov. 1, p. 9). In addition, FDA has tentatively set a March 1-2 date for a public workshop to discuss UVA claims for sunscreens, Gilbertson said. The workshop is intended to help FDA develop a consensus on UVA testing, protection, ingredients and labeling for possible inclusion in the sunscreen tentative final monograph. The agency also is in the process of devising a warning on the tumorigenic potential of benzoyl peroxide. Gilbertson said FDA is "toying around with . . . package inserts" containing information on potential benzoyl peroxide carcinogenicity "in addition to labeling for the products." NDMA is expected to begin rat/mouse oncogenicity studies on benzoyl peroxide by the end of the year ("The Tan Sheet" Nov. 15, p. 7).

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