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ANTIHISTAMINE COUGH/COLD CLAIMS, PPA STATUS ARE LIKELY FUTURE TOPICS

This article was originally published in The Tan Sheet

Executive Summary

ANTIHISTAMINE COUGH/COLD CLAIMS, PPA STATUS ARE LIKELY FUTURE TOPICS for FDA's Nonprescription Drugs Advisory Committee, Sandoz Drug Registration and Regulatory Affairs Director Mark Gelbert, PhD, predicted at a July 12 session of the Drug Information Association's annual meeting in Chicago. Speculating about potential issues that could be addressed by the advisory committee in the next year, Gelbert suggested that the "use of antihistamines for the treatment of cold symptoms" would be brought before the committee because it is one of several "safety and efficacy issues that are still open in the monographs." During a question-and-answer session, Gelbert elaborated: "I know that FDA is not only concerned about efficacy in general of an antihistamine for cold symptoms, but whether that efficacy extends over and above the decongestant [that the antihistamine] is usually combined with in a product." FDA chose not to address antihistamine claims for treating symptoms of the common cold in its December 1992 final monograph for OTC Antihistamine Drug Products. The Nonprescription Drug Manufacturers Association asked FDA for a feedback meeting to discuss cold claims for antihistamines in February ("The Tan Sheet" March 15, In Brief). However, the agency has not yet scheduled a meeting. Gelbert based his predictions on future NDAC meeting topics on "overtures by the committee and other FDA officials" that "have highlighted several issues of importance." The Sandoz exec speculated that phenylpropanolamine's use as a diet aid as well as its association with hemorrhagic stroke would probably be discussed by the committee at a future date. The committee is unlikely to review the status of PPA, however, until the completion of an NDMA population-based, case-control study evaluating whether PPA users aged 18-54 have an increased risk of hemorrhagic stroke ("The Tan Sheet" March 15, p. 8). In addition, Gelbert predicted that the advisory committee would take up "positive carcinogenicity studies on benzoyl peroxide" and "Reye syndrome on nonaspirin salicylates." FDA already has asked NDAC for its opinion on proposed labeling for carcinogenicity warnings for benzoyl peroxide-containing products ("The Tan Sheet" July 5, p. 5). The agency also has announced that it is considering a Reye syndrome warning for all nonaspirin salicylates. The agency proposed requiring a Reye syndrome warning for bismuth subsalicylate products in May ("The Tan Sheet" May 10, p. 6). "Other easy calls" for future advisory committee topics are Rx-to-OTC switch applications, Gelbert said, including SmithKline Beecham's cimetidine (Tagamet), which appears to be headed for an advisory committee review in September ("The Tan Sheet" May 31, p. 1). Gelbert suggested that one focus of the Tagamet discussion might be the H[2] antagonist's drug-drug interactions. Among the cross-cutting issues that Gelbert predicted would be addressed by NDAC in the future were "pediatric dosing, label readability and quite possibly, although this might be a stretch, the issue of brand names and line extensions" (see related story, p. 5). Regarding pediatric dosing, Gelbert pointed out that "traditional clinical data evaluating dosing in children is not available for many OTC drug products." If this issue "continues to raise doubts with FDA, then additional studies may be necessary as has been the case with analgesics and their antipyretic value and also in the case of Pepto-Bismol and its dosing in children," Gelbert asserted. "There is no doubt in my mind that OTC manufacturers will rise to the occasion," however, and "develop databases of a standard that [will] rival prescription drug development" databases, he concluded. "I think it's also safe to assume that if you are currently developing data on one of your monographed drugs, either to reclassify it to Category I or to add additional indications," Gelbert said, "it is likely to be reviewed by NDAC before FDA rules on the petition." Based on comments made by advisory committee chairman Randy Juhl, PhD, Gelbert suggested that an NDAC review may not augur well for many of the older monograph ingredients. "It behooves the OTC industry to begin working against these potential issues so as not to be caught dataless at some future time" if these issues go before the OTC advisory committee, he advised. Although Gelbert acknowledged that the advisory committee is a good forum to discuss OTC issues, he admitted that it is "the dynamics of NDAC meetings that has caused me the most concern." For example, Gelbert pointed out that at NDAC meetings thus far, "the manufacturer was given only a short time to make a presentation, usually much less than an hour." He maintained that this format is different from other FDA advisory committee meetings, where companies are given several hours to present information. Gelbert added that Office of OTC Drug Evaluation Director Michael Weintraub, MD, "has made it clear at least at this point in time that the NDAC meetings will continue to use a more collegial format similar to the [National Institutes of Health] meetings, and that industry will not receive more time to present" information. The Sandoz exec attributed this set-up to Weintraub being "concerned that there might be too much showmanship involved in the [company] presentation."
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