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This article was originally published in The Tan Sheet

Executive Summary

INACTIVE INGREDIENTS MAY HAVE TO DEMONSTRATE "PHARMACEUTICAL PURPOSE" to be included in over-the-counter products, OTC Monograph Review Staff Director William Gilbertson told a March 25 Food and Drug Law Institute meeting. Gilbertson said that FDA is considering a rule to include in "one of the monograph's preamble language that basically says if [a one-time active ingredient] has been found to be an ineffective ingredient, [and] if it [has] not demonstrated that it [has] served a pharmaceutical purpose, it cannot be included in the product." FDA proposed a regulation "as far back as the late '70s/early '80s," which would have required "all those ingredients in your OTC product to either be active and have a demonstrated effect or be inactive but play a pharmaceutical role that can be demonstrated," Gilbertson explained. The reg also "listed . . . examples of 'demonstrated pharmaceutical effect.'" Although that proposed regulation was never finalized, Gilbertson said "there is thought of bringing that particular rule back." If the proposal is resurrected, Gilbertson suggested that the "pharmaceutical role" clause could be broadly interpreted. For example, an ingredient such as aloe, which can add cosmetic enhancement by making the overall product more palatable to the consumer, might, in fact, be serving a pharmaceutical role, he indicated. Gilbertson also informed the FDLI group that FDA is still actively re-evaluating whether to allow "common cold" claims for antihistamines. He said that the agency will not have a position on the issue "until we have gone back and reassessed the data we have." "Questions were raised about the data we have," Gilbertson explained, "and until that assessment is done -- it's still ongoing, it's massive, it really is -- we have no position on it." He noted, however, that "when we're ready to make a decision" on the issue, "most likely it will be taken to our" OTC Drugs Advisory Committee. Gilbertson pointed out that Sandoz' spring 1992 Rx-to-OTC switch of Tavist (clemastine) did not include "common cold" claims because of the uncertain regulatory status of OTC antihistamine use for treating cold symptoms. "We can't perpetuate something that may, at some time, require further testing of the labeling," he said. Earlier during the March 25 FDLI meeting, FDA Analgesic, Antiperspirant, and Antimicrobial Drug Monograph Section Medical Officer Lee Geismar said that ibuprofen is not likely to be included in the internal analgesics final monograph when it is published because no one has asked the agency to add the ingredient to the monograph. FDA Gastrointestinal and Contraceptive Drug Monograph Section Medical Officer Helen Cothran also reported that some movement towards a tentative final monograph for vaginal contraceptives is expected in the "near future," possibly in 1993.

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