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This article was originally published in The Tan Sheet

Executive Summary

SILVER ACETATE MONOGRAPH STATUS DELAY REQUESTED by New Life Health Products President Michael Fey, PhD, in a Nov. 12 letter to Center for Drug Evaluation and Research Acting Director Gerald Meyer. Fey asked that "silver acetate status under the [OTC smoking deterrents final] monograph be deferred until FDA can review at least the results" of the company's ongoing clinical trial, which is projected to be completed "during the month of January 1994." Fey noted that he hoped Meyer could "undertake unilateral action" that would "create an exception for silver acetate from the explicit terms of the final monograph." Issued June 1, the final monograph for OTC smoking deterrent products does not deem any active ingredients Category I (safe and effective). FDA noted in the monograph, however, that should adequate data from controlled clinical trials become available, a citizen petition containing the data may be submitted to FDA ("The Tan Sheet" June 7, p. 15). The smoking deterrents final monograph became effective on Dec. 1. New Life Health Products markets Stop Smoking Aid and Quit Aid lozenges. Both contain 2.5 mg silver acetate. If FDA decides that it cannot separate silver acetate from the final monograph, Fey suggested that the agency instead could "delay enforcement of the final monograph" and allow continued marketing of silver acetate-containing products. Such an action, Fey stressed, would be "contingent upon the availability" of the data from New Life's current clinical trial as well as a second, more detailed trial that the company would conduct only if silver acetate remains on the market. Fey also indicated that he "would not object" if FDA limits distribution of smoking deterrent products to smoking cessation professionals only. New Life's 500-patient clinical trial is under way at the University of Medicine and Dentistry of New Jersey. Under the study, 460 enrolled subjects will receive a silver acetate-based smoking deterrent product for a minimum of 30 days. Study endpoints include smoking cessation at three weeks and relapse prevention at one year. New Life Health Products initially projected that the study would be completed this fall ("The Tan Sheet" June 21, p. 15). The trial is funded through a $ 500,000 Small Business Innovative Research (SBIR) grant awarded to New Life Health Products by the National Heart, Lung and Blood Institute. Fey added that the New Jersey State Commission on Science and Technology also has provided $ 10,000 in funds to the project. The current clinical trial follows the results of a "pilot clinical study" that was also funded by an SBIR grant. The pilot trial reported a 40% smoking cessation rate in the silver acetate group compared to a 20% smoking cessation rate for the placebo group, Fey told FDA. Fey added that he has submitted to FDA's Pilot Drug Evaluation Staff the protocol for a second clinical trial. However, Fey lamented that "if you decide that [silver acetate] must come off the market and thus there is no income stream to support the continued life of the company, it is unlikely that this clinical trial can be undertaken." New Life Health Products' letter to Meyer is the latest in a series of industry requests that FDA delay action on a specific ingredient in an OTC monograph while additional data are collected. Over the summer, the Nonprescription Drug Manufacturers Association asked FDA to defer final action on attapulgite in the antidiarrheal products final monograph pending, the results of an attapulgite study by the association. NDMA cited several instances in which the agency had delayed final action on specific OTC ingredients while additional data were gathered, including benzoyl peroxide, doxylamine succinate, live yeast cell derivative, yellow mercuric oxide and nighttime sleep-aid combinations. However, FDA denied NDMA's request to defer action on attapulgite ("The Tan Sheet" Oct. 4, p. 1). More recently, Caprice-Greystoke asked FDA in a Nov. 19 citizen petition to hold off on any decision-making on phenylpropanolamine HCl "until our clinical studies, that are in complete accordance with (and beyond) FDA protocols," are finished "so that a comprehensive and scientific reasoning can be made." Caprice-Greystoke said it is "in the process of reviewing a proposed clinical study" with the University of California-San Diego to evaluate PPA "as it relates to its appetite suppressant action in a measured liquid controlled form." Caprice-Greystoke markets Spray-U-Thin appetite suppressant spray. NDMA also is planning a case-control study on PPA to determine whether PPA users experience an increased risk of hemorrhagic stroke. That trial is expected to generate preliminary data by the spring of 1996, provided that the study begins by January 1994 ("The Tan Sheet" Nov. 1, p. 9). Another recent industry request to defer action on a particular OTC ingredient was from Kramer Labs, which asked FDA in June to allow continued marketing of Fungi-Nail pending the submission of safety and efficacy data on the product. The OTC antifungal products final monograph, published in September, did not allow manufacturers to make claims for antifungal use on the scalp or nails ("The Tan Sheet" Sept. 6, p. 3). However, the agency told Kramer in a Nov. 18 letter that "sufficient time has been provided to your company to present safety and effectiveness data for Fungi-Nail." Therefore, "interim marketing is inappropriate while new data are being developed," FDA said.

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