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This article was originally published in The Tan Sheet

Executive Summary

FDA HAS FORWARDED SEVEN FINAL MONOGRAPHS TO OMB and anticipates that "eight other final monographs will be completed by FDA and could be published by the end of the year," the agency told Rep. Henry Waxman (D-Calif.) in a March 12 letter. The final monographs awaiting clearance by the Office of Management and Budget are topical antifungals, boil treatments, anorectal (live yeast cell derivative) drugs, topical hormones, ingrown toenail relief products, nailbiting and thumbsucking products, and smoking deterrents. In total, 43 final monographs remain unpublished. Two amendments to existing final monographs developed last year also are at OMB -- warnings for OTC antacids and warnings and directions for water-soluble gum-containing agents, FDA said. FDA's March 16 letter to Waxman is in response to a Jan. 26 letter from the California congressman requesting an update on the monograph process since Commissioner David Kessler's testimony before the House Energy & Commerce/health subcommittee in April 1992 ("The Tan Sheet" March 1, p. 3). At last year's hearing, according to FDA, Kessler projected that 75% of the final monographs would be published by the end of 1993 and 90% by the end of 1994. Waxman had asserted in his Jan. 26 correspondence that Kessler made "commitments" at the hearing to issue 75% of the monographs by 1992 and 90% by 1993. Kessler's projections, the letter explains, "depended on choices to reallocate staff to the OTC drug review activities." However, "the necessary staff reallocation was not possible," FDA stated. The OTC Drug Evaluation Office had a 34-person staff in 1992, and is projected to "increase by three-to-five people in 1993, with emphasis on hiring of medical staff," the agency added. Revised projections offered by FDA in the letter are that "by the end of 1993, we will have 67% of the final monographs either published or submitted to OMB for review and 80% by the end of 1994." FDA noted that seven final monographs were published in 1992: Male Genital Desensitizing Drug Products (June 19), Orally Administered Fever Blister Treatment Drug Products (June 30), Expectorant (Ipecac) Drug Products (Sept. 14), Antihistamine Drug Products (Dec. 9), Ophthalmic (Anti-infective) Drug Products (Dec. 18), External Analgesic Diaper Rash Drug Products (Dec. 18), and Antifungal Diaper Rash Drug Products (Dec. 18). Six amendments to existing final monographs also were issued in 1992, FDA told Waxman. They included warnings for bronchodilators, antitussives, and expectorants; directions for use of corn and callus removers and wart removers; and the addition of diphenhydramine HCI and diphenhydramine citrate to the the Antitussive Drug Products TFM. FDA said that a final rule removing from the market "415 additional Category II and III ingredients before completion of their respective rulemakings" is expected to be forwarded to OMB "by the end of April of this year." Proposed in August 1992 to expedite completion of the monograph process, the proposed withdrawal of 415 active ingredients included the removal of 86 ingredients from the external analgesic drugs monograph. After publication of a final rule, manufacturers would have six months to make changes in their products or take them off the market. The agency also explained to Waxman that "a number" of other monograph-related documents are "in progress," including "warning statements for water soluble gums (final rule) and labeling for benzoyl peroxide acne products (proposed rule)." FDA is apparently considering whether to seek comments on FDA's Dermatologic Drugs Advisory Committee's March 1992 recommendation that benzoyl peroxide remain on the market pending results from ongoing carcinogenicity studies, but that a warning be included in labeling about the current lack of information on the ingredient's safety. The agency reclassified benzoyl peroxide from Category I (safe and effective) to Category III (safety and efficacy data insufficient to permit classification) in August 1991 after some animal tests showed that the ingredient promoted tumors in rodents. In addition, based on recommendations from the agency's OTC Drugs Advisory Committee at its inaugural meeting, FDA said that it is "developing a regulation regarding alcohol in OTC drug products." The advisory committee recommended at the December 1992 session that the alcohol content of OTC systemic medications should not exceed 5%-10% for individuals over 12 years of age, should range between .5%-5% for children between six and 12, and should be "alcohol-free" (less than .5%) for children under six. Of the five remaining tentative final monographs, FDA told Waxman that "two are currently at OMB pending publication, two are being processed for publication in the agency, and one is nearing completion in the Office of OTC Drug Evaluation." Last year, FDA issued amendments to three tentative final monographs covering the labeling of oral health care drugs, ingredient combinations of laxative products and labeling and package size of anticaries drug products. The agency also noted that, in 1992, it issued two notices of enforcement policy -- covering antacid and acetaminophen combination drug products in a solid dosage form, and combination drug products containing potassium nitrate and an anticaries ingredient -- that "will be included in a final monograph still under development." Enforcement policy notices allow manufacturers to begin marketing these products "under specific described conditions, so that consumers may obtain products determined to be safe and effective before a final monograph is issued," the agency explained. Due to the antacid/acetaminophen combination policy, for example, McNeil has been able to market its Extra Strength Tylenol Headache Plus, and Bristol-Myers Squibb its Aspirin Free Excedrin Dual.

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