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Executive Summary

Antibacterial Category I claims for benzoyl peroxide and sulfur/resorcinol should be included in the final monograph for OTC acne products, the Proprietary Assn. (P-A) asserted in May 15 comments to FDA. FDA's contention in the tentative final monograph (TFM) that "no ingredients met the in vivo test [as an antibacterial] is in error," P-A declared. The assn. said data "regarding the antibacterial efficacy (P. acneL and free fatty acid reduction) of benzoyl peroxide and the sulfurresorcinol combination were made to the panel" three times in 1980. Both ingredients were proposed for Category I status in treating acne in the TFM. P-A also included a portion of the transcript of a November 1980 meeting in which the panel unanimously voted to move the antibacterial claim from Category III to Category I. The assn. attached to its comments an additional three clinical studies on the effectiveness of benzoyl peroxide in reducing P. acneL and free fatty acids. In further comments on the acne TFM, P-A asserted that cosmetic/drug products such as medicated acne cleansers or soaps "should be recognized as adjuncts to acne treatment for the purpose of 'promoting drying and peeling,' 'alleviating oiliness,' 'removing/reducing sebum.' " The assn. commented: "The panel's failure to recognize adjuvant acne therapy is inexplicable -- it has left without classification an entire class of cosmetic/drug products whose purpose is to aid in the treatment of acne." P-A submitted comments on three additional TFMs: OTC antihistamine products; OTC nasal decongestant products; and OTC hyperphosphatemia and hypophosphatemia products. The TFMs were among a set of nine published by the agency in the Jan. 15 Federal Register. With respect to the antihistamine monograph, P-A requested that indications for post-nasal drip be included in final monographs for OTC antihistamine products and for OTC cold/cough combinations containing antihistamines. P-A noted that the panel report considered references to post-nasal drip to be Category III labeling as " 'unsubstantiated claims' unless studies specifically designed to assess these activities were presented." The assn. said two consumer mail panel studies designed to investigate consumer attitudes and usage of sinus and hay fever remedies demonstrated that "substantial numbers of consumers recognize that relief of post-nasal drip is a desirable end benefit and consequence of the use of OTC products containing antihistamines." In comments on both the OTC antihistamine and OTC nasal decongestant TFMs, the assn. recommended changes in pediatric dosage schedules. P-A advised that a pediatric dosing system based on a pediatric dosing unit as currently used in the analgesic/antipyretic proposed monograph would "provide a consistency between various monographs and allow for consistency in the formulation of combination products." P-A said the most appropriate unit "would be a pediatric dosing unit that is one-eighth of the adult dose." The assn. also recommended an optionally available weight-related dosing schedule. With regard to OTC hyperphosphatemia and hypophosphatemia drug products, the assn. objected to the professional label warning for aluminum-containing antacids that advises that "elevated aluminum tissue levels may have a role in development of dialysis encephalopathy syndrome." P-A said it was highly improbable patients with impaired renal function or on kidney dialysis would be permitted by a physician to take such medication. The assn. also requested that the warning that addresses normal phosphatemic patients be deleted since phosphorous depletion syndrome is an extremely rare phenomenon.

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