FDA Seeks Data On Triclosan, Considers OTC Acne Monograph Inclusion
This article was originally published in The Tan Sheet
Executive Summary
FDA is issuing a call-for-data for information on the safety and effectiveness of triclosan when used as an anti-acne ingredient
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FDA is issuing a call-for-data for information on the safety and effectiveness of triclosan when used as an anti-acne ingredient. Specifically, the agency requests safety and efficacy information on 0.2%-0.5% and 0.3%-1.0% triclosan as a topical acne active ingredient in leave-on and rinse-off dosage forms, according to a notice published in the Federal Register Dec. 5. The agency has determined the antibacterial agent is eligible for inclusion in the OTC topical acne drug products monograph in response to a Time & Extent Application (TEA) filed by Ciba Specialty Chemicals in April 2004. The TEA application process was established by FDA in 2002 to provide a means for establishing eligibility for monograph status for ingredients marketed outside the U.S. (1 (Also see "Monograph Eligibility To Include U.S. Rx-Only Drugs With Foreign OTC Data" - Pink Sheet, 28 Jan, 2002.), p. 4). Triclosan already is used in some acne products, such as several items in Boots' Clearasil line. Ciba cites 19 countries where triclosan has been marketed as an active ingredient in OTC acne medication for at least five consecutive years, according to an FDA review of the application. The firm estimates 21 mil. dosage units of acne medication containing triclosan have been sold in the selected countries without any reported adverse events. The FDA review points to the ingredient's safety, noting that "much larger quantities of triclosan are used topically in antibacterial soaps and as antigingivitis ingredients in oral rinses and toothpastes marketed worldwide without reported adverse effect." Ciba still is awaiting an FDA decision on a TEA it submitted for triclosan in 2003 requesting inclusion in the antigingivitis/antiplaque oral care products OTC monograph (2 (Also see "Triclosan Antigingivitis/Antiplaque Monograph Status Sought By Ciba" - Pink Sheet, 8 Dec, 2003.), p. 8). Despite the ingredient's common use, some industry stakeholders have expressed concerns about the repercussions of widespread consumer use. Triclosan's use in antibacterial soaps and the possibility of antibiotic resistance was discussed at a meeting of the Nonprescription Drugs Advisory Committee in October. The committee unanimously agreed that makers of non-alcohol-based antimicrobials should be required to demonstrate the product's clinical benefit prior to sale (3 , p. 5). According to separate notices also published by FDA Dec. 5, the agency is considering amendments to two other monographs. Safety and efficacy data are requested for up to 10% bisoctrizole and 10% bemotrizinol as single active ingredients and as ingredients used in combination with others in sunscreen products. Ciba requested the ingredients be added to the monograph for OTC sunscreen drug products through a TEA submitted in April 2005. In its review of the application, the agency recommends that both bisoctrizole (up to 10%) and bemotrizinol (up to 10%), either as single active ingredients or in combination with others, be eligible for monograph inclusion. Both ingredients have been marketed "for a material time" and "to a material extent" in at least five countries with no adverse effects, FDA determines. At least 17 mil. dosage units of bisoctrizole and 32 mil. dosage units of bemotrizinol have been sold on every continent excluding Antarctica, the agency adds. FDA also is seeking safety and efficacy data for 0.1%-0.5% and 0.5%-2.0% climbazole for use as an additional dandruff control ingredient under the monograph systems. German firm Symrise submitted the TEA in December 2004. The ingredient has been marketed for longer than five years in six countries, and also is marketed in 61 other countries, according to Symrise. Data, information and general comments on all three announcements are due March 6. In a separate announcement Dec. 9, FDA proposes amending the monograph for OTC dandruff, seborrheic dermatitis and psoriasis drug products to include the combination of 1.8% coal tar solution and 1.5% menthol in dandruff shampoos. - Jessica Lake |