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Executive Summary

FDA will not include Givaudan's OTC sunscreen ingredient Parsol 1789 in the upcoming tentative final monograph for sunscreens, the agency informed the company at a Nov. 9 OTC feedback meeting. The agency is prepared to move ahead with the publication of the TFM and does not want to further delay the sunscreen review. Givaudan petitioned FDA in October 1990 to re-open the administrative record for sunscreen ingredients to include the broad-spectrum UVA filter Parsol 1789 (avobenzone) based on European use data. Sunscreens formulated with Parsol 1789 have been marketed overseas since 1981. FDA said the petition was filed too late to be considered in the record. FDA's regulatory agenda, published in the Nov. 3 Federal Register, says the sunscreen TFM could be released as early as next month. FDA does not plan to include in the TFM any of the sunscreen ingredients that are the subject of citizen petitions from European firms. The agency expects to deal with the issue of foreign use data in future rulemaking. Representing Givaudan at the feedback meeting were company Technical Support Director Richard Naipower, MD, Assistant General Counsel Eugene DeFelice and outside counsel Gene Pfeifer and Edward Basile (King & Spaulding). FDAers included OTC Division Director William Gilbertson, microbiologist Jeanne Rippere, who has been actively involved in the sunscreen monograph, and Rippere's branch chief, Ann Mustafa, chief of the Eye, Ear, Nose, Throat and Oral Cavity Drug Monograph Branch. A single OTC formulation containing Parsol 1789 has been marketed in the U.S. by Herbert Labs (Photoplex) since late 1988, following FDA approval of an NDA for the product. Only one other Parsol 1789-containing product, Schering-Plough's Shade UVA Guard, appears close to U.S. marketing. An NDA for the sunscreen formulation has been "approvable" at FDA since May 29. Schering- Plough licenses Parsol 1789 from Givaudan, whose patent rights to the ingredient expire in 2002. Givaudan was among a group of European firms, including E. Merck, Haarmann & Reimer and L'Oreal, that filed an earlier citizen petition with FDA in July 1990 in support of using foreign use data to support a safety and efficacy finding by the agency. A May 1989 BASF AG petition and a 1980 E. Merck petition are awaiting a response from FDA on the issue of foreign use data for OTC sunscreen ingredients. Speaking at the Nonprescription Drug Manufacturers Association's annual Research & Scientific Development Conference on Nov. 12, attorney Stephen Mahinka (D.C. firm Morgan, Lewis & Bockius) suggested that FDA is resistant to opening the monograph process for sunscreens due to fear that one OTC approval via the petition route will open the "floodgates" for a wave of petitions. Mahinka, who filed the first sunscreen petition on behalf of BASF in 1989, suggested that the "basic problem" is that FDA "has not decided that it ought to use this mechanism." The problem for FDA, he continued, is "how do you structure this so that you don't have 4,000 of these [petitions] come along." The creation of the Office of OTC Drug Evaluation and the establishment of an OTC drugs advisory committee, Mahinka observed, may provide "an opportunity to develop more effective and refined policy in this area to utilize [existing] mechanisms" for making a product available OTC. He also suggested that user fees could address "the institutional concern about lack of resources" at FDA. Mahinka did not advocate the petition route for OTC availability to companies given the absence of market exclusivity and the uncertainty for approval. However, he suggested that "as a practical matter" FDA "ought to make the OTC monograph process more available." He maintained that "adoption of a flexible approach likely will result in reduced demands on the agency in drug evaluation resources." To that end, Mahinka said FDA should permit evidence from foreign use to support a GRASE finding. In addition, he asserted that FDA should "refine" the definition of its use standard for monograph status -- "material extent for a material time" -- and provide industry with guidance on how to meet this standard.

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