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PARSOL 1789 OTC MONOGRAPH AMENDMENT MAY BE DELAYED

This article was originally published in The Tan Sheet

Executive Summary

PARSOL 1789 OTC MONOGRAPH AMENDMENT MAY BE DELAYED until after FDA holds a workshop next spring on UVA testing methods, FDA reportedly told Givaudan-Roure. In a Sept. 24 letter to OTC Monograph Review Staff Director William Gilbertson, Washington, D.C. attorney Edward Basile (King & Spalding) questioned whether a delay in publishing the proposed monograph amendment is "valid" on a scientific, legal or regulatory basis. Basile said he was responding to a Sept. 16 telephone conversation in which Gilbertson reportedly indicated that the agency may wait until after the upcoming workshop to issue a proposal on the OTC monograph status of Parsol 1789. "The issue before the FDA regarding the subject petition is whether a valid scientific method is available to determine the safety and efficacy of Parsol 1789," Basile declared in the letter. He asserted that a "determination of the safety and efficacy of Parsol 1789 should not be conditioned on developing a consensus" on a testing method. The agency is planning to hold the workshop in the spring of 1994 in order to develop a consensus on changes and scientific advances in UVA testing, protection, ingredients and labeling for likely inclusion in the TFM. In preparation for the session, the agency is requesting that all UVA-related comments on the TFM be submitted by Nov. 8 ("The Tan Sheet" Oct. 11, p. 12). Givaudan- Roure filed its petition requesting monograph status for Parsol 1789 in March ("The Tan Sheet" March 8, p. 4). FDA decided to address Parsol 1789 in a separate amendment in order to avoid further delaying publication of the TFM. Basile noted that the Cosmetic, Toiletry and Fragrance Association "has been attempting to develop a consensus regarding a UVA test method for sunscreen ingredients for years without success largely because of the divergent product base for these ingredients." He added that "withholding issuance of the proposed Federal Register notice for Parsol 1789 pending the outcome of a workshop could delay this process indefinitely and is unlikely to result in a unanimous consensus on a single method." In approving two NDAs covering Parsol 1789 sunscreen formulas, FDA "must have concluded that at least one specific test method is adequate to assure the safety and efficacy of Parsol 1789," Basile said. He added: "While we do not have access to the approved NDAS, it is our understanding that a testing procedure known as the Phototoxic Protective Factor . . . method using 8-MOP was used in one of the NDAs and demonstrated Parsol 1789 to be safe and effective." He noted that "while Givaudan-Roure does not necessarily favor this method, its adoption demonstrates that a method can be selected." FDA approved Herbert Labs NDA for Photoplex in 1988 and Schering-Plough's NDA for Shade UVAGuard in 1992. Givaudan-Roure favors the "immediate pigment darkening . . . methodology of testing for UVA protection," Basile said. Outlined in the company's petition, "the IPD methodology is an accurate and scientifically valid measurement of exposure to UVA," he maintained. "Thus, there are at least two separate and scientifically valid methods that the agency could use for evaluating the safety and efficacy of Parsol 1789." Basile's letter expands upon arguments he made in an Aug. 31 letter to Gilbertson. Basile had urged the agency to "immediately propose to amend the TFM to include Parsol 1789, abbreviate the comment period to 30 days, and quickly publish tentative conclusions that would permit interim marketing of Parsol 1789." Basile asserted that FDA's failure to substantively respond to the Parsol 1789 petition imposes 11 significant financial hardship on Givaudan-Roure because many manufacturers are anxious to include Parsol 1789 in their products, but cannot, without submitting an NDA, until interim marketing is permitted." Givaudan-Roure's patent for Parsol 1789 is due to expire in 2002, he noted, and "further delay by FDA decreases any meaningful manufacturing exclusivity they are entitled to enjoy from the patent." Basile also maintained that FDA's failure to act on the petition "is contrary to its important mandate to protect the public health." The scientific community and FDA itself "have recognized that the use of traditional sunscreen that enable consumers to spend longer periods of time in the sun without experiencing sunburn, actually increases the consumers' exposure to UVA," he added. FDA informed Givaudan-Roure in an Aug. 19 letter that the safety and efficacy of Parsol 1789 will be addressed in an upcoming amendment to the sunscreen TFM ("The Tan Sheet" Aug. 30, p. 11).
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