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FDA REVIEW OF RU-486 COULD BE COMPLETED FOUR-TO-SIX MONTHS AFTER FILING

Executive Summary

FDA REVIEW OF RU-486 COULD BE COMPLETED FOUR-TO-SIX MONTHS AFTER FILING an NDA for the Roussel-Uclaf abortifacient drug, Deputy Commissioner for External Affairs Carol Scheman reported in a Dec. 15 letter to Rep. Wyden (D-Ore.). "Based on our current knowledge regarding the data on the drug's safety and effectiveness, we estimate that the review process at the FDA would take approximately four to six months, which would include the involvement of a public advisory committee," Scheman wrote. Scheman's calculation came in response to Wyden's Dec. 10 letter asking FDA to assess the regulatory status of RU-486 (mifepristone) if French manufacturer Roussel-Uclaf were able to seek U.S. approval. Importation of the abortifacient for research purposes currently is prohibited by the Bush Administration; President-elect Bill Clinton has expressed support for overturning the existing ban. FDA "is willing to consider foreign clinical trials as evidence of safety and efficacy," Scheman noted, adding that the agency "recently approved an oral contraceptive [Organon's Desogen] based entirely on clinical studies conducted in the United Kingdom" ("The Pink Sheet" Dec. 14, T&G-2 and). As a result, "agency staff who will be responsible for reviewing any mifepristone application report that, based on publicly-available information and literature reports, the available data may well be sufficient to permit an adequate review," Scheman wrote Wyden. "Therefore, further clinical trials may not be required." Scheman pointed out, however, that "without an application submitted to the agency for review, we cannot give a definitive answer" to the question about adequacy of existing clinical trial data. Furthermore, Scheman reminded Wyden that "an unresolved issue would be obtaining access in this country to a prostaglandin which, as you know, under the terms of the foreign approvals, must be taken in conjunction with mifepristone." Because the distribution of mifepristone "is closely controlled under the terms of the foreign approvals," Scheman stated that "the appropriate distribution system for mifepristone in this country would also need to be resolved." In a Dec. 16 statement, Wyden maintained that "with this letter, the FDA is clearing a path for quick approval, and is removing the regulatory roadblocks to permitting this drug into the United States." During the 102nd Congress, Wyden supported legislation that would have overturned FDA's import ban and required HHS to conduct clinical trials of RU-486 ("The Pink Sheet" Aug. 3, T&G-4). In a letter to Roussel-Uclaf President Edouard Sakiz, Wyden recently urged the company to allow introduction of RU-486 in the U.S., noting that Gynex, Cabot Medical and Adeza Biomedical have expressed an interest in marketing the abortifacient in this country ("The Pink Sheet," Dec. 7, T&G-15). Roussel-Uclaf executives have expressed doubts, however, about introducing the abortifacient in the U.S. despite the possibility of the import ban being lifted next year. In a Dec. 15 letter to Sakiz, Rep.-elect Lynn Woolsey (D- Calif.) and 33 other newly-elected Representatives said: "The recent election results have given us renewed optimism that the political climate favors the introduction of RU-486 into the United States." Apparently unaware of Scheman's comments on the potential acceptability of European trials of RU-486, the freshman Representatives urged Roussel-Uclaf to "commence clinical trials on the drug in the United States immediately."

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