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RU-486 LARGE U.S. CLINICAL TRIAL SUGGESTED BY ROUSSEL-UCLAF

Executive Summary

RU-486 LARGE U.S. CLINICAL TRIAL SUGGESTED BY ROUSSEL-UCLAF as an "early step" toward FDA approval of the abortifacient drug, the agency said Feb. 25. In a "Talk Paper" on a Feb. 24 meeting between FDA Commissioner Kessler and Roussel-Uclaf President Edouard Sakiz, the agency said Roussel-Uclaf "pointed out that an early step toward approval would be a large clinical trial in which U.S. physicians would be trained in the use of RU-486 and would administer the drug to women participating in the trial." The clinical trial proposed by the company could generate data "on how the drug could be safely and effectively administered in typical medical settings in this country," the "Talk Paper" states. RU-486 (mifepristone) is currently available through controlled distribution in France, England and Sweden. One of Roussel-Uclaf's positions on RU-486 is that it will permit the drug to be marketed only in countries where controlled distribution systems are enforced. The face-to-face meeting between Kessler and Sakiz at FDA headquarters in Rockville, Md. appears to signal a further softening of Roussel-Uclaf's refusal to submit registration materials for approval of the drug in the U.S. The meeting concerned "clinical and manufacturing data on the drug, focusing on the types of data FDA would need in considering an NDA for RU- 486," the "Talk Paper" states. In a Dec. 15, 1992 letter to Rep. Wyden (D-Ore.), FDA Deputy Commissioner for External Affairs Carol Scheman said that FDA has communicated to the company that it "is willing to accept foreign clinical trials as evidence of safety and efficacy" of RU-486 ("The Pink Sheet" Dec. 21, 1992, T&G-11). Scheman said that FDA reviewers who would be responsible for reviewing an NDA for RU-486 report that "available data may well be sufficient to permit an adequate review." FDA has estimated the review process for an NDA "would take approximately four to six months." Although it is advancing toward the notion of allowing RU-486 to be marketed in the U.S., Roussel-Uclaf nonetheless wants to distance itself from direct involvement in U.S. marketing. "While asserting that RU-486 should be made available in the United States, the firm emphasized the importance of finding a way to achieve that goal without the involvement of Roussel-Uclaf," FDA said. "Among the possible avenues discussed were a U.S. pharmaceutical firm, a research center or a university." A number of U.S. drug firms are reported to have expressed interest in obtaining the drug from Roussel-Uclaf. At least three companies publicly have stated their interest in marketing RU-486: Gynex, Cabot Medical and Adeza Biomedical. Gynex said Feb. 25 that it received a letter from Roussel-Uclaf about four weeks ago saying that the French firm is considering its options and will be back in touch. "FDA and Roussel-Uclaf agreed to continue to work on this matter until remaining issues can be resolved," the "Talk Paper" concludes. Another obstacle to the use of RU-486 in the U.S. is currently being scrutinized by FDA at the request of President Clinton, who soon after his inauguration called on HHS Secretary Shalala to review the personal use import ban on RU-486 ("The Pink Sheet" Jan. 25, T&G-7). The agency said the review is "being done expeditiously."
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