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FDA REVIEW OF RU-486 PERSONAL USE IMPORT BAN REQUESTED BY PRESIDENT CLINTON

Executive Summary

FDA REVIEW OF RU-486 PERSONAL USE IMPORT BAN REQUESTED BY PRESIDENT CLINTON in one of his first actions as chief executive. Clinton asked HHS Secretary Shalala in a Jan. 22 memorandum to "promptly instruct the FDA to determine whether there is sufficient evidence to warrant exclusion of RU-486 [the oral abortifacient mifepristine] from the list of drugs that qualify" for the personal use exemption to the import ban (FDA Import Alert 66-47). Noting that the "assessment will begin immediately," FDA emphasized in a same-day statement that "research on RU-486 should continue" as the agency conducts its review. In the memo to Shalala, Clinton said he has been "informed that in excluding RU-486 from the personal use importation exemption, the FDA appears to have based its decision on factors other than an assessment of the possible health and safety risks of the drug." If FDA concludes that RU-486 "meets the criteria" for the personal use exemption," Clinton directs Shalala to "immediately take steps to rescind Import Alert 66-47." FDA has previously stated that if Roussel-Uclaf, the French manufacturer of the abortifacient drug, decided to file an NDA for RU-486, agency review of the drug would take approximately four to six months due to the availability of adequate foreign clinical data ("The Pink Sheet" Dec. 21, 1992, T&G-11). The FDA estimate was made in response to an inquiry by Rep. Wyden (D-Ore.), an advocate of getting RU-486 on the U.S. market. However, Roussel-Uclaf indicated in the past that it was not interested in introducing RU-486 while abortion remained divisive issue in the U.S. Syntex, Cabot Medical and Adeza Biomedical have expressed interest in marketing the drug. In addition to reviewing the ban on importation of RU-496 imposed by his Republican predecessors, President Clinton signed another memorandum on Jan. 22 directing Shalala to "immediately lift" the ban on using fetal tissue for federally funded medical research. The ban was conceived as a "temporary moratorium" signed on March 22, 1988, by then-HHS Secretary Bowen and extended indefinitely on Nov. 2, 1989, "contrary to the recommendations" of an NIH advisory panel, the memo notes. Clinton aides predicted days after the general election that the new administration would lift the bans on both RU- 486 importation and fetal tissue research ("The Pink Sheet" Nov. 9, 1992, p. 23). In a Jan. 22 letter to President Clinton, the Association of Biotechnology Companies wrote that "we are delighted to hear of your decision to lift the ban on fetal tissue transplantation research, thereby depoliticizing this issue in the interest of public health." ABC added that the biotech industry has supported lifting the ban for several years "to no avail," including a June 1992 appeal to former President Bush.
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