The controversial abortion pill, RU-486 (mifepristone) has been recommended for approval in the USA by a US Food and Drug Administration advisory panel. FDA Commissioner David Kessler has promised a final decision by September 18.
Dr Kessler told panel members that the only issue was the drug's safety and efficacy, and said that, although subject was highly politically sensitive, the coming US elections would not affect his final decision on the matter.
The eight-member committee, consisting of mainly obstetricians and gynecologists, took a series of three votes to make their recommendation. By a vote of six to nil, with two abstentions, it decided that the drug was safe; and by six to two it voted that data from two French studies, which enrolled a total of 2,480 women, were sufficient to support the use of the drug in the USA. The committee, however, reserved the right to reevaluate the research, currently being undertaken in US women, if it contradicted data found in the French trials. Some panel members also expressed concern at the cost and the inconvenience of the drug as it requires several visits to the physician. Some also noted that the drug failed to induce abortion in a small percentage of women (1.5%).
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