Approval for RU-486

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he Food and Drug Administration is expected to announce a decision next week on the fate of RU- 486, the abortion pill that can offer women a safe, non-invasive alternative to surgical abortion. The agency faces a Sept. 30 deadline on whether to give final marketing approval for the drug, call for a delay of action or deny approval.

RU-486 would be a crucial breakthrough in abortion access in this country because it can be administered by primary care doctors in communities where surgical abortion services are nonexistent. Patients with RU-486 prescriptions would no longer need to travel to clinics that are targets of abortion protests. Not surprisingly, anti-abortion groups have vehemently opposed F.D.A. approval.

There is overwhelming evidence of RU-486's safety and effectiveness in a decade of use by more than 500,000 women in Europe and in clinical trials in this country. It is time the F.D.A. allowed women access to this important medical option without unnecessary restrictions.

RU-486, also known as mifepristone, was determined by the F.D.A. in 1996 to be safe and effective in terminating early pregnancies when used with another already approved drug called misoprostol. But RU-486 cannot be marketed until the F.D.A. resolves some manufacturing, labeling and distribution concerns. Those issues are being negotiated between the agency and Danco Laboratories, the group that seeks to market the drug.

Earlier this year there was considerable concern among pro-choice groups that the F.D.A. would impose strict distribution limits on RU-486. The F.D.A. was said to want only doctors who can perform surgical abortions to prescribe RU-486. Another proposal was to require prescribing doctors to have admitting privileges at hospitals within an hour of their offices. Such restrictions would greatly limit use of the drug, and do not seem medically necessary. The F.D.A. should approve RU-486 promptly without restrictions that undermine broad access.