Ready for Battle: The FDA Considers the Fate of RU-486

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This week, the Food and Drug Administration is ground zero in the American debate over abortion. The administration faces a Friday deadline to determine whether the so-called "French abortion pill," or RU-486, should be marketed in the United States. The drug, which is actually two separate pills taken under a physician's supervision over the course of two days, has been proven extremely effective in ending pregnancies up to the 50th day following conception. The drug is very different from the "morning-after pill," or emergency contraceptive, which is administered in the 24 hours following intercourse.

This moment has been a long time coming: When the Clinton administration lifted a ban on importing the controversial drug in 1993, the French manufacturer declined to distribute the pill here, citing the explosive political undercurrents of the U.S. marketplace.

Instead, Roussel-UCLAF, the patent holder of the 20-year-old pill, granted sole American distribution rights to the Population Council, a nonprofit organization specializing in reproductive issues, with the understanding that the group would conduct clinical trials and find a manufacturer for the drug. After six years of research and more than a few last-minute panic attacks from would-be manufacturing companies, the moment of reckoning has arrived: The Population Council has concluded a hugely successful drug trial in which 92 percent of the participants achieved a "favorable" outcome and a marketing group, Banco Laboratories, and manufacturer (the name of which remains anonymous) have been pinpointed.

Now all that stands in between American women and non-surgical abortion is the FDA's stamp of approval. And the agency, which has been hemming and hawing over final approval for RU-486 for almost four years, is under enormous pressure — from both the medical and political worlds. Anti-abortion activists are predictably opposed to the pill, while abortion rights groups argue RU-486 offers women a more private, less invasive and ultimately safer way to terminate unwanted pregnancies.

The FDA is no doubt steeling itself for the rash of phone calls, protests and editorials that will accompany any decision they make. But come Friday, there may be no movement at all. Political observers speculate it's quite possible the agency will hedge its bets and ask for more time to consider the issue, in an effort to divert attention from the pill — and its purpose — until after the November 7 election. And Al Gore isn't likely to protest that line of logic.