RU-486 Nod Ushers New Era of Abortion Debate

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Let the protests begin. On Thursday, under extraordinary scrutiny, the Food and Drug Administration approved RU-486, otherwise known as "the French abortion pill," for marketing in the United States under the name Mifeprex. The drug, which is actually two 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. These pills are different from the "morning after pill," or emergency contraceptive, which is administered in the 72 hours following intercourse. The FDA, which has been hemming and hawing over final approval for RU-486 for almost four years, made its decision under enormous pressure — from both political and medical organizations.

Pro-life groups responded to the announcement immediately, deploring the FDA's action and citing their concern for the health of women who will take the drug. "This is a sad day for women," said a spokesperson for the Family Research Council. Pro-choice groups, longtime supporters of the drug, expressed gratification at the decision, calling the approval an advance in women's health on par with the introduction of the birth control pill.

This moment has been a long time coming: European women have had access to RU-486 for 12 years, but attempts to import the drug to the United States have been stymied internally by contentious debate. And even 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 in the U.S.

Instead, Roussel-UCLAF, which holds the pill's 20-year-old patent, granted sole American distribution rights to the Population Council, a nonprofit organization specializing in reproductive issues, with the understanding the group would conduct clinical trials and find a manufacturer for the drug. And after six years of research and more than a few last-minute panic attacks from would-be manufacturing companies, the moment has arrived. The Population Council concluded a hugely successful drug trial in which 92 percent of the participants achieved successful medical abortions — the remaining 8 percent required surgical intervention to complete the procedure. Within the study, two thirds of women who'd previously had a surgical abortion rated their experience with RU-486 as far preferable, particularly citing privacy and the absence of invasive measures. The pills must be taken in the presence of a surgically qualified doctor, who must be capable of performing a surgical abortion if the medical abortion fails. Ironically, this restriction means accessibility, which had been one of the drug's major selling points among pro-choice groups, is not likely to be affected by the approval. The guidelines mean the growing number of women who do not have access to surgical abortion will likewise not have access to medical abortion.

Barring any major political upheaval — like the appointment of a new, anti-choice FDA commissioner — the door to the American drug marketplace now stands wide open: After several false starts, a marketing group (the New York–based Danco Laboratories) and manufacturer (the name of which remains anonymous) have signed on. The drug is expected to become available in about a month.