RU-486 Arrives, Limping, on American Soil

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The perennially explosive American abortion debate appears to have penetrated even the relatively apolitical halls of the Food and Drug Administration. After years of political and medical debate, the FDA, according to a report in the Washington Post, looks ready to approve the controversial RU-486 abortion pill — a development that might have been welcomed by women's health advocates, if not for what they consider extreme limitations on the drug's availability and dissemination. The FDA, it seems, has given in to the allure of the status quo — granting approval without rocking the boat.

RU-486, also known as mifepristone, is widely used in much of the world, and is prized for being both discreet — allowing women to induce abortions (largely without complications) in their own homes within 50 days of conception — and democratic, providing the possibility of abortion to women living in areas without doctors willing to perform the surgical procedure. But according to the drug's supporters, those very attributes will be effectively negated by the restrictions currently under consideration by the FDA; the rules include allowing only doctors trained to perform surgical abortions to prescribe the drug, a requirement that those doctors have admitting privileges at a hospital within one hour of their offices (in the rare instance that the patient hemorrhages), keeping a national database of physicians who write the prescriptions, and follow-up studies on all women who receive the drug.

For RU-486, the road to the American marketplace has been long, winding and more than a little bit bumpy. More than a medical breakthrough, the pill is also a flash point for political dissension: The efficacy of the pill is a boon to women's health care advocates, who see RU-486 as a much-needed, less invasive alternative to surgical abortions. Abortion opponents, of course, view the pill's potency with alarm, and have urged the FDA to withhold approval of the drug.

This leaves the medical community caught between the proverbial rock and a hard place, forced to deal not only with a new medical advancement but with its political fallout as well. "With a drug like this, it's nearly impossible to separate the political from the scientific," says TIME medical contributor Dr. Ian Smith. But while many of the medical issues surrounding RU-486 may be rooted in a political distaste for the pill's purpose, Smith says there are still some genuine medical concerns that the FDA is correct in addressing. "There are legitimate medical questions here that we will have to watch carefully as the drug is used," he says. "How will doctors ensure the safety of an unsupervised patient with a history of hemorrhaging? Will doctors only prescribe the drug within the designated window of gestation? What if the drug makes its way to the black market, and women take it outside of the prescribed time frame?" Some of those issues, of course, apply to many other drugs — drugs that have passed muster with the FDA. It remains to be seen whether the agency sticks with its present, rather conservative position, or relaxes as the drug achieves a higher comfort level, both medically and politically.