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Since 1988, when mifepristone was first approved in Europe, abortion-rights activists have fought to introduce it to the U.S. as the first alternative to surgical abortion. The FDA under President Bush banned its import in 1989, citing safety concerns. On his third day in office, President Clinton lifted the ban and ordered the FDA to begin safety testing. Developer Roussel Uclaf, meanwhile, sick of getting hammered by both sides, donated U.S. patent rights for mifepristone to the Population Council, a nonprofit reproductive-rights group founded 50 years ago by John D. Rockefeller. The council had to steer the drug through U.S. trials, file the applications for approval, weather the political storms and lawsuits that followed every step of the process. No wonder it took nearly eight years.
Even advocates who had been hoping for this ruling for years were surprised at how few restrictions came with it. Though the agency had ruled mifepristone "safe and effective" back in 1996, it took four more years to find an acceptable manufacturer and figure out distribution. Last summer the FDA hinted that it was thinking of playing very tough: that only doctors who currently do surgical abortions would be allowed to prescribe mifepristone; that there might be some special certification required, or a rule that the doctor have access to an emergency room less than one hour away. All of that would have made the approval of the pill almost meaningless; abortion would still be unavailable in vast swaths of the country.
But last week's ruling said that to prescribe the drug, a doctor must be able only to date the pregnancy conclusively and, if anything goes wrong, provide surgical intervention, either to complete the abortion or to stop heavy bleeding. "All this says is that physicians prescribing this should be good doctors," says Dr. Wendy Chavkin, an ob-gyn at Columbia School of Public Health. In 1998, when the Henry J. Kaiser Family Foundation polled family practitioners about their interest in using mifepristone once it was approved and available, 45% of doctors responding said they were "very" or "somewhat" likely to use it--even though only 3% of them had performed surgical abortions.
But at the time of the survey, the drug was still crawling through the approval process. Now that it has been cleared, the real test begins. A doctor's decision to offer the drug rests on a complex calculation. Many may read the FDA language about the pill's being limited to "physicians who can accurately determine the duration of a patient's pregnancy" to mean that they should do this with ultrasound--and most do not have ultrasound equipment in their office. Likewise, special training and extra malpractice insurance might dampen enthusiasm for offering the drug. Doctors will have the extra burden of locating those women who do not return for the final visit to make sure their pregnancy has been terminated. Were there to be an increase in complications or birth defects associated with mifepristone (none have yet been reported), insurance companies would probably adjust their rates accordingly.