On Wednesday, the medical abortion pill got a new label from the Food and Drug Administration—one that finally reflects the way doctors have been prescribing it for years. In the process, Republicans lost at least one strategy that they’ve used to block women’s access to abortion.
In the political tug-of-war over this pill—as in most every fight over abortion—legislators have inserted themselves into consummately routine aspects of medical practice. In this case, they interfered with the common and totally legal practice of off-label prescription, in which doctors use the most up-to-date medical information and their own best instincts to dictate how patients should use a drug, deviating from often outdated FDA guidelines. The U.S. Department of Health and Human Services estimates that 1 in 5 prescriptions written are for off-label use. That didn’t stop Republicans from banning it in the case of the abortion pill, mifepristone, when best practice evolved beyond the guidelines that the FDA wrote upon first approving the drug in 2000.
Mifepristone (brand name Mifeprex) terminates pregnancy by blocking the necessary hormones; doctors prescribe it with a second pill, misoprostol, which induces contractions to start what resembles a heavy period. When the FDA originally wrote the protocol for the drug, it specified a dose of 600 milligrams. Over the years, however, doctors have found that a 200-milligram dose is just as effective and causes fewer unpleasant side effects, such as nausea, vomiting, soreness, and fever. As the New York Times’s Linda Greenhouse reported in 2013, “The 200-milligram regimen is so widely accepted that the 600-milligram dose is now considered bad medicine, and many doctors would refuse the procedure entirely rather than follow the old guideline.” That appears to be exactly what Republicans were hoping for when they passed laws in six states—still in effect in North Dakota and Ohio—that forced practitioners to stick to the FDA guidelines or stop offering the procedure altogether.
The new FDA guidelines vindicate doctors, embracing the 200-milligram regimen and reflecting several other changes in the way practitioners have been prescribing the drug that broaden women’s access to abortion. Where the 2000 guidelines defined the mifepristone-misoprostol regimen as safe through the seventh week of pregnancy, medical experts have determined that it should be offered through at least the ninth week; the National Abortion Federation has set the line at 70 days, or 10 weeks, since 2013. And where the old FDA guidelines required women to come into the doctor’s office three times—first to take the mifepristone, then a day or two later to take the misoprostol, and then a week or two after that for a checkup—doctors have found that results stay the same when they allowed their patients to take the misoprostol at home, saving them one potentially burdensome visit.
The new label for mifepristone also says that the drug should be “ordered, prescribed and dispensed by or under the supervision of a healthcare provider who prescribes and who meets certain qualifications.” Crucially, the guidelines do not contain the word physician. Here, the FDA has given at least subtle backing to the argument that women’s health groups—and the World Health Organization—have been making for years: that midlevel providers, such as midwives and nurse practitioners, should be able to administer medical abortions. As abortion clinics across the country continue to close because of targeted GOP legislation, expanding the circle of who can prescribe this pill could be invaluable for many women. Thirty-seven states currently require that mifepristone be provided by a “licensed physician.” The FDA’s new guidelines are a reminder that, as with so many laws imposed on abortion, there’s no good medical justification for that rule.
