The U.S. Supreme Court next year will decide whether more restrictions should be placed on mifepristone, part of a two-drug regimen for medication abortion. Although mifepristone doesn’t seem to be at risk of being yanked from the market entirely, if the court sides with the Fifth Circuit, that would still hamper abortion access.
Mifepristone is used in more than half of abortions in the U.S. in conjunction with a second drug, misoprostol. If the Supreme Court agrees with the Fifth Circuit, it would turn back the regulatory clock on mifepristone to the year 2000, when the drug was approved. That would restore old barriers to accessing the drug — and discard more than 20 years of medical knowledge guiding the safe and effective use of the medication.
In accepting the case, the high court seems to have narrowed the issue to the pill’s restrictions rather than its approval. That’s welcome news, but the stakes of the narrower case are still high. Expanded access to mifepristone has become essential for abortion care, says Ushma Upadhyay, a professor at the University of California, San Francisco.
When mifepristone was first brought to market, the FDA laid out strict guidelines for how it could be used. Only physicians (not a pharmacy) could dispense it, and only when a patient visited their office in person. Over time, the FDA has slowly loosened those rules in recognition of the drug’s safety and efficacy. (The drug is still more tightly regulated than many doctors think is necessary.)
If the rules revert to their original 2000 form, the most obvious loss will be the use of telehealth to prescribe mifepristone. Virtual care has become a cornerstone of the Herculean effort to maintain abortion in states with bans. Upadhyay recently published data showing that even before Dobbs was overturned, telehealth significantly improved access to care. Of more than 1,500 telehealth patients surveyed, 43% said virtual service allowed them to receive a timely abortion. And 2% of responders said without it, they wouldn’t have been able to get an abortion at all.
And there’s every reason to believe that there will be more reliance on telehealth in a post-Dobbs era. According to a recent study by the #WeCount project at the Society of Family Planning, the number of abortions provided by virtual-only clinics increased from 4,045 per month before Dobbs to an average 6,950 per month in the first year after the ruling.
But telehealth isn’t all that’s on the line. So is the ability of nurse practitioners to prescribe the drug, something clinics in haven states have come to rely on to handle increased demand and allow physicians to focus on more medically complex procedures. But if 2000-era restrictions on mifepristone are restored, it will mean only physicians can prescribe and dispense the drug.
If the Supreme Court chooses to walk back mifepristone to its 2000-era restrictions, misoprostol, the second component of the two-drug regimen, could continue to be prescribed via telehealth and used on its own to end a pregnancy. Robust data show that misoprostol can be safely used up to 12 weeks of gestation. But while a backup plan is always welcome, the reality is the combination of the two drugs has fewer side effects and is somewhat more effective.
“The irony here is [that] a case premised upon patient safety would force providers to use a less-effective medication abortion regimen and force people probably into the informal markets for trying to find mifepristone,” says Greer Donley, an associate professor at the University of Pittsburgh School of Law and expert on abortion and the law.
There are other ways the ruling could force women to receive suboptimal care. The decision could revert mifepristone’s label to its 2000 form. That would walk back advances in medical understanding about the ideal dosage. In 2016, the FDA label was changed to formally decrease the dose of mifepristone and increase the amount of misoprostol. That modification has been shown to significantly improve the chances of completing the abortion without needing additional medication or other intervention.
While doctors are free to prescribe drugs outside of the confines of the label, some might worry about straying given the current legal climate. And a law in Ohio that went into effect in 2011 requires physicians to follow FDA protocol for mifepristone, which could relegate women in that state to subpar care. That law could also mean they aren’t able to get the drug past seven weeks (the original gestational limit set by FDA), rather than up until 10 or even, as the World Health Organization advocates, 12 weeks.
Decreeing that the last 23 years of medical knowledge on mifepristone simply irrelevant would not only undermine abortion access, but also undermine the Food and Drug Administration’s regulatory authority. That could have implications far beyond mifepristone, jeopardizing the availability of any approved drug that someone decides to challenge in court. Doctors and scientists should be the ones deciding how to prescribe medications — not lawyers and judges.
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