Appeals court imposes restrictions on abortion pill, but drug will stay on the market for now

A federal appeals court on Wednesday imposed restrictions on the abortion pill mifepristone, though the ruling will not have an immediate impact on the medication’s availability.

The U.S. Court of Appeals for the 5th Circuit ruled that several decisions the Food and Drug Administration took to make mifepristone more broadly available to women did not take safety concerns into account.

The ruling is paused from taking effect until the Supreme Court makes a decision about the case. The high court imposed the pause in April upon request from the Biden administration after lower courts had ruled against the pill in the spring.

If the Supreme Court upholds Wednesday’s ruling, women would no longer be able to obtain the abortion pill through telemedicine appointments and by mail. Patients would have to receive a prescription from a doctor and have three follow-up appointments in person.

The restrictions would also shorten the time period when women can take the pill to 49 days into their pregnancy, down from 70 days.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote for the court Wednesday. “It failed to consider the cumulative effect of removing several important safeguards at the same time.”

The appeals court left the FDA’s underlying 2000 approval of mifepristone and its 2019 authorization of a generic form of the drug in place.

In a dissenting opinion, Judge James Ho arguedthe appeals court should also have rolled back the FDA’s original approval of mifepristone, an action that would remove the medication from the U.S. market.

The American College of Obstetricians and Gynecologists criticized the appeals court decision as “judicial activism.” The medical association said mifepristone is “demonstrably safe and effective” for its FDA-approved use up to 10 weeks of pregnancy.

Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S.

The case ended up in the 5th Circuit on appeal after U.S Judge Matthew Kacsmaryk of the Northern District of Texas issued a much broader ruling in April that suspended the FDA approval of mifepristone.

The three-judge panel at the 5th Circuit heard oral arguments in May from the FDA, mifepristone distributor Danco Laboratories and a group of anti-abortion doctors called the Alliance for Hippocratic Medicine.

The appeals court judges were all appointed by Republican presidents. Elrod was appointed by George W. Bush. Ho and Judge Cory Wilson were appointed by Donald Trump.

The FDA and Danco argued during the May hearing that the lawsuit seeking to pull mifepristone from the U.S. market is unprecedented, has no basis in science and will jeopardize women’s health.

The panel of judges pushed back hard on those arguments.

The judges questioned whether allowing women to receive mifepristone by mail without having to see a doctor would result in more patients seeking emergency care. Ho took issue with the characterization of the case as unprecedented.

“I don’t understand this theme — the FDA can do no wrong. That is basically the narrative you all are putting forth — nobody should ever question the FDA,” Ho said during the hearing.

“We are allowed to look at the FDA just like we are allowed to look at any agency, that’s the role of the courts,” Ho said. 

Correction: Justice Samuel Alito dissented from the Supreme Court emergency decision on April 21 that kept mifepristone broadly available. A previous version of this story misstated his position.