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

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A container holding boxes of Mifepristone, the first medication in a medical abortion, are prepared for patients at Alamo Women’s Clinic in Carbondale, Illinois, April 20, 2023.

Evelyn Hockstein | Reuters

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

The Supreme Court in April granted an emergency request to pause any ruling until the high court decides whether to take the case. If the high court declines to take the case, the restrictions will go into effect.

Under the restrictions, women would no longer be able to obtain the abortion pill 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 in the majority opinion Wednesday. “It failed to consider the cumulative effect of removing several important safeguards at the same time.”

The appeals court left the Food and Drug Administration’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 argued that the appeals court should have also rolled back the FDA’s original approval of mifepristone, an action that would remove the medication from the U.S. market.

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

The court battle over mifepristone comes more than a year after the Supreme Court abolished federal abortion rights by overturning the landmark 1973 Roe v. Wade ruling.

The ruling Wednesday comes nearly three months after a three-judge panel at the 5th Circuit heard arguments 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 oral arguments in May 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 pushed back on the FDA and Danco’s 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. 



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