Appeals court upholds some restrictions on abortion pill mifepristone

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Mifepristone’s availability for by-mail dispensing remains unchanged for now due to an emergency order from the U.S. Supreme Court in April preserving the status quo of its access during the appeal.

The three-judge panel for the 5th Circuit was reviewing an April order from Amarillo-based U.S. District Judge Matthew Kacsmaryk.

The original suit was filed in November by four groups against abortions, including the Alliance for Hippocratic Medicine, along with four doctors.

The 5th Circuit panel held that the challenges to mifepristone’s initial approval and the generic approval likely fail, but that the 2016 and later rule changes likely succeed.

The judges on the panel were all appointees of Republican presidents: James Ho, Cory Wilson, and Jennifer Elrod.

During oral arguments over the case on May 17, the FDA and Danco Laboratories, the maker of the pill, argued that the lawsuit seeking to pull the drug from the U.S. market was 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.

Wilson, an appointee of former President Donald Trump, said the FDA’s broadening of mifepristone’s availability in the mid-2010s created a greater likelihood that patients would show up in an emergency room to address complications.

“It just strikes me what FDA has done … you’ve made it much more likely that patients are going to go to the emergency room,” Wilson said.

The Alliance Defending Freedom, the legal firm representing the anti-abortion groups, released a statement celebrating the decision.

“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” ADF senior counsel Erin Hawley said in a statement. “This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.”

First approved by the FDA in 2000, mifepristone is the first pill in a two-pill chemical abortion series. Mifepristone works by blocking a woman’s progesterone receptors, essentially stopping fetal growth. The second pill, misoprostol, induces contractions to expel the fetus.

The FDA loosened the restrictions on mifepristone in 2016 to allow for the abortion agent to be used up to 10 weeks gestation, and in 2019 approved the generic medication mifepristone.

In July 2020, a federal district court judge issued a preliminary injunction to prevent the FDA from enforcing the regulation that a prescription for mifepristone required both an in-person evaluation and the patient to pick up the prescription in person. The FDA codified this restriction in January 2023.

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Wednesday’s decision will likely be appealed first to the full 5th Circuit and then to the Supreme Court, which last year overturned nearly 50 years of precedent under Roe v. Wade, allowing states to impose laws restricting abortion access.

The pro-abortion group NARAL issued a statement on X, the social media platform formerly known as Twitter, saying, “We always knew this case would go to SCOTUS’ anti-abortion majority. The fight for medication abortion continues—and we’re ready.”