Appeals court says abortion pill mifepristone should remain on the market but rules in favor of limiting access

A federal appeals court on Wednesday wiped away a lower court’s ruling that would’ve taken the medication abortion drug mifepristone off the market, but upheld aspects of the ruling that could cut back access to the pills.

The ruling from a conservative three-judge panel of the 5th US Circuit Court of Appeals will not affect the current availability of mifepristone, as the Supreme Court has already said that the drug and regulations that make it accessible will remain in place for the time being.

Wednesday’s opinion, by Circuit Judge Jennifer Walker Elrod, said that the statute of limitations likely barred the legal challenge to the FDA’s 2000 approval of the drug, mifepristone.

Circuit Judge James Ho, a Donald Trump appointee, wrote a partial dissent, in which he said he believed the 2000 approval of mifepristone to be unlawful.

The ruling is the latest twist in the dramatic case, which is the most consequential legal battle over abortion since the Supreme Court last summer overturned the 1973 Roe v. Wade precedent that protected abortion rights nationwide.

While the ruling has no immediate impact on access to medication abortion drugs, it sets the stage for the Supreme Court to yet again weigh in on abortion. The Justice Department said later Wednesday that it will ask the Supreme Court to review the ruling.

Wednesday’s appeals court decision – by ruling in favor of cutbacks to the drug’s access while concluding the pills can remain on the market – lays out the stakes for the case’s return to the justices. And it will likely shape the contours of what both sides will be arguing to the high court.

Medication abortion makes up the majority of abortions obtained in the United States. Since Roe’s reversal, abortion providers in states where abortion remains legal have relied upon the availability of abortion pills to relieve the burdens on clinics that have been flooded with patients from regions of the county where abortion has been severely restricted.

Mifepristone is exceedingly safe and has a lower death rate than commonly prescribed drugs like penicillin and Viagra.

“Today, generic mifepristone remains lawful and available on the market,” said Evan Masingill, the CEO of GenBioPro, which manufactures the generic version of the drug.

Reverses controversial Texas opinion

Wednesday’s ruling reversed parts of April’s blockbuster ruling from US District Judge Matthew Kacsmaryk that would have suspended the federal government’s two-decade old approval of the drug. The appeals court, however, agreed with Kascmaryk that it was likely unlawful for the government to make more recent changes to the drug’s regulations that made it easier to obtain.

While the appeals court majority did not rule in favor of pulling the mifepristone off the market, as abortion foes were seeking, the appeals court showed itself to be very sympathetic to a large swath of the challengers’ arguments.

The appeals court endorsed most of the procedural arguments that the challengers made for why it was appropriate for a court to intervene. Elrod’s opinion also embraced claims about mifepristone’s risks, put forward by anti-abortion doctors challenging the FDA approval, even though those characterizations had been widely rebuked by mainstream medical groups.

In concluding that FDA’s moves to relax the pills’ regulations should be reversed, Elrod wrote, “the public interest is disserved by a drug that does not afford adequate protections to its users.”

“To be clear, the evidence does not show that mifepristone is unsafe in all applications,” the appeals court said. “But on this record and at this preliminary stage, the Medical Organizations and Doctors have made a substantial showing that the 2016 Amendments and 2021 Non-Enforcement Decision were taken without sufficient consideration of the effects those changes would have on patients.”

The lawsuit was filed in a Texas federal court in November by anti-abortion doctors and medical organizations seeking to pull mifepristone – the first drug in the two-pill regimen for terminating pregnancies – from the market. The challengers argue that the US Food and Drug Administration broke the law in how it approved mifepristone in 2000 and in how it has since relaxed certain restrictions for the drug’s use.

The case was filed in a remote Texas court division that guaranteed it would be heard by Kacsmaryk, an appointee of former President Donald Trump who worked for a conservative religious liberty organization before joining the bench and whose personal hostility toward abortion has been reported by The Washington Post.

Kacsmaryk embraced whole-heartedly the arguments put forward by the abortion opponents, with an April 7 ruling that would have suspended mifepristone’s approval but that was not allowed to take effect.

A previous panel of the 5th Circuit – during an earlier, emergency round of litigation – put parts of Kacsmaryk’s ruling on hold, and on April 21, the Supreme Court issued an unsigned order that froze the entirety of the judge’s decision while an appeal of it played out.

Mixed ruling sets the stage for the Supreme Court

In the most recent stage of the proceedings, the 5th Circuit was giving a fuller review of Kacsmaryk’s ruling. The abortion foes drew an extremely friendly panel, made up of three very conservative judges who have ruled against abortion rights in the past, all appointed by Republican presidents.

Wednesday’s 5th Circuit ruling, if allowed to take effect, would put on hold 2016 FDA regulatory changes that, among other things, allowed women to take the drug later into their pregnancies and allowed non-physicians to prescribe the drug. The ruling would also reverse, while the litigation in the case continued, the FDA’s more recent moves to allow the pills to be dispensed via the mail.

Alliance Defending Freedom, a conservative legal group that represented the anti-abortion doctors and medical associations that brought the case, said the ruling was a “significant victory.”

“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,” the group’s senior counsel, Erin Hawley, said in the statement.

On a conference call with reporters, Hawley said that they had not made a decision yet whether to appeal the ruling.

Danco, a mifepristone manufacturer that intervened in the case to defend the FDA’s approach to the drug, said in a statement that it will “continue to pursue reversal of this injunction.”

“The Fifth Circuit panel’s decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges,” the company said in a statement.

The 5th Circuit opinion repeatedly noted that its ruling will not take effect while the Supreme Court order maintaining the status quo was in place.

The case is now expected to travel back to the justices. Their previous order will stay in place at least until the justices decide whether to take up the case and possibly longer.

Planned Parenthood called on the Supreme Court to “reject this clearly baseless and political attempt to interfere with our ability to get health care.”

Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in the statement that “the 5th Circuit’s opinion makes it clear that mifepristone’s approval is very much still at risk, as is the FDA’s independence.”

“Pregnant people should be the ones who make decisions about their own health care, and medical professionals should be the ones who make evidence-based decisions about the safety of medications — not judges,” she said.

During May 17 oral arguments in New Orleans, where the 5th Circuit is based, the judges tore into the FDA.

“We are allowed to look at the FDA just like we’re allowed to look at any agency,” Ho said, while decrying what he described as theme of “the FDA can do no wrong.”

Elrod, a George W. Bush appointee, railed against the briefs filed by a mifepristone manufacturer that has intervened in the case, with the judge claiming that the briefs amounted to “personally attacking” Kacsmaryk.

In one line of questioning, Trump-appointed Circuit Judge Cory Wilson zeroed in on the FDA’s moves to allow the pills to be mailed to patients and to lift requirements for an in-person visit with a provider.

Hinting that he was convinced by the anti-abortion doctors’ arguments that the drug was leading to medical emergencies that were causing them harms, Wilson said that FDA had “made it much more likely that patients are going to go to emergency care or a medical clinic where one of the doctors is a member.”

This story has been updated with additional details.

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