Appeals court revives FDA approval of abortion pill mifepristone, allows some restrictions to stand

WASHINGTON – A federal appeals court late Wednesday pressed pause on part of a lower court ruling that had suspended approval of mifepristone but allowed other parts of that decision to stand, potentially setting up a showdown at the Supreme Court.

The order from a divided three-judge panel in Louisiana allowed the Food and Drug Administration's 23-year-old approval of mifepristone to remain in effect but declined to stay a lower court's ruling that imposed significant restrictions on access to the drug.

In a controversial ruling last week, a federal judge in Texas suspended the FDA's approval of mifepristone. U.S. District Judge Matthew Kacsmaryk, appointed by former President Donald Trump, paused his own decision for seven days to give the Biden administration time to file the appeal.

The question before the U.S. Court of Appeals for the 5th Circuit was a technical one: Whether to continue that pause past Friday. But the answer had real-world consequences for the ability of Americans to access the drug.

Abortion pill: How the appeals court ruled on mifepristone

• The appeals court paused the critical section of Kacsmaryk's ruling dealing with the original Clinton administration approval of mifepristone. That means the drug will remain available to Americans as the courts consider the merits of the case.

• But it may be available on a much more limited basis. That's because the appeals court allowed to stand portions of Kacsmaryk's ruling that knocked  down subsequent FDA actions that expanded access to the drug. For instance, in 2016 the FDA allowed non-doctors to prescribe the drug. In 2021, the agency permitted the drug to be dispensed through the mail.

• The big question now is whether the Biden administration will appeal those portions of the ruling dealing with the restrictions to the Supreme Court. Neither the Justice Department nor the White House immediately responded to a request for comment.

What did the 5th Circuit judges write about the abortion bill?

Two of the appeals court judges were appointed by Trump. A third judge, appointed by President George W. Bush, would have temporarily paused all of the lower court's ruling.

The court ruled that the coalition of anti-abortion groups challenging the drug had standing to sue because "as a result of FDA’s failure to regulate this potent drug" the doctors who are members of the groups "have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects."

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The judges said the statute of limitations had run out on the group's challenge to the original approval. But it said that was not the case for the subsequent actions beginning in 2016 that expanded access to the drug. The court characterized the FDA as willingly ignoring the potential consequences of expanding access to mifepristone.

"This ostrich’s-head-in-the-sand approach is deeply troubling," the court wrote.

What is the potential impact of the mifepristone ruling?

A coalition of anti-abortion groups challenged mifepristone's approval, asserting in part that the FDA during the Clinton administration did not follow its own protocols. The case is the most significant dealing with abortion to work its way through the federal court system since the Supreme Court last year overturned Roe v. Wade, the landmark 1973 decision that established a constitutional right to abortion.

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Medication abortion accounts for about half of all U.S. abortions. The availability of mifepristone has taken on added significance as some states have banned in-clinic abortions following the Supreme Court's decision in 2022.

In the U.S., mifepristone is typically taken with another drug called misoprostol. But misoprostol-only methods have been used globally for years and are largely considered to be safe and effective. Still, studies show that misoprostol-only methods are less effective than the two-step regimen.

What is the likelihood the mifepristone case goes to the Supreme Court?

Either side of the lawsuit may appeal the 5th Circuit's decision to the U.S. Supreme Court, said I. Glenn Cohen, law professor at Harvard Law School.

The plaintiffs may try to dissolve the stay and ask the Supreme Court to allow the full Texas court ruling to take effect. Meanwhile, the Biden administration may appeal due to the 5th Circuit allowing other parts of Kacsmaryk's decision by reducing the period of pregnancy when mifepristone can be used and restricting it from being dispensed by mail.

"That said, FDA going to the Supreme Court and the Supreme Court granting the stay is less likely than it was before the 5th Circuit ruling," he said. "The claim that the Supreme Court must act now and that there is irreparable harm if they don’t stay the order is weaker because, under the 5th Circuit ruling, there will still be the drug on the market."

A separate ruling from a federal district court in Washington that ordered the FDA to continue the status quote with mifepristone  may also make the need to go to the Supreme Court more compelling, Cohen said.

What they're saying about the abortion pill ruling

Morgan Hopkins, president of the national reproductive justice organization All* Above All, said she is "relieved that mifepristone can remain on the shelves for now."

"But the Fifth Circuit’s decision to roll back recent measures that have ensured greater access to medication abortion undermines the FDA’s authority and science, all while real people pay the price," Hopkins said.

Mini Timmaraju, president of NARAL Pro-Choice America, said the group was "relieved that the FDA's approval of mifepristone stands for now" but said that "by reinstating outdated and unnecessary restrictions, these judges...put tens of millions of people’s health at risk."

This article originally appeared on USA TODAY: Appeals court revives FDA approval of mifepristone but with limits