Federal appeals court revives FDA approval of mifepristone but 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.

The appeals court paused the part of Kacsmaryk's ruling dealing with the original 2000 approval of mifepristone, meaning the drug will continue to be available as the courts hash out the underlying questions raised by the case. But the appeals court declined to halt Kacsmaryk's decision to block subsequent FDA actions that expanded access to the drug.

Those include FDA actions that allowed the drug to be sent through the mail.

The Justice Department did not immediately respond to a request for comment.

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.

A coalition of anti-abortion groups is challenging 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.

A pro-abortion activist displays abortion pills as she counter-protests during an anti-abortion demonstration on March 25, 2023 in New York City.
A pro-abortion activist displays abortion pills as she counter-protests during an anti-abortion demonstration on March 25, 2023 in New York City.

The Alliance for Hippocratic Medicine, one of the groups challenging the drug, told the appeals court that mifepristone does "not provide a 'therapeutic' benefit," as required by the FDA's regulations for fast-track approval. The group also asserts the FDA violated federal law by authorizing mifepristone to be sent through the mail.

Biden administration lawyers told the appeals court in its appeal Monday that the FDA has determined mifepristone is safe and effective to terminate early pregnancies in a decision that five presidential administrations upheld. Serious adverse effects are "exceedingly rare," as they are for common drugs such as ibuprofen, the FDA said.

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