A federal appeals court partly granted the Biden administration’s request to put on hold a Texas court ruling overturning FDA approval of the abortion pill, but allowed restrictions that were lifted since 2016 to be reinstated.
A divided three-judge panel of the 5th U.S. Circuit Court of Appeals on Wednesday declined the Justice Department’s bid for an emergency stay on the part of the order as it related to the changes the FDA made since 2016. The court agreed to expedite the appeal.
According to the ruling, the challenge to the 2000 approval of mifepristone appears to be barred by the statute of limitations, but the challenges brought to changes the FDA implemented since 2016, including allowing the delivery of the drug by mail and without follow-up visits to a doctor, are timely.
The ruling means that unless the U.S. Supreme Court intervenes by Friday, mifepristone will no longer be approved for use after the seventh week and cannot be dispensed by mail.
The panel ruled that the government failed to show that the plaintiffs are not likely to succeed on their timely challenges and “failed to carry their burden at this preliminary stage to show that FDA’s actions were not arbitrary and capricious.”
5th Circuit Judge Catharina Haynes, who was appointed by President George W. Bush, said she would have granted an administrative stay to allow for arguments. President Donald Trump appointees Judge Kurt Engelhardt and Judge Andrew Oldham declined to grant the stay relating to the FDA changes.
U.S. District Judge Matthew Kacsmaryk, also a Trump appointee, upended the U.S. Food and Drug Administration’s decades-old approval of mifepristone with his ruling Friday. The judge sided with plaintiffs who claim the government fast-tracked approval of the drug over safety concerns and that its green light was politically motivated.
“The Court does not second-guess FDA’s decision-making lightly,” wrote Kacsmaryk, who sits in Amarillo, Texas. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
The FDA says the pill has proved safe and effective since its approval more than 22 years ago and that the initial authorization of the drug was within the scope of the agency’s authority.
Medication abortion is the most popular method for terminating a pregnancy in the U.S. and has become a prime target for abortion opponents since the overturning of Roe v. Wade in June.
The order by Kacsmaryk appears to be the first time a judge has challenged a drug approval over the FDA’s objections and it has the potential to curtail abortion access across the country — even in states where the procedure remains legal. It’s also fueling a political fight over abortion rights before the 2024 election.
The ruling in Texas drew a backlash from drug manufacturers and pharmaceutical executives, who said Kacsmaryk ignored decades of legal precedent and undermined the FDA’s authority to regulate drugs.
If access to mifepristone is restricted, women seeking to terminate their pregnancies would have to use misoprostol, a less-effective single-pill regimen, or obtain a surgical abortion in states where the procedure is still legal. Several states including New York, Massachusetts, Washington and California have announced plans to stockpile misoprostol following the Texas decision.
The conservative legal group Alliance Defending Freedom challenged FDA approval of mifepristone in a November lawsuit on behalf of anti-abortion medical organizations and some doctors who claim to have treated patients who experienced complications from taking the pill. The plaintiffs said they filed a citizen petition with the agency in 2002 asking officials to review the decision, but it was rejected in 2016.
The lawsuit alleges the FDA fast-tracked approval without sufficient scientific evidence through a process reserved for accelerating authorization of drugs for treating illnesses like cancer and HIV.
It also takes issue with several subsequent decisions by the agency to loosen restrictions on the pill, including a 2016 move to extend the window of use from seven weeks of gestation to 10 weeks and a more recent decision permitting the pill to be distributed through the mail.
The case is Alliance for Hippocratic Medicine v. US Food and Drug Administration, 2:22-cv-00223, US District Court, Northern District of Texas (Amarillo). The appellate case is Alliance for Hippocratic Medicine v. US Food and Drug Administration, 23-10362, 5th US Circuit Court of Appeals.
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(With assistance from Greg Stohr.)
