Federal appeals court rules mifepristone can remain available

April 13, 2023

A federal appeals court has ruled that the medical abortion drug, mifepristone, can remain available in the U.S. —  but with significant restrictions.

The New Orleans-based 5th U.S. Circuit Court of Appeals partly overruled an order put in place last Friday by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, that had suspended the FDA's approval for mifepristone while the lawsuit is heard.

The Biden administration and the brand-name manufacturer, Danco Labs, immediately asked for an emergency stay of Kacsmaryk's order.

The pharma industry quickly jumped to the defense of the FDA, signing onto an amicus brief to challenge the district court’s unprecedented ruling. In the 4,542-word brief, pharma companies and trade group BIO asked the U.S. Court of Appeals for the Fifth Circuit to grant the government’s request to stay the lower court’s ruling, arguing that the "FDA’s scientific and medical judgments regarding drug approval decisions should not be second-guessed by courts that lack similar expertise."

"Left standing, this non-expert, judicial second-guessing threatens to cause turmoil for the industry and those that invest in it, and for patients as well," read the brief.

While the 5th Circuit granted a portion of the emergency stay request, the three judge panel declined to block portions of Kacsmaryk's order — specifically steps the FDA took beginning in 2016 to ease access restrictions for mifepristone.

Those actions included a change in the drug's REMS program which increased the maximum gestational age to 70 days, eliminated the in-person dispensing requirement, allowed non-doctors to prescribe and administer mifepristone and eliminated reporting of non-fatal adverse events.

"The stay applicants warn us of significant public consequences should the district court's order result in the withdrawal of mifepristone from the market," said the panel in its ruling. "The applicants make no arguments as to why the 2016 major REMS changes, the 2019 generic approval, or the 2021 and 2023 mail order decisions are similarly critical to the public even though they were on notice of plaintiffs alternative requests for relief."

The emergency stay will remain in place until the 5th Circuit can hear the Biden administration's appeal of Kacsmaryk's order in full.

Read about what drugmakers are doing to keep reproductive health drugs safe, available and legal in our recent cover story.