Mifepristone to remain available during appeals process

Key takeaways:

• An appeals court said mifepristone will remain available for now but restricted distribution and indication.
• U.S. Supreme Court stayed new restrictions through Friday to give it time to consider the case.

On Wednesday, April 12, judges from the 5th U.S. Circuit Court of Appeals granted a stay of a federal court decision that would reverse FDA approval of the abortion drug mifepristone. That original decision is on hold during the appeals process.

“At this preliminary stage, and based on our necessarily abbreviated review, it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000,” the unpublished order states.

The appeals court let stand parts of the original ruling that reverse regulations since 2016 governing distribution of mifepristone. That means for now the drug is approved for use up to 49 days’ gestation, a prescription must be preceded by an office visit, and the drug must be administered in a physician office.

As Healio previously reported, on April 7, a U.S. District Court judge in Texas suspended FDA approval of the abortifacient mifepristone, giving the government 7 days to appeal. The case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, brought in the U.S. District Court for the Northern District of Texas, Amarillo Division, challenged the FDA’s approval of mifepristone. The ruling by U.S. District Judge Matthew Kacsmaryk declared the FDA’s approval of mifepristone (Danco) in 2000 invalid and suspended the subsequent decisions expanding the use of this drug in terminating early pregnancies.

“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in the ruling. “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 Biden administration filed an emergency appeal and sought a stay during the appeal process.

Editor’s Note: On April 13, the U.S. Supreme Court stayed the restrictions on distribution of mifepristone until midnight April 19. On April 19, the stay was extended through April 21.