The abortion pill combination of mifepristone and misoprostol will remain available in the United States, but only under the original safety protocols the Food and Drug Administration adopted in 2000, the Fifth Circuit Court of Appeals held on Thursday. The FDA’s authorization of a generic version of the drugs and its ruling that the drug may be distributed through the mail remain on hold, however — unless the Supreme Court intervenes.
Last Friday, in a 67-page opinion in Alliance for Hippocratic Medicine v. FDA, a federal judge “stayed” the FDA’s Sept. 28, 2000, approval of the abortion pill and the agency’s follow-up decisions from 2016, 2019, and 2021 that increasingly loosened safety restrictions. The Biden administration immediately filed a notice of appeal with the Fifth Circuit Court of Appeals and then asked the federal appellate court to freeze the trial court’s ruling that, in effect, banned distribution of the abortion pill.
Early yesterday, a three-judge panel ruled partially in favor of the Biden administration, staying the stay of the FDA’s 2000 approval of the abortion pill. But the panel otherwise refused to put on hold the trial court’s decision in favor of the plaintiffs. Now without Supreme Court intervention and until the Fifth Circuit considers the merits of the FDA’s appeal, distribution of the abortion pill will be governed by the 2000 FDA approval, not the changes the FDA adopted in 2016.
Arbitrary and Capricious
The differences between the two FDA approvals are significant. In 2000, the FDA approved the
