On Wednesday, for the second time, the U.S. Court of Appeals for the 5th Circuit concluded that the Food and Drug Administration violated federal law when it removed safety restrictions for mifepristone, the drug used for a majority of abortions in the United States. But despite the intense focus…
four times that of a surgical abortion, and the risk of complication increases the farther along a woman is in her pregnancy.
Violating its 180-day response requirement again, the FDA waited until December 2021 to deny this petition. At the same time, the FDA announced it was loosening the drug’s restrictions yet again, and dropped its in-person dispensing requirement, so that mifepristone could now be obtained through the mail or mail-order pharmacies.
On April 7, 2023, U.S. District Judge Matthew Kacsmaryk concluded that the plaintiffs had met the legal “standing” requirement by sufficiently showing that they had been harmed by the FDA’s action’s and that they were likely to win on the merits. He issued a, putting the FDA’s approval of Mifeprex on hold while the lawsuit proceeded.
On Wednesday, a different panel of three 5th Circuit judges came to the same conclusion as their colleagues had in April. The plaintiffs did have standing to sue, and while their challenge to the original FDA approval of Mifeprex came too late, the FDA’s decision to drop the drug’s safety restrictions in 2016 and 2021 were arbitrary and capricious.
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