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Reason
Reason
Jonathan H. Adler

Mifepristone Returns to the Shadow Docket

In 2023, the Supreme Court stayed a district court order undoing the Food and Drug Administration's approval of mifepristone (aka RU-486), a medication used (in combination with misoprostol) to terminate pregnancies. The U.S. Court of Appeals for the Fifth Circuit had partially stayed the district court's decision, but had left portions that would have restricted mifepristone's availability in place. One year later the case returned to the Supreme Court, only to be dismissed unanimously due to a lack of Article III standing in FDA v. Alliance for Hippocratic Medicine.

Litigation over the FDA's regulation of mifepristone has continued, and the drug's manufacturers are once again headed to One First Street seeking interim relief.

On Friday, in Louisiana v. FDA, a unanimous panel of the U.S. Court of Appeals for the Fifth Circuit stayed the FDA's 2023 regulation allowing mifepristone to be prescribed without an in-person medical visit (i.e. through telemedicine). Concluding that Louisiana was strongly likely to prevail in its arguments that it had standing (unlike AHM) and that the FDA's decision to formally allow prescribing mifepristone via telemedicine was arbitrary and capricious, the Fifth Circuit entered a stay of the rule under Section 705 of the APA.

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