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Justices press evidence on mifepristone safety, REMS changes and the Comstock question
Summary
Arguing the merits, government and company counsel defended FDA’s 2016 and 2021 modifications to labeling and REMS for mifepristone as supported by studies and pandemic-era data; challengers said those changes increased ER visits and surgical interventions and accused the agency of inadequate explanation. The court probed data quality, adverse-event reporting, and whether the Comstock Act bears on FDA jurisdiction.
The argument shifted from standing to technical and factual questions about safety data, post‑market surveillance and the regulatory framework FDA used to modify mifepristone’s REMS. Government counsel stressed that FDA’s determination — reached after examining multiple studies and real‑world pandemic data — fell within the zone of reasonableness under the Administrative Procedure Act. Counsel for the manufacturer likewise urged deference, warning that courts are ill‑suited to second‑guess complex clinical and statistical analyses.
Challengers’ critique: Respondents and their counsel urged the court that FDA relied on imperfect…
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