U.S. District Judge Reed O'Connor paused a lawsuit by Florida and Texas attorneys general seeking to revoke the FDA's approval of mifepristone, granting the FDA's request for a stay while it conducts a safety review — a delay that pushes any ruling past the midterm elections to at least Dec. 1. The judge also denied a motion to dismiss from drugmakers Danco Laboratories and GenBioPro, who intervened as defendants.
The lawsuit, one of three pending challenges nationally, cites the 150-year-old Comstock Act and seeks to make the drug unavailable in all states regardless of local abortion law. Mifepristone has repeatedly been found safe and effective in studies, including the FDA's own 2023 review, which the manufacturer's CEO says it expects the new six-month review not to contradict.
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