Federal judge pauses Florida and Texas lawsuit seeking to restrict mifepristone access

U.S. District Judge Reed O'Connor has paused a lawsuit by Florida and Texas that seeks to overturn the FDA's 2000 approval of the abortion pill mifepristone. The pause lasts until December 1, 2026, or until the FDA completes an ongoing safety review of the drug. While Judge O'Connor rejected a motion by drugmakers GenBioPro and Danco Laboratories to dismiss the case, the stay temporarily preserves current nationwide access to the medication, which is used in over 60% of U.S. abortions.

Federal judge pauses mifepristone lawsuit

• ▪Judge Reed O'Connor paused the Florida and Texas lawsuit until the sooner of December 1, 2026, or when the FDA completes its safety review of mifepristone
• ▪U.S. District Judge Reed O'Connor paused a lawsuit by Florida and Texas seeking to restrict nationwide access to the abortion pill mifepristone
• ▪Judge Reed O'Connor rejected a motion by drugmakers GenBioPro and Danco Laboratories to dismiss the Florida and Texas lawsuit

Texas Florida challenge FDA approval

• ▪The lawsuit filed by Florida and Texas seeks to completely roll back the FDA's initial 2000 approval of mifepristone
• ▪The Florida and Texas lawsuit argues that the FDA failed to properly evaluate the safety and effectiveness of mifepristone

Pending mifepristone litigation nationwide

• ▪A pending lawsuit in the Eastern District of Missouri filed by Missouri, Kansas, and Idaho seeks to reinstate pre-2016 restrictions on mifepristone
• ▪The U.S. Court of Appeals for the 5th Circuit will hear arguments on September 9, 2026, in a separate lawsuit filed by Louisiana challenging mail-order mifepristone regulations

FDA mifepristone safety review

• ▪The FDA first announced its safety review of mifepristone in 2025, and the study has reportedly been delayed until after the November 2026 midterm elections
• ▪The FDA is conducting a safety review of mifepristone, which an administration official in June 2026 stated would likely take six months to complete

Medication abortion regulation changes

• ▪The Biden administration in 2023 permanently ended the in-person dispensing requirement for mifepristone, allowing the drug to be dispensed through the mail
• ▪The Trump administration has left the 2023 Biden-era mifepristone regulations in place, keeping the issue out of the political spotlight

Comstock Act abortion pill ban

• ▪The Florida and Texas lawsuit cites the 1873 Comstock Act to argue for a ban on all mail-order abortion pills and associated medical instruments
• ▪Conservatives seek to use the long-dormant 1873 Comstock Act anti-obscenity law to restrict nationwide access to medication abortion

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