A Texas federal judge granted the FDA’s request to stay a challenge that seeks to revoke nationwide approval of mifepristone, delaying action until at least Dec. 1 and allowing the agency to continue a safety review.
U.S. District Judge Reed O’Connor granted a stay on a lawsuit seeking to revoke FDA approval of mifepristone and set the next hearing no earlier than Dec. 1.
The suit was filed by the Republican attorneys general of Florida and Texas and aims to rescind the FDA’s initial 2000 approval and later access-expanding decisions.
Other related cases remain active in federal appeals and district courts, targeting dispensing rules and in-person requirements for the drug.
# What happened A federal judge in Texas paused a lawsuit that seeks to revoke nationwide approval of the abortion medication mifepristone. The judge granted the U.S. Food and Drug Administration's request for a stay and set the case to be held at least until Dec. 1. The stay allows the FDA to continue a safety review of the drug.
# Who brought the case
# Court action taken U.S. Chief District Judge Reed O'Connor denied a motion to dismiss filed by distributor Danco Laboratories and one of the drug's manufacturers, GenBioPro. GenBioPro intervened as a defendant in April and its motion to dismiss was rejected, meaning the company remains a party to the case even as the lawsuit is paused.
# Why the pause matters If a court ultimately ruled in favor of Florida and Texas, mifepristone's nationwide approval could be revoked, which would make the medication unavailable across all states regardless of state abortion laws. The stay prevents immediate changes while the FDA completes its safety review.
# FDA safety review June and said that review would take about six months. The agency requested the stay so it could finish that review without the case proceeding in the meantime.
# Related cases and legal issues
Florida and Texas's complaint also cites the Comstock Act, a 150-year-old federal law that banned mailing materials that could induce an abortion. That law has not been enforced for decades, but some anti-abortion groups have urged the U.S. attorney general to revisit its application to mailings of abortion pills.
# Manufacturer statement GenBioPro's CEO, Evan Masingill, issued a statement saying the company expects the FDA's review to reaffirm the product's safety and effectiveness and that GenBioPro will use legal and regulatory tools available to protect access to reproductive care.
# Immediate implications The ruling delays court action until after the midterm elections and keeps the status quo for now: mifepristone remains approved and available while the FDA conducts its review and while related litigation continues in other courts.
# Bottom line The case that seeks to remove mifepristone's nationwide approval is paused through at least Dec. 1, giving the FDA time to complete a safety review and preventing an immediate judicial change to the drug's availability. Other legal challenges targeting dispensing rules remain active in different federal courts.
Federal judge pauses mifepristone case until after elections
A federal judge in Texas on Sunday paused a lawsuit seeking to revoke nationwide approval of the abortion drug mifepristone, saying the case won’t be heard until at least Dec. 1 and granting the U.S. Food and Drug Administration’s request for a stay to continue its safety review of the drug. The Republican attorneys ge
A federal judge in Texas on Sunday paused a lawsuit seeking to revoke nationwide approval of the abortion drug mifepristone, saying the case won’t be heard until at least Dec. 1 and granting the U.S. Food and Drug Administration’s request for a stay to continue its safety review of the drug. The Republican attorneys ge
A federal judge in Texas on Sunday paused a lawsuit seeking to revoke nationwide approval of the abortion drug mifepristone, saying the case won’t be heard until at least Dec. 1 and granting the U.S. Food and Drug Administration’s request for a stay to continue its safety review of the drug. The Republican attorneys ge
A federal judge in Texas on Sunday paused a lawsuit seeking to revoke nationwide approval of the abortion drug mifepristone, saying the case won’t be heard until at least Dec. 1 and granting the U.S. Food and Drug Administration’s request for a stay to continue its safety review of the drug. The Republican attorneys ge
A federal judge froze for two weeks a Trump administration regulation to restrict mail voting late Thursday, calling the U.S. Postal Service rule a violation of states’ power to administer elections. U.S. District Judge Indira Talwani’s temporary restraining order reinstated a pause that she had lifted just a day earli
Open the app view to save this story, compare related coverage, and continue from the same source.