Federal judge delays a mifepristone lawsuit until after midterms

A federal judge on Sunday paused a lawsuit seeking to revoke the Food and Drug Administration’s (FDA) approval of the abortion pill mifepristone until after the midterm elections.

Judge Reed O’Connor, of the U.S. District Court for the Northern District of Texas, granted a request by the Department of Justice to delay the lawsuit filed by the attorneys general of Texas and Florida until either Dec. 1 or when the FDA finishes an ongoing safety review of mifepristone, whichever occurs sooner.

Texas and Florida both agreed to the pause.

The states are asking the court to completely roll back the FDA’s 2000 approval of the drug. Their lawsuit argues the FDA did not properly evaluate mifepristone’s safety and effectiveness. It also cites in part the federal Comstock Act, a long-dormant anti-obscenity law from 1873 that conservatives want to use to ban all mail-order abortion pills and associated medical instruments.

If the court rules in favor of Texas and Florida, it could restrict access to mifepristone nationwide.

In the same opinion, O’Connor, an appointee of former President George W. Bush, denied a request by generic mifepristone maker GenBioPro and distributor Danco Labs to dismiss the case.

“We expect the FDA’s review of mifepristone to not contradict the decision they made in 2023 that reaffirmed our product is safe and effective,” GenBioPro CEO Evan Masingill said in a statement. “GenBioPro will continue to use all legal and regulatory tools available to ensure Americans’ access to reproductive care.”

With the stay, the current state-by-state legal access to mifepristone will not change. But the drug’s availability is under constant threat.

The lawsuit by Florida and Texas is one of three suits pending in various federal courts that would change nationwide access to mifepristone. It’s the only one that seeks to invalidate the drug’s approval.

The U.S. Court of Appeals for the 5th Circuit will hear arguments Sept. 9 in a lawsuit filed by Louisiana challenging an FDA regulation allowing mifepristone to be prescribed through telehealth, in pharmacies and through the mail.

Another pending lawsuit, in the Eastern District of Missouri from the red states of Missouri, Kansas and Idaho, seeks to reinstate the conditions on the use of mifepristone that existed before 2016.

Prior to that year, the drug was only approved for use before seven weeks’ gestation and required three in-person office visits. There was also no generic version.

Mifepristone has been used by more than 7.5 million people in the U.S. for medication abortion and miscarriage care since the FDA approved it more than two decades ago.

The FDA has repeatedly found mifepristone is safe and that a medication abortion regimen that includes mifepristone and a second drug, misoprostol, is a safe and effective alternative to surgical abortions.

However, facing pressure from anti-abortion lawmakers and activists, the agency has been conducting a safety review of the drug. An administration official said in June the retrospective analysis of data is likely to take six months to complete, but initial results could be released earlier.

Medication abortion is the most common pregnancy termination method. Mail-order pharmacies, combined with blue state “shield laws” protecting clinicians from prosecution, have helped women maintain access even as conservative states have banned or severely limited access to abortion clinics.

As a result, abortions have increased despite there no longer being a constitutional right to abortion.

After Roe v. Wade was overturned, the Biden administration in 2023 permanently ended the in-person dispensing requirement for mifepristone.

The Trump administration has left those Biden-era regulations in place, keeping the issue out of the political spotlight but angering anti-abortion lawmakers and advocates.