Judge Allows Red States to Proceed With Abortion Pill Challenge

Litigation over the abortion pill mifepristone is set to continue after a federal judge on Thursday issued an order allowing a group of Republican-led states to file an amended complaint against FDA regulations.

The Food and Drug Administration and mifepristone manufacturer Danco Laboratories failed to show that a lawsuit from Idaho, Kansas, and Missouri wouldn’t survive a motion to dismiss, Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas wrote in his order. Kacsmaryk previously allowed the states to intervene in the case initially brought by anti-abortion doctors.

The US Supreme Court in June tossed the challenge from the doctors, ruling that they lacked standing to bring the suit. The doctors voluntarily dropped their suit in November, but the Republican-led states have sought to continue the case.

Mifepristone is approved by the FDA for use in a regimen with a second drug—misoprostol—to terminate a pregnancy through the first 10 weeks of gestation. The litigation centers on actions the FDA has taken since 2016 gradually expanding access to the drug, including widening the window of approved use from seven to 10 weeks and removing a requirement that the drug be dispensed in-person.

The Republican state attorneys general argue the doctors lost on standing grounds solely because the Biden administration changed its interpretation of federal conscience protections in arguments to the Supreme Court. The states claim that this allowed justices to determine that federal conscience laws protect providers in specific circumstances and that the plaintiffs therefore no “longer faced a harm to conscience.”

The FDA said in a Dec. 6 motion to dismiss that Idaho, Kansas, and Missouri’s lawsuit has “no plausible connection” to the Texas federal court, and that the states “have articulated no valid reason for seeking to litigate their claims before this Court, as opposed to the Federal courts located in their home jurisdictions or where Defendants are headquartered.”

Kacsmaryk, however, wrote Thursday that the court has a high standard for denying leave to amend a complaint and that there is a “bias in favor of granting leave to amend.”

The order allows the FDA and Danco to filed renewed motions to dismiss, in which both parties will have an “opportunity to focus their arguments and space on the one complaint remaining in this action,” Kacsmaryk said.

The decision comes as many expect the incoming Trump administration to withdraw the federal government’s defense of mifepristone in the litigation.

The case is Missouri v. FDA, N.D. Tex., No. 2:22-cv-00223, order granting motion for leave to file amended complaint 1/16/25.