Supreme Court keeps medication abortion drug available, with eased access, during appeals

Judge Kacsmaryk's order is on hold in full while appeals continue through the courts. Justices Thomas and Alito dissent.

Apr 21, 2023

The U.S. Supreme Court on Friday evening issued a full stay of U.S District Judge Matthew Kacsmaryk’s order purporting to remove approval of the medication abortion drug mifepristone during appeals of the ruling — meaning that the drug will remain available under the U.S. Food and Drug Administration’s eased rules for access of the drug.

The stay of Kacsmaryk’s order granted on Friday will remain in place through the pending appeal at the U.S. Court of Appeals for the Fifth Circuit and during any appeal to the U.S. Supreme Court that follows.

Both Justices Clarence Thomas and Samuel Alito signaled their disagreement with the ruling.

Friday’s ruling means that mifepristone will remain available on current, eased terms — including the recent decision ending the in-person dispensing requirement — for the near future, as any Supreme Court appeal almost certainly wouldn’t even be considered until next term.

SUPREME COURT OF THE UNITED STATES _________________ No. 22A901 _________________ DANCO LABORATORIES, LLC v. ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL. ON APPLICATION FOR STAY _________________ No. 22A902 _________________ FOOD AND DRUG ADMINISTRATION, ET AL. v. ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL. ON APPLICATION FOR STAY [April 21, 2023] The applications for stays presented to JUSTICE ALITO and by him referred to the Court are granted. The April 7, 2023 order of the United States District Court for the Northern District of Texas, case No. 2:22–cv–223, is stayed pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari, if such a writ is timely sought. Should certiorari be denied, this stay shall termi- nate automatically. In the event certiorari is granted, the stay shall terminate upon the sending down of the judg- ment of this Court. JUSTICE THOMAS would deny the applications for stays. JUSTICE ALITO, dissenting from grant of applications for stays.

In dissenting, Thomas simply stated that he would have denied the stay requests from the Justice Department and Danco Laboratories, the maker of Mifeprex. Alito wrote a four-page dissent, explaining why he did not believe the government or Danco justified a stay is needed in the case given the fact that the Fifth Circuit had already narrowed Kacsmaryk’s order during appeals.

Alito did include a note in his dissent insisting that his vote here should not be seen as a vote on the merits: “Contrary to the impression that may be held by many, [denying the stay request] would not express any view on the merits of the question whether the FDA acted lawfully in any of its actions regarding mifepristone.” In the next sentence, however, he wrote that denying the stay — which, again, he wanted the court to do — would just have been a sign that the stay wasn’t “necessary to avoid the threat of any real harm during the presumably short period at issue.”

The justices do not have to reveal their votes in such situations — applications that have led to cases that reach the court in this posture to be referred to as the shadow docket — so we don’t actually know the outcome of the vote for a stay or how the other seven justices voted. We just know that Thomas and Alito voted against the stay, and that a majority of the court voted for the stay.

In Kacsmaryk’s April 7 ruling, he purported to halt the U.S. Food and Drug Administration’s 2000 approval of mifepristone and all changes easing access to the drug since. That ruling has already been appealed and is slated to be argued at the Fifth Circuit on May 17. At the same time, the Fifth Circuit has narrowed the effect of Kacsmaryk’s ruling during the appeal. Under the appeals court’s April 12 ruling, only the changes easing access to the drug would be halted during the appeal — meaning the drug would remain available but under its 2000 restrictions.

Friday’s ruling from the U.S. Supreme Court, in effect, overrules that, putting all of Kacsmaryk’s ruling on hold during appeals.

After the Fifth Circuit’s ruling on the stay, the Justice Department and Danco Laboratories quickly went to the Supreme Court, asking on April 14 for a full stay of Kacsmaryk’s ruling during the appeal — so the drug would remain available under the current, eased standards that include ending the in-person dispensing requirement for mifepristone.

Later that day, Justice Samuel Alito issued an administrative stay, halting the enforcement of Kacsmaryk’s order in full until 11:59 p.m. April 19. The challengers, anti-abortion medical groups and doctors, opposed DOJ and Danco’s requests early April 18, as requests by Alito. DOJ replied late April 18, with Danco’s reply coming shortly thereafter before 1 a.m. April 19. On April 19, Alito extended the administrative stay for 48 hours — until 11:59 p.m. Friday.

In addition to Kacsmaryk’s order out of Texas, another judge in another case — brought in Washington state by Democratic attorneys general of 16 states and Washington, DC — has ordered the FDA to keep mifepristone available on the same terms as it was available under the FDA’s January 2023 eased restrictions. The potential conflicting effect of that ruling, by US District Judge Thomas Rice, was raised in the Supreme Court filings.

Another lawsuit was filed Wednesday by GenBioPro, the maker of the generic mifepristone, whose lawyers are seeking an order protecting their claimed rights against government enforcement of Kacsmaryk’s order against them and their generic drug. The company had brought these concerns to the Supreme Court as well, in the form of an amicus brief.

This story was updated after initial publication, with the final update at 7:30 p.m. ET.