The abortion-inducing medication mifepristone can remain on the market with regulations after the Court of Appeals for the Fifth Circuit decided earlier this month that the FDA neglected safety concerns when it loosened the drug’s regulations in 2016.

Despite this new order, the court’s decision has no effect on access to or the use of mifepristone. Instead, it will remain on the market as-is until the Supreme Court decides whether to take up the case on appeal. 

The decision is the latest in a legal battle over the medication that originated with a lawsuit made by the Alliance for Hippocratic Medicine in a U.S. District Court in Texas. In his decision, U.S. District Judge Matthew Kacsmaryk suspended the FDA’s over twenty-year approval of mifepristone. 

University of Texas Law professor Elizabeth Sepper said if the circuit court’s decision were to go into effect, it would reduce the maximum gestational age for mifepristone from ten to seven weeks, require mifepristone be prescribed only by a physician, require patients make multiple in-person visits to obtain the drug and would change the dosage amount. 

“On top of that, what we know because of the ways that drugs are regulated, if this order were to take effect, the FDA would have to actually pull mifepristone down from the market for a period of months,” Sepper said. “Every batch of mifepristone on the market now would be mislabeled and misdosed, which would mean that the pharmaceutical companies couldn’t distribute them.” 

Sepper said the circuit court also concluded the Alliance for Hippocratic Medicine did not have legal standing to challenge the FDA’s original approval of the drug in 2000 because their claims are no longer timely through the statute of limitations, which sets a time limit for when a plaintiff can bring about legal action. 

The next step is for the Biden administration to file a petition at the Supreme Court where the justices will decide whether to take the case upon its merits, Sepper said. If the Court decides not to hear the case themselves, only then would the circuit court’s decision go into effect. 

“The most important thing to take away from the decision is that it has no effect,” Sepper said. “No effect on mifepristone, no effect on the legality of these drugs or (on) access to them.”