Appeals court upholds FDA approval of abortion pill, but allows some limits

Washington— A federal appeals court upheld the Food and Drug Administration’s 23-year-old approval of the widely used abortion pill mifepristone, but said a series of actions the agency took in recent years to make it easier to obtain went too far.

A three-judge panel from the U.S. Court of Appeals for the 5th Circuit issued a divided ruling Wednesday regarding an order from a federal district court in Texas. The panel agreed with the lower court that the agency’s moves since 2016 to relax the rules for mifepristone’s use should be reversed, but the panel declined to suspend the underlying approval of the medication. 

The ruling will not affect availability of the drug, since the Supreme Court paused the entirety of the lower court’s order as the appeals process plays out.

“This means that, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016,” the court said, referencing the name of the drug manufactured by the company Danco Laboratories.

The 5th Circuit panel also said the FDA’s 2019 approval of a generic version of mifepristone, made by the company GenBioPro, should be left in place and “will also be available under the same conditions as Mifeprix.”

The panel of Judges Jennifer Walker Elrod, James Ho and Cory Wilson noted its decision is subject to the earlier ruling from the Supreme Court. Ho said in a separate opinion that while he agrees with the majority that the 2016 and 2021 changes to mifepristone’s rules must be set aside, he believes the FDA’s initial approval in 2000 violates the agency’s own rules and must also be invalidated.

Under the tighter rules, the drug can be taken up to seven weeks into a pregnancy, rather than 10 weeks, and must be dispensed in-person instead of by mail.