Appeals court rules abortion pill sales can continue, but with restrictions

A federal appeals court this week ruled that sales of a widely used abortion drug can continue with some restrictions, setting the stage for the next Supreme Court battle over abortion access in the US.

The US Court of Appeals for the 5th Circuit struck down part of a lower court’s ruling that put a hold on the federal government’s approval of mifepristone, a drug that the FDA signed off on in 2000. But the three-judge panel upheld restrictions on how the drug—also known as Mifeprex—can be used and prescribed as the case works its way through the courts.

“Mifeprex will remain available under the safety restrictions that were in effect prior to 2016. Generic mifepristone will also remain available under those same restrictions,” the judges wrote in a 93-page opinion released late Wednesday.

The FDA in 2016 loosened restrictions on who can prescribe the drug and how long into a pregnancy it can be used. In 2021, the agency said it would not enforce in-person dispensing requirements due to the Covid-19 pandemic, allowing it to be prescribed remotely and sent via mail.

The court said its decision to reinstate previous restrictions on mifepristone was due to the FDA’s failure to “address several important concerns about whether the drug would be safe for the women who use it” and “gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed or dispensed in person.”

Medication abortions have grown in popularity since the FDA’s approval of mifepristone. They accounted for more than half (53%) of facility-based abortions in the US in 2020—or 492,210 out of a total 930,160 abortions—according to a 2022 analysis from Guttmacher Institute, a sexual and reproductive health and rights policy organization. That’s up from 39% in 2017 and 6% in 2001.

If mifepristone loses federal approval, that leaves just one FDA-approved drug option—misoprostol—for people seeking medication abortions in the US (including in states with strong abortion protections and access). Often, the two are used together for a medication abortion.

Abby Long, a spokesperson for Danco Laboratories, the company behind Mifeprex, said the court’s ruling “seeks to undo FDA actions that are well supported by extensive safety and effectiveness data from clinical trials and real-world experience in millions of patients, and that are decisions Congress entrusted to FDA.”

“The changes in 2016 and 2021 that the panel would strike down—changes approved by FDA after careful analysis—have expanded the availability and use of Mifeprex, providing crucial individual and public health benefits,” she said in a statement. “Danco will continue to be at the forefront of this fight, working closely with the reproductive rights community and pharmaceutical industry, as this case moves forward.”

Danco previously argued in court documents that the case threatens the company’s “very existence.” Long said that the company “will continue to pursue reversal of this injunction.” GenBioPro, which received FDA approval in 2019 to sell generic mifepristone, has also pushed back against efforts to restrict mifepristone access.

Meanwhile, President Joe Biden said in a statement that his administration will continue “to protect access to abortion and defend the FDA in the courts.”

The Alliance for Hippocratic Medicine filed a federal lawsuit in November 2022 against the FDA over its approval of mifepristone.

In April, Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas ordered a hold on the federal government’s approval of the drug. But a simultaneous ruling from another federal judge directed the government to not restrict access to mifepristone in at least 17 states and Washington, DC.

The conflicting orders elevated the case to the US Supreme Court, which ruled that the abortion pill could remain available as the lawsuit works its way through the 5th Circuit.