Fifth Circuit Court partially upholds Amarillo judge’s ruling on mifepristone

The U.S. Fifth Circuit Court of Appeals partially upheld a federal judge’s recent ruling that challenged the U.S. Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone.

Mifepristone was approved by the FDA in 2000 and is one of two drugs used in chemical abortions, the other being misoprostol. In Amarillo, U.S. Judge Matthew Kacsmaryk issued a stay order to the FDA on their approval of mifepristone. He also included a seven-day grace period for the appeals court to seek relief judgment on the order.

Danco Laboratories, the manufacturer of Mifeprex, a trade name for mifepristone, filed an appeal to the Fifth Circuit asking for a stay on Kacsmaryk’s ruling.

The Fifth Circuit ruled a stay on only part of Kacsmaryk’s order.

The ruling said mifepristone will remain approved during the appeal process but that the changes made in 2016 to the drug’s Risk Evaluation and Mitigation Strategy (REMS) will no longer apply.

Starting in 2016, the FDA changed four REMS parameters for attaining mifepristone. It increased the maximum gestational age of the fetus to 70 days, reduced the required in-person office visits to one, allowed non-doctors to prescribe the drug, and eliminated reporting of non-fatal adverse events.

Another change came in 2021 when the FDA announced its enforcement discretion would allow mifepristone to be sent through the mail, and then in 2023 the FDA permanently removed the in-person requirement for dispensing mifepristone.

With the Fifth Circuit’s new order, the FDA will return mifepristone regulations to their 2000-era status where mifepristone approval will only be granted when pregnancies are under 50 days of gestation, require three in-person visits, a qualified physician must supervise, and reporting must be done on all adverse events.

The dispute surrounding the mailing of abortion drugs also factored into the decision, centered on the Comstock Act of 1873. “To the extent the Comstock Act introduces uncertainty into the ultimate merits of the case, that uncertainty favors the plaintiffs,” the court said.

The Comstock Act states that “[e]very article or thing designed, adapted, or intended for producing abortion,” as well as “[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion,” is a “non mailable matter.”

The representing attorney team from Alliance Defending Freedom held a press conference following the ruling expressing their approval.

“What the Fifth Circuit did here is really recognize that the FDA’s actions have been unlawful from the very beginning, and it also implemented a number of requirements to put them back in place,” said Erin Hawley, senior counsel and vice president of Center for Life and Regulatory Practice at ADF.

Hawley said that ”the FDA put politics ahead of the health of women and girls” when it “removed every meaningful safeguard” for the use of “dangerous chemical abortion drugs.”

The Fifth Circuit’s partial stay on the appeal will now face future litigation over the Fifth Circuit’s ruling and the initial approval in 2000, and will potentially lead to filings with the U.S. Supreme Court.