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5th Circuit Court of Appeals imposes restrictions on abortion pill mifepristone, however drug will stay on the market for now

by | Aug 16, 2023

By Dave Andrusko

A three-judge panel of the 5th Circuit Court of Appeals said Wednesday that it would impose major restrictions on the abortion pill mifepristone.

The panel “said it would restrict access to a widely used abortion medication after finding that the federal government did not follow the proper process when it loosened regulations in 2016 to make the pill more easily available,” The Washington Post reported.

The panel, consisting of Judges Jennifer Elrod, James Ho, and Cory Wilson, found that the FDA’s “decisions to allow the drug mifepristone to be taken later in pregnancy, be mailed directly to patients and be prescribed by a medical professional other than a doctor were not lawful,” according to Ann E. Marimow and Perry Stein.

However, the appeals court left in place the FDA’s underlying 2000 approval of mifepristone and its 2019 authorization of a generic form of the drug.

The decision is universally expected to be appeal to the United States Supreme Court which will ultimately decide the case. “In a ruling this spring, the high court said mifepristone should remain available under the current rules until the appeals process concludes,” according to Pam Belluck of the New York Times.

Marimow and Stein wrote “The main impact of the appeals court decision, if it is upheld by the Supreme Court, would be to reverse changes made by the F.D.A. in recent years that allowed patients to obtain the pill without visiting a doctor or other health provider in person.”

The decision surprised few court observers. As NRL News Today reported at the time, the panel (described as “conservative,” “very conservative,” “highly conservative,” or even “extremely conservative”) peppered lawyers from  all sides with questions that pointed to two options: uphold the trial judge Matthew Kacsmaryk’s conclusion to suspend mifepristone, or reverse actions taken by the FDA since 2016 that have greatly increased the dangers to women. They largely chose the second option.

Clearly, the panel was not going to roll over and blindly accept what the FDA said as if it were gospel. The oral arguments had barely gotten started when Circuit Judge Ho “showed his hostility to the idea of giving the FDA deference.”

Department of Justice attorney Sarah Harrington started out saying that Judge Kacsmaryk’s opinion was “unprecedented.”

Judge Ho interrupted to say, “I’m just wondering why not just focus on facts of the case rather than have this sort of ‘FDA can do no wrong’ theme?” Later he said “We are allowed to look at FDA just like any other agency. That’s the role of the courts.”

Background

In recent years, the FDA has made mifepristone much easier to get and has removed critical safeguards for women. 

For example, the FDA weakened the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug to allow it to be dispensed and even mailed by pharmacies. According to the 5th Circuit opinion, prior to the 2023 changes, the “FDA removed four of the original safety restrictions by

increasing the maximum gestational age at which a woman can use the drug from 49 to 70 days; (2) reducing the number of required in-person office visits from three to one; (3) allowing non-doctors to prescribe and administer the chemical abortions drugs; and (4) eliminating the requirement for prescribers to report non-fatal adverse events from chemical abortion.”

The Alliance for Hippocratic Medicine, an association of pro-life doctors and others, brought the challenge. They asserted that “the FDA did not sufficiently consider safety concerns when it approved the drug or when it subsequently removed some restrictions — extending the approved use of mifepristone, for instance, through 10 weeks of pregnancy instead of seven,” The Washington Post reported.

Ground zero for the fast-moving case was U.S. District Judge Matthew Kacsmaryk’s April 7 decision to suspend FDA approval of mifepristone. He accepted the argument of the Alliance for Hippocratic Medicine that the FDA had fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses.

On April 5, National Right to Life released a white paper about the myths involving the Food and Drug Administration’s (FDA) approval and management of mifepristone (generic for Mifeprex).

Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone)” can be accessed here.