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August 18, 2023
Health Law Weekly

Fifth Circuit Ruling Maintains Abortion Pill Access, But with Additional Restrictions

  • August 18, 2023

A three-judge panel of the Fifth Circuit ruled that the abortion pill mifepristone should remain on the market but found the Food and Drug Administration (FDA) improperly lifted certain restrictions, which expanded access to the drug.

The 2-1 ruling has no immediate impact on the availability of mifepristone since the Supreme Court in April ordered that the status quo under existing regulations remain while the litigation plays out.

Department of Health and Human Services Secretary Xavier Becerra released a statement criticizing the decision. “Today’s decision undermines our nation’s entire system of drug approval by overriding the scientific, evidence-based decision-making of the FDA. This decision threatens Americans’ right to access the medications they need and, if it stands, would have a devastating impact on women’s health by restricting their access to reproductive health care."

“The most important thing to know is that mifepristone remains approved and available while we fight this decision in the courts. We remain confident the law is on our side, and we will continue to vigorously defend the FDA’s independent, science-based drug approval process, and Americans’ right to access the health care they need," Becerra said. 

The FDA approved the brand-name version of mifepristone in 2000 for medical termination of pregnancy up to seven weeks. In 2016, the FDA extended the drug’s availability through ten weeks gestation among other changes. The agency further loosened restrictions on the drug in 2021 during the COVID-19 pandemic, including allowing mifepristone to be delivered by mail. Mifepristone and a second drug misoprostol account for about half of abortions nationwide.

The Fifth Circuit’s decision partially reverses a ruling in April by U.S. District Court for the Northern District of Texas Judge Matthew J. Kacksmaryk that granted a preliminary injunction to plaintiff doctors and medical associations who argued the FDA’s fast-track approval of the drug ignored safety concerns and was politically motivated. Alliance for Hippocratic Med. v. U.S. Food and Drug Admin., No. 2:22-CV-223-Z (N.D. Tex. Apr. 7, 2023).

The Department of Justice then filed an emergency motion for a stay of the injunction pending appeal. A separate Fifth Circuit panel in April agreed to stay the decision blocking access to the drug nationwide after finding the challenge to the FDA’s decision to approve mifepristone more than two decades ago likely was untimely under the statute of limitations.

However, the appeals court panel said the post-2016 challenge was timely and that the government had failed show that the FDA’s actions were not arbitrary and capricious for purposes of staying that aspect of the injunction. Alliance for Hippocratic Med. v. Food and Drug Admin., No. 23-10362 (5th Cir. Apr. 13, 2023). The Supreme Court ultimately stepped in and stayed the entire injunction pending resolution of the appeal and disposition of any petition for writ of certiorari.

Following the emergency proceedings, the Fifth Circuit heard oral arguments in May to fully consider the appeal. In its ruling this week, the panel majority agreed that the challenge to the 2000 approval was likely untimely.

The panel also found that plaintiffs sufficiently demonstrated injuries for standing purposes, including requiring the physician challengers to perform or complete an abortion contrary to their sincerely held beliefs as part of treating women suffering from mifepristone complications; the “mental and emotional strain above what is ordinarily experienced in an emergency-room setting”; forcing them to divert time and resources from other patients; and the heightened risk of liability and higher insurance premiums.  

The appeals court did hold that plaintiffs lacked standing to challenge the FDA’s approval of the generic version of the abortion pill in 2019. Plaintiffs failed to show they suffered any additional injury traceable specifically to the generic. As a result, the generic version of mifepristone should be available under the same conditions as the brand-name drug Mifeprex, the appeals court said.

Turning to the merits, the appeals court held that the FDA likely violated the Administrative Procedure Act (APA) in loosening safety restrictions for mifepristone in 2016 and 2021.

According to the panel, “FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”

A dissenting judge argued that the FDA’s initial approval of mifepristone in 2000 also violated agency rules and should be set aside under the APA as well.

Alliance for Hippocratic Med. v. Food and Drug Admin., No. 23-10362 (5th Cir. Aug. 16, 2023).