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February 02, 2024

ABA asks Supreme Court to reverse 5th Circuit’s second-guessing of the FDA

CHICAGO, Feb. 2, 2024 — The American Bar Association submitted an amicus brief today with the U.S. Supreme Court, urging the justices to reject a decision by a federal court of appeals that substituted the judgment of the appeals court for that of the U.S. Food and Drug Administration (FDA) regarding the drug mifepristone.

The ABA brief, which supports the position of the FDA, argues that the August 2023 decision by the U.S. Court of Appeals for the 5th Circuit effectively second-guesses the FDA’s scientific judgment, contrary to the standard of review of FDA decisions that Congress and Supreme Court precedent has mandated. The brief recognizes that judicial review of administrative decisions is a cornerstone of the American rule of law, but it also explains that the failure of courts to apply the proper standards when conducting that review can reduce public confidence in the courts and the predictability and stability that form the basis of the rule of law.

“Contrary to congressional design, the 5th Circuit substituted its judgment for the FDA’s expertise when it rejected conclusions the FDA drew from scientific evidence,” the ABA brief said.

“In this case, the court of appeals departed markedly from settled principles of judicial review enshrined in both the Administrative Procedure Act and in this court’s precedent,” the ABA brief added.

In 2000, the FDA approved mifepristone, which can be used to terminate early pregnancies. In 2016 the FDA amended some of the approved conditions for its use, making them less rigid, and later approved a generic version. In 2021, it announced a policy of nonenforcement of the condition that the drug be dispensed in person, a condition it subsequently lifted altogether. That action prompted a 2022 suit in federal court in Texas from doctors and associations of doctors who oppose abortion and who contend the FDA exceeded its authority.

In a complicated decision, the 5th Circuit partially agreed with the plaintiffs, holding that some of the FDA’s actions were likely arbitrary and capricious. In its brief, the ABA explains how the 5th Circuit failed to apply the proper standard of review in reaching that ruling, and argues that the court’s position, if upheld, could lead to “broader deleterious consequences” to the rule of law.

The ABA brief in the case U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, et al is here. The law firm of Schnapper-Casteras PLLC prepared the brief pro bono for the ABA.

The ABA is the largest voluntary association of lawyers in the world. As the national voice of the legal profession, the ABA works to improve the administration of justice, promotes programs that assist lawyers and judges in their work, accredits law schools, provides continuing legal education, and works to build public understanding around the world of the importance of the rule of law. View our privacy statement online. Follow the latest ABA news at and on X (formerly Twitter) @ABANews.