The American Bar Association is urging the U.S. Supreme Court 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 mifepristone ? a drug that can be used to terminate early pregnancies.
On Feb. 2, the ABA submitted an amicus brief to the Supreme Court which supports the position of the FDA, arguing that the August 2023 decision by the U.S. Court of Appeals for the 5th Circuit effectively second-guesses the FDA’s scientific judgment. The brief also said the appeals court ruling is contrary to the standard of review for FDA decisions that precedent by Congress and Supreme Court has mandated.
The brief recognizes judicial review of administrative decisions as a cornerstone of the American rule of law but 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. 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 it would no longer enforce a requirement that the drug be dispensed in person.
The requirement was later lifted entirely. 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.
On Feb. 2, the ABA submitted an amicus brief to the Supreme Court which supports the position of the FDA, arguing that the August 2023 decision by the U.S. Court of Appeals for the 5th Circuit effectively second-guesses the FDA’s scientific judgment. The brief also said the appeals court ruling is contrary to the standard of review for FDA decisions that precedent by Congress and Supreme Court has mandated.
The brief recognizes judicial review of administrative decisions as a cornerstone of the American rule of law but 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. 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 it would no longer enforce a requirement that the drug be dispensed in person.
The requirement was later lifted entirely. 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.
