The U.S. Supreme Court on June 13, 2024, unanimously held in Food and Drug Administration v. Alliance for Hippocratic Medicine that the plaintiffs lacked standing to challenge the Food and Drug Administration’s (FDA) regulatory actions related to approved use conditions of mifepristone—a drug used in medication abortions.
The FDA approved the drug mifepristone in 2000 to be used in medication abortions. A group of doctors and medical groups in 2022 challenged the approval, arguing in part that the drug was unsafe. The U.S. Court of Appeals for the Fifth Circuit ruled in August 2023 that the group could not challenge the 2000 approval of mifepristone, however, the court found that the agency’s 2016 amendments and 2021 non-enforcement decision were arbitrary and capricious under the Administrative Procedure Act. By changing certain conditions of the drug’s use, such as allowing it to be used later in pregnancy and removing the in-person prescription requirement, the court ruled that the agency’s actions “failed to address several important concerns about whether the drug would be safe for the women who use it.” The Biden administration and Danco Laboratories, L.L.C. appealed the decision to the Supreme Court in September 2023.
The Supreme Court found that the group of doctors and medical groups did not have standing to challenge the FDA’s regulatory actions. Justice Brett Kavanaugh wrote in the majority opinion, “The plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone. But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court. Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
Additional reading: