Supreme Court Rejects Challenge to Abortion Drug Regulations in FDA v. Alliance for Hippocratic Medicine

On June 13, the U.S. Supreme Court unanimously ruled that a challenge to the Food and Drug Administration’s regulation of the abortion drug mifepristone cannot proceed because the plaintiffs (doctors and medical associations) lack standing. In other words, the plaintiffs could not demonstrate that the regulation would harm them.

The dispute concerned whether the FDA acted illegally by removing several health and patient safety protections related to the abortion drug mifepristone. The FDA approved mifepristone in September 2000. In 2016, the FDA began allowing doctors, such as nurse practitioners, to prescribe the drug, whereas previously only hospitals and medical facilities could distribute it; extended the period of use to the 10th week of pregnancy; and changed the requirement of three in-person visits for a patient to a physician to only one in-person visit. In 2019, the FDA approved an application for generic mifepristone. In 2021, the FDA announced that it would no longer tighten even the requirement for a single in-person visit, and in 2023 it also allowed pharmacies to begin distributing the drug.

The plaintiffs include pro-life physicians and medical associations who have legal, moral, ideological and political objections to the prescription of mifepristone. Before the case reached the Supreme Court, the U.S. Court of Appeals for the Fifth Circuit ruled that the plaintiffs had standing, and while it was unlikely they would succeed in challenging FDA drug approvals in 2000 and 2019, they would likely be able to show that FDA’s actions in 2016 and 2021 were unlawful. The Supreme Court granted certiorari only for the 2016 and 2021 petitions.

In Justice Kavanaugh’s opinion, the Supreme Court reaffirmed its long-established jurisprudence rooted in the constitutional doctrine of the separation of powers: Federal courts do not act as an open forum in which citizens can bring general complaints about the way the government conducts its affairs. Instead, to obtain a judicial decision on applicable law, the plaintiff must have a personal stake in the dispute. The plaintiff may demonstrate personal involvement by showing that he or she has suffered or is likely to suffer “harm in fact”; the damage is likely to have been caused or will be caused by the defendant (“causal cause”); and the damage is likely to be compensated under the remedy sought (“remediability”).

The Court found that because the plaintiffs do not prescribe or use mifepristone, they attempted to challenge the FDA’s regulation of others. Even if easing the mifepristone regulations resulted in more pregnant women requiring emergency abortions and some likely seeking treatment from plaintiffs’ physicians, plaintiffs’ physicians have failed to demonstrate that they could be forced to participate in abortion-related treatment because of opposition. conscience, which is protected by federal law. The Court also rejected the plaintiffs’ physicians’ argument that they would be financially harmed by having to devote resources and other patients’ time to treating patients with mifepristone-related complications, finding that causation was too speculative and attenuated. The Court noted that the law had never allowed doctors to challenge the government’s relaxation of general public safety requirements simply because more people might end up in the emergency department. Instead, physicians who oppose such laws may petition the executive and legislative branches for greater regulatory or legislative restrictions.

As for medical associations, the Court held that their alleged harm from expending costs and resources to oppose FDA actions and engage in public advocacy and education did not constitute cognizable harm. Despite the plaintiffs’ arguments, the Court said it had never accepted their expansive theory that standing occurs when an organization diverts its resources in response to a defendant’s actions.

The Court was unmoved by the argument that plaintiffs must have standing because otherwise there would be no one to challenge the FDA’s actions, noting that some issues were left to the political and democratic processes.