On June 13, the U.S. Supreme Court unanimously held that a challenge to the Food & Drug Administration’s regulation of the abortion drug mifepristone could not proceed because the plaintiffs (doctors and medical associations) did not have standing. In other words, the plaintiffs could not show that they would be harmed by the regulation.

At issue was whether the FDA acted unlawfully when it removed several patient health and safety safeguards for the chemical abortion drug mifepristone. The FDA approved mifepristone in September 2000. In 2016, the FDA began to allow medical practitioners such as nurse practitioners to prescribe the drug, when previously only hospitals and medical facilities could distribute it; extended the usage period to 10 weeks of gestation; and changed the requirement that a patient have three in-person visits with a doctor to just one in-person visit. In 2019, the FDA approved an application for generic mifepristone. In 2021, the FDA announced that it would no longer reinforce even the single in-person visit requirement, and in 2023, it allowed pharmacies to begin distributing the drug as well.

The plaintiffs are pro-life doctors and medical associations who have legal, moral, ideological, and policy objections to mifepristone being prescribed. Before the case reached the Supreme Court, the U.S. Court of Appeals for the Fifth Circuit held that the plaintiffs had standing and that while they were unlikely to succeed in their challenge to the FDA’s 2000 and 2019 drug approvals, they were likely to succeed in showing that the FDA’s 2016 and 2021 actions were unlawful. The Supreme Court granted certiorari only to address the 2016 and 2021 actions.  

In an opinion by Judge Kavanaugh, the Supreme Court reaffirmed its standing jurisprudence rooted in the constitutional doctrine of separation of powers: Federal courts do not operate as an open forum for citizens to press general complaints about the way the government goes about its business. Rather, to obtain a judicial determination of what the governing law is, a plaintiff must have a personal stake in the dispute. A plaintiff can demonstrate that personal stake by showing that she has suffered or will likely suffer an “injury in fact”; the injury likely was caused or will be caused by the defendant (“causation”); and the injury likely would be redressed by the requested judicial relief (“redressability”).

The Court found that because the plaintiffs do not prescribe or use mifepristone, they sought to challenge the FDA’s regulation of others. Even if the relaxed regulation of mifepristone caused more pregnant women to require emergency abortions and some would likely seek treatment from the plaintiff doctors, the plaintiff doctors had not shown that they could be forced to participate in abortion-related medical treatment over their conscience objections, which are protected by federal law. The Court also rejected the plaintiff doctors’ argument that they would be harmed financially by having to divert resources and time from other patients to treat patients with mifepristone complications, holding that the causal link was too speculative and attenuated. The Court noted that the law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might end up in the emergency department. Instead, the recourse for doctors who object to such laws is to petition the executive and legislative branches for greater regulatory or legislative restrictions.  

As to the medical associations, the Court held that their alleged harm in expending costs and resources to oppose the FDA’s actions and to engage in public advocacy and education were not cognizable injuries. Contrary to plaintiffs’ arguments, the Court stated that it had never adopted their expansive theory that standing exists when an organization diverts its resources in response to a defendant’s actions.

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