The Supreme Court’s decision in the mifepristone case does not affect the FDA’s approval authority

On June 13, 2024, the United States Supreme Court unanimously dismissed the FDA’s lawsuit against the Alliance for Hippocratic Medicine on a technicality: the plaintiff’s lack of standing. On that basis, the case raises challenges about the U.S. Food and Drug Administration’s (FDA) authority to approve drugs and, more broadly, whether courts can overrule federal agencies’ findings.

What is mifepristone?

Mifepristone was approved by the FDA in 2000 for use in terminating pregnancies up to seven weeks. To ensure the drug’s safety, the FDA has placed restrictions on its use, including requiring doctors to prescribe or supervise it and requiring patients to attend three in-person visits. In 2016, the FDA approved the drug to terminate pregnancies up to ten weeks, while also easing previous restrictions, limiting the in-person requirement to one visit and allowing the drug to be prescribed by non-physicians. In 2019, the FDA approved an application for generic mifepristone. In response to the COVID-19 pandemic, the FDA announced in 2021 that the in-person visit requirement would no longer be enforced, allowing mifepristone to be prescribed via telehealth and mail ordering.

The road to the Supreme Court

After the Supreme Court judgment of 2022 Dobbs v. Jackson Women’s Health fall over Roe v. Wade and Planned Parenthood of Southern Pa. v. Casey, which abolished the constitutional right to abortion, the use of mail-order abortion drugs such as mifepristone became a viable alternative for patients who, due to state restrictions, were unable to obtain abortion services in person. In 2023, the anti-abortion medical group Alliance for Hippocratic Medicine filed a lawsuit against the federal government.

The Alliance for Hippocratic Medicine, along with other anti-abortion medical groups, argued that in approving mifepristone in 2000, the FDA improperly used an expedited approval process for drugs used to treat life-threatening diseases. The groups argued that the process was inappropriate for pregnancy and said the drug itself was too dangerous. As part of that lawsuit, the Alliance for Hippocrates Medicine asked for a preliminary injunction that would require the FDA to rescind the approval of mifepristone or require the FDA to rescind the 2016 and 2021 actions.

In April 2023, the federal district court judge hearing the case issued a preliminary injunction blocking the drug’s approval and giving the Biden administration one week to appeal. On appeal, the Fifth Circuit found that challenges to the drug’s 2000 and 2019 FDA approvals were unlikely due to the statute of limitations and lack of evidence of injury. In addition, pending final judgment, the Fifth Court restored conditions that existed before the FDA’s 2016 and 2021 changes to the drug. These conditions included a requirement that the drug may only be prescribed by a physician and that it must be dispensed in person and not allowed to prescribe mifepristone remotely and send it by post. FDA’s main concern was that the Fifth Circuit’s decision threatened the agency’s scientific drug approval process and decision-making authority as a federal agency. Parties on both sides have asked the Supreme Court to review the issue.

Unanimous decision of the Supreme Court

Despite several theories presented to the Supreme Court linking the FDA’s actions to the alleged harm, the Supreme Court unanimously ruled in its June 13, 2024 decision, authored by Justice Kavanaugh, that the Alliance for Hippocratic Medicine lacked standing under Art. III to challenge the FDA’s regulation of mifepristone.

Standing requires the plaintiff to show that (1) he has actually suffered or is likely to suffer damage, (2) the damage has been or is likely to be caused by the defendant, and (3) the damage is likely to be compensated by the defendant. court relief. The Supreme Court reasoned that the plaintiff’s “legal, moral, ideological and political objections” to the use of mifepristone by others who did not themselves prescribe or use mifepristone were insufficient to demonstrate actual harm and establish standing.

The outcome of the present case therefore maintains the status quo. By basing its decision on lack of standing, the Supreme Court did not address the issue of FDA’s rulemaking authority, and as a result, avoided creating consequences for the decision-making and authority of other federal agencies. Moreover, the Supreme Court did not address the issue of access to mifepristone, which means that under Dobbs’ framework, states are free to restrict or protect access to abortion services, including medication abortion. The postponed decision will lead to the emergence of groups advocating for regulatory and legislative changes and expressing their views in the political and electoral processes.