Supreme Court confirms FDA’s approval of the abortion pill mifepristone

The Supreme Court on Thursday dismissed a case surrounding a challenge to the common abortion drug mifepristone, saying the plaintiffs lacked standing.

The ruling means the drug may continue to be prescribed online and shipped by mail, upholding recent regulatory changes made by the Food and Drug Administration.

The decision by the high court was unanimous and written by Justice Brett Kavanaugh, an appointee of former president Donald Trump. It marks a major victory for the Biden administration, which since 2022 has sought to fight against efforts by anti-abortion groups to limit access to abortifacients in the wake of the landmark decision overturning Roe v. Wade.

The legal fight against mifepristone started in November 2022, when the Alliance for Hippocratic Medicine, a group of religious doctors who oppose abortion, sued to reverse the FDA’s 2000 approval of the drug.

U.S. Judge Matthew Kacsmaryk, a Trump appointee in the Northern District of Texas, completely suspended the FDA’s approval of the pill in April 2023, an unprecedented move that critics said destabilized the authority of the federal public health agency.

The Justice Department responded by appealing Kacsmaryk’s decision to the U.S. Court of Appeals for the 5th Circuit, which is considered one of the most conservative federal appellate courts in the nation.

A three-judge panel on the 5th Circuit agreed with Kacsmaryk in part, overturning deregulation measures of the drug the FDA instituted in 2016 and 2021, respectively. The appeals court ruled, however, that the statute of limitations had passed to overturn the drug’s approval entirely.

In 2016, the FDA increased the gestational age of the pregnancy for which the abortifacient can be used, raising it from 8 weeks to 10 weeks. The agency also removed in-person screening requirements for receipt of the pills in 2021 during the coronavirus pandemic, allowing healthcare providers to ship the pills directly to patients by mail.

Mifepristone is the first drug in a two-agent chemical abortion process. Mifepristone, also referred to as “plan C” by abortion advocates, works by cutting off the woman’s progesterone receptors, preventing the fetus from continuing to grow and live. The second agent, misoprostol, induces contractions to expel the pregnancy tissue.

As of a March report from the pro-abortion rights Guttmacher Institute, nearly two-thirds of all abortions in the United States use mifepristone.

The oral arguments for the case before the Supreme Court in late March largely boiled down to the legal principle of standing, or whether or not the doctors who brought suit had been sufficiently harmed by the agency’s deregulation of the pill.

OB-GYN hospitalists involved in the case argued that when they are on call, they are the only ones who are able to treat patients following complications from a chemical abortion procedure. They argued that participating in the patient’s recovery, up to and including removing the unsuccessfully aborted fetus, is a violation of conscience protections.

During oral arguments, justices seemed skeptical as to the breadth of the decision either to eliminate or substantially curtail mifepristone as a remedy for a handful of doctors with ethical objections to participating in the aftermath of an abortion procedure.

Justice Amy Coney Barrett questioned both sides about whether it would be possible to create a religious exemption in hospitals to prevent physicians with ethical objections from needing to treat patients presenting with abortion complications.

Erin Hawley, an attorney for Alliance Defending Freedom representing AHM, argued that physicians often do not know until they are treating a patient whether or not she is suffering from a natural miscarriage or complications from a failed at-home abortion.

ADF also backed the case that the justices decided two years ago known as Dobbs v. Jackson Women’s Health Organization, which was a challenge to Mississippi’s ban on abortions after 15 weeks of pregnancy. The result of the case prompted numerous Republican-backed states to begin imposing stricter limits of abortion.

Justice Brett Kavanaugh, who was part of the majority in Dobbs, stressed at the time that the high court would no longer meddle in the contentious abortion debate. “Instead, those difficult moral and policy questions will be decided, as the Constitution dictates, by the people and their elected representatives through the constitutional processes of democratic self-government.”

But the case of mifepristone has always had less to do with abortion and more to do with FDA’s regulatory authority. The central legal question in the case is the Administrative Procedure Act, which requires agencies to have sufficient evidence of the benefits before making a decision.

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The main question is whether the doctors who face the downstream effects of the deregulation have the standing to charge the FDA with violating these federal standards.

It is unclear how the case will affect the approval authority of the agency.