Supreme Court upholds FDA approval of abortion pill mifepristone

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.

Lead-up to the decision

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. However, the appeals court ruled that the statute of limitations had passed to overturn the drug’s approval entirely.

In 2016, the FDA increased the gestational age of pregnancy for which the abortifacient can be used, raising it from eight weeks to 10 weeks. The agency also removed in-person screening requirements for receipt of the pills in 2021 during COVID-19, allowing healthcare providers to ship the pills directly to patients by mail.

Doctors did not have standing to sue

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 the 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 argue that participating in the patient’s recovery, up to and including removing the unsuccessfully aborted fetus, is a violation of conscience protections.

Kavanaugh wrote in the final decision that the plaintiff doctors argued that they “must have standing because otherwise it may be that no one would have standing to challenge the FDA’s 2016 and 2021 actions.”

“That suggestion fails because the court has long rejected that kind of argument as a basis for standing,” Kavanaugh added. “Rather, some issues may be left to the political and democratic process.”

During oral arguments, justices seemed skeptical as to the breadth of the decision to eliminate or curtail substantially 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 of the argument 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.

Alliance Defending Freedom attorney Erin Hawley, 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.

Hawley said the high court’s decision came down to a “legal technicality” that was “occasioned by the federal government’s about-face.”

“The federal government told the Supreme Court that our pro-life doctors absolutely have federal conscience protections, even though it had said before to other federal courts that they did not. So that’s a huge win for the pro-life cause,” Hawley argued.

Justice Clarence Thomas, the court’s longest-serving Republican-appointed jurist, sided with Kavanaugh’s opinion but took a more skeptical look at the “associational-standing doctrine” that kept the court from finding that the plaintiffs could bring the case.

Associational standing is the legal principle that would allow an organization to sue on behalf of its members to address an injury to them, even if the organization itself is unharmed.

Thomas agreed that the doctrine meant the anti-abortion doctors lacked standing but said the court should revisit the principle in future cases.

“I am particularly doubtful of associational-standing doctrine because the court has never attempted to reconcile it with the traditional understanding of the judicial power,” Thomas wrote.

The justice added that the Supreme Court in recent times has “departed from that traditional understanding without explanation, seemingly by accident.” Thomas argued the court has only given practical reasons for its standing doctrine, suggesting that the justices should address this matter in an “appropriate case” down the line.

Not weighing the merits of the FDA’s decision

Anti-abortion advocates have been quick to highlight that the court did not rule upon the safety and efficacy of mifepristone. Rather, they weighed whether or not the doctors involved in the case had been harmed.

“The Court did not weigh in on the merits of the case, but the fact remains this is a high-risk drug that ends the life of an unborn child,” Sen. Bill Cassidy (R-LA), Health, Education, Labor, and Pensions Committee ranking member, posted on X. “I urge FDA to follow the law and reinstate important safeguards.”

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 abortion-rights think tank, the Guttmacher Institute, nearly two-thirds of all abortions in the United States use mifepristone.

Abigail Long, spokeswoman for the maker of mifepristone, Danco Laboratories, told reporters her company was pleased with the court’s decision “in this incredibly important case.”

“By rejecting the Fifth Circuit’s radical, unprecedented, and unsupportable interpretation of who has standing to sue, the justices reaffirmed long-standing basic principles of administrative law,” Long said. “In doing so, they maintained the stability of the FDA drug approval process, which is based on the agency’s expertise and on which patients, healthcare providers, and the U.S. pharmaceutical industry rely.”

“While we’re disappointed the court did not reach the merits of the FDA’s unlawful actions, nothing in today’s decision changes this fact: Women and girls are being harmed by the FDA’s recklessness,” an ADF spokesperson posted on X.

Connections to Dobbs decision

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 on abortion.

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Kavanaugh, who was part of the majority in the Dobbs decision, stressed at the time that the high court would no longer meddle in the 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,” he said.

But the case of mifepristone has always had less to do with abortion and more to do with the 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.