The U.S. Supreme Court unanimously ruled against a challenge to restrict access to the abortion pill mifepristone, stating that the plaintiffs, anti-abortion doctors, lacked standing to sue.
This decision preserves the current accessibility of mifepristone, a common abortion inducing medication, allowing it to remain on the market without additional restrictions.
In a unanimous ruling, the court sided with the Biden administration and the manufacturer of mifepristone, and reversed a lower court decision that would have made it more difficult to obtain the drug used in more than 60 percent of U.S. abortions. The ruling was not on the substance of the case, but on a procedural ruling that the plaintiffs did not have standing to bring the case.
In the high court’s first abortion-related ruling since it overturned Roe v. Wade in 2022, the nine justices ruled to change nothing about the drug’s legal status.
The justices were reviewing a decision from the conservative U.S. Court of Appeals for the 5th Circuit that said that the Food and Drug Administration failed to follow proper procedures or thoroughly explain its reasoning when it loosened regulations for obtaining mifepristone in 2016 and 2021.
The opinion, written by Justice Brett Kavanaugh, with a concurring opinion by Justice Clarence Thomas, is a rebuke to the 5th U.S. Circuit Court of Appeals and District Judge Matthew Kacsmaryk of Amarillo.
Medication abortion, typically performed with a combination of mifepristone and misoprostol, is the most common abortion method in the United States. In the nearly 25 years since it was first approved by the U.S. Food and Drug Administration, mifepristone has been conclusively shown to be safe and effective.
This case originated in Amarillo, where only one anti-abortion judge hears almost all cases, and then went to the conservative 5th Circuit in New Orleans, which upheld most of the ruling. The Supreme Court stepped in at that point and allowed mifepristone to remain on the market while the case proceeded.
With abortion all but banned in more than a dozen states, these medications have become a key part of the strategy to help people continue to access the procedure — and, as a result, a major focus for anti-abortion groups.
This ruling comes as a relief to abortion providers and advocates, but also pharmaceutical companies, who had expressed concern about the precedent of allowing a judge to overturn a long-standing drug approval.
Mifepristone was first approved in 2000 to be used alongside misoprostol to terminate a pregnancy up to seven weeks. The medication is also commonly used to pass fetal tissue after a miscarriage.
Almost immediately, anti-abortion groups began challenging the drug’s approval, starting with a citizen petition in 2002. The FDA did not respond to the petition until 2016, rejecting it the same day it announced new guidelines allowing the medication to be used through 10 weeks of pregnancy.
A group of antiabortion doctors sued the FDA, saying the agency did not sufficiently consider safety concerns when it removed restrictions starting in 2016 that allowed the use of mifepristone later in pregnancy; permitted medical providers other than doctors to prescribe it; and cleared the way for the medication to be sent directly to patients by mail.
The FDA, considered one of the world’s most stringent regulators, first approved the medication in 2000. The agency has repeatedly found the medication-abortion protocol that includes mifepristone and a second drug, misoprostol, to be a safe and effective alternative to surgical abortions.
Leading studies have shown that the changes in regulations that are the focus of the lawsuit do not affect the safety or efficacy of the medication.
In 2019, the FDA approved a generic version of mifepristone, and later began allowing the drug to be prescribed through telehealth, dispensed at retail pharmacies and sent through the mail.
In November 2022, the Alliance for Hippocratic Medicine, an anti-abortion medical group, filed a lawsuit arguing that the original 2000 drug approval was improper and should be reversed, alongside all the recent changes.
The group filed the lawsuit in Amarillo, where all cases are heard by Kacsmaryk, a former religious liberty lawyer who previously litigated against abortion and contraception access before he was appointed to the bench by President Donald Trump.
In a ruling laced with anti-abortion rhetoric, Kacsmaryk ruled that the FDA’s approval of mifepristone was improper and should be revoked.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”