Mifepristone, a common abortion inducing medication, will remain on the market without additional restrictions after the U.S. Supreme Court unanimously rejected an anti-abortion group’s challenge to the drug’s approval.
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 ruling is a rebuke to the 5th U.S. Circuit Court of Appeals and District Judge Matthew Kacsmaryk of Amarillo. The opinion was written by Justice Brett Kavanaugh, with a concurring opinion by Justice Clarence Thomas.
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.
The mifepristone challenge from Texas
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.
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 U.S. District Judge Matthew 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.”
Kacsmaryk gave the U.S. Department of Justice five days to appeal the ruling before it went into effect, which it did. The 5th Circuit ruled that the drug could remain on the market, but reinstated the restrictions that were in place before 2016. The Supreme Court stepped in at that point and ruled that nothing about mifepristone’s approval would change until the case was resolved.
In late March, the Supreme Court heard arguments about whether the drug’s status should remain unchanged — or whether it should revert back to the pre-2016 restrictions, when it could only be used up to seven weeks of pregnancy, and not prescribed via telehealth or sent through the mail. The hearing also focused on whether the anti-abortion doctors who brought the lawsuit had legal standing to file their lawsuit.
“Rolling back FDA's changes would unnecessarily restrict access to mifepristone with no safety justification,” U.S. Solicitor General Elizabeth Prelogar argued. “Some women could be forced to undergo more invasive surgical abortions. Others might not be able to access the drug at all. And all of this would happen at the request of plaintiffs who have no certain injury of their own. The Court should reject that profoundly inequitable result.”
The ruling
In his opinion on Thursday, Kavanaugh wrote that the plaintiffs can’t sue simply because they might “desire to make a drug less available for others.”
The ruling notes that the plaintiffs bringing the lawsuit do not, in fact, use or prescribe mifepristone and are not required by the FDA to do so — and therefore they are unaffected by its accessibility in the market.
“Federal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences—and therefore breaks any chain of causation between FDA’s relaxed regulation of mifepristone and any asserted conscience injuries to the doctors,” the ruling reads.
On a broader scale, doctors do not and should not have the power to change federal public health policy and allowing the lawsuit to succeed would set a dangerous precedent, the ruling reads.
“Allowing doctors or other healthcare providers to challenge general safety regulations as unlawfully lax would be an unprecedented and limitless approach and would allow doctors to sue in federal court to challenge almost any policy affecting public health,” it reads.
The ruling also leaves open the possibility that another plaintiff, including one who could show direct injury or a “sufficient likelihood of future injury” could successfully bring the case in the future.
“But in this case — even assuming for the sake of argument that FDA’s 2016 and 2021 changes to mifepristone’s conditions of use cause more pregnant women to require emergency abortions and that some women would likely seek treatment from these plaintiff doctors — the plaintiff doctors have not shown that they could be forced to participate in an abortion or provide abortion-related medical treatment over their conscience objections,” the ruling reads.
