But a Supreme Court ruling along those lines, which could come as soon as Thursday and must land by the end of the court term in late June or early July, is unlikely to end the legal fight over access to the drug that is used in more than six in 10 of all U.S. abortions.
That’s because the justices could leave an opening for three states – Missouri, Kansas and Idaho, each of which has a Republican attorney general – to try to quickly revive the challenge to abortion pills, which have moved to the forefront of the battle over reproductive rights in the two years since the high court’s conservative majority overturned Roe v. Wade.
The anticipated push by the states to take over where the antiabortion doctors left off would open a new round of litigation, keeping the controversial issue before the courts for another year or more and creating fresh uncertainty about access to the drug in a presidential election year where abortion is a central topic. Democrats are eager to draw attention to conservative attacks on mifepristone and other matters relative to reproductive health, hoping the subject will galvanize abortion-rights voters in November.
With medication abortions now accounting for at least 63 percent of pregnancy terminations nationwide — and thousands of pills flowing freely through the mail into states that ban the procedure — mifepristone has become a major target for antiabortion advocates.
The lawsuit challenging the drug was filed by the Alliance for Hippocratic Medicine before federal Judge Matthew Kacsmaryk, who is the only District Court judge in his Amarillo, Tex., courthouse and is well-known for his antiabortion views.
Kacsmaryk’s 2023 ruling would have removed the drug from the market, but an appeals court scaled back the decision, opting instead to roll back FDA changes since 2016 that made the medication easier to access. The Biden administration and the manufacturer of mifepristone then appealed that ruling to the Supreme Court.
The justices denied a request by Missouri, Kansas and Idaho to intervene in the lawsuit. But Kacsmaryk had already separately allowed them to join the litigation as plaintiffs in District Court. That means that if the Supreme Court sends the case back to Texas, saying the anti-abortion doctors don’t have standing to sue, the states could quickly try to revive the litigation.
Greer Donley, a University of Pittsburgh law professor who closely tracks litigation involving the pills, said abortion rights advocates should prepare for what could be a “2.0 of this case,” with Kacsmaryk able to use the upcoming Supreme Court opinions and dissents to help him craft a decision that would be more persuasive to the high court.
During oral argument in late March, a majority of justices from across the ideological spectrum seemed doubtful the antiabortion doctors, who do not prescribe mifepristone, had suffered the type of direct harm that would give them legal grounds to bring the lawsuit.
Justice Neil M. Gorsuch, a nominee of President Donald Trump, and Justice Ketanji Brown Jackson, a nominee of President Biden, emphasized that the Supreme Court often says its rulings should address the specific alleged harm and go no further.
The toughest questions for the Biden administration came from Justice Samuel A. Alito Jr., who wrote the decision overturning Roe. He expressed strong support for the idea that somebody should be able to sue the FDA — if not the group of anti-abortion doctors, then some other plaintiff.
“Maybe what they did was perfectly lawful,” Alito said of the FDA’s actions. “But shouldn’t somebody be able to challenge that in court? Who in your view? Who would have standing to bring that suit?”
When Prelogar said it was hard to identify anyone, Alito followed up: “So your argument is that it doesn’t matter if FDA flagrantly violated the law, it didn’t do what it should have done, endangered the health of women, it’s just too bad, nobody can sue in court?”
The FDA 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.
Medication abortions may also be done using misoprostol alone, though that regimen typically causes more cramping and bleeding.
Alito and Justice Clarence Thomas seemed open during oral argument to the idea that, when deciding how to regulate mifepristone, the FDA should have considered the Comstock Act, long-dormant legislation from the 1800s that prohibits the mailing of “any drug, medicine, article or thing designed, adapted, or intended for producing abortion.” Kacsmaryk included that concept in his decision last April that would have taken mifepristone off the market.
Abortion rights groups say a decision to begin enforcing the Comstock Act could immediately stop the mailing of abortion pills nationwide, even in states where abortion is legal, and could affect surgical abortions as well.
Abortion opponents initially sued the FDA over mifepristone in 2022, saying the agency had unlawfully approved the drug and then loosened regulations without properly assessing safety data and potential risks for patients. The lawsuit focused in part on the FDA decision in 2016 to allow the drug to be used up to 10 weeks into pregnancy, instead of seven; allow health-care providers other than doctors to prescribe mifepristone; and reduce from three to one the number of in-person visits required before getting the medication. In 2021, the FDA allowed the drug to be sent directly to patients by mail without an in-person medical consultation.
Antiabortion advocates say they will not be deterred if the Supreme Court dismisses the case after finding that the doctors involved did not suffer sufficient harm. They say they are confident that other plaintiffs could be more successful.
“I would hope and anticipate that we do go back for round two,” said Kristi Hamrick, vice president of media and policy at Students for Life, one of the largest national antiabortion groups.
The states have already made the case in court filings that they should be allowed to pursue a challenge in part because of what they describe as added public insurance costs for emergency medical care and mental health support because of complications from abortion pills. Missouri and Idaho officials say they have a separate interest in enforcing the state’s strict bans on abortion, which they say are undermined by the dispensing of abortion pills through the mail sent from states where the procedure is legal.
Missouri Attorney General Andrew Bailey said his state, joined by Idaho and Kansas, has an “interest in protecting the health and wellbeing of their citizens—including the women and girls who have suffered (and will suffer) from complications from the FDA’s unlawful approval of chemical abortion drugs.”
The Biden administration and drug manufacturer Danco say the states’ claims are just as speculative as those of the antiabortion doctors because only a small percentage of women experience complications that require emergency care. In addition, they say the states could not proceed on their own with this lawsuit unless they have a more direct tie to the courts in Texas, and would have to transfer or refile in another venue for the challenge to once again move forward.
With the states as plaintiffs, Kacsmaryk would again have the power to issue a nationwide injunction that reimposes restrictions on mifepristone, Donley said — though she suspects he would tread carefully, not eager to have his decision overturned by the U.S. Court of Appeals for the 5th Circuit.
Whatever happens in court, a new presidential administration could have the final say on mifepristone restrictions.
If Trump, the presumptive Republican nominee, were to appoint an antiabortion advocate to lead the FDA, Donley said, the agency could unilaterally decide to start the process of reimposing old restrictions that require an in-person consultation to obtain the drug, or that narrow the approved window for using the pills.
Such a move would be highly unusual for the regulatory agency. But anti-abortion activists have focused on that option as something they might push for with Trump in the White House.
“They don’t need the court’s permission to do a lot of this stuff,” Donley said.