Supreme Court upholds broad access to key abortion pill mifepristone (2024)

Writing for the court, Justice Brett M. Kavanaugh said the antiabortion doctors behind the case do not prescribe or use mifepristone, and the FDA’s relaxed regulation of the medication does not require those doctors to do or refrain from doing anything.

“Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain,” Kavanaugh wrote. Under the Constitution, he added, a group’s “desire to make a drug less available for others does not establish standing to sue.”

Kavanaugh emphasized in his opinion that doctors opposed to abortion are protected by federal conscience laws from having to perform abortion-related care that violates their beliefs, and that they can instead voice objections to the medication through the legislative, regulatory or political processes.

Ever since the high court eliminated the nationwide right to abortion in 2022, medications to terminate pregnancy have grown in importance and become a major target of litigation, in part because the pills can be sent by mail, including to states that have severely limited or banned abortions.

Even though the court’s decision was unanimous, it is unlikely to be the end of efforts to restrict access to the pill. The ruling leaves an opening for three states with Republican attorneys general — Missouri, Kansas and Idaho — to quickly try to revive the challenge before a federal judge in Texas who is well-known for his antiabortion views.

After the ruling, abortion opponents pledged to continue their efforts to limit access to mifepristone, promising that this case is not over.

“While we’re disappointed with the court’s decision, we will continue to advocate for women and work to restore common-sense safeguards for abortion drugs,” said the Alliance Defending Freedom’s senior counsel, Erin Hawley, who represented the doctors. “We are grateful that three states stand ready to hold the FDA accountable for jeopardizing the health and safety of women and girls across this country.”

President Biden said in a statement Thursday that the court’s decision “does not change the fact that the fight for reproductive freedom continues. … It does not change the fact that the right for a woman to get the treatment she needs is imperiled if not impossible in many states.”

Nancy Northup, president of the Center for Reproductive Rights, said she felt “both relief and anger” about the court’s decision.

“In the end, this ruling is not a ‘win’ for abortion,” she said in a statement. “It just maintains the status quo, which is a dire public health crisis in which 14 states have criminalized abortion.”

The issue of who has standing to sue over FDA decisions could also resurface if former president Donald Trump, the presumptive Republican nominee in the November election, returns to the White House and appoints an FDA commissioner who reinstates restrictions on the medication — sparking legal challenges from abortion rights groups.

While this decision is a “resounding victory” for reproductive rights advocates, the opinion “sidesteps the core issue of how involved in the FDA decision-making process the courts will be,” said Ameet Sarpatwari, an attorney and assistant professor of medicine at Harvard Medical School.

Before the end of the month, the justices are also set to decide in a separate abortion case from Idaho whether hospitals that receive federal funds must provide emergency abortion care to stabilize patients even in states with strict bans on the procedure.

The high court’s decision on Thursday reversed a ruling 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.

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 advance of oral argument in March, hundreds of pharmaceutical companies and former FDA officials warned the justices not to second-guess scientific experts, and said a ruling against the FDA would destabilize the regulatory system and jeopardize investments in research and innovation.

The justices did not decide Thursday whether the FDA acted lawfully when it made it easier to obtain mifepristone starting in 2016. Instead, the court issued a procedural ruling, finding that the antiabortion doctors could not challenge FDA approval of a drug just because the use of some medication may require additional visits to a health-care provider.

“Virtually all drugs come with complications, risks, and side effects. Some drugs increase the risk of heart attack, some may cause cancer, some may cause birth defects, and some heighten the possibility of stroke,” Kavanaugh wrote. “Approval of a new drug may therefore yield more visits to doctors to treat complications or side effects.”

Individual physicians and the Alliance for Hippocratic Medicine filed the initial lawsuit in Amarillo, Tex., where the only sitting District Court judge is Matthew Kacsmaryk, a Trump nominee known for his opposition to abortion.

Kacsmaryk’s 2023 ruling would have removed the medication from the market completely, but the 5th Circuit scaled back the decision. It was the first time a judge suspended longtime approval of a medication despite opposition from the FDA and the drug’s manufacturer. Kacsmaryk will now be in position to decide whether the three states are permitted to pursue a separate challenge to the drug without the doctors leading the lawsuit.

When the Supreme Court agreed to review the case, the justices said they would not consider taking mifepristone off the market but would look at the rule changes in 2016 and 2021.

In its opinion Thursday, the court acknowledged the strongly-held objections of the antiabortion doctors but said those beliefs were not sufficient to meet the standard for bringing a case in court because the doctors had not suffered a direct injury.

“We recognize that many citizens, including the plaintiff doctors here, have sincere concerns about and objections to others using mifepristone and obtaining abortions. But citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities,” wrote Kavanaugh, who was one of five justices in the majority in 2022 who voted to eliminate the nationwide right to abortion after nearly 50 years.

The justices said they would not invent a new rule of “doctor standing.” Allowing doctors or other health-care providers to challenge general safety regulations as unlawfully lax would be “an unprecedented and limitless approach” that would open the door to lawsuits from doctors over numerous policies affecting public health, the court said.

In making their case, the antiabortion doctors said the FDA’s loosening of regulations would cause more pregnant women to suffer complications from mifepristone, and that the doctors would therefore be required — against their consciences — to provide emergency abortion or related treatment.

But the court echoed assurances in its opinion from the Biden administration that federal conscience laws protect doctors from being required to perform abortions or to provide other treatment that violates their consciences. The justices said the doctors had not identified any examples in which they were required to perform an abortion or of a hospital failing to accommodate a doctor’s objections.

The court’s opinion quotes Solicitor General Elizabeth B. Prelogar’s comments at oral argument, including her statement that the protections provide “broad coverage” and “shield a doctor who doesn’t want to provide care in violation of those protections.”

Elizabeth Sepper, a law professor at the University of Texas at Austin, said the Biden administration seemed to embrace a broad reading of those protections as a way to ensure support from as many justices as possible on a court with a 6-3 conservative majority.

When the Supreme Court initially put a lower court decision in the case on hold last April and maintained access to mifepristone while the litigation continued, Justices Clarence Thomas and Samuel A. Alito Jr. dissented. Alito said at the time that the public would not be harmed by reimposing restrictions on the pill. But on Thursday, all nine justices signed on to Kavanaugh’s opinion.

Sepper said the unanimous decision was overbroad in interpreting federal laws that protect doctors from being required to perform certain procedures. Conscience laws have previously been defined as applying to abortions and sterilizations, she said, not as a “general carve-out for anyone who objects to any kind of treatment.”

She said she worries the ruling could embolden providers or institutions to refuse treatments such as vaccines, care for women who have previously had abortions or LGBTQ+ communities. Sepper also said the Supreme Court’s expansive interpretation of the law could spur religiously affiliated hospitals to claim conscience objections to providing abortions in emergency rooms.

“I still think the mid- to long-term effects could be quite devastating for emergency abortion care, particularly in blue states,” Sepper said.

Justin Jouvenal and Caroline Kitchener contributed to this report.