A majority of the Supreme Court appeared skeptical Tuesday of arguments calling for a rollback of Food and Drug Administration authorizations made in 2016 and later for mifepristone, an abortion pill the regulator first approved in 2000. 

If the justices rule against the FDA and mifepristone maker Danco Laboratories, it could further restrict abortions in the United States, including in states where it is still legal. The high court's decision is expected by late June. Two years ago, the Supreme Court overturned the nationwide right to abortion two years ago. 

A group of doctors and other medical professionals argue the FDA did not consider safety concerns when it extended the time frame for taking mifepristone from seven weeks of pregnancy to 10 weeks, allowed medical professionals other than doctors to prescribe the drug and dispensed of a requirement for an in-person medical visit, opening the door for it to be mailed directly to patients.

The FDA and mifepristone maker Danco Laboratories insisted studies show mifepristone is safe and highly effective and that the agency did its homework before making the drug more accessible in recent years. They also argued a lawsuit overturning the agency’s approval would set a dangerous precedent that could threaten other drugs. In addition, the agency and pharmaceutical company said the plaintiffs lack the legal standing needed to sue because they have not been directly harmed.

Solicitor General Elizabeth Prelogar, arguing the case for the FDA, said the plaintiffs’ claims that completing an elective abortion violates their beliefs are invalid because the law already protects them against doing so. 

Erin Hawley, the lawyer representing the Alliance for Hippocratic Medicine, argued it was “impractical” for doctors to raise a conscience objection because they had no time when faced with life-threatening emergencies. Prelogar said the plaintiffs failed to cite an example of when the doctors tried to object, adding that if they had been denied, the FDA is not the proper target of a lawsuit because it does not enforce conscience protections.

Prelogar and Danco attorney Jessica Ellsworth argued that, even if the plaintiffs had an argument, rescinding FDA approvals would be a disproportionate response, an argument with which Justice Ketanji Brown Jackson seemed to agree.

“The obvious common sense remedy would be to provide them with an exemption that they don’t have to participate in this procedure,” Jackson said. “ … What they’re asking for in this lawsuit is more than that. They’re saying, because we object to having to be forced to participate in this procedure, we’re seeking an order preventing anyone from having access to these drugs at all.”

Some conservative-leaning justices, too, asked questions suggesting they have doubts about the plaintiffs’ case. 

Justice Neil Gorsuch said the court traditionally asks plaintiffs to “provide a remedy sufficient to address the plaintiffs asserted injuries and go no further,” adding, “We have before us a handful of individuals who have asserted a conscience objection,” he said.

“This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal government action,” he said. 

Gorsuch expressed reservations about the high court pursuing a “new remedial course.”

Justices John Roberts and Clarence Thomas, however, seemed unwilling to dismiss the case based on legal standing. Both asked Prelogar if the plaintiffs could not file such a lawsuit against the FDA, then who could?

Prelogar said, “It’s hard to identify anyone who would have standing to sue, but the court has said time and again that the fact that no one would have standing doesn’t provide a basis to depart” from the Constitution’s injury requirement.

“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,” Roberts said. “There’s no remedy. The American people have no remedy for that.”

But while Roberts asked if the FDA should be considered “infallible,” Jackson asked Ellsworth is if companies such as Danco would be comfortable with courts overruling FDA decisions on drug safety. 

“I think we have significant concerns about that,” said Ellsworth, who called the agency’s review process the “gold standard.”

Prelogar said the lower court’s ruling curtailing access to mifepristone was the first known instance of a court second-guessing the FDA’s approval of a drug.

Thomas also seemed interested in how the Comstock Act, which prevents the mailing of abortion drugs, applied to the case. Prelogar argued, “Comstock provisions don’t fall within FDA’s lane” because the agency is limited to weighing the safety and efficacy of drugs. Ellsworth, meanwhile, cautioned the court to “think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory responsibilities that Congress has assigned to other agencies.”

Hawley, however, said, “We don’t think that there’s any case of this court that empowers FDA to ignore other federal law.”

Last April, a Texas judge invalidated the FDA’s approval of mifepristone. An appeals court later narrowed U.S. District Judge Matthew Kacsmaryk’s ruling, instead only rolling back FDA authorizations from 2016 and later that made mifepristone more accessible. The Supreme Court has put that action on hold while it considers the appeal.

The overall authorization of mifepristone is not at issue.

Since Roe v. Wade was struck down in 2022, 14 states have passed near-total abortion bans, while five others have outlawed them after six weeks of pregnancy.

Yet, there were more than 1 million abortions performed last year in the U.S. health care system, a 12-year high, according to the abortion-rights policy think tank the Guttmacher Institute. Medication abortion accounted for 63% of all abortions last year, up 10 percentage points from 2020.

The combination of mifepristone and misoprostol is the most common medication abortion regimen in the U.S. Misoprostol alone can be used for medication abortions, although it is not as effective and can cause more pronounced side effects than the combination.

Mifepristone results in a completed abortion 97.4% of the time, according to studies cited by the FDA. Another study quoted in a brief by the American College of Obstetricians and Gynecologists in the case found mifepristone results in major side effects — significant infection, excessive blood loss or hospitalization — in less than 0.32% of patients.