Background

In April 2023, Judge Matthew Kacsmaryk issued a ruling invalidating FDA's approval of mifepristone, arguing the agency didn't adequately review scientific evidence or follow the proper protocols when it approved the drug in 2000.

In response to Kacsmaryk's ruling, more than 200 pharmaceutical companies signed a statement calling for the reversal of the decision. More than 400 leaders from some of the most prominent companies in the drug and biotech industry criticized Kacsmaryk for issuing the ruling, noting that he has "no scientific training" and warning that the decision has "undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American."

In addition, "[t]he decision ignores decades of scientific evidence and legal precedent," the drugmakers wrote. "Judge Kacsmaryk's act of judicial interference has set a precedent for diminishing FDA's authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry," they wrote.

Later that month, SCOTUS ruled that mifepristone could remain on the market with no new restrictions while the case against FDA's approval of the drug played out.

SCOTUS hears oral arguments

During Tuesday's oral arguments, Solicitor General Elizabeth Prelogar, arguing on behalf of the federal government, said the plaintiffs in the case did not "come within 100 miles of the kinds of circumstances this court has previously identified" as grounds for standing in the case.

Prelogar noted that the doctors who brought the case forward don't prescribe abortion pills and aren't forced to treat women who take those pills. She added that since serious complications from abortion pills are very rare, doctors would not often encounter a woman who had experienced a serious complication that would require them to provide treatment.

Erin Hawley, the lawyer for the plaintiffs, said the doctors had treated abortion pill patients in EDs and cited written declarations from doctors Christina Francis and Ingrid Skop.

However, some of the justices questioned the plaintiffs on their standing in the case. Justice Amy Coney Barrett asked whether the doctors had provided examples of "actually participating in the abortion to end the life of the embryo or fetus," adding that she didn't "read either Skop or Francis to say that they ever participated in that."

In addition, Justice Elena Kagan asked Hawley to point to an individual who could show they were harmed by FDA's rules for mifepristone.

"You need a person to be able to come in and meet the court's regular standing requirements," she said. "Who is your person?"

However, Justice Samuel Alito said the argument advanced by the Biden administration suggests that even if FDA had violated the law, no one has standing to sue them.

"Shouldn't somebody be able to challenge that in court? Who? Who would have standing to bring that suit?" Alito said. "There's no remedy, the American people have no remedy for that," he added, saying that FDA wants to be "infallible."

Other justices had issues with the idea that the case could affect the availability of mifepristone nationwide. Justice Ketanji Brown Jackson said there is a "significant mismatch" between the injury claimed by the doctors and the remedy sought of a nationwide order blocking FDA's actions on mifepristone.

"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," Jackson said.

Gorsuch said the 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 government action."

Separately, Justice Brett Kavanaugh asked whether federal law protects doctors who object to providing an abortion on moral or religious grounds.

"Just to confirm on the standing issue: under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?" Kavanaugh asked Prelogar.

"Yes, we think that federal conscience protections provide broad coverage here," Prelogar said. "We think that those amendments guard against the kind of injury that respondents are asserting."

Several of the justices also asked detailed questions about medical procedures and practices relating to reproductive care and mifepristone.

Barrett asked about a dilation and curettage (D&C) — the procedure in which tissue is removed from the uterus — noting that it didn't necessarily mean a doctor was removing a living embryo, since D&C can occur following a miscarriage. Barrett also inquired about the need for tissue to be removed if an abortion wasn't complete after a medication.

Barrett also asked whether the elimination of the requirement for in-person visits to receive mifepristone, which was eliminated by FDA in 2023, would "lead to mistakes in gestational aging which could increase the need for a D&C or the amount of bleeding."

During the arguments, Alito also brought up the Comstock Act, a 19th century statute that outlaws the use of mail to send "lewd" materials, as well as drugs used for abortions. Alito argued the law was not "obscure" but rather "prominent."

Prelogar argued it isn't FDA's job to enforce criminal law but noted the agency did receive advance at the time from the Justice Department about its interpretation of the Comstock Act. "I think the Comstock provisions don't fall within FDA's lane," she said.

How is SCOTUS likely to rule?

Some legal experts said the line of questioning from the justices suggested there's a strong chance the case could be dismissed.

"Even the conservative justices seemed skeptical of the standing claims and the merits of the case were not really the focus," said Greer Donley, a professor of law at the University of Pittsburgh School of Law. "If enough justices thought there was standing then there would be more focus on the merits," she added.

However, Elizabeth Sepper, a professor at the University of Texas Law School, noted legal experts have been wrong in the past, including around abortion cases, like Texas's 2021 abortion ban, which many experts expected to be challenged under judicial review.

Leah Litman, a law professor at the University of Michigan, said that the repeated mentioning of the Comstock Act during oral arguments is notable.

"When you hear the justices asking repeated questions, it's definitely something that they are interested in," she said, adding that she expected Justices Alito or Clarence Thomas to write an opinion focused on the Comstock Act.

Litman criticized the justices for suggesting the Comstock Act applies today, saying it's "outlandish" to believe the 19th-century law "all of a sudden allows the federal government to start throwing providers and distributors of medication abortion into jail."

"That has never been how the law has been understood by the Department of Justice or by the courts," Litman added. "It's always been narrowly interpreted."

Advisory Board's Gabriela Marmolejos also said the mention of the Comstock Act by Justices Alito and Thomas "is concerning as it suggests a future case could threaten access to medication abortion delivered by mail nationwide."

What the case could mean for industry stakeholders

Advisory Board's Amanda Okaka said that if the court chooses to recognize a conscience injury to regulate medicine, the ruling would set "a dangerous precedent for courts to undermine the FDA's authority and interfere with the dissemination of reproductive care."

"It opens the door for any healthcare provider to challenge FDA actions, potentially leading to the contested approval of various drugs and reducing investment in beneficial but controversial medications — further destabilizing an already rocky pharmaceutical industry," Okaka said.

Advisory Board's Ellie Wiles noted that mifepristone isn't just used for abortion but also used to manage miscarriages.

"This hearing creates ethical and legal uncertainties for healthcare providers regarding their ability to provide comprehensive reproductive care to patients," Wiles said. "And although abortion services are the most contested at the moment, the grounds of hearing have implications for patient and physician autonomy in all types of medical care." (Cole et al., CNN, 3/26; Quinn, CBS News, 3/26; Belluck, New York Times, 3/26; Diamond, Washington Post, 3/26; Owermohle, STAT, 3/26)

Pharmacy is at the center of much of reproductive-related care. Medication abortions account for more than half of abortions, and these medications are becoming even more sought after in the wake of the Dobbs v. Jackson ruling. This expert insight outlines three of the most pressing implications for pharmacy in a post-Roe world, focusing on the immediate considerations for pharmacy leaders through the next presidential election.