Bloomberg Law
December 14, 2023, 10:05 AM UTC

Abortion Pill Access Threatened as Justices Take Narrow Appeal

Ian Lopez
Ian Lopez
Senior Reporter
Kimberly Strawbridge Robinson
Kimberly Strawbridge Robinson
Senior Reporter

The US Supreme Court’s decision to review only part of the appeal over the abortion drug mifepristone is a partial win for abortion advocates, as the justices declined to consider a challenge to the decades-old approval of the drug.

But legal experts note that even upholding lower court restrictions on the drug’s access could prove perilous for people seeking reproductive services and the medical professionals tasked with providing them.

The justices on Wednesday agreed to hear appeals from the Food and Drug Administration and Danco Laboratories, the maker of the name brand version of the abortion drug mifepristone, regarding changes the agency made to how the drug is administered. At the same time, the justices refused to review an appeal brought by a group of anti-abortion doctors who challenged original approval.

That outcome “prevents the worst catastrophe,” said Greer Donley, a University of Pittsburgh law professor.

“To the extent you can say the worst outcome is off the table, it’s a victory of sorts,” Donley said. But if the Supreme Court were to agree with the decision out of the U.S. Court of Appeals for the Firth Circuit that was being appealed, “that would still be catastrophic.”

The Supreme Court’s decision to consider only the more narrow challenges means mifepristone won’t be taken off the shelves wholesale, regardless of what the Supreme Court ultimately decides.

The court’s decision could still make it harder for patients to access the drug. Should the justices side with the Fifth Circuit, mail-order prescriptions of mifepristone could be off the table, a crucial outcome in light of the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization—which undid the right to an abortion guaranteed by Roe v. Wade—and the state bans that followed.

For people seeking abortion services, “telehealth has really served as a lifeline since the Dobbs decision,” said Sabrina Talukder, director of the Women’s Initiative at the Center for American Progress.

“Now, we are facing the reality that the same court that overturned the constitutional right to abortion is now deciding the next step in abortion access for women in America,” Talukder said.

FDA Approvals, Modifications

The FDA originally approved mifepristone, along with another drug, for early-term abortions in 2000. Since then, medication abortion has come to account for more than half of the abortions nationwide, according to The Guttmacher Institute, a reproductive rights research and policy organization.

That’s in part due to changes the FDA has since made to the way the drug is prescribed and dispensed.

In 2016 and 2021, for example, the agency lifted certain measures to expand access to the drug, including the requirement that mifepristone be dispensed in-person and extending the time in which the drug can be used for abortions. And in 2019, the FDA approved a generic version.

The Alliance for Hippocratic Medicine, the anti-abortion group which brought the current suit in 2022, challenged those various FDA actions in federal court after the agency rejected their claims that the drugs were unsafe.

A federal trial court in Texas initially sided with the doctors, saying the original approval and the subsequent actions were unlawful.

The US Court of Appeals for the Fifth Circuit, based in New Orleans, pulled back on that ruling, finding that the challenge to the 2000 approval was brought too late. It also upheld the FDA’s approval of the generic version.

But the conservative Fifth Circuit agreed with the challengers that the FDA’s 2016 and 2021 changes regarding mifepristone’s availability were likely unlawful.

The US Supreme Court earlier this year stepped in to put things on hold and keep mifeprisone available until the case worked its way through the judicial system. The justices then said it will review the Fifth Circuit’s decision regarding the 2016 and 2021 changes, but declined to upset the lower court’s ruling regarding the 2000 approval.

“By not granting the cross-petition, the Court is leaving intact that part of the Fifth Circuit’s decision that reversed the district court, including the district court’s invalidation of the original 2000 approval of mifepristone,” said University of Texas at Austin law professor Stephen Vladeck.

However, Rachel Rebouché, dean of Temple University’s Beasley School of Law, said that the Supreme Court’s call on which appeals to take “doesn’t tell us anything about what they’re going to do about what the Fifth Circuit held to be arbitrary and capricious actions in 2016 and 2021.”

“There are a number of changes that took effect in 2016 that are the standard of care for medication abortion,” Rebouche said.

If those 2016 and 2021 actions are struck down, access would be threatened in part because it would limit the ability to secure mifepristone without visiting a doctor in person.

‘Threat’ to Court Functioning

Vladeck said the decision not to review the entire Fifth Circuit ruling—along with the court’s unexplained stay from earlier this year—signals that the justices are likely to ultimately side with the Biden administration and Danco on the other issues, particularly on the technical issue of standing.

They argue that the doctors haven’t shown that they are actually harmed by the FDA’s actions because they don’t prescribe abortion medication. The doctors’ objections must therefore be put to the executive and legislative branches—not the judiciary, the federal government said in its brief.

“The standing issue is a threat to the proper functioning of courts,” said Sara Rosenbaum, health law professor at George Washington University.

And that problem, she said, “goes way beyond the context of this specific case,” noting that in recent years, “activist courts” have taken up cases that should never have made it there.

“This may be an opportunity for the Supreme Court to start setting some ground rules,” Rosenbaum said.

Yet Heritage Foundation legal fellow Thomas Jipping said that “the issue here is whether the FDA followed the right decisionmaking process in coming to its conclusions.”

“The case is not about the decision they made, it’s about how they made the decision,” Jipping said.

Still, Donley noted that cutting down the Fifth Circuit restrictions is critical for abortion services.

“The whole abortion ecosystem at this point, in a post-Dobbs world, where half the states in the country are absorbing all of the country’s patients, is extremely dependent on telehealth,” Donley said.

To contact the reporters on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com; Kimberly Strawbridge Robinson in Washington at krobinson@bloomberglaw.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bloombergindustry.com; Seth Stern at sstern@bloomberglaw.com

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