The Supreme Court hears arguments Tuesday in a challenge that could limit access to a widely used drug for medication abortions, reshape health care policy and upend the Food and Drug Administration’s regulation process.
The justices will focus on a decision from the U.S. Court of Appeals for the 5th Circuit that found the FDA erred when it expanded how and when the abortion drug mifepristone can be dispensed.
The drug is used in more than half of U.S. abortions, and the decision would impact access to the drug nationwide, even in states that do not restrict abortion rights.
“This Supreme Court decision will impact people in all 50 states and will impact the provision of medication abortion care in all 50 states,” said Ushma Upadhyay, professor at Advancing New Standards in Reproductive Health at University of California San Francisco.
Although the case may turn on the minutiae of administrative law and FDA drug approvals, access to mifepristone represents the new frontier in the abortion debate since the landmark 2022 decision in Dobbs v. Jackson Women’s Health Organization that overturned the constitutional right to an abortion.
The Dobbs decision set off a chain of new state laws, referendums and regulations to restrict or expand access to abortion, along with legal fights across the nation.
Conservative legal group Alliance Defending Freedom represents anti-abortion medical groups and four physicians that filed a lawsuit to challenge the FDA’s 2000 approval and subsequent regulation of mifepristone as unsafe.
The Supreme Court declined to review the original 2000 approval of the drug, but focused the case on FDA decisions in 2016, 2021 and 2023 that allowed non-doctors to prescribe the medication, reduced the dose, reduced in-person visitation rules, reporting requirements and allowed the drug to be sent through the mail.
The Biden administration and Danco Laboratories, the maker of Mifeprex, the name brand drug of mifepristone, appealed the 5th Circuit decision, and the Supreme Court is expected to rule before the conclusion of the term at the end of June.
That means the decision will land in the middle of the election season, as protecting and increasing abortion access has emerged as the key campaign issue for Democrats. President Joe Biden used his first campaign rally of 2024 to build voter enthusiasm and boost turnout on abortion rights, which the campaign sees as a golden ticket to reelection.
For conservatives, the case represents the next step in the abortion fight, even while Republicans largely have shied away from directly campaigning on the issue.
“We’ve got an election coming up, you know, and everybody’s worried about what the polls say. They need to worry about what their conscience says,” Rep. Tim Burchett, R-Tenn, said Thursday during a Thursday conference put on by ADF. “This White House should be ashamed.”
Women’s health
The Alliance for Hippocratic Medicine and individual doctors challenging the FDA decisions argued the agency decisions “jeopardize women’s health throughout the nation,” in their court papers.
The FDA argued the 5th Circuit decision endangered abortion access nationwide and upset long-established procedures for drug approvals. “The loss of access to mifepristone would be damaging for women and healthcare providers around the Nation,” the government brief said.
Lurking in the background of the case has been the Comstock Act, a more than 100-year-old statute that criminalizes sending contraceptives, abortifacients and other “obscene” material through the mail. The challengers argued that the 2021 and 2023 decisions by the FDA violated that law by allowing the drug to be distributed through the mail.
Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas ruled in favor of the challengers on that front.
The Biden administration has argued the law does not cover legal distribution of mifepristone through the mail, pointing out in a brief that courts have held that the law “should be interpreted to bar only items intended for unlawful use.”
Possible implications
The Supreme Court’s handling of the case could have ripple effects through healthcare policy and the FDA’s drug approval process, experts said.
Ashley Jeanlus, an OB-GYN and assistant professor at the University of California San Francisco, said if the court rules to revert approval of the drug through seven weeks of pregnancy instead of 10 weeks, it would result in increased logistical hurdles for providers.
“It would have a huge impact on the actual infrastructure within our clinical care to try to take care of all the individuals that we would easily have been able to care of if we had medication abortion as an option for them as well,” Jeanlus said.
Lawmakers have highlighted the risks in the case, with more than 260 Democrats in Congress signing onto a brief asking the justices to overturn the lower court. They argued the Dobbs decisions and other lower court decisions have jeopardized access to abortion care nationwide.
“The resulting delays and denials of care have already had baleful effects on the health of pregnant individuals, for some of whom pregnancy is a life-threatening condition, regardless of their desire to carry their fetus to term,” the lawmaker brief said.
Adam Unikowsky, a partner at Jenner & Block who has argued before the Supreme Court, said that existing mifepristone stock “would be immediately deemed misbranded” with any ruling against the FDA.
“The orders that permitted the current branding regime would be deemed to be illegal and that would cause significant problems and [the drug would] have to be withdrawn from the market,” Unikowsky said.
For the FDA, the prospect of the court reneging its authority to approve and regulate drugs would be unprecedented.
Marsha Henderson, a former associate commissioner for women’s health at the FDA, told reporters during a March 14 briefing that she was “very comfortable” with the current regulations of mifepristone.
“We know that science has evolved, and the recommendations related to the product have evolved with that new information,” Henderson, who worked for the FDA for more than 20 years, said.
“The scientific evidence is now vulnerable to those kinds of misleading statements,” Henderson said. “And so it would not surprise me that the courts would be flooded with various suits that would come if this one is successful.”
The Biden administration said the lower courts in the case set new standards for how drug approvals would be handled that went far beyond what Congress meant.
The law set up an agency to make its best judgment, “not require agencies to act based on perfect data, which seldom exists. Instead, it requires them to act reasonably based on the information available,” the administration argued in court papers.
Jeremy Levin, CEO and chairman of Ovid Therapeutics, said a ruling against the FDA would immediately lead to companies increasing costs of their legal review to determine the effects of the decision.
“But internationally, I think we’d fall into the laughingstock of the world,” Levin, who signed onto an amicus brief filed in the case, said. “The industry will be thrown into complete disarray. Finding new medicines will be nearly impossible to do.”
Another issue
One major portion of the case has been the fight over “standing,” or whether the anti-abortion medical groups and four physicians had a legal right to bring the case in the first place.
The Biden administration and Danco Laboratories have argued the doctors and group do not have standing because they have not actually been harmed by the FDA approvals, such as having to treat patients who took the drug. However, jettisoning the case on those grounds will not get rid of the issue for the court.
Thomas Jipping, a senior legal fellow at the Heritage Foundation, pointed out that several anti-abortion states have contemplated filing lawsuits challenging the FDA’s decision-making. He told reporters during a Heritage foundation event Thursday that lawsuits would mirror those from Democrat-led states in 2023 that defended mifepristone.
“If the abortion states had standing last year, the pro-life states would have standing this year,” to continue the fight in the courts, Jipping said.
Unikowsky said that if the Supreme Court finds the groups and doctors do not have standing, lawsuits from states could move forward and be back at the high court in a couple of years.
“A ruling that there’s no standing would not end the litigation forever,” Unikowsky said. “Someone else could certainly give it a shot.”
The justice scheduled oral arguments next month in another abortion case, a dispute between Idaho and the Biden administration over the application of the state’s six-week abortion ban to emergency room care in the state.
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