Following a week-long delay on a federal appeals court decision that halted mail orders of the abortion drug mifepristone, the Supreme Court is poised to make further decisions in the case by the end of Monday. The court’s actions could significantly influence the regulatory power of the Food and Drug Administration, as well as affect abortion providers and patients.
“The fundamental question is: Who gets to regulate mifepristone?” said Laurie Sobel, an associate director for women’s health policy at KFF. “Can a state go further than the FDA? Is the FDA the floor or the ceiling?”
While states have clear legal rights to regulate abortion, the FDA oversees drug regulation. In 2023, the FDA lifted the requirement for in-person dispensing of mifepristone. After the Dobbs decision, state abortion restrictions increased, yet the total number of abortions in the U.S. slightly increased, mainly due to the accessibility of mifepristone and misoprostol through mail and pharmacies after telehealth consultations.
The Supreme Court might issue a swift shadow docket decision on the emergency requests from two mifepristone manufacturers or remand the case to the 5th Circuit, with the possibility of it returning to the Supreme Court on an official appeal. According to Sobel, the pause permitting mail orders might extend beyond the initial Monday 5 p.m. deadline.
Former FDA leaders, the main lobbying group for the pharmaceutical industry, and more than two dozen food and drug law scholars have filed amicus briefs advocating that the FDA should retain its drug regulation authority.
A group of nine former FDA commissioners, including Janet Woodcock and Robert Califf, who were involved in past mifepristone changes, argued that the FDA’s decision to eliminate the in-person dispensing requirement was “extremely cautious” and aligned with “sound science.” They warned that overturning this decision, as the 5th Circuit did, would undermine the FDA’s science-based drug approval system and encourage challenges to such decisions.
The pharmaceutical industry has previously engaged in abortion-related legal disputes. In 2024, the Supreme Court found that the Alliance for Hippocratic Medicine, an anti-abortion coalition, lacked standing to contest the FDA’s drug dispensing decisions. During that case, pharmaceutical companies, manufacturers, investors, and researchers submitted amicus briefs supporting the FDA. Among these was a brief from over 200 pharmaceutical companies, executives, and investors, including Biogen, Pfizer, and Gilead. More time was available for responses in that case.
In the current case, Louisiana contends that the FDA’s removal of the in-person prescription requirement for mifepristone breaches the Administrative Procedure Act, arguing the agency didn’t base its decision on scientific evidence as required. The state also claims the decision violates the 1873 Comstock Act, which forbids mailing abortion materials, and can be interpreted differently by different administrations and courts.
Louisiana asserts its standing, unlike anti-abortion groups, due to the impact of mailed mifepristone on its abortion ban and the state’s financial responsibility for any medical complications arising from drug use.
The Supreme Court could again decide Louisiana lacks standing. If it doesn’t, the court’s consideration of the case’s merits remains uncertain, as justices didn’t address the potential merits in the 2024 case. Any ruling on the Administrative Procedure Act allegations would most significantly affect the FDA.
The 5th Circuit reinstated the in-person requirement partly because the FDA stopped mandatory adverse event reporting for the drug. However, former commissioners noted in their brief that voluntary reporting is standard for nearly all of the 20,000 FDA-approved drugs.
“The orderly system that Congress and the FDA have established would screech to a halt if litigants could weaponize the limitations of [FDA Adverse Event Reporting System] data to support successful challenges to drug approvals,” they wrote.
The industry lobbying group, PhRMA, argued in a separate document that Louisiana unlawfully seeks to impose its view of a drug’s safety profile on the nation without engaging with the FDA’s process. PhRMA warned that upholding the 5th Circuit’s decision could deter companies from introducing new drugs.
“Drug sponsors and the FDA would have to continuously look over their shoulders to determine whether someone is going to try to seek an injunction to undo science- and evidence-based determinations,” the group stated, adding that Louisiana’s safety claims reflect a misunderstanding of the adverse-event reporting system.
Legal scholars, with less financial interest in drug regulation than the lobbying group, concurred, stating the 5th Circuit’s decision “rests on critical misunderstandings of federal food and drug law, the regulatory history of mifepristone, and the evidence relied on by FDA.”
If the Supreme Court sides with the 5th Circuit, enforcing the ruling would be challenging, Sobel said. The FDA oversees drug manufacturers, which certify providers dispensing the drug. “[The FDA] would be relying on their power over the manufacturers, to say, ‘hey, we need to comply with this court order,'” she explained.
A new Risk Evaluation and Mitigation Strategy (REMS) would need to be developed to reinstate more stringent safety measures. With mifepristone distributed under the 2023 policy, a delay would be necessary before new rules could be fully implemented. Even if in-person restrictions are reinstated, providers could still offer abortion medication virtually and by mail with a misoprostol-only regimen. (Misoprostol was initially approved for gastric ulcers but can safely and effectively be used for abortions.)
If the Supreme Court aims to more directly address abortion and potential loopholes, it might rule based on the Comstock Act, Sobel suggested. This would limit the decision’s impact to abortion medication, with Congress able to amend the law to reverse the repercussions.
As various stakeholders submitted responses to the Supreme Court, the federal government’s perspective was notably absent. The FDA and the Trump administration have not defended their stance on mifepristone regulation.
Other mifepristone-related cases in the courts have been paused, pending the FDA’s safety review of mifepristone. This review, expected in the fall, could allow the agency to affirm its authority and defend its practices regarding the drug.
However, experts do not anticipate the review will support the FDA’s prior decisions, as federal health leaders described the review as “informed by the lack of adequate consideration underlying the prior REMS approvals.”
