The Supreme Court is expected to take further action in the case by the end of Monday, after ordering a one-week stay on a federal appeals court’s decision blocking the mail-order sale of the abortion drug mifepristone. How the court proceeds could have major implications for Food and Drug Administration regulators, as well as abortion providers and patients.
“The fundamental question is: Who can regulate mifepristone?” said Laurie Sobel, associate director of women’s health policy at KFF. “Can states act beyond the FDA? Is the FDA the floor or the ceiling?”
While states have clear legal authority to regulate abortion, the FDA regulates the drug and officially removed the in-person dispensing requirement for mifepristone in 2023. After the Dobbs decision, the total number of abortions in the United States increased slightly as states tightened abortion regulations, primarily because mifepristone and misoprostol (a two-drug combination therapy) became available by mail and in person at pharmacies after a telemedicine appointment.
The Supreme Court could issue a quick shadow docket decision on the emergency requests from the two manufacturers of mifepristone, or send the case back to the Fifth Circuit with the knowledge that it would eventually return to the Supreme Court on formal appeal. In any event, the moratorium allowing mail-order sales to continue could be extended beyond the original Monday deadline of 5 p.m., Sobel said.
Former FDA leaders, major drug industry lobbying groups, and more than 20 food and drug legal scholars filed a court brief arguing that the FDA should retain its authority to regulate drugs.
Mifepristone court ruling makes drug development riskier for everyone
A coalition of nine former FDA commissioners, including Janet Woodcock and Robert Khalif, who led the FDA when the mifepristone changes were made, argued that the FDA was “very prudent” in its decision to eliminate the in-person dispensing requirement and that the move was “consistent with sound science.” Ruling against this decision, as the Fifth Circuit did, “would undermine the FDA’s gold standard science-based drug approval system and create a roadmap for attacks on science-based drug regulatory decisions,” the groups wrote.
This is not the first time the industry has been embroiled in abortion-related legal disputes. In 2024, the Supreme Court ruled that the Hippocratic Medical Alliance, a coalition of anti-abortion groups, had no standing to challenge FDA decisions about how drugs are compounded. As the court considered the case, drug companies, manufacturers, investors, and researchers filed court briefs in support of the FDA. One such brief came from more than 200 pharmaceutical companies, executives, and investors, including Biogen, Pfizer, and Gilead. (In that case, stakeholders needed more time to compile a response (about a month).)
In a lawsuit currently before the Supreme Court, the state of Louisiana argues that the FDA’s decision to eliminate the in-person prescribing requirement for mifepristone violates the Administrative Procedure Act, meaning the agency is not basing its decisions on scientific evidence as required. The state also argues that the decision violates an 1873 law known as the Comstock Act that prohibits the mailing of abortion materials, which can be interpreted differently by presidential administrations and federal courts.
Louisiana argues that the state has the right to sue, unlike anti-abortion groups, because mifepristone mailed to the state undermines the ban on virtually all abortions and the state pays for any complications if a trip to the hospital is required after taking the drug.
The Supreme Court could again rule that states are not eligible. But otherwise, it is unclear how the court will consider the merits of the 2024 case, as the justices have declined to comment on its potential merits. An agreement on the Administrative Procedure Act complaint would have the biggest impact on the FDA.
One of the grounds on which the Fifth Circuit reinstated the in-person requirement was the fact that the FDA had eliminated the requirement to report adverse events associated with the drug. But as former commissioners argue in court briefs, voluntary reporting is now the standard for nearly all of the 20,000 drugs currently approved by the agency.
“If litigants were able to weaponize the limitations of[FDA Adverse Event Reporting System]data to support successful challenges to drug approvals, the orderly system established by Congress and the FDA would come to a screeching halt,” they wrote.
In a separate document, the Pharmaceutical Research and Manufacturers Association of America (PhRMA), an industry lobbying group, added that Louisiana is illegally attempting to “impose its own views on a drug’s safety profile nationwide” without first engaging with the FDA’s established processes. PhRMA argued that leaving the Fifth Circuit’s decision in place could reduce incentives for companies to introduce new drugs.
“Drug sponsors and the FDA must constantly look over their shoulders to determine whether someone is seeking an injunction to reverse science and evidence-based decisions,” the group argues, adding that Louisiana’s claims about safety “are based on a fundamental misunderstanding of the adverse event reporting system created by Congress and currently administered by FDA.”
Academics with less financial stake in drug regulation than lobbying groups agreed, saying the Fifth Circuit’s decision was “based on a serious misinterpretation of the federal Food and Drug Act, mifepristone’s regulatory history, and the evidence relied upon by FDA.”
If the Supreme Court sided with the 5th Circuit, it would be difficult to actually enforce the ruling, Sobel said. The FDA oversees drug manufacturers, and drug manufacturers certify providers who dispense drugs. “[The FDA]will rely on its power over manufacturers to say, ‘Hey, we need to comply with this court order,'” she says.
Celebrating the 25th Anniversary of Mifepristone, a Hero of Modern Abortion Access in the United States
A new risk assessment and mitigation strategy (REMS) should be created that reinstates more restrictive safety measures. And with mifepristone now being distributed around the world labeled as Policy 2023, there will likely be a delay before the new rules are fully implemented. When in-person restrictions on mifepristone were reinstated, health care providers were able to offer misoprostol-only prescription abortion pills virtually and by mail. (Misoprostol was originally approved for stomach ulcers, but it can also be used safely and effectively for abortion.)
If the Supreme Court wants to target abortion and these potential loopholes more directly, it could base its decision on the Comstock Act, Sobel said. That would limit the impact of the decision on abortion pills, which could be reversed if Congress changed the law.
As pro-abortion and anti-abortion voices submitted their responses to the Supreme Court, the federal government’s perspective was missing. The FDA and the Trump administration have not defended themselves regarding the regulation of mifepristone.
Other mifepristone cases proceeding in court have been suspended pending the outcome of the FDA’s safety review of mifepristone. The review, scheduled for autumn, could be an opportunity for authorities to assert their authority and defend their practices regarding the drug.
However, experts do not expect the review to confirm the FDA’s previous decision, given that federal health leaders announced the review citing a “lack of due consideration underlying the prior REMS approval.”
