Former FDA leaders, pharma speak out on mifepristone

Politics Former FDA leaders, pharma speak out on mifepristone The Supreme Court’s decision on the abortion pill could impact U.S. drug regulation writ large Manage alerts for this article Email this article Share this article By Theresa GaffneyMay 8, 2026 Morning Rounds Writer and Reporter Theresa Gaffney[email protected]Theresa Gaffney is the lead Morning Rounds writer and reports on health care, new research, and public policy, with a particular interest in mental health, gender-affirming care, and LGBTQ+ patient communities. You can reach Theresa on Signal at theresagaff.97. After issuing a week-long pause on a federal appeals court decision to stop mail orders of the abortion medication mifepristone, the Supreme Court is expected to take further steps in the case by the end of the day Monday. How the court moves forward could have a major impact on the regulatory authority of the Food and Drug Administration as well as on 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?”Advertisement Each state has clear legal authority to regulate abortion — but the FDA regulates drugs, and in 2023 it officially removed the requirement for in-person dispensing of mifepristone. As state abortion restrictions multiplied after the Dobbs decision, the total number of abortions in the U.S. slightly increased, largely due to the availability of mifepristone and misoprostol (a two-drug regimen) through the mail and directly at pharmacies after telehealth appointments. The Supreme Court could issue a quick shadow docket decision on the emergency requests, which were made by two mifepristone manufacturers, or send the case back to the 5th Circuit with the understanding that it will eventually return to the Supreme Court on an official appeal. Either way, the pause allowing mail orders to continue could be extended past the initial deadline of Monday at 5 p.m., Sobel said. Former FDA leaders, the pharmaceutical industry’s main lobbying group, and more than two dozen food and drug law scholars have submitted amicus briefs arguing that the FDA should maintain the authority to regulate drugs. Advertisement A coalition of nine former FDA commissioners — including Janet Woodcock and Robert Califf, who each led the agency when some mifepristone changes were made — argued that the FDA was “extremely cautious” in its decision to remove the in-person dispensing requirement, and that the move was “consistent with sound science.” Ruling against the decision as the 5th Circuit did “would upend FDA’s gold-standard, science-based drug approval system, and creates a roadmap for attacks on science-based drug regulatory decisions,” the group wrote. It’s not the first time that the industry has gotten involved in an abortion-related legal dispute. In 2024, the Supreme Court ruled that the Alliance for Hippocratic Medicine, a coalition of anti-abortion groups, did not have standing to challenge the FDA’s decisions on how the drug is dispensed. As the court contemplated that case, pharmaceutical companies, manufacturers, investors, and researchers submitted amicus 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, interested parties had more time — about a month — to put together responses.) In the case currently in front of the Supreme Court, Louisiana argues that the FDA’s decision to end the in-person prescription requirement for mifepristone violates the Administrative Procedure Act, meaning that the agency didn’t base the decision on the scientific evidence as it is required to. The state also claims that the decision violates an 1873 law called the Comstock Act that prohibits the mailing of abortion materials, and can be interpreted differently by presidential administrations and federal courts. Louisiana claims that, unlike the anti-abortion groups, it has the right to bring the case because mifepristone mailed into the state undermines its ban on virtually all abortions, and because the state bears the cost of complications if people need to go to the hospital after taking the drugs. Advertisement The Supreme Court may rule again that the state does not have standing. But if not, it’s unclear how the court may consider the merits of the case, as the justices declined to comment on the potential merits of the 2024 case. Any agreement on the allegations regarding the Administrative Procedure Act would have the biggest impact on the FDA. Part of the 5th Circuit’s rationale for reinstating the in-person requirement was the fact that the FDA eliminated mandatory reporting of adverse events associated with the drug. But as the former commissioners argue in their amicus brief, voluntary reporting is the standard for nearly all of the 20,000 drugs currently approved by the agency. “The orderly system that Congress and 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’s lobbying group, the Pharmaceutical Research and Manufacturers of America (PhRMA), adds in a separate document that Louisiana is unlawfully attempting “to impose its own view of a drug’s safety profile on the entire nation” without first engaging with the FDA’s established process. Letting the 5th Circuit’s decision stand could also reduce the incentives for companies to introduce new drugs, PhRMA argued. “Drug sponsors and 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 asserted, adding that Louisiana’s claims regarding safety “are based on a fundamental misunderstanding of the adverse-event reporting system that Congress created and FDA now administers.” Scholars, with less of a financial stake in drug regulation than the lobbying group, agreed, saying 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.”Advertisement If the Supreme Court does side with the 5th Circuit, it would be difficult to actually enforce the ruling, Sobel said. The FDA oversees the drug manufacturers, which in turn certify providers who dispense 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 said. A new Risk Evaluation and Mitigation Strategy (REMS) would need to be created reinstating more restrictive safety measures. And since there’s currently mifepristone out in the world labelled with the 2023 policy, there would need to be a delay before new rules could be fully enforced. Once in-person restrictions on mifepristone were restored, providers could still offer abortion medication virtually and through the mail with a misoprostol-only regimen. (Misoprostol was originally approved for gastric ulcers but can be used safely and effectively for abortions.) If the Supreme Court wants to more directly target abortion and these potential loopholes, it could rule based on the Comstock Act, Sobel said. That would limit the impact of the decision to abortion medication, and the repercussions could be undone if Congress amended the law. As pro- and anti-abortion voices submitted responses to the Supreme Court, one perspective was missing: the federal government’s. The FDA and the Trump administration have not defended themselves regarding the regulation of mifepristone. Other mifepristone cases making their way through the courts have been paused pending the results of the FDA’s safety review on mifepristone. The review, expected in the fall, could be a chance for the agency to assert its authority and defend its practices regarding the drug. But experts don’t expect the review to support the FDA’s previous decisions, given that federal health leaders announced the review as “informed by the lack of adequate consideration underlying the prior REMS approvals.” abortion, Congress, FDA, legal, Pharmaceuticals, reproductive health, states, Supreme Court Submit a correction requestReprints Theresa Gaffney Morning Rounds Writer and Reporter Theresa Gaffney is the lead Morning Rounds writer and reports on health care, new research, and public policy, with a particular interest in mental health, gender-affirming care, and LGBTQ+ patient communities. You can reach Theresa on Signal at theresagaff.97. Newsletter Understand how science, health policy, and medicine shape the world every day Recommended STATus Report May 8, 2026 Why we left the FDA: Six former officials share their stories Exclusive May 7, 2026 Official leading CDC’s cruise ship program retires Advertisement D.C. 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