On June 13, 2024, the Supreme Court of the United States unanimously rejected a challenge to the U.S. Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name “Mifeprix”), a drug used in medically induced abortions. In a 9-0 decision delivered by Justice Brett Kavanaugh, the Supreme Court held that the plaintiffs, a group of anti-abortion doctors and medical associations, lacked standing to challenge the FDA’s regulation of mifepristone because the plaintiffs do not prescribe or use the drug. While the decision resolves recent litigation against the FDA and maintains the current regulatory structure governing both for the prescription and use of mifepristone in place, it leaves the door open for possible future challenges.
For a summary of the FDA’s approval of mifepristone and this case’s history, please see our previous client alert here.
Looking Ahead and Practical Takeaways
The Supreme Court’s ruling means that mifepristone will continue to be widely accessible under the FDA’s 2023 Risk Evaluation and Mitigation Strategy (the “2023 REMS”). The 2023 REMS allows the administration of mifepristone through ten weeks’ gestation, does not require in-person dispensing or administration and allows for prescription by certain non-physicians. While current FDA regulations allow for greater flexibility in dispensing mifepristone, both prescribers and pharmacists should be aware of any applicable state laws affecting the permissibility of prescribing and dispensing the drug, for both abortion care and the common off-label use of miscarriage management, following the 2022 Supreme Court decision in Dobbs v. Jackson Women’s Health Organization.
Furthermore, because the decision was based on the plaintiffs’ lack of standing, the Supreme Court did not address the merits of the challenge, namely whether the FDA appropriately expanded access to mifepristone in 2023. Therefore, the case now returns to the lower courts and the dispute over access to the drug is most likely not over. As a result, health care providers and pharmacies should continue to closely monitor ongoing developments, including future legal challenges.
Hall Render will continue to track litigation and regulatory activity related to mifepristone as well as the related state law issues. If you have questions regarding mifepristone or need assistance in reviewing and updating practices related to mifepristone use, please contact:
- Jennifer Skeels at (317) 977-1497 or jskeels@hallrender.com;
- Todd Nova at (414) 721-0464 or tnova@hallrender.com;
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Caitlin Bell-Butterfield at (919) 228-2408 or cbell-butterfield@hallrender.com; or
- Your primary Hall Render contact.
Special thanks to Anna Lantz, Summer Associate, for her assistance in drafting this article.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
