Danco Laboratories, LLC v. Louisiana et al. / GenBioPro, Inc. v. Louisiana et al.

Issue: Whether the Food and Drug Administration’s (FDA) 2023 action revising the Risk Evaluation and Mitigation Strategy for mifepristone, including allowing prescribing via telehealth, violates the Administrative Procedure Act?  

Background: In October 2025, the state of Louisiana sued the FDA, arguing the 2023 revision of the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone violates the Administrative Procedure Act because it is arbitrary and capricious, an abuse of discretion, and contrary to law. The 2023 revision removed a requirement that mifepristone be dispensed in person in a medical facility, a requirement that has not been in effect since 2020.  

In May 2026, the Fifth Circuit issued a stay effectively reimposing a requirement that health care providers prescribe mifepristone only after having examined patients in person, not via telehealth. Manufacturers of mifepristone, Danco Laboratories and Gen Bio Pro, submitted applications to the Supreme Court for an emergency administrative stay.  

Current Status: Fifth Circuit decision is stayed as the litigation proceeds

Health Scholars Amicus Brief**

** This brief was led by the Center for Health Law and Policy Innovation at Harvard Law School  

Amici: 175 professors, health organizations, and health care providers.

Argument Summary: This brief explains the extensive benefits of telehealth and encourages the Court to consider the negative effects that a ruling imposing medically unnecessary restrictions on the ability to access a particular kind of care via telehealth may have on telehealth services broadly. Imposing further barriers to telehealth would hamper patients’ ability to obtain necessary health care services, reduce access to care, and worsen health outcomes for Americans of every age and across the country.

Outside Counsel: Morrison & Foerster LLP, Center for Health Law and Policy Innovation at Harvard Law School

Funding Acknowledgement: Support for this program is provided by the Commonwealth Fund and the Robert Wood Johnson Foundation. The views presented here are those of the authors and not necessarily those of the Commonwealth Fund, its directors, officers, or staff, or the Robert Wood Johnson Foundation.