State of Louisiana et al. v. Food and Drug Administration et al.

Why This Matters:

In 2023, the FDA revised the Risk Evaluation and Mitigation Strategy for mifepristone to, among other changes, remove a requirement that the medication be dispensed in-person in a medical facility. This revision allowed prescribers to send, and their patients to receive, the medication by mail. Plaintiffs challenge the FDA’s revision as arbitrary and capricious, an abuse of discretion, and contrary to law in violation of the Administrative Procedure Act. Reinstating the in-person dispensing requirement, which has not been in effect since 2020, would create a serious barrier for women seeking reproductive care.

Potential Impact:

Unnecessary restrictions on safe and effective drugs can create obstacles for doctors to promote medically appropriate care and jeopardize the health and safety of patients.