Hope Medical Enterprises, Inc., dba Hope Pharmaceuticals v. Fagron Compounding Services, LLC, et al.

Before Congress enacted the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., the States had the exclusive power to regulate drug sales within their borders. Wyeth v. Levine, 555 U.S. 555, 566 (2009). After the FDCA’s enactment, States continued to exercise their historical power to regulate drug safety by passing statutes that prohibit the in-state sale of drugs that have not been approved under the FDCA by the federal Food and Drug Administration. Until recently, all courts had agreed that the FDCA does not preempt such state statutes. E.g., Allergan, Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350, 1354–56 (Fed. Cir. 2013). The Ninth Circuit created a circuit split in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022), where it held that the FDCA preempts state drug-approval statutes even when there is no difference in the requirements of state and federal law. In the decision below, the Ninth Circuit followed Nexus to hold that the FDCA preempts the enforcement of state drugapproval statutes against an unapproved drug that is also undisputedly illegal under the FDCA. The question presented is: Whether the FDCA preempts state laws prohibiting the in-state sale of unapproved drugs whose sale is also prohibited as a matter of federal law by the FDCA.