Nexus Pharms. v. Central Admixture Pharmacy Servs.

“Proceedings to enforce or restrain violations of the Federal Food, Drug, and Cosmetic Act (FDCA), including the compounding [pharmacy] statute, must be by and in the name of the United States, not a private party.” 21 U.S.C. § 337.

Defendant operates “outsourcing facilities,” compounding pharmacies exempted from the FDA’s new-drug approval process required to modify existing drugs into alternate forms. 21 U.S.C. § 353b. Plaintiff/Appellant alleges that Defendant/Appellee meets the “essentially a copy” exclusion, making the exception inapplicable. Id. § 353b(a)(5). Appellant alleges to be the only FDA approved manufacturer of the drug Emerphed, Appellee subsequently is in violation of state law requiring compliance with FDA regulations by manufacturing “essentially a copy” of Emerphed, injuring Appellant. The lower court dismissed the case for failure to state a claim, noting the FDA’s exclusive enforcement of the Federal Food, Drug, and Cosmetic Act (“FDCA”). On appeal, the panel affirmed, finding Appellant's claims impliedly preempted, necessarily requiring litigation of whether the drugs are “essentially a copy,” which the FDA has not itself concluded. See PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 922 (9th Cir. 2010); U.S. Const. art. VI, cl. 2. Unlike traditional state-based claims, such as state tort law, allowing Appellant to pursue a claim based on violations of the FDCA would upset the “delicate balance of statutory objectives” Congress set in providing for exclusive enforcement of the FDCA by the FDA. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). Affirmed.