Preemption of Non-Federal Restraints on Off-Label Product Communications.

Abstract

Evolving First Amendment principles are forcing FDA and other federal regulators of medical products to rethink traditional regulatory approaches to off-label product communications. State regulators, which have actively sought injunctions restricting manufacturer communications to the four-corners of the FDA-approved product label, must additionally abide by federal preemption principles. This article reviews the application of preemption principles to off-label communications and concludes that most, if not all, state-law restraints on off-label communications are preempted by federal law. This finding has important implications for state enforcement initiatives, and puts into question the validity of some elements of existing state-law injunctions.