The Neurontin Controversy: The Saga of Off-Label Drug Regulation Continues

Abstract

The regulation off-label drugs is a complicated and controversial area of the law. Regulators must protect patients’ safety without interfering with physicians’ practice of medicine or manufacturers’ First Amendment rights. The recent Neurontin decisions, which apply the doctrine of false claims to prescription drug regulation, only adds additional complexity. This paper explores the federal government’s attempts to regulate the promotion of off-label drugs. It discussed the advantages and disadvantages of off-label marketing, the current regulatory environment, and the implications of the Neurontin lawsuit.