The Continued Erosion of FDA’s Authority to Regulate Off-Label Marketing and Implications for False Claims Act Cases

The courts continue to erode the FDA’s authority to regulate off-label marketing of pharmaceutical products and medical devices. In United States v. Caronia, the Second Circuit issued a seminal decision recognizing that the First Amendment places significant limits on the FDA’s authority to regulate truthful and non-misleading statements by pharmaceutical manufacturers regarding potential uses of their products that are not covered in the FDA-approved labeling.¹703 F.3d 149, 2d Cir.

As the court recognized, manufacturers have a constitutional right to provide such information, which cannot be restricted by regulators with threats of criminal and civil penalties based on ...