The Ban on Off-Label Advertising and the Theory of Free Expression Martin H. Redish Louis and Harriet Ancel Professor of Law and Public Policy Northwestern Pritzker School of Law

The FDA’s Ban on Off-Label Advertising

The Trichotomy of Free Speech Theory 1. The Speaker-Centric Model 2. The Listener-Centric Model 3. The Regulatory-Centric Model

The Underlying Postulates of Free Expression : 1. Government may not attempt to manipulate lawful citizen behavior by means of the selective suppression of truthful expression advocating lawful activity. 2.The Self-motivated nature of expression does not automatically render it false or misleading. 3.Government has greater power to regulate conduct than it has to regulate expression. 4.Government may not hold fully protected expression hostage as a means of extortion.

Applying the Underlying Postulates of Free Expression to the Off-Label Advertising Ban

Justifications for the FDA’s Ban: 1. The ban as a regulation of non-expressive conduct 2. The ban as a means of enforcing the FDA’s regulatory structure 3. The ban as consumer protection