The Lanham Act and the FD&C Act: Shaping the Law of False Advertising into a Tool for Drug Manufacturers to Self-Regulate Their Industry and Protect Consumers

Abstract

While Section 43(a) of the Lanham Act has the potential to become an extremely useful tool to ensure competitive fairness and consumer safety in the pharmaceutical industry, recent cases show that numerous obstacles prevent Lanham Act plaintiffs from prevailing in their lawsuits. In this Paper, I will examine how the procedural requirements of false advertising law and substantive FDA doctrines combine to hinder drug manufacturer-plaintiffs’ chances for success in Lanham Act claims. I will advocate greater clarification of the evidentiary standards and standing requirements for Lanham Act claims and suggest reforms for FDA’s regulations regarding manufacturers of generic drugs and foreign manufacturers whose drugs are not approved for use in the United States. I will describe the elements necessary for a successful claim under the Lanham Act using the recent case of Zeneca, Inc. v. Eli Lilly & Co., 1999 U.S. Dist. LEXIS 10852 (S.D.N.Y. July 19, 1999) as an example. Finally, I will explore alternatives to private litigation for false advertising cases, including trademark infringement litigation, lawsuits initiated by FDA and the Federal Trade Commission (“FTCâ€), and suits by state attorneys general.