A Case at a Crossroad: United States ex rel. Franklin v. Parke-Davis and the Intersection of Regulating Promotion of Off-Label Uses and Medicaid Fraud and Abuse

Abstract

In United States ex rel. Franklin v. Parke-Davis, a former employee of a pharmaceutical manufacturing company alleged violations of the federal False Claims Act stemming from the company’s promotion of an FDA-approved drug for an unapproved use. The suit presented a novel legal claim that brought together two otherwise distinct elements of food and drug law – the regulation of promotion of off-label uses of approved drugs and the prosecution of Medicare and Medicaid fraud and abuse via the federal False Claims Act. This paper examines individually each of these areas of food and drug law and then turns to the conjunction between the two created by the lawsuit. The paper concludes with a discussion of the potential policy ramifications of a decision in United States ex rel. Franklin v. Parke-Davis.