The False Claims Act and the Policing of Promotion Claims About Drugs: A Call for Increased Transparency

Abstract

The intersection of the False Claims Act with the FDA rules restricting the promotion of off-label uses of approved drugs has generated a confusing blend of public and private enforcement, primarily through settlements that provide little hard law. Many question whether this multi-billion dollar enforcement regime achieves its public policy goals. This white paper comprehensively describes how a False Claims Act case evolves, especially with regard to the relationship between the U.S. Department of Justice and the multiple interested federal and state agencies. While the traditional off-label promotion case may be waning, the white paper predicts and analyzes the next frontier of off-label enforcement – the provision of pharmacoeconomics information to pharmacy benefit managers, payers, and provider organizations. The paper draws from a thorough review of the cases, literature and numerous interviews with players in all sectors of the enforcement space, and exhaustively canvasses the challenges for all parties in reaching appropriate policy solutions. It ultimately recommends transparency, both in what is (and is not) "promotion" and in enforcement. The latter recommendations address both government sharing of information with qui tam relators when it does not assume control of a case and disclosure of the government's rationale for the remedies it seeks in negotiating settlements.