The Federal Food and Drug administration approves all prescription drugs in the United States based upon the drug’s safety and efficacy. Once approved for a particular indication, the manufacturer or distributor may only market that drug for the approved use. The promotion of any drug outside of the FDA approval (or label) constitutes “off label” marketing. If a government health care program pays for a drug’s off label use as a result of unlawful marketing, such payments will likely fall within the False Claims Act or qui tam statute.
Our attorneys have represented whistleblowers in successful off label cases, for example, United States v. Elan Corporation, PLC, et al. In this and the related case of United States v. Esai Inc., et al. the Irish manufacturer of the anti-seizure medication Zonegran paid a total of $214 million to settle whistleblower allegations that the company was marketing the drug for the off label indications of weight loss and mood stabilization.