"Off-label prescribing is lawful, common and vital to the practice of medicine. Many beneficial uses for approved drugs are not discovered until after the initial FDA approval and the federal government has acknowledged that off-label usage may be the standard of care. Nevertheless, in the last several years the Department of Justice has pursued a large number of criminal investigations and civil False Claims Act cases based on allegations of illegal off-label promotion, and some of these matters have resulted in settlements in the hundreds of millions of dollars. The cases involving off-label dissemination raise a number of serious legal, regulatory and policy issues."

Objective1:Summarize recent government enforcement and related civil actions in the off-label arena.

Objective2:Discuss the legal theories supporting government prosecutions and civil claims in off-label cases, and identify when off-label dissemination is likely to trigger government scrutiny.

Objective3:Highlight the important patient health and public policy considerations implicated by criminal and civil off-label cases.