Government Regulation of Off-Label Drug Prescriptions: Balancing Healthcare Innovation with Public Safety and Fiscal Responsibility

Abstract

This paper examines the government’s role in regulating off-label drug prescriptions, both as a patient safety advocate and as a health insurer. Part One describes why off-label drug prescriptions occur, including an analysis of the risks and benefits of this practice. Part Two examines how FDA drug marketing regulations, Medicare and Medicaid reimbursement rules, and healthcare fraud and abuse laws have shaped the current landscape of off-label prescription policies. Finally, Part Three proposes regulatory reforms that could help the government to better achieve its goal of encouraging drug treatment innovation, while still protecting the public from the medical and fiscal harms of inappropriate and excessive off-label drug prescriptions.