Federal Enforcement of Pharmaceutical Fraud under the False Claims Act, 2006–2022

Abstract Context: The False Claims Act is the federal government's primary tool to identify and penalize pharmaceutical fraud. The Department of Justice uses the False Claims Act to bring civil cases against drug manufacturers that allegedly obtain improper payment from federal programs. Methods: We searched the Department of Justice website for press releases published between 2006 and 2022 that announced fraud actions brought against drug companies. We identified the classes of prescription drugs implicated in fraud actions using the World Health Organization's Anatomical Therapeutic Classification index. Findings: Between fiscal years 2006 and 2022, payments by six manufacturers amounted to over 28% of total payments made as a result of Department of Justice fraud actions. Nervous system and cardiovascular drugs were the most common classes of medications implicated in alleged fraud. Federal officials most frequently alleged that companies improperly promoted nervous system drugs and paid kickbacks to increase revenues from cardiovascular, antineoplastic and immunomodulating, and alimentary tract and metabolism drugs. Conclusions: Despite frequent pharmaceutical fraud settlements and penalties, incidence of alleged fraud among drug companies remains high. Alternative methods of preventing and deterring fraud could help safeguard our health systems and promote public health, and policymakers should ensure that effective fraud enforcement complements preventive public health regulation.