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

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    • Subject Terms:
      DRUG laws; HEALTH insurance reimbursement laws; FEDERAL government of the United States; WORLD Health Organization; DRUG approval; GOVERNMENT regulation; PUBLIC health; ANTINEOPLASTIC agents; FRAUD; UNITED States. Food & Drug Administration; DRUGS; DESCRIPTIVE statistics; DRUG development; POLICY sciences; LEGISLATION; LAW
    • Subject Terms:
      UNITED States
    • Abstract:
      Context: The False Claims Act is the US federal government's primary tool for identifying and penalizing 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: The authors searched the Department of Justice website for press releases published between 2006 and 2022 that announced fraud actions brought against drug companies. They then used the World Health Organization's Anatomical Therapeutic Classification index to identify the classes of prescription drugs implicated in fraud actions. Findings: During fiscal years 2006–2022, payments by six manufacturers amounted to more than 28% of total payments made as a result of federal False Claims Act actions. Nervous system and cardiovascular drugs were the classes of medications most commonly 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 for preventing and deterring fraud could help safeguard our health systems and promote public health, and policy makers should ensure that effective fraud enforcement complements preventive public health regulation. [ABSTRACT FROM AUTHOR]
    • Abstract:
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