Influence of Pharmacy Benefit Practices on Off-Label Dispensing of Drugs in the United States

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Statutory limits on the US Food and Drug Administration (FDA) authority to control the clinical use of drugs after approval raise concerns about unapproved uses (known as “off-label uses”). However, where the FDA cannot check off-label uses, various components of the US health-care system can. Pharmacy benefit management is one of these components. We describe how pharmacy benefit management influences off-label use through coverage policies and clinical management practices.

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