Off-label Prescribing Among Office-Based Physicians

Abstract

The Food and Drug Administration (FDA) focuses on market entry for prescription drugs rather than regulating physicians' prescribing practices, allowing off-label use of medications for indications beyond those formally evaluated by the manufacturer. Off-label prescribing of medications is legal,¹ often thought to be supported by scientific evidence,² and common in certain clinical settings.^3,4 Although this practice provides a pathway to innovation in clinical practice, it raises key concerns about risks to patients and costs to the health care system.^5-7