Off‐Label Prescribing as Therapeutic Governance: Regulation and Inequality in Contemporary Medicine

ABSTRACT Off‐label prescribing is a recurrent feature of contemporary therapeutic practice, especially in fields such as pediatrics, oncology, and rare diseases, where authorized options may be limited, delayed, or poorly adapted to clinical need. Biomedical research has examined its prevalence, risks, and potential benefits, but its broader sociological implications have received less sustained attention. This paper develops a sociological analysis of off‐label prescribing through a narrative review of biomedical, regulatory, ethical, and sociological literature. It reconstructs the regulatory role of the Summary of Product Characteristics (SmPC), reviews the empirical literature on the uses and consequences of off‐label prescribing, and situates the phenomenon within broader debates on medicalization, biomedicalization, and pharmaceuticalization. The article conceptualizes off‐label prescribing as a socially organized mode of therapeutic governance that takes shape where regulatory classifications, evidentiary production, market incentives, reimbursement arrangements, and clinical need remain only partially aligned. From this perspective, off‐label prescribing redistributes epistemic authority, practical responsibility, and unequal access across clinicians, regulators, pharmaceutical firms, patients, and reimbursement institutions. The analysis highlights the ambivalence of off‐label prescribing as a practice that can expand therapeutic possibilities while also producing uneven evidentiary support, variable monitoring, limited transparency, and differentiated exposure to risk. Off‐label prescribing thus provides a revealing site for analyzing how evidence, regulation, markets, and care are coordinated in contemporary health systems, and how their partial misalignment shapes therapeutic legitimacy in practice.