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  • Balancing on the Edge: The Implications and Acceptability of Off-Label Drug Use

    Off-label drug use presents a unique paradox: it can both aid and harm the patient. Typically, the Food and Drug Administration (“FDA”) has an arduous process for pharmaceutical companies to go through to have a drug approved. The purpose of this is to certify the safety and efficacy of the drug. However, the use of off-label drugs, those that are not used for the approved indications by the FDA on the label, is prevalent. Estimates have shown that off-label drug use varies extensively from 21% to over 50% for specific medications or drug classifications. The study further noted that some uses were a “logical extension” while others were “therapy for indications distinctly different from those for which the drug was approved.” Off-label drug use thus falls in the gray area between constituting human experimentation and a widely accepted practice by physicians.