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Comment & Response
June 2016

In Defense of Off-label Prescribing

Author Affiliations
  • 1Independent Internist, Lomita, California
JAMA Intern Med. 2016;176(6):861. doi:10.1001/jamainternmed.2016.1403

To the Editor The study by Eguale and colleagues1 demonstrates that off-label use of prescription drugs is associated with increased ADEs (adverse drug events) only when such use lacks strong scientific evidence. Specifically, off-label uses of drugs with strong scientific evidence had the same risk of ADEs as on-label use. This finding implies that the extreme expense and delay caused by the process of US Food and Drug Administration (FDA) approval of an already-approved drug for a new indication may not be necessary if strong scientific evidence supports such use. The take-home message of this study is not that we need to crack down on off-label prescribing but that we need to crack down on unscientific prescribing.2 Electronic health records should be programmed to discourage unscientific prescribing, not off-label prescribing. Because off-label prescriptions backed by strong evidence are just as safe as prescriptions for FDA-approved indications, the FDA ban on promotion of the former denies patients the benefits of safe and scientifically proven medications. The focus should shift to suppression of off-label prescribing only when it is not backed by strong evidence.