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Invited Commentary
January 2016

Off-label Drug Use and Adverse Drug Events: Turning up the Heat on Off-label Prescribing

Author Affiliations
  • 1Pharmacy Benefits Management Services, US Department of Veterans Affairs, Hines, Illinois
  • 2Division of General Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 3Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania
  • 4Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania
JAMA Intern Med. 2016;176(1):63-64. doi:10.1001/jamainternmed.2015.6068

Yelling “Fire!” in a crowded theater without any imminent danger is an oft-cited example of free speech that is not protected. For many years, the US Food and Drug Administration (FDA) has prohibited the promotion of unapproved uses of drugs. This restriction has recently been challenged under the guise of free speech. In a potential landmark decision in August 2015, a federal judge ruled against the FDA’s restrictions on off-label drug promotion, referencing protection by the First Amendment.1 Critics of off-label drug promotion point to dietary supplements as an example of the kinds of claims that are commonplace when regulation is lax and worry about an erosion of the authority of the FDA to ensure safety and efficacy of drugs.2 Are these concerns about safety warranted? Does evidence show that off-label prescribing might be less safe than on-label prescribing? In light of these concerns, the study of off-label drug use and adverse drug events by Eguale and colleagues3 in this issue of JAMA Internal Medicine is particularly timely.

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1 Comment for this article
Evidence, not FDA approval, reduced adverse events
David L. Keller | none
The study by Eguale et al demonstrated that off-label prescribing is not associated with increased adverse drug events (ADEs) when supported by strong scientific evidence. Since 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 must shift to suppression of off-label prescribing only when it is not backed by strong evidence. So says the evidence.<br/><br/>