title: Regulating off-label promotion of medications: has the pendulum swung too far?
abstract: Prescribing medications off-label is commonplace in dermatology. Recent policy changes on the regulatory abilities of the US FDA and legal precedents regarding this topic have led to intense debate on free speech about off-label drug use by physicians and drug manufacturers. Here, we summarize and discuss the risks and benefits of off-label promotion and how this relates to quality patient care in dermatology.
authors.affiliation: University of Buffalo School of Medicine, Buffalo, NY, USA.
authors.forename: M B
authors.initials: MB
authors.lastname: Hoffman
authors.affiliation: The Corvallis Clinic, Corvallis, OR, USA.
authors.forename: B A
authors.initials: BA
authors.lastname: Yentzer
authors.affiliation: Center for Dermatology Research, Departments of Dermatology, Pathology and Public Health Sciences; Wake Forest University School of Medicine, Winston-Salem, NC, USA.
authors.forename: S R
authors.initials: SR
authors.lastname: Feldman
mesh_terms: D003880:Dermatology; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D010818:Practice Patterns, Physicians'; D014481:United States; D014486:United States Food and Drug Administration