As detailed in an August 6, 2012 online edition of Mayo Clinic Proceedings, “off-label use” describes a scenario in which a physician prescribes a medication in a way that was not previously approved by the U.S. Food & Drug Administration (“FDA”). Off-label uses include an unapproved:
• Form of dosage; and/or
• Condition or disease for which the medication is prescribed.
However, “[s]ince the U.S. Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common.” A 2006 report concluded that, among the most common medications, roughly one in five prescriptions were for an off-label use. Included in common off-label prescriptions are antidepressant drugs, which are often prescribed as a primary treatment for neuropathic pain—though no such FDA-approval exists. Similarly, morphine and many inhaled bronchodilators, antimicrobials, anticonvulsants and proton pump inhibitors are prescribed to children without prior approval.
While it is true that physicians are not required to disclose their off-label practices, drug manufacturers are precluded from promoting and marketing their drugs for unapproved uses. Any violation will result in significant fines; for example, GlaxoSmithKline, LLC recently agreed to pay approximately $3 billion to settle off-label marketing suits.
Many patients are unaware of their off-label use or what precisely the term means—particularly since doctors are not required to report the data. It is strongly suggested that “[h]ealth care providers and patients . . . educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one.”