'Off-label' drug use: an FDA regulatory term, not a negative implication of its medical use

Int J Impot Res. 2008 Mar-Apr;20(2):135-44. doi: 10.1038/sj.ijir.3901619. Epub 2007 Nov 15.


As physicians continue to prescribe more and more drugs, plaintiff's attorneys in the wake of tort reform are attempting to carve out or create informed consent cases based on the Food and Drug Administration's (FDA) labeling requirements and the doctors' communications with their patients as it relates to those requirements. The theory of tort litigation revolves around whether the doctor disclosed to his patient the fact that he prescribed a drug in an 'off-label' manner, or for a purpose not approved by the FDA's testing process. This article argues that the doctor's decision to inform the patient of the 'off-label' status of the prescription is not relevant to the physician's standard of care for an informed consent case. First, the FDA has specifically stated that its procedures and requirements have no effect on the practice of medicine and that the FDA does not prohibit doctors from prescribing drugs in an 'off-label' manner. Second, the FDA's approval of a drug is immaterial to the effectiveness in the drug's 'off-label' use. In fact, prescribing medication in an 'off-label' manner can constitute the standard of care in many cases. Third, a doctor's duty is to practice medicine and treat his patient, not inform the patient of the FDA's non-medically related labeling. Therefore, doctors should not be branded with the additional duty of disclosing non-pertinent information, such as the FDA's medically irrelevant distinction, to their patients.

Publication types

  • Review

MeSH terms

  • Decision Making
  • Delivery of Health Care / standards*
  • Drug Labeling*
  • Female
  • Humans
  • Informed Consent*
  • Male
  • Physician-Patient Relations*
  • Practice Patterns, Physicians'*