Following on from last week’s conversation, I left off with the issues surrounding the off-label prescriptive habits by physicians and the implicit role of the sponsors. The Academy of Managed Care Pharmacy (AMCP) supports off-label use of FDA-approved drugs when medically appropriate and necessary, but opposes government-mandated coverage of specific pharmaceuticals, whether for FDA-approved or off-label uses.

Mentioned last week was the original definition of off-label use as the use of a drug for clinical indications other than those stated in the labelling approved by the US Food and Drug Administration (FDA) and other regulators. An example would be the use of a drug for oncological treatment (e.g. pancreatic), where the drug would originally have been approved for treating other maladies of the same class (e.g. ovarian, bladder and genitourinary cancer).

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