Products approved by the US Food and Drug Administration (FDA) for one use are often put to other uses. This practice, known colloquially as "off-label usage," is neither illegal nor unethical. Physicians can and should pursue scientifically sound use supported by medical evidence. The FDA requires only that we:
--Be well informed about the product
--Base its use on firm scientific rationale and sound medical evidence, if available
--Maintain records of the product’s use and effects
--Carry out good medical practice
--Use good judgment
--Consider the best interests of the patient before all else
Recommended CitationReiter, David MD, "Sailing the straits of approval: The nature of FDA approval and its implications for surgeons" (2007). Department of Otolaryngology - Head and Neck Surgery Faculty Papers. Paper 2.