'Off-label' prescribing, the Physician's Desk Reference and the court

Abstract

"Off-label" prescribing is the use of a drug in a fashion other than one approved by the Food and Drug Administration (FDA). Some courts assume that the PDR is comprehensive enough to apply its guidelines to establish the standard of care. This assumption undermines the physician's judgment in deciding how, when and for what ailment a drug should be used. It substitutes the judgment of the PDR and FDA for the physician in assessing illness and applied pharmacology. We report the results of a survey presented to leaders in the United States medical community and review medical literature and legal cases addressing off-label prescribing. Unlike some US courts, the medical community does not consider the PDR as representative of all applications of drug use, nor does it consider the PDR as the standard of medical care.