Click here to return to category. Unlabeled uses are defined as the use of a drug product for indications or in patient populations, doses, or routes of administration that are not included in FDA-approved labeling. The prevalence and clinical importance of prescribing drugs for unlabeled uses are substantial.
Unlabeled indications are especially common in oncology, rare diseases, and pediatrics.
Thus, the prescribing of drugs for unlabeled uses is often necessary for optimal patient care. The Council recommends that AMA Policy 120.988, which addresses this issue, be reaffirmed. A practical problem associated with the prescribing of unlabeled uses is that third-party payors frequently deny reimbursement for drug products prescribed for unlabeled uses. It is imperative that physicians have access to accurate and unbiased information about unlabeled uses of prescription drugs. Currently, physicians obtain this information through a variety of sources, including drug compendia, journal articles, continuing medical education symposia, and professional meetings.