Physician-Directed Applications
A Position Statement of the Alliance of Specialty Medicine
Physician-Directed Applications
Physician-directed applications, also known as “off-label” 1 uses, are an integral
component of the art and science of medical practice, particularly for specialty
physicians. Using their medical expertise and judgment, physicians may choose to use
approved medical products such as prescription drugs, biologics, and devices, for uses
not listed in the United States Food and Drug Administration (FDA) approved or cleared
labeling, as appropriate.
Background
It is not uncommon for some off-label uses of medical products to become standard of
care in the practice of medicine. In fact, off-label uses of certain medical devices and
drugs can be found in standard textbooks for medical subspecialties. In certain patient
populations, such as children and cancer patients, off-label use of medical products is
extensive when appropriate therapies have not been developed or evaluated for the
populations or a clinical trial is not feasible (such as in the case of rare diseases). In
these circumstances, physician-directed applications provide treatments that may not
otherwise be available for some of the nation’s youngest and most critically ill patients.
Physicians use the best available clinical evidence, judgment, and consideration of
individual patient circumstances and preferences in treating and managing disease and
injury. Good medical practice and the best interests of the patient require that
physicians use legally-available drugs, biologics, and devices according to their best
clinical expertise and judgment.
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