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 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.
…
Read full article here
