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 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.2
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.
Click here to view the full AANS/CNS Joins Alliance in Position Statement on Physician-Directed Applications.
