It is unsettled whether a physician is obligated to inform patients that a drug’s proposed use is considered off label. As a practical matter, it may be difficult to explain why its use is as yet unapproved by the FDA. Besides, the public is guarded over off-label prescriptions, approximately half believing that such uses should be prohibited. A patient may reasonably want to know whether a drug or device is being used in an approved or unapproved manner, in addition to knowing its benefits and risks. This has led some observers to call for a legal requirement of disclosure.
Dr. Tan is a former professor of medicine and adjunct professor of law at the University of Hawaii. This column, "Law and Medicine," regularly appears in Internal Medicine News, an Elsevier publication; it is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at siang@hawaii.edu.