What does it mean when a drug or medical device is used “off-label”?
When the FDA approves a drug or medical device for marketing, the specific clinical conditions for which it has been approved are listed in its label (i.e., product package insert). The drug or device can legally be used “off-label” by a licensed physician, but it cannot be marketed for use in an “off-label” application. Additionally, the FDA has not evaluated the drug’s or device’s safety and effectiveness in this “off-label” use. Supporting scientific evidence supporting off-label use varies from conclusive to insufficient. Ask your doctor or health plan about the quality of scientific evidence supporting this “off-label” use.
