Approval of a drug for human use requires proof of efficacy and safety for its specific intended use in human beings established by well controlled clinical trials. Once approved for specific indications, the drug is labeled for interstate commerce. The labeling contains the approved prescribing information including indications, contraindications, precautions, warnings, adverse reactions, and dosage recommendations.

The Kefauver-Harris amendments to the Food and Drug Act, passed in 1962, require that drugs be demonstrated by well-controlled studies to be safe, as well as effective for their intended uses.

An off-label use, also known as an "unapproved" use of an approved drug, refers to using a drug in a manner that is not an FDA approved use of the drug, or using a drug in a manner that is specifically disclaimed in the approved labeling. It is important to emphasize that "unapproved use" or "off-label" use does not imply an improper or illegal use.

The pros and cons of off-label drug use will be discussed by the panel. The use of off-label drugs, insuring their ethical use, and being aware of their inherent dangers, are issues and topics that can affect every person's health and life.