Off-Label Drug Use and Promotion

摘要

Off-label drug use (OLDU) refers to the useof FDA-approved drugs for unapproved uses. OLDUis common in many patient populations, especially inchildren and the elderly. While the FDA approves drugsfor specific uses, it does not regulate how drugs areprescribed. However, the FDA limits how drugs may bepromoted for off-label uses and has issued large finesto manufacturers who have violated its guidelines. Thepractice of OLDU and the role of the FDA in regulatingpromotion will be discussed.