Off-label marketing of medicines in the US is rife but difficult to control
Despite Federal Drug Administration regulation of the approval and use of pharmaceutical products, "off-label" marketing of drugs (for purposes other than those for which the drug was approved) has occurred in all aspects of the US health care system. In a study published in this week's PLoS Medicine, Aaron S. Kesselheim from Brigham and Women's Hospital, Boston, USA and colleagues report that the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches. They identified three main goals of alleged off-label marketing programs: expansion of drug use to unapproved diseases, expansion to unapproved disease subtypes, and expansion to unapproved drug dosing strategies, typically higher doses.