Program Integrity: Off Label Pharmaceutical Marketing
The use of pharmaceuticals for unapproved symptoms or conditions, in unapproved patient groups, or in unapproved dosages is referred to as "off-label" use. The promotion of such off-label use by pharmaceutical manufacturers is among the top four types of drug promotion problems identified by the U.S. Food and Drug Administration (FDA). The following resource guide and fact sheet are intended to educate healthcare professionals, manufacturers, and sales representatives about the promotion and use of off-label pharmaceutical marketing.
Off-Label Promotion (PDF) (resource guide - updated October 2015)
Off-Label Pharmaceutical Marketing: How to Recognize and Report It (PDF) (fact sheet - updated October 2015)