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.

Image of a pill bottle laying on its side with blue pills spilled out on a table.

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)

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Page Last Modified:
03/13/2018 12:37 PM