MANUFACTURER PROMOTION OF OFF-LABEL USES

To advocate for authority for the Food and Drug Administration (FDA) to regulate the promotion and dissemination of information about off-label uses of medications and medication-containing devices by manufacturers and their representatives; further, 

To advocate that such off-label promotion and marketing be limited to the FDA-regulated dissemination of unbiased, truthful, and scientifically accurate information based on peer-reviewed literature not included in the New Drug Approval process. 

Rationale

Congress is considering significant changes in the way drugs are developed, approved, and marketed in the United States. A provision in the House-passed 21st Century Cures bill (H.R. 6) would allow pharmaceutical manufacturers to promote off-label uses of their products to clinicians and formulary committees. This change has raised concerns about the accuracy and sources of such information. Sources of such information, if unreliable, could put patient safety at risk. Despite these concerns about promotion of off-label uses by manufacturers and their drug representatives, ASHP has suggested an amendment that would require Food and Drug Administration (FDA) oversight of such promotion and require promotional materials to be unbiased, truthful, scientifically accurate, and based upon peer-reviewed literature not included in the approved labeling of the drug. Materials would therefore require approval by the proper authority (FDA), meet certain requirements, and be truthful and scientifically accurate. This policy is not intended to curtail the ability of clinicians to use, or discuss the use of, products off-label.