FDA Finalizes Guidance on Dissemination of Off-Label Journal Articles

January 29, 2009

The FDA has finalized its previously draft guidance on the dissemination of information on unapproved uses of medical products. The final guidance is in substantially the same form as was initially published in draft form in February of 2008. The guidance provides criteria for scientific or medical journal articles and reference publications appropriate for distribution. It also requires that the information in articles and reference publications not contain false or misleading information or pose a significant risk to the public health if the information was relied upon.

A summary of the FDA’s initial draft guidance is available on our website. The final guidance did not make any significant substantive changes except for a criterion on disclosure of a journal author’s financial interest in a particular product. In the finalized guidance, any reprint should be accompanied not only by a statement disclosing any author known to the manufacturer as having a financial interest in the product or manufacturer, or who is receiving compensation from the manufacturer, but also by the affiliation of the author, and the nature and amount of any such financial interest of the author or compensation received by the author from the manufacturer.

The draft guidance provided that if companies follow the FDA’s recommendations, the FDA will not use the dissemination as evidence of the companies’ intent to promote an off-label use. However, the FDA emphasizes in the final guidance that if a manufacturer engages in other conduct that unlawfully promotes an unapproved use of a medical product, such conduct may result in an enforcement action, regardless of whether the manufacturer followed the guidance. The full text of the final guidance is available from the FDA.