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Practice Tip: FDA's Allowance of Off-Label Information

BY Alan G. Minsk
August 02, 2014

The United States Food and Drug Administration (FDA) recently issued a draft guidance document to make “recommendations” and to clarify its position regarding the dissemination of scientific information that discusses unapproved (i.e., off-label) uses of approved products. (The draft guidance document, “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses ' Recommended Practices,” can be accessed at: http://1.usa.gov/1nHQNGu.)

This guidance follows the FDA's guidance, entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” The FDA issued the most recent guidance, in part, in response to some industry concerns that the earlier guidance was too limiting on companies' ability to distribute off-label information that might benefit the public.

While the FDA may permit dissemination of off-label information in certain cases, life science companies must be aware that such an allowance does not exempt or protect against potential liability exposure. This article summarizes the FDA's two guidance documents and cautions that, despite the agency's acceptance of off-label dissemination practices, companies should consider the potential liability exposure when distributing information about unapproved uses of their products.

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