On February 28, 2014, the U.S. Food and Drug Administration (FDA) released the revised draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices." The draft guidance recommends practices for pharmaceutical and medical device manufacturers when disseminating scientific and medical literature that include discussions of off-label uses for approved or cleared products. The scientific and medical literature addressed in the guidance include scientific or medical journal articles, scientific or medical reference texts, and clinical practice guidelines.
The revised draft guidance is a modification of the FDA's 2009 draft guidance entitled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of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 The revised draft guidance contains many of the recommendations in the 2009 guidance, but provides more detailed definitions and examples. It also contains a comprehensive background discussion of prohibitions regarding off-label promotion and Section 401 of the Food and Drug Modernization Act (FDAMA).
Perhaps most significantly, the revised draft guidance includes a separate discussion of recommendations for distribution of reference texts and clinical practice guidelines. As stated in the guidance, "because … reference texts are considerably longer than journal articles, and generally address a wide range of topics, FDA believes that it is appropriate to make specific recommendations for distribution of reference texts that differ somewhat from the recommendations for journal articles." The FDA also sets forth separate recommendations for dissemination of clinical practice guidelines (CPG) because "a CPG may be much longer and often covers a wider range of topics than a journal article." With respect to CPGs, some of the FDA recommendations incorporate the Institute for Medicine's standards for CPG "trustworthiness."
Comments on the draft guidance (Docket No. FDA–2008–D–0053) are due by May 2, 2014. Interested persons may submit electronic comments regarding the revised draft guidance to http://www.regulations.gov, or written comments to the Division of Dockets Management.