Today, FDA announced the availability of a revised draft guidance, Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices (Revised Draft Guidance).  The Revised Draft Guidance sets forth FDA’s recommendations for drug and medical device manufacturers when distributing scientific or medical publications that include off-label information to health care professionals or health care entities.

Today’s Revised Draft Guidance revises the agency’s January 2009 guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference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 January 2009 guidance provided a combined set of guidelines for the dissemination of journal articles and reference publications that contain off-label information.  The Revised Draft Guidance provides discrete recommendations for the dissemination of three categories of information when they contain off-label information:

  • scientific or medical journal articles,
  • scientific or medical reference texts, and
  • clinical practice guidelines (CPGs)

 FDA believes it is appropriate to have recommendations for the distribution of reference texts and CPGs that differ to some degree from the recommendations for distribution of journal articles.  For example, the Revised Draft Guidance specifies for CPGs that manufacturers should only disseminate guidelines that are “trustworthy,” as defined in a 2011 Institute of Medicine study.

Consistent with past policy, FDA states that if a manufacturer distributes materials that fall within any of the three categories in accordance with the Revised Draft Guidance, FDA will not use such distribution as evidence of the manufacturer’s intent to promote the product for that use.  FDA also invites public comment on the approaches set forth in the Revised Draft Guidance.