FDA Releases Revised Draft Guidance on the Distribution of Scientific and Medical Publications About Unapproved Uses: Guidance Clarifies Prior Guidance and Addresses Reference Texts and Clinical Practice Guidelines


On March 3, 2014, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (“Revised Draft Guidance”). This guidance revises the 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.” Consistent with longstanding FDA policy, if manufacturers distribute scientific or medical publications as recommended in the Revised Draft Guidance, FDA does not intend to use the distribution as evidence of the manufacturer’s intent to promote the product for an unapproved new use. The deadline for public comments on the Revised Draft Guidance is May 2, 2014.

In the Revised Draft Guidance, FDA confirms the recommendations outlined in the 2009 guidance for the distribution of scientific and medical journal articles, while clarifying several recommendations, particularly as they apply to device manufacturers. FDA also provides specific recommendations regarding the distribution of reference texts and clinical practice guidelines (“CPGs”) in response to stakeholder requests.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© King & Spalding | Attorney Advertising

Written by:


King & Spalding on:

JD Supra Readers' Choice 2016 Awards
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.