FDA Releases Revised Draft Guidance on the Distribution of Scientific and Medical Publications About Unapproved Uses: Guidance Clarifies Prior Guidance and Addresses Reference Texts and Clinical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

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On March 3, 2014, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (“Revised Draft Guidance”).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longstanding FDA policy, if manufacturers distribute scientific or medical publications as recommended in the Revised Draft Guidance, FDA does not intend to use the distribution as evidence of the manufacturer’s intent to promote the product for an unapproved new use. The deadline for public comments on the Revised Draft Guidance is May 2, 2014.

In the Revised Draft Guidance, FDA confirms the recommendations outlined in the 2009 guidance for the distribution of scientific and medical journal articles, while clarifying several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.

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