FDA seeks comments on new draft guidance clarifying good reprint practices

In a 3 March 2014 Federal Register notice, the US Food and Drug Administration (FDA) distributed a revised draft guidance document titled ‘Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices’ for comment. The draft guidance, when finalised, is intended to replace FDA’s January 2009 final guidance titled ‘Good Reprint Practices for the Distribution of Medical Journal Articles and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’. While the draft guidance is largely consistent with the 2009 guidance, restating and providing additional details that build on the existing criteria for the distribution of journal articles describing unapproved uses of drugs and medical devices, it does include new requirements for the dissemination of medical or scientific reference texts and clinical practice guidelines (CPGs), neither of which are explicitly discussed in the 2009 guidance.

The most notable difference between the draft guidance and the 2009 guidance is the introduction of a new category of publications, i.e. CPGs, that can fall within the ‘safe harbour’ for distribution of publications that discuss unapproved uses of drugs and devices. To fall within the scope of the draft guidance, CPGs must meet the Institute of Medicine’s standards for CPG ‘tustworthiness’…

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