Unapproved New Uses: FDA Revisits Policies on Distributing Scientific Publications


In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices.

On March 3, 2014, the Food and Drug Administration (FDA) released a draft guidance document, “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices” (2014 Draft Guidance), which is intended to revise FDA’s 2009 Guidance on this topic.2 The 2014 Draft Guidance uses the terms “unapproved new use,” “unapproved use,” and “off-label use” interchangeably to refer to any use of an approved or cleared drug or medical device that is not included in that product’s approved labelling or cleared indications for use. FDA published the 2014 Draft Guidance in response to citizen petitions and industry requests for clarification of the 2009 Guidance and its application to medical reference texts and clinical practice guidelines (CPGs) that report on unapproved new uses of a manufacturer’s products. The Draft Guidance recommends drug and medical device manufacturers and their representatives provide additional detailed information when distributing to health care professionals or entities (i) scientific or medical journal articles; (ii) scientific or medical reference texts; or (iii) CPGs that discuss unapproved new uses for approved drugs or devices marketed in the US. Interested parties may submit comments to the FDA about the 2014 Draft Guidance until May 2, 2014.

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