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In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices.

On March 3, 2014, the Food and Drug Administration (FDA) released a draft guidance document, “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices” (2014 Draft Guidance), which is intended to revise FDA’s 2009 Guidance on this topic.2 The 2014 Draft Guidance uses the terms “unapproved new use,” “unapproved use,” and “off-label use” interchangeably to refer to any use of an approved or cleared drug or medical device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 FDA published the 2014 Draft Guidance in response to citizen petitions and industry requests for clarification of the 2009 Guidance and its application to medical reference texts and clinical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 The Draft Guidance recommends drug and medical device manufacturers and their representatives provide additional detailed information when distributing to health care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 Interested parties may submit comments to the FDA about the 2014 Draft Guidance until May 2, 2014.

Please see full Alert below for more information.

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

Topics:  Drug Manufacturers, FDA, Off-Label Use, Pharmaceutical, Prescription Drugs

Published In: Administrative Agency Updates, Health Updates, Science, Computers & Technology Updates

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.

© Latham & Watkins LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »