On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.” The draft guidance, which sets forth principles consistent with previous agency pronouncements regarding the dissemination of off-label information, updates a guidance released in January 2009 to add recommendations pertaining to the dissemination of clinical practice guidelines that include references to off-label use of a manufacturer’s product(s). This On the Subject provides a high-level overview of the new draft guidance.
In January 2009, the U.S. Food and Drug Administration (FDA) issued guidance that was intended to provide drug and medical device manufacturers and their representatives with recommendations regarding the dissemination of scientific or medical information on unapproved uses to health care professionals and health care entities, without such activities being considered evidence of the manufacturer’s intent to promote the product for an off-label use. Since its publication, however, stakeholders raised questions regarding the extent to which the 2009 draft guidance applies to the distribution of clinical practice guidelines (CPGs) that include (or may include) information regarding off-label use of the manufacturer’s product(s). To address these issues, on February 28, 2014, FDA issued a revised draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices."
In the draft guidance, FDA sets forth “recommended practices” specific to the dissemination of three types of scientific or medical publications—journal articles, reference texts and CPGs. In recognition of the different characteristics of each of these types of publications (e.g., length, scope of topics addressed), the draft guidance sets forth separate principles for each publication type. The draft guidance provides recommendations as to (1) characteristics that a publication should have, (2) characteristics that a publication must not have, (3) characteristics that a publication should not have and (4) the materials/disclosures that should accompany each type of publication. The following table provides a high-level overview of FDA’s guidance.
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If manufacturers distribute scientific or medical publications as recommended in the draft guidance, FDA does not intend to use such distribution as evidence of the manufacturer’s intent that the product be used off-label.
FDA recommends that comments regarding the draft guidance be submitted by May 2, 2014 (to ensure consideration before the agency begins preparing the final guidance).
With the exception of a few relatively minor clarifications, the principles set forth in the draft guidance are consistent with the principles set forth in the January 2009 guidance. Nevertheless, the draft guidance is important in that it (1) reaffirms the fundamental position FDA took in 2009 relative to the distribution of these types of materials; (2) adds guidance from the agency regarding the dissemination of CPGs; and (3) sets forth separate tailored recommendations for journal reprints, reference texts and CPGs, respectively, based on the unique characteristics of each type of publication. Importantly, the guidance reaffirms the need for care in ensuring a separation between promotional activities and the dissemination of these types of materials. Manufacturers should take this opportunity to review (and revise, as appropriate) their standard operating procedures regarding the dissemination of off-label information to ensure compliance with the draft guidance, assess the need to refresh the training program for sales and marketing personnel, and consider submitting comments to FDA.