FDA Seeks Comments on Draft Guidance Document Addressing the Distribution of Information on Nonapproved Uses of Drugs and Devices

March 3, 2014—The US Food and Drug Administration (FDA) has issued a revised draft guidance for manufacturers and distributors of approved drug products or approved/cleared medical devices titled “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.” The notice and draft guidance were published in the Federal Register (2014;79:11793-11796).

According to the FDA, the draft guidance revises the final guidance titled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on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” that was published in January 2009. It is available online at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm.

The draft guidance provides FDA’s current thinking on recommended practices for drug or medical device manufacturers and their representatives to follow when distributing scientific and medical publications (scientific or medical journal articles or reference texts, and/or clinical practice guidelines) to health care professionals or health care entities when these publications discuss unapproved new uses for approved drugs or approved or cleared medical devices marketed in the United States.

To ensure timely consideration of comments, FDA requests that interested parties submit comments on the proposed collection of information by May 2, 2014, before the agency begins the work on the final version of the guidance. However, comments on any guidance can be submitted at any time.Comments on the draft guidance can be submitted online at http://www.regulations.gov or submitted by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Further instructions and contact information are available in the Federal Register notice.

Among the issues under evaluation, FDA is considering a range of options for responding to questions about industry participation in scientific discussions and for addressing industry dissemination of new scientific information related to approved or cleared uses of marketed drugs and devices.

With respect to the collection of information associated with this draft guidance, FDA invites comments on the following topics: (1) whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including the use of automated collection techniques (when appropriate) and other forms of information technology.

The draft guidance also provides recommendations regarding the characteristics of scientific and medical publications that companies may choose to distribute. Elaborated in more detail in the draft guidance, these characteristics in general include that these publications be from journals, scientific or medical reference texts, and clinical practice guidelines that are produced by independent sources and meet criteria for professional/peer review; be based on specified types of scientific evidence; and be complete, unabridged, and without highlighting or characterization by the manufacturer. In addition, the draft guidance provides recommendations for additional information to be supplied with the publications.

The specific recommendations are detailed in the 2014 draft guidance document, which is available online at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.