The Food and Drug Administration (FDA) has announced the publication of a new draft guidance document, Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.i The new draft guidance is intended to replace the agency’s final guidance published in 2009 that provides recommendations for good reprint practices. The principal difference from FDA’s past approach is that the new guidance distinguishes between and provides specific recommendations for three categories of publications: scientific and medical journal articles, scientific and medical reference texts, and clinical practice guidelines (CPGs).
In January 2009, FDA finalized guidance on good reprint practices for the distribution of scientific or medical journal articles and scientific or medical reference publications that discuss off-label uses of FDA- approved or -cleared medical products, including drugs, biologics and medical devices, to health care professionals and organizations (2009 Guidance).ii Subsequently, one comment was submitted asking that FDA clarify and adjust application of the guidance to medical textbooks. In addition, two citizen petitions were filed to request, among other things, that FDA address the distribution of CPGs that discuss unapproved or uncleared uses of legally marketed drugs and devices. Although FDA intends to further evaluate and develop approaches on several related issues, such as scientific exchange (see Request for Comments below), the draft guidance is the agency’s response to these specific requests.
Summary of New Draft Guidance
The draft guidance lists specific recommendations for scientific or medical publications, including portions of such publications where applicable, that contain information on off-label uses of legally marketed drugs (including biologics) and devices and are distributed by the product’s manufacturer.iii The recommendations are specific to three categories of publications: journal articles, reference texts and CPGs. According to FDA, “[i]f the recommended practices are followed, FDA does not intend to use distribution of these publications as evidence of the manufacturer’s intent that the product be used for an unapproved new use.”iv
Where FDA’s 2009 Guidance provided recommendations for all scientific or medical publications without differentiation, the new draft guidance provides specific and separate recommendations for journal articles, reference texts and CPGs. On the whole, FDA’s recommendations in the draft guidance for scientific and medical journal articles and reference texts are not substantially different from its previous recommendations. In fact, but for the clarification of a few specific points and reorganization of concepts, recommendations for journal articles are nearly identical to FDA’s 2009 Guidance.
Recommendations for the distribution of scientific or medical reference texts depart from the 2009 Guidance only where necessary to reflect the different nature and scope of such publications. Specifically, FDA believes separate recommendations are appropriate for reference texts because they “are considerably longer than journal articles, and generally address a wide range of topics.”v The draft guidance includes recommendations for the distribution of a reference text in its entirety, as well as individual chapters of such publications.
The 2009 Guidance did not include recommendations for the distribution of CPGs, which include clinical recommendations for individual patient care. Like reference texts, CPGs are typically longer than journal articles and broader in scope. FDA’s new recommendations for the distribution of CPGs are consistent with its recommendations for the other types of publications, but also incorporate the Institute of Medicine’s standards for “trustworthiness,” which help ensure that “CPGs are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”vi
Request for Comments
With publication of the new draft guidance, FDA is seeking comments on the recommendations proposed in the draft guidance, as well as a number of other related issues. Specifically, as part of an ongoing effort to answer questions from industry, the agency seeks public input on the following issues:vii
- Scientific exchange. FDA’s request for comments is in furtherance of its December 2011 notice requesting comments on all aspects of scientific exchange communications and activities.viii
- Responses to unsolicited requests for medical information. FDA invites comments on its draft guidance, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,ix to support the development and issuance of final guidance on the same topic.
- Interactions with formulary committees, payors and similar entities. Comments will help inform the development of draft guidance on this topic, including clarifying FDA’s interpretation of “healthcare economic information” and evidentiary support for the communication of such information to formulary committees and similar entities.