On March 3, 2014, FDA announced the availability of a revised draft guidance document entitled “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.” This draft guidance revises the final guidance, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on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” published in January 2009.
The revised guidance goes beyond the previous document in that it separately addresses journal articles, reference texts, and clinical practice guidelines (CPGs). In the Federal Register notice of publication, FDA notes that the draft guidance was issued in part to respond to citizen petitions from drug and device manufacturers received in July 2011 and September 2013 that included requests specifically related to the distribution of CPGs.
In the revised draft guidance, FDA’s recommendations for distribution of scientific or medical journal articles remain largely the same. The revised guidance, however, contains a distinction between drugs and devices that was not present in the 2009 guidance. The previous guidance document provided that information in the journal articles should “address adequate and well-controlled clinical investigations” that “can include historically controlled studies, pharmacokinetic (PK) and pharmacodynamic (PD) studies, and meta-analyses if they are testing a specific clinical hypothesis.” The revised guidance provides that journal articles should “contain information that describes and addresses adequate and well-controlled clinical investigations,” and only for devices states that “significant investigations other than adequate and well-controlled studies, such as meta-analyses, if they are testing a specific clinical hypothesis, and journal articles discussing significant non-clinical research (such as well-designed bench or animal studies) may be consistent with this guidance.”
For scientific or medical reference texts distributed in their entirety, FDA recommendations are similar to those for journal articles, such as texts should be based on a systematic review of existing evidence, be published by an independent publisher, be the most current version, be peer-reviewed, be distributed separately from promotional material, and contain a prominent disclosure identifying that some uses may not be approved or cleared by FDA. For distribution of individual chapters, manufacturers should ensure that the chapter comes from a reference text that follows the recommendations of the guidance, is unaltered and unabridged, is disseminated with other chapters when necessary to provide context, contains a prominent disclosure statement, and is disseminated with the approved labeling.
For CPGs, “statements that include recommendations intended to help clinicians make decisions for individual patient care, including in circumstances where there are few or no approved drugs or devices indicated for the patient’s condition or the approved therapies have not proven successful for the individual,” FDA sets forth standards that include the Institute of Medicine’s standards for CPG “trustworthiness.” At a “minimum,” the CPG should:
- be based on a systematic review of existing evidence;
- be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups;
- consider important patient subgroups and patient preferences;
- be based on an explicit and transparent (publicly accessible) process by which the CPG is developed and funded that minimizes distortions, biases, and conflicts of interest;
- provide a clear explanation of the logical relationships between alternative care options and health outcomes, provide clearly articulated recommendations in standardized form, and provide ratings of both quality of evidence and the strength of recommendations; and
- be reconsidered and revised when important new evidence warrants modifications of recommendations.
Similar to reference texts, FDA also sets forth requirements for CPGs that are distributed in their entirety, and additional requirements if only a section is used.
FDA requests that comments on the draft guidance be submitted by May 2, 2014. In addition to soliciting public comment on the new draft guidance, FDA is soliciting public comment on three additional issues:
- further explaining “scientific exchange”;
- developing guidance on manufacturer responses to unsolicited requests for information relating to unapproved or uncleared uses; and
- considering draft guidance on industry interactions with formulary committees, payors, and similar entities, including clarifying terms discussed in section 114 of Food and Drug Administration Modernization Act of 1997 (FDAMA) and recommendations for evidentiary support for health care economic information disseminated to formulary committees and similar entities.