In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”). This revises the FDA’s 2009 draft guidance document on the subject, which was titled: “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” (the “2009 Draft Guidance”). Key changes in the Revised Draft Reprint Guidance as compared to the 2009 Draft Guidance include the provision of a number of “explanatory sections” as well as a new section addressing clinical practice guidelines (or “CPGs”). Comments on guidance documents may be submitted at any time; however, the FDA encourages stakeholders to submit comments by May 2, 2014, “to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance.” The FDA has not indicated when it would anticipate publication of a final guidance document. As with all FDA guidance documents, both draft and final, the Revised Draft Reprint Guidance is not binding on the FDA, but rather represents the Agency’s “current thinking.”
The Revised Draft Reprint Guidance breaks down the FDA’s recommendations into three categories: scientific journal articles, scientific or medical reference texts, and CPGs:
Scientific or Medical Articles
The FDA revised its draft recommendations regarding scientific and medical journal articles to, among other things, state that manufacturer-disseminated articles “must” not contain information “recommending or suggesting use of the product that makes the product dangerous to health when used in the manner suggested.” In addition, the FDA revised its previous draft recommendations for journal article dissemination, stating, among other things, that a manufacturer-disseminated article “should” not “be attached to specific product information (other than the approved product labeling or the product’s cleared indications for use statement). This is in contrast to the 2009 Draft Guidance, which recommended that a reprint “be distributed separately from information that is promotional in nature” (emphasis added).
Scientific or Medical Reference Texts
The FDA breaks out “scientific or medical reference texts” for more specific recommendations than were provided in the 2009 Draft Guidance. With some exception, these publications were treated similarly to journal articles in the 2009 Draft Guidance. While a number of the FDA’s draft recommendations for such publications remain similar, the FDA also adds more specific recommendations because “these reference texts are considerably longer than journal articles, and generally address a wide range of topics.” The additional draft recommendations include, without limitation, that the reference text(s):
- Be based on a systematic review of the existing evidence.
- Be published (in print or electronic format) by an independent publisher, not substantially dependent on financial support from drug or medical device manufacturers, who publishes scientific or medical educational content for health care professionals and students.
- Be the most current version.
- Be authored, edited, and/or contributed to by experts who have demonstrated expertise in the subject area.
The FDA also recommends that the proscribed disclaimer statement should be on the cover of the text (this was not previously stated in the 2009 Draft Guidance), and provides additional guidance designed to address situations where an individual chapter of a larger reference text is disseminated.
Clinical Practice Guidelines
The FDA has added a new section on Clinical Practice Guidelines, which were not clearly addressed in the 2009 Draft Guidance. The FDA defines CPGs as “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. A CPG may be much longer and often covers a wider range of topics than a journal article.” While the CPG recommendations are largely similar to those for reference texts, there are some key differences. Among other things, FDA recommends that manufacturer-disseminated “trustworthy” CPGs:
- 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.
- Be reconsidered and revised when important new evidence warrants modifications of recommendations.
In addition, FDA states that “a CPG that addresses only one disease state should be disseminated in its entirety.”
The FDA states that it does not intend to use a manufacturer’s distribution of publications as recommended in the guidance as evidence of a manufacturer’s intent that the product be used for an unapproved new use. However, as with the 2009 Draft Guidance, the Revised Draft Reprint Guidance may be relatively difficult for manufacturers to strictly comply with in many cases. Failure to comply strictly with the FDA’s recommendations would not be a “per se” violation of the federal Food, Drug, and Cosmetic Act, but may subject a manufacturer’s activities to greater enforcement scrutiny. We strongly encourage drug, biologic, and device manufacturers to carefully review the Revised Draft Guidance in considering whether to submit comments, as well as in creating and revising their company compliance and materials review policies and procedures.