FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of Approved/Cleared Drugs and Devices
The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and device manufacturers, physicians and health care providers.
On March 3, 2014, the FDA announced a revised draft guidance entitled “Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices; Availability” (“Draft Guidance”). The Draft Guidance provides recommended steps for the distribution of scientific or medical publications that discuss off-label uses of approved or cleared drugs and devices, which if followed, would not be used by the FDA as evidence of the manufacturer’s intent to promote a product for an off-label use. 79 Fed. Reg. 41, 11793-96 (Mar. 3, 2014). The Draft Guidance revises a 2009 guidance on the same topic.
The Draft Guidance mirrors the 2009 guidance with regard to the distribution of journal articles and ensuring that the scientific and medical publications that are disseminated are unbiased, peer reviewed, unaltered or unabridged, accurate and updated, and distributed separately from promotional materials. However, the Draft Guidance deviates from the 2009 guidance in several significant ways, including the establishment of clinical practice guidelines (“CPGs”) as a scientific and medical publication that can be distributed to provide information on off-label uses of drugs and devices, the content of required disclosure statements, and the inclusion of product labeling with the distributed reprint.
For reference texts and CPGs distributed in their entirety, the statement of disclosures must be affixed to the cover of the text or CPG and must identify the distributing manufacturer, disclose that some of the uses of the drugs or devices discussed “might not be approved or cleared by FDA" and state that “authors of some chapters . . . might have a financial interest in the manufacturer or its products” unless the manufacturer can verify that "none of the authors ... has a financial interest in the manufacturer or a product being written about."
For reference texts and CPGs distributed in part (e.g., a chapter or section), the statement of disclosures must be affixed to the cover of the text or CPG and must identify the distributing manufacturer, disclose that some of the uses of the drugs or devices discussed “might not be approved or cleared” by FDA, and identify any author “known to the manufacturer” as having a financial interest in the manufacturer or product or who is “receiving compensation from the manufacturer” as well as the amount and nature of that compensation or financial interest. The statement of disclosures must also include, “all significant risks or safety concerns associated with the unapproved use of the products … that are known to the manufacturer but not discussed.”
When reference texts and CPGs are distributed in their entirety, product labeling need not accompany the publication unless one or more of the chapters or sections “devotes primary substantive discussion of the product(s) of the manufacturer.” If only a chapter or section of the reference text or CPG is distributed, product labeling must accompany the publication.
Finally, when reference texts and CPGs are distributed in part rather than in their entirety, unaltered/unabridged chapters or sections from the same text or CPG, respectively, must accompany the selected chapter or section if needed to provide context. While the Draft Guidance does not fully explain when a manufacturer would need to do this, it does state that the additional chapters or sections would be those that provide “related or supportive information.”
As interactions by and between device and drug manufacturers and providers continue to be scrutinized by various parties, additional clarity regarding the distribution of publications discussing off-label uses of approved/cleared drugs and devices will be useful for all parties in the health care delivery system.
The FDA is requesting comments to the Draft Guidance by May 2, 2014. The finalization by the FDA of the Draft Guidance will provide important and current insights with respect to the FDA’s thoughts regarding the distribution of these materials to providers.
Members of the Health and Life Sciences Practices have experience in off-label issues, regulatory compliance and best practice efforts in all facets of the health care delivery system. If you have any questions about this Client Alert or would like more information, please contact Deborah Shuff, Bruce D. Armon or Karilynn Bayus, one of the other attorneys in the Health or Life Sciences Practices, or the attorney in the Firm with whom you are regularly in contact.