FDA Issues Revised Off-Label Communications Guidance

The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs") on unapproved uses of approved/cleared medical products.

On October 24, 2023, the FDA issued new revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products ("2023 Guidance"), that discusses the agency's evolving policy regarding how scientific information on unapproved uses ("SIUU") of approved/cleared medical products can be communicated to HCPs. If a firm complies with the 2023 Guidance, then FDA will not argue that it improperly promoted its product off-label. When finalized, the 2023 Guidance will replace its 2014 draft guidance on the same topic, Distributing Scientific and Medical Publications on Unapproved New Uses ("2014 Guidance").

While the 2023 Guidance does not represent a significant policy shift from FDA's 2014 Guidance on SIUU communications, it does provide more clarity on the scope of scientific information that may be disseminated and how such information may be communicated to HCPs. Notably, the 2023 Guidance expands the scope of FDA's recommendations to apply not only to dissemination of scientific/medical journal articles (reprints), scientific/medical reference texts, and clinical practice guidelines, but also to "independent clinical practice resources" and "firm-generated presentations of scientific information from an accompanying published reprint." Further, the 2023 Guidance introduces a new evidentiary standard for source publications that serve as the basis of SIUU communications, stating that they must be based on studies and analyses that are "scientifically sound" and "clinically relevant."

The 2023 Guidance also elaborates further on certain expectations and recommendations that were previously expressed or implied in the 2014 Guidance, including:

  • SIUU communications must be "truthful, non-misleading, factual, and unbiased" and must "provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility" of the information being conveyed.
  • To ensure the SIUU communications are conveyed in a manner that enhances HCP understanding and evaluation of the underlying scientific information, firms must take into account several presentational considerations:
    • SIUU communications should clearly and prominently present all disclosures recommended in the 2023 Guidance;
    • SIUU communications should not use "persuasive marketing techniques" (e.g., celebrity endorsements, gifts, and premium offers);
    • SIUU communications should be separate and distinct from promotional communications about approved uses;
    • SIUU communications should be shared through media and via platforms that enable firms to implement the recommendations in the 2023 Guidance (e.g., social media platforms with space limitations may not be suitable); and

Firms should use "plain language" in the content they develop for SIUU communications to facilitate comprehension by HCPs.

Comments on the 2023 Guidance should be submitted by January 5, 2024.

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