On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” The final guidance supersedes the agency’s revised draft guidance of the same title issued in October 2023 (see our analysis of the draft guidance here) and includes several key updates, including further describing scientific standards for appropriate source publications, providing additional examples of the separate dissemination of information on approved and unapproved uses in different scenarios, and expanding the section on firm-generated presentations with further context on what is permitted and what would be viewed as inappropriate when an SIUU communication includes a source publication and firm-generated content.
Several of these updates appear to be responsive to comments from industry stakeholders on the draft guidance. For example, the draft guidance stated that source publications for SIUU communications should describe “scientifically sound” studies and analyses that provide “clinically relevant” information. Multiple commenters requested that the “clinically relevant” and “scientifically sound” concepts be either removed or more clearly defined. The final guidance no longer contains the “clinically relevant” terminology, but provides some further recommendations on what constitutes a “scientifically sound” study or analysis, noting for example that certain early-phase studies could meet this standard.
Similar to the draft guidance, the final guidance document is written in a question and answer format and addresses: (1) what firms should consider when determining whether a source publication is appropriate to be the basis for an SIUU communication; (2) what information should be included as part of an SIUU communication; (3) how SIUU communications should be presented (e.g., the format and accompanying disclosures); and (4) recommendations for specific types of materials (including reprints and clinical reference resources). The final guidance includes a new question and answer focusing specifically on recommendations for firm-generated presentations.
The final guidance also provides an expanded list of examples of communication techniques that FDA regards as “encouraging” an unapproved use of a medical product. In addition to celebrity endorsements, premium offers, and gifts (which were noted in the draft guidance), the final guidance identifies emotional appeals unrelated to scientific content, promotional tag lines, and jingles, along with “calls to value” that “pre-judge the benefit(s) of the medical product for individual patients” (e.g., “Click here to start improving your patients’ lives today”), as techniques that would take a firm-generated presentation outside the scope of the guidance’s enforcement policy.
FDA has submitted the guidance to the Office of Management and Budget for review and clearance of certain information collection provisions contained in the guidance. As such, the final guidance is not for current implementation, but we expect to see a Federal Register notice about the final guidance’s applicability once this administrative step is complete.
Please contact any of the authors or your Goodwin attorney if you have any questions about this final guidance.
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