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On Oct. 23, the FDA issued draft guidance titled “<a href="https://www.fda.gov/media/173172/download">Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answer</a>s,” often referred to as the SIUU Guidance. This much-awaited guidance seeks to address common questions and concerns associated with firms’ communications to healthcare providers (HCPs) regarding the scientific information on unapproved uses of FDA-approved/cleared medical products.

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While the guidance retains several principles from previous iterations focusing on the communication of scientific information to HCPs regarding unapproved uses of FDA-approved/cleared medical products, the FDA introduces two new concepts that are noteworthy for industry stakeholders:

Safe Harbor for Firm-Generated Presentations: The FDA acknowledges that firms may create presentations of scientific information based on accompanying reprints. These firm-generated communications must meet specific criteria, including being truthful, non-misleading, factual and unbiased. Importantly, the presentation should be accompanied by the reprint, which must also meet specific criteria articulated in the guidance.

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Introduction of a New Evidentiary Standard: Departing from the prior clinical practice guidelines approach that emphasized adequate and well-controlled clinical investigations, the guidance introduces a new standard: “scientifically sound and clinically relevant.” This broadens the scope of acceptable publications and acknowledges the potential relevance of real-world data.

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The draft guidance addresses several other important topics:

Source Publication Appropriateness: A critical aspect addressed in the guidance is the determination of source publication appropriateness for SIUU communications. Source publications should adhere to the principles of scientific soundness and clinical relevance. For instance, randomized double-blind controlled trials are typically regarded as rigorous for human and animal drugs. However, the guidance acknowledges that well-designed trials other than this specific format may also provide sound and relevant information.

Real-World Data Evaluation: The guidance recognizes the potential value of real-world data but emphasizes the importance of evaluating the data’s characteristics and analysis quality. It’s essential to weigh the suitability of such studies carefully.

Exclusions From Appropriateness: Certain exclusions are outlined in the guidance. For instance, studies lacking adequate comparison or control groups, isolated case reports, or those without sufficient detail generally do not meet the criteria of scientific soundness or clinical relevance. Communications based on distorted or fraudulent data are strictly discouraged.

Transparency and Disclosure: SIUU communications must prioritize transparency and disclosure. This includes providing comprehensive information such as statements about unapproved use, FDA-approved uses, labeling limitations, contraindications and safety risks. Additionally, firms should disclose any relationships between contributors and the firm, ensuring transparency regarding potential conflicts of interest.

Presentational Considerations: Presenting SIUU communications requires clear and prominent disclosures. The guidance emphasizes avoiding persuasive marketing techniques that could potentially influence HCPs beyond the scientific content of the communication. The goal is to convey information in a factual and unbiased manner, aligned with regulatory requirements.

Balancing Interests: Throughout the guidance, the FDA emphasizes the need to strike a balance between HCPs’ interest in scientific information about unapproved uses and government interests in effectively regulating medical products. Maintaining transparency, scientific integrity and regulatory compliance is paramount.

Pharmaceutical and medical device firms should carefully review this draft guidance to confirm that their practices around providing literature and information on unapproved uses align with the FDA’s expectations. While the FDA’s guidance is not legally binding, following it reduces risk for regulated firms. For those interested in obtaining further details about the revised draft guidance, the FDA encourages visiting the Office of Prescription Drug Promotion webpage. This resource will provide additional information, clarifications and insights into the FDA’s expectations for firms and healthcare providers in the realm of scientific information dissemination. Interested parties have 60 days to submit public comments to the FDA concerning the draft guidance.

Navigating the FDA’s SIUU Guidance: Key Insights for Pharma and MedTech