SIUU Final Guidance: Opportunities for Proactive Scientific Messaging
February 11, 2025
The FDA recently finalized its guidance on sharing scientific information on unapproved uses (SIUU) of medical products. FDA regulates the promotion of medical products such as medical devices and pharmaceuticals.
Companies will promote these products using claims that are consistent with their intended use. If a company makes claims beyond their approved intended use, FDA may allege that the company has established a new intended use and require regulatory submissions to account for the gap.
However, FDA recognizes the need for sharing scientific information with healthcare professionals who utilize medical products in the care they provide. As a result, FDA has a history of releasing guidance documents on communicating scientific information, though never going as far as full First Amendment protections for truthful speech.
The final guidance on SIUU issued January 2025, follows a draft guidance on the same subject issued in 2023. If industry follows this guidance to share SIUU, FDA does not intend to allege that a company has created a new intended use.
Key Takeaways from the Final Guidance
How Final Is It?
It is important to note that though the issued guidance is considered final per FDA, it is still under review by the Office of Management and Budget (OMB) and may be subject to revisions. Questions two, four, and five are under OMB review and may be altered. Industry should watch for announced updates and adjust accordingly.
SIUU Defined
SIUU, as the name suggests, deals with unapproved uses of medical products. However, the guidance document makes it clear that not all communications regarding unapproved uses fall within the guidance’s protection. Source publications with rigorous science, such as published medical or scientific journals, clinical reference resources, and firm-generated presentations of the source publications fall within the guidance’s scope.
Essentially, the guidance allows for the sharing of adequate, robust scientific information where medical products were studied in ways not consistent with the labeling. Refer to the guidance for determining whether the scientific information sought to be shared meets the threshold for adequacy.
Required Disclosures
To share SIUU and avoid allegations of misleading communications or a new intended use, the guidance lays out information companies should disclose.* It should be clear that the use described is not approved and safety and effectiveness have not been established.
Companies should disclose the approved use and any limitations of use from the labeling. A statement disclosing other limiting information, such as warnings or precautions from the approved labeling, regarding the unapproved use should be included. Companies should present a copy or link to the current FDA-approved labeling. A statement of contraindications or serious risks regarding the unapproved use is also required.
Companies should disclose financial conflicts with individuals involved in the creation of the source document. Importantly, companies should pay close attention to disclose certain aspects of the source document, such as limitations of the study, the existence of contradicting data, and other important, material aspects.
The list of disclosures is long. Creating a proper document to accompany the source document that includes FDA’s recommendations will allow industry to easily prove compliance.
Nate Downing, Managing Attorney at Gardner Law, recommended, “Companies seeking to share scientific information regarding the unapproved uses of their medical products should align their documents with the FDA guidance. Doing so will allow industry to place important information in the hands of prescribers while avoiding FDA scrutiny. If this is not feasible, then it is important to carefully assess any First Amendment implications.”
Taking Advantage of SIUU
SIUU is not a free pass to promote off-label. As the guidance points out, SIUU communications are separate from promotional communications. Companies need to consider the platforms in which they share SIUU and whether they meet the guidance’s intent. However, with close compliance to the guidance, companies can confidently share SIUU and help healthcare professionals better utilize their medical products, and ultimately better serve their patients.
Contact Gardner Law
All external communications regarding medical products, including scientific exchange and promotional labeling, require oversight. Having a robust review process can allow you to maximize your messaging and scientific communications while maintaining compliance. Following FDA’s SIUU guidance should be a priority for companies that seek to share data on unapproved uses.
If you have questions about sharing SIUU and whether you align with the FDA guidance, reach out to Gardner Law.