In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on Scientific Information on Unapproved Uses (SIUU), Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers. The final guidance details how pharmaceutical companies and medical device manufacturers can communicate scientific information about unapproved uses of approved products without crossing into promotional territory.
This final guidance builds upon the draft guidance by emphasizing the need for communications to be truthful, non-misleading, and supported by scientifically sound evidence. Notably, the final guidance clarifies the conditions under which real-world data can be considered in communications, expanding the scope beyond controlled clinical trial data.
As of the writing of this article, this guidance is not for current implementation, and is pending the Office of Management and Budget’s (OMB’s) decision on the collection of information. Comments can be submitted by February 21, 2025.
Changes from the draft to the final guidance include (1) reorganizing the guidance to include dedicated glossary and policy sections for ease of use; (2) revising the recommendations for source publications to provide additional specificity and examples to illustrate the recommendations; (3) refining language around presentational considerations to provide additional clarity and an additional example; and (4) updating the section on firm-generated presentations to specify that the recommendations apply to firm-generated presentations of scientific information from any of the source publications addressed in the guidance. Some additional editorial changes were also made for clarity.
Key Differences Between the Draft and Final Guidance
The transition from the draft to the final guidance marks a change in development in regulatory expectations. One difference is that the final guidance emphasizes “scientific soundness” over the draft’s “scientifically sound and clinically relevant” standard, urging reliance on well-designed and controlled studies. It removes specific endorsements of real-world data, instead suggesting a more nuanced approach to evaluating scientific evidence. However, while it no longer emphasizes “clinically relevant,” the need for clinical relevance does still seem to be a factor and it is incorporated into the “scientifically sound” standard.
In the final guidance, the FDA also points out study design features that would generally meet the “scientifically sound” standard, such as a robust design and a prespecified statistical analysis plan. Also, certain phase II studies could meet the “scientifically sound” standard when adequately designed and conducted, as could other less-conventional study designs.
In the final guidance, FDA also notes that appropriate source publications for firm-generated presentations include clinical practice guidelines, scientific or medical reference texts, and digital clinical practice resources – in addition to published scientific or medical journal articles.
The final guidance also updates the draft guidance’s indication that SIUU and promotional communications must be “separate and distinct” to simply saying they must be “separate.” Even still, the standard remains essentially the same as FDA emphasizes that companies should maintain dedicated spaces for discussion of unapproved uses apart from where approved uses are promoted – such as separate webpages, email messages, and physical spaces within a commercial exhibit booth. For in-person discussions, the SIUU communication(s) should be clearly identified through the ”clear and prominent presentation of the disclosures” recommended in the guidance.
Companies should evaluate existing scientific knowledge critically to determine the appropriateness of source publications for SIUU communications. This shift requires medical affairs teams to enhance their scrutiny and verification of the scientific rigor of the data they disseminate.
For medical affairs and compliance departments, these updates necessitate a thorough review of current practices and possibly, the development of new training and compliance checks to ensure all communications align with the updated FDA expectations.
Further Reading and Resources
To fully integrate the new SIUU guidance into your operational strategies, detailed understanding and continual reference to the official FDA document will be essential. You can access the final SIUU guidance directly through the FDA’s official guidance document.
This guidance serves not only to protect patients by ensuring they receive accurate information but also helps firms navigate complex regulatory landscapes without compromising their ability to share valuable scientific knowledge.
Important Resources and Further Reading
- Comprehensive FDA Guidance Resources: FDA’s guidance on communications, offering insights into broader regulatory policies.
- Federal Register Notice: Details on public feedback and regulatory considerations for SIUU.
- Draft Guidance 2023 Access Draft Guidance
- FDA Law Blog Overview: Insightful analysis on the finalized SIUU guidance, providing context and implications for the industry.
- Troutman Law Firm Review of Final FDA SIUU Guidance
- Hogan and Lovells Review of Final FDA SIUU Guidance
- Arnold and Porter Review of Final FDA SIUU Guidance