Understanding Scientific Exchange Following the FDA’s 2025 SIUU Guidance

Medical Science Liaisons (MSLs) play a crucial role in exchanging scientific information compliantly. To clarify recent regulatory shifts, Susan Giacalone, SVP, Medical Deployment of EVERSANA, Beth Giblin, Head, Field Medical Affairs for PRECIGEN and Amber Svardal Director, Medical Excellence & Sr. MSL for PRECIGEN, recently explored how MSLs can navigate these interactions under the FDA’s 2025 Scientific Information on Unapproved Uses (SIUU) guidance in The MSL Journal.

Read the full article, Understanding the Two Types of Scientific Exchange Following 2025 SIUU Guidance.

Key Highlights: Navigating the 2025 SIUU Guidance

• Modernized Framework: The 2025 SIUU guidance clarifies rules for proactive, company-initiated communications regarding unapproved uses of approved products.

• Strict Pathways: MSLs must strictly differentiate between proactive sharing and reactive, unsolicited requests from Healthcare Professionals (HCPs).

• Compliance: Mastering these rules ensures regulatory compliance, scientific integrity, and provider trust.

Proactive vs. Reactive Scientific Exchange

The FDA’s SIUU guidance specifically shapes proactive communication, while existing regulations continue to govern unsolicited requests. MSLs must understand the boundaries of both:

Proactive Scientific Exchange

Under SIUU guidance, organizations may proactively share information supported by published evidence. This includes distributing peer-reviewed articles, clinical practice guidelines, and scientific summaries derived directly from published data.

Reactive Scientific Exchange

This occurs only when an HCP initiates the conversation by requesting information. MSL responses must be narrowly tailored to the specific question asked and delivered through approved medical information channels.

5 Compliance Considerations for MSLs

When preparing for scientific exchange, Medical Affairs teams must evaluate:

1. Initiation: Did the company or the HCP initiate the interaction?
2. Evidence: What specific types of data are permitted?
3. Format: What is the approved format of the communication?
4. Setting: Is the exchange occurring in a public forum or private setting?
5. Documentation: Are all compliance and recording requirements met?

Supporting Effective Scientific Engagement

As field medical teams navigate an increasingly complex regulatory environment, ongoing training, clear processes, and strong operational support are more important than ever. Organizations that invest in these foundations can help MSLs engage confidently while maintaining consistency and compliance across scientific interactions.

To learn how EVERSANA optimizes high-performing field medical teams, explore our Field Deployment Solutions capabilities.