On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for industry: “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” This is the second piece in our discussion of the FDA’s recent guidance on firm-to-HCP communications regarding SIUU; the first piece dives deeper into understanding the key pieces of the guidance here. 

Firm to HCP Communications Questions and Answers

Section V Questions and Answers addresses five questions that frequently arose during the review process. The answers are intended to clarify the recommendations from Section IV of the guidance. 

Q1. What should firms consider when determining whether a source publication is appropriate to be included in an SIUU communication? 

A1. The FDA requests firms consider three factors when determining whether a source publication is appropriate.  

• First is that the publication should describe studies and analyses that are scientifically sound. If the study has any scientific lapses or flaws that render it unreliable, it should not be referenced even with full disclosure. 
• Second, the firm should consider existing scientific knowledge when preparing the presentation and again at dissemination to ensure that the source study is appropriate in a SIUU communication. For example, knowledge about a disease may have advanced enough to know that a previous recommendation is no longer appropriate or may even cause the patient harm. In that case, a source study discussing the obsolete recommendations should not be included in a SIUU communication.  
• Third is that the study conclusions align with the prespecified hypothesis or research question and are supported by the results of the study or analysis. The FDA’s intent is to ensure the source publication will not cause any direct or indirect harm to patients when relied upon by the HCPs to inform clinical decisions. 

Q2. What information should firms include as part of SIUU communications? 

A2. The FDA recommends including statements for all the following in SIUU communications: 

• The medical product has not been approved by the FDA for this use and the safety and effectiveness of the product for this condition has not been established. 
• Listing of FDA approved uses of the medical product. Include any limitations as specified in the FDA required labeling. 
• Limitations, restrictions, cautions, warnings, or precautions listed in the FDA required labeling about unapproved uses. 
• Copy of, or reference to, the most current FDA required labeling. 
• Description of any contraindications per the FDA required labeling. 
• Any serious, life-threatening, or fatal risks posed by the product that are relevant to the unapproved use(s). 
• Disclosure of any authors, editors, or contributors to publications included in the SIUU communication who had ties to the firm at the time of writing, editing, or contributing to the publication. 
• Material aspects and limitations of the study design, methodology, and results. Include conclusions and provide citations for any studies that provide conflicting conclusions to the same or similar hypotheses or research questions. 
• The publication date, if not specified in the publication or citation. 

Q3. What presentational considerations should firms take into account for SIUU communications? 

A3. The FDA provides three recommendations: 

• Clearly and prominently present the recommended disclosures. If both audio and visual components are present, present the disclosures at the same time using the same words. 
• Keep SIUU communications separate from promotional communications about approved uses of the product. This means separate posters within a divided booth space; separate pages on websites with no direct links between pages discussing approved and unapproved uses of the product; separate email messages; and separate SIUU communications during in-person visits. Do not forget to include the clear and prominent presentation of the recommended disclosures for each of these communication pathways. Remember: Do not intermingle promotional communications about approved uses of the product with the SIUU communications. 
• Limit SIUU communications to media and platforms that enable firms to implement the recommendations in the guidance. For example, online platforms that impose character space limitations or otherwise prevent a firm from including all the disclosures that are recommended would require you to direct HCPs to an SIUU communication through a statement that does not mention the name of any specific product. 

Q4. What additional recommendations apply to reprints, CPGs, reference texts, and materials from digital clinical practice resources that are included in a SIUU communication? 

A4. Reprints should be unaltered/unabridged.  

• The publishing journal should have an independent editorial board with expertise in the peer-reviewed article. The article is available through independent distribution channels.  
• When a firm shares section(s) from CPGs, reference texts, or materials from digital clinical practice resources, those individual section(s) should be unaltered / unabridged and extracted directly from the clinical reference resource. 

Clarkston Note: The Q4 answer includes a lot of detailed information, so review the guidance for further document specific recommendations. 

Q5. What additional recommendations apply to firm-generated presentations of scientific information on unapproved use(s) provided with a source publication? 

A5. Any firm-generated presentations included in SIUU communications should be truthful and non-misleading.  

• Extra care is warranted since firm generated presentations do not have the same level of independence as the source publications we have been discussing.  
• The firm generated presentation should provide and appropriately present all information necessary for HCPs to understand and evaluate the strengths, weaknesses, validity, and clinical utility of the presented scientific information on unapproved use(s) of the product.  
• Firms should provide the source publication(s) along with the firm-generated presentation. All firm-generated presentations should be consistent with the recommendations in this guidance regarding presentational considerations as discussed in Q3/A3.  

Clarkston Note: The Q5 answer also includes a lot of detailed information, so review the guidance before preparing or giving a firm-generated presentation to supplement your SIUU communications. 

Adhering to FDA Guidance on Firm-to-HCP Communications Regarding SIUU 

We recommend that firms incorporate the guidance’s recommendations into their quality system. Start by developing a policy document outlining the firm’s commitment to these guidelines, then reinforce it with standard operating procedures detailing how you will implement the specific recommendations. Finally, establish supporting work instructions and forms with checklists to ensure communications to HCPs comply with the guidelines. 

Clarkston has experience helping firms navigate the complexities of FDA regulations within the medical device space and the larger life sciences sector. If you have questions about the FDA’s recent guidance on communicating SIUU to healthcare providers – or if you need support implementing the requirements from this guidance – our team can help. Contact us today.