Firms should be selective in which source publications they choose to share with HCPs and consider delivery methods and disclosure visibility, as discussed below.

The U.S. Food and Drug Administration (FDA) recently finalized a draft Guidance informing firms who communicate scientific information that reflects unapproved uses of medical products to healthcare providers who can prescribe such products (SIUU communications) how to structure SIUU communications to ensure that they do not reflect a new indication.

This Guidance applies to firms—individuals legally responsible for product labeling or communicating on behalf of such individuals—who are sharing source publications such as scientific journals and clinical reference resources, or firm-generated presentations on scientific information.

The Guidance strikes a balance between FDA’s interest in promoting healthcare practitioners’ (HCPs) ability to consider unapproved uses of medical products that may be appropriate for patients and FDA’s desire to encourage both adherence to premarket requirements and medical product development.

However, FDA prohibits introducing into interstate commerce a medical product intended for a use that is unapproved and can extrapolate a product’s intended use from communications such as promotional claims and advertising. FDA is clear that if a firm follows the recommendations in this Guidance, it does not plan to use the firm’s communications “standing alone” as evidence of an unapproved intended use.

To adhere to the recommendations in the Guidance, all SIUU communications should be truthful, not misleading, and present all information necessary for HCPs to understand the strength and clinical validity of the provided information. Firms should be selective in which source publications they choose to share with HCPs and consider delivery methods and disclosure visibility, as discussed below.

FDA conveyed its finalized Guidance through a series of questions and answers, with key points summarized, as follows:

1. FDA recommends that in selecting appropriate source publications to share, firms select those that describe scientifically sound studies and analyze and use generally accepted design and methodological standards. FDA warns against sharing studies with flaws that render them unreliable, because even with disclosure of study limitations, firms would not be permitted to attribute such study results to a medical product.
2. In disseminating SIUU communications, firms should consider scientific knowledge not only at the time of preparing the communication, but at the time of communication. Firms should consider if existing knowledge has since refuted a study conclusion or the foundation of a study conclusion, and if so, they should not share such information.
3. SIUU communications should include a set of disclosures, including an express statement that the discussed use is unapproved and safety and effectiveness for that use has not been established. Firms should also disclose the contents of the product’s label, such as contraindications, FDA-approved uses or limitations, and restrictions. Additional disclosures should describe authors or editors involved in an SIUU communication who were compensated by the firm and any study details not provided in the source publication (e.g., design, results, methodology and limitations).
4. Presenters of SIUU communications should ensure that these aid in HCP understanding of scientific information. That said, disclosures should be prominently displayed (via audio and text, if applicable) and shared through a medium that allows compliance, such as one with enough character limits to include all previously mentioned disclosures.
5. Importantly, SIUU communications should be separate from promotional communications about approved uses. For example, firms may use a separate webpage to host SIUU communications, not link SIUU communications on pages that host promotional content or deliver SIUU communications in separate emails from promotional content. Physical barriers between SIUU communications and promotional communications may include setting up dedicated conference spaces for promotional information. Central to maintaining this separation is clearly displaying the disclosures mentioned in the Guidance.
6. FDA included specific recommendations for disclosures and selection considerations to accompany specific source material such as reprints, clinical practice guidelines, reference texts and materials from digital clinical practice resources. These recommendations differ per source type, and firms should refer to this information in preparing SIUU communications.
7. Firm-generated presentations included in SIUU communications involve a firm creating and selecting their own material, which FDA notes poses additional considerations. Such presentations should include copies of source publications and clear disclosures of which content is firm-generated (e.g., “This presentation was developed by Firm X”). FDA warns that firm-generated presentations should not include representations inconsistent with the source publication about safety or effectiveness of the medical product for unapproved uses.

Aside from content considerations, firms should ensure that the individual delivering an SIUU communication is trained in ensuring truthful, nonmisleading scientific information about the medical product’s unapproved uses. Firms should also ensure that the individual is trained in answering questions spurred by SIUU communications or to direct questions to proper firm personnel.

For more information about SIUU communications and ensuring that SIUU communications are structured to benefit from the Guidance’s enforcement policy, please refer to the Guidance in full.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Kelly A. Bonner, Coleen W. Hill, Victoria (Tori) Hawekotte, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact. 

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.