Lawyers Critique Guide on Unapproved Use Dissemination

A final guidance released earlier this month on communicating scientific information to healthcare professionals (HCPs) about unapproved uses of medical products emphasizes the importance of selecting appropriate source publications to share, and companies should select those that “describe scientifically sound studies and analyze and use generally accepted design and methodological standards,” according to a client alert from the law firm Duane Morris. “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,” the alert says.

To be compliant with recommendations in the guidance, Duane Morris says that all scientific information on unapproved uses (SIUU) “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.”

Other key points in the guidance summarized by Duane Morris include:

1. If distributing 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 Firms should consider if current data/information has superseded any study conclusion, and if so, they should discontinue its use.
2. SIUU communications should be prepared with disclosures, including an express statement that the discussed use is unapproved and safety and effectiveness for that use have not been established. Firms should also provide a product’s approved label, including contraindications, use limitations, and restrictions. Additional disclosures should disclose if the SIUU author was compensated by the firm, and if any study details were not provided in the source publication.
3. SIUU communications should not be included with any promotional communications about approved uses.

Additionally, the guidance says firms should ensure that the individual delivering an SIUU communication is trained in providing 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,” the alert says.