FDA finalizes guidance on off-label communications

The US Food and Drug Administration (FDA) finalized guidance to industry on allowable communications to health care providers about off-label drug and device uses.

The Q&A document, issued on 6 January 2025, outlines the agency’s enforcement policy for firm-initiated communications to health care providers that contain scientific information on unapproved uses (SIUU) for approved or cleared drug and device products.

“FDA is issuing this guidance to provide reassurance to firms that, if they choose to provide communications consistent with the recommendations of this guidance, FDA does not intend to use the firm’s dissemination of such communication standing alone as evidence of a new intended use. Additionally, FDA does not expect a firm to submit such a communication to the Agency at the time the communication is initially shared with HCPs,” the agency wrote.

The final guidance applies to firm-initiated communications of SIUU based on published scientific or medical journal articles (reprints) and published clinical reference resources, such as clinical practice guidelines, reference texts and digital clinical practice resources. It also applies to firm-generated presentations that include these sources. The guidance is aimed at balancing the need for premarket review with clinician interest in scientific information about off-label uses.