In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, which focuses on how firms can communicate with healthcare providers (HCPs) regarding off-label uses of medical products. In describing this enforcement policy, the guidance balances the interest in preventing the marketing and sale of products that do not comply with premarket and labeling requirements with the understanding that HCPs may want scientific information regarding unapproved uses of medical products to make clinical decisions for the care of their patients.
In the guidance, “firm” or “firms” refers to persons legally responsible for the labeling of medical products and includes applicants, sponsors, requestors, manufacturers, packers, and distributors of medical products, and licensees of such persons, and any persons communicating on behalf of these entities. The guidance defines “SIUU communication” as firm-initiated communication of scientific information on unapproved use(s) of the firm’s approved/cleared medical product that (1) is shared with HCPs engaged in prescribing or administering approved/cleared medical products to individual patients; (2) includes disclosures recommended in the guidance; and (3) includes one or more source publications, such as published clinical reference resources. An SIUU communication can also include a firm-generated presentation of scientific information on unapproved use(s) from one or more source publications under certain circumstances explained in the guidance.
The guidance is presented as responses to five questions formulated by the FDA:
Question 1: What should firms consider when determining whether a source publication is appropriate to be included in an SIUU communication? The guidance advises that source publications in SIUU communications should describe studies and analyses that (a) are scientifically sound; (b) account for existing scientific knowledge (e.g., not refuted or retracted); and (c) include conclusions supported by results.
Question 2: What information should firms include as part of SIUU communications? The guidance recommends that firms include certain disclosures in the SIUU communication, including that the unapproved use has or uses have not been approved and whether any contributors to the publication(s) received compensation from the firm at the time.
Question 3: What presentational considerations should firms take into account for SIUU communications? The guidance recommends presentational considerations to help ensure SIUU communications enhance and do not interfere with an HCP’s understanding of the scientific information (e.g., clear and prominent disclosures and SIUU communications separated from promotional communications about approved uses).
Question 4: What additional recommendations apply to reprints, CPGs, reference texts, and materials from digital clinical practice resources that are included in an SIUU communication? The guidance offers detailed recommendations for each of these items, such as, reprints should not be altered or that reference texts should be published by an independent publisher that is in the business of publishing scientific or medical educational content.
Question 5: What additional recommendations apply to firm-generated presentations of scientific information on unapproved use(s) provided with a source publication? The guidance provides, among other things, communication techniques that would fall outside the scope of the enforcement policy, such as, celebrity endorsements, emotional appeals, gifts, promotional tag lines, jingles, premium offers and calls to value.
HCPs may find this guidance helpful when receiving SIUU communications from firms, and it offers an avenue to obtain such information.
Note that this guidance is not for current implementation. Provisions have been submitted to the Office of Management and Budget for review as required by the Paperwork Reduction Act. Before implementing this guidance, FDA will publish a notice in the Federal Register.