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# New FDA Off-Label Guide Has ‘Challenges’: Lawyers
- URL: https://www.fdaweb.com/new-fda-off-label-guide-has-challenges-lawyers/
- Published: 2023-11-01T12:00:00.000Z
- Updated: 2026-09-14T14:14:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155700

Five Sidley Austin attorneys say a 10/24 FDA draft guidance on communications from firms to healthcare providers on unapproved uses of approved or cleared medical products raises many questions. Writing in an online [post](ttps://www.sidley.com/en/insights/newsupdates/11/fda-s-latest-off-label-guidance), the attorneys say the revision of a 2009 final guidance on off-label reprints reflects significant changes from the original.

First, they write, the new draft adopts new terminology for the communications it addresses, calling them communications of “scientific information on unapproved uses (SIUU).” Also, it expands the scope of the guidance to include two new communications types — materials from independent clinical practice resources and firm-generated presentations of scientific information from an accompanying published reprint.

Finally, they say, the draft introduces significant new standards and recommendations for:

- determining when a study or analysis is appropriate for communication under the guidance, in that it should be “scientifically sound” and “clinically relevant”;
- substantive disclosures to be included; and
- several new “presentational considerations,” including a recommendation to avoid “persuasive marketing techniques.”

“In general,” the attorneys write, “while the document provides useful discussion of two new types of communications that FDA recognizes as appropriate, the remainder presents challenges.” They offer these five practical takeaways:

- new types of communications are recognized as appropriate;
- the revised draft appears narrowly focused on communications intended to guide clinical decision-making;
- the revised draft does not expressly answer significant questions about who may be involved, or how, in SIUU communications;
- applying the new disclosure recommendations may be particularly challenging; and
- manufacturers face potential liability for off-label promotion based on communications that fully comply with the revised draft.