FDA Finalises Guidelines on Off-Label Communications in the U.S. For Medical Devices and Drugs
On January 6, 2025, the FDA published a guide addressed to the drug and medical device industry entitled: “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers Guidance for Industry”. This document provides clarification, including questions and answers, on the dissemination of scientific information to health care professionals (HCPs) regarding unapproved (off-label) uses of approved medical products. It is, therefore, Scientific Information on Unapproved Uses (SIUU).
Regulatory Framework, Off-Label Use and Objectives of the Guide
In the United States, off-label use refers to the use of drugs or Medical Devices for indications not approved by the FDA, including different dosages, modes of administration or patient populations. Off-label uses are not included in the official indications on the product label and instructions for use (IFU).
Under current law, corporate disclosure of such unapproved uses could be considered evidence of a new ‘intended use’, with the risk of regulatory violations, i.e., the product could be considered ‘misbranded’ under the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
However, the FDA recognises that healthcare professionals may need access to scientific data to make informed clinical decisions. Consequently, off-label communication in the US by manufacturers remains prohibited to the general public, but the dissemination of scientific information to healthcare professionals is permitted under certain conditions.
The objective of the guide is to provide a clear framework for sharing scientific information on unapproved uses, ensuring that such communications are truthful, not misleading, free of advertising intent, and appropriately present the strengths, limitations, validity and clinical utility of the information provided.
FDA addressed this issue back in 2009 with an initial guide, updated in 2014 and then in October 2023. The final version of 2025 incorporates the feedback received and reiterates the importance of providing valid scientific information without encouraging unapproved uses.
Requirements for Off-Label Communication in the USA to Healthcare Professionals
Companies can share information from reliable scientific sources, including:
- Published scientific or medical articles
- Clinical Practice Guidelines (CPGs)
- Reference scientific documents
- Materials from digital resources for clinical practice
For such information to comply with FDA guidelines, it must meet certain basic requirements:
- Be based on authoritative and independent scientific publications
- Not to be selected in a partial or distorted manner
- Be accompanied by transparency statements clarifying the unapproved nature of the discussed use
- Include original studies for completeness
- Specify the limits of the research, avoiding misleading interpretations
- Declare any conflicts of interest of the authors
- Not having promotional purposes or using persuasive marketing techniques
This guidance represents a further significant step in balancing the regulation of off-label communication in the US with the right of healthcare professionals to access up-to-date scientific information.
The guidance offers reassurance to companies sharing such information with healthcare professionals (HCPs), as the dissemination of these communications alone, if under the recommendations, will not automatically be considered evidence of a new Intended Use and, therefore, will be considered appropriate.
For further information, please consult the official FDA document.
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SOURCE:
https://www.fda.gov/media/184871/download
02/18/2025
