{"id":33674,"date":"2025-02-18T16:14:16","date_gmt":"2025-02-18T15:14:16","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=33674"},"modified":"2025-06-16T16:39:13","modified_gmt":"2025-06-16T14:39:13","slug":"fda-finalises-guidelines-on-off-label-communications-in-the-u-s-for-medical-devices-and-drugs","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/02\/18\/fda-finalises-guidelines-on-off-label-communications-in-the-u-s-for-medical-devices-and-drugs\/","title":{"rendered":"FDA Finalises Guidelines on Off-Label Communications in the U.S. For Medical Devices and Drugs"},"content":{"rendered":"

FDA Finalises Guidelines on Off-Label Communications in the U.S. For Medical Devices and Drugs<\/span><\/h1>\n

On January 6, 2025<\/strong>, the FDA published a guide addressed to the drug and medical device industry entitled: \u201cCommunications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved\/Cleared Medical Products Questions and Answers Guidance for Industry\u201d<\/em>. This document provides clarification, including questions and answers, on the dissemination <\/strong>of scientific information to health care professionals (HCPs) <\/strong>regarding unapproved<\/strong> (off-label) uses<\/strong> of approved medical products<\/strong>. It is, therefore, Scientific Information on Unapproved Uses (SIUU). <\/strong><\/p>\n

Regulatory Framework, Off-Label Use and Objectives of the Guide <\/span><\/h2>\n

In the United States, off-label<\/strong> use refers to the use of drugs or medical devices for indications not approved<\/strong> by the FDA,<\/strong> including different dosages, modes of administration or patient populations. Off-label uses are not <\/strong>included in the official indications on the product label and instructions for use (IFU).<\/p>\n

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).<\/em><\/p>\n

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<\/strong> by manufacturers remains prohibited to the general public, but the dissemination of scientific information to healthcare professionals<\/strong> is permitted under certain conditions.<\/strong><\/p>\n

The objective of the guide<\/strong> is to provide a clear framework for sharing scientific information<\/strong> on unapproved uses, ensuring that such communications are truthful, not misleading, free of advertising intent<\/strong>, and appropriately present the strengths, limitations, validity and clinical utility of the information provided.<\/p>\n

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.<\/p>\n

Requirements for Off-Label Communication in the USA to Healthcare Professionals <\/span><\/h2>\n

Companies can share information from reliable scientific sources, including:<\/p>\n