FDA’s New Guidance on Off-Label Information Sharing
(Thursday, October 26, 2023)
FDA’s enforcement policy for the distribution of off-label or unapproved information by manufacturers has come a long way in the last decade; from very conservative to reasonably flexible where companies can share off-label information freely provided they follow some basic rules prohibiting overt promotion using such information. This week’s new FDA guidance adds to the previous similar guidance docs by providing more details regarding the FDA policy. The guidance emphasizes that this is in line with the previous guidelines and not a new policy.
Off-label information or unapproved information is an intended use of an FDA-approved product that is not included in the labeling approved by the FDA. Legally such information must be reviewed by the FDA and approved as supplemental approval prior to commercial use. However, frequently, off-label information may become available prior to it being presented or reviewed by the FDA during clinical experience with a given product. Physicians could become aware of such off-label information through a variety of sources such as published literature, presentations at conferences, scientific discussions, and peer-to-peer information sharing. The FDA acknowledges that scientific or medical information regarding unapproved uses of products may help health care providers make better decisions regarding a patient, such as where the patient has a disease for which there is no approved/cleared treatment, where the patient is part of a population that has not been studied, or where all approved/cleared treatments have been exhausted. However, there is a fine balance between the public interest in helping a patient and the malicious use of dubious off-label information for commercial use by circumventing the FDA review and approval of such use.
The FDA used to have a very strict enforcement policy for companies accused of discussing off-label information. However, that policy was successfully legally challenged as it could conflict with the First Amendment rights of an individual regarding free speech. To balance the public interest in disclosing off-label information and the First Amendment rights, the FDA revised its enforcement policy to specifically prohibit false and misleading information only, and not all off-label information discussions. Under this policy, firms are allowed to distribute scientifically sound and clinically relevant information such as that generated from a controlled clinical trial, scientifically validated real world data, or other similar credible studies. Any information that does not meet the above criteria is not permitted and is subject to enforcement actions.
This policy has been described in guidance documents and other publications by the FDA over the last decade. The new guidance released this week provides additional clarifications of the previous documents with examples, case studies, and reference material. Overall, as the guidance states, this does not create new policies but clarifies those that have been described over the last decade.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC