FDA Issues Revised Draft Guidance on “Off-Label” Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain

Lexology November 2, 2023
Dechert LLP

Key Takeaways

• The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products.
• The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on “Distributing Scientific and Medical Publications on Unapproved New Uses.”
• The Revised Draft Guidance expands the scope of permissible communications, yet limitations and restrictions remain.
• FDA continues to exercise enforcement discretion for communications that are consistent with the recommendations in the guidance.

On October 23, 2023, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.”¹ This revised draft guidance supersedes FDA’s 2014 draft guidance document, “Distributing Scientific and...

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