On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, Questions and Answers (the “2023 Draft Guidance”). The 2023 Draft Guidance is a revision to, and builds upon, FDA’s 2014 draft guidance on the same issue, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, which itself was a revision to FDA’s 2009 guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. Drug and device manufacturers (“firms”) will note that in the 2023 Draft Guidance, FDA introduces multiple new concepts. Addition of terms such as “SIUU Communications” and “Firm-Generated Presentations” appear to broaden the possibilities for firms’ communications with healthcare providers (“HCPs”) while inclusion of concepts such as “scientifically sound” and “clinically relevant” can be read as imposing certain limitations on what can be included in SIUU Communications. FDA’s inclusion of these new concepts provides both guidance and guardrails for firms to ensure SIUU Communications with HCPs stay in line with FDA regulatory requirements. With the 2023 Draft Guidance, FDA continues to be thoughtful and intentional with its views on communications between firms and HCPs, and demonstrates to industry that the agency will continue to evolve its thinking with the advent of new technologies, advancements in science, medicine, and the delivery of care, and in light of the ever-changing modes and methods of communication.Continue Reading From Good Reprint Practices to SIUU Communications: What Firms Need to Know