Explore crucial aspects of topics such as unapproved use and intended use, and the First Amendment legal decisions underlying these concepts. Discuss guidance documents FDA has issued on this topic, as well as special circumstances regarding dissemination of use information.

Why It Matters and What It Means

• First Amendment Jurisprudence: Central Hudson, Washington Legal Foundation v. Henney, Caronia, and Other Key Decisions
• Key Concepts: Intended Use, Unapproved Use, and Practice of Medicine
• FDA Final Guidance: Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers
• FDA Final Guidance: Medical Product Communications that are Consistent with the FDA-Required Labeling – Questions and Answers
• Good Reprint Practices
• Scientific and Educational Activities, Including Continuing Education
• Role of Medical Science Liaisons (MSLs); Unsolicited Requests for Information by Medical Professionals

Gillian M. Russell, Counsel, King & Spalding LLP

This session was recorded as part of FDLI’s Virtual Introduction to Advertising and Promotion for Medical Products Course in October 2022.