Health Law Highlights

FDA Issues Revised Off-Label Communications Guidance

From Jones Day, by Anthony Dick, Harrison Farmer, Colleen Heisey, Laura Laemmle-Weidenfeld, Rebecca Martin:

  • The FDA has issued a revised draft guidance on the sharing of scientific information with healthcare providers (HCPs) regarding unapproved uses of approved/cleared medical products.
  • The 2023 Guidance expands the scope of recommendations to include independent clinical practice resources and firm-generated presentations of scientific information.
  • It introduces a new evidentiary standard for source publications and emphasizes the importance of truthful, non-misleading, factual, and unbiased communications.
  • The guidance also provides presentational considerations, such as clear disclosures, avoidance of persuasive marketing techniques, and the use of plain language.
  • Comments on the guidance can be submitted until January 5, 2024.