Hype, Promise and Reality: Orthopaedic Use of Biologics in 2020 (AANA20)-The FDA View of Musculoskeletal Biologics_ Where We Are in 2020

The FDA View of Musculoskeletal Biologics_ Where We Are in 2020 – The Truth-Dr. Stephen C. Weber

Video Transcription

Video Summary

Steve Weber discusses the FDA's regulatory framework for biologic products, emphasizing the distinction between minimally regulated 361 and more strictly regulated 351 products. Key issues include "minimal manipulation" and "homologous use" criteria, which complicate regulation. The FDA uses warning and untitled letters to enforce compliance, especially due to risks like infections and severe adverse events from unregulated stem cell use. Recent regulatory changes may reclassify some products. Weber stresses the importance of informed patient consent and caution due to limited evidence supporting many biologics, highlighting ongoing challenges in balancing innovation, safety, and enforcement in biologic therapies.

Keywords

FDA regulatory framework

biologic products

minimal manipulation

homologous use

patient consent