IC 303-2023: 'Hype, Promise, and Reality: Orthopedic Use of Biologics in 2023'-IC 303 - 'Hype, Promise, and Reality: Orthopedic Use of Biologics in 2023' (3/5)

Video Transcription

Video Summary

In the video, the speaker discusses the FDA's regulations on musculoskeletal biologics and provides an overview of the current state of the market. The speaker explains the definition of biologics according to the FDA, which includes various products such as vaccines, blood products, gene therapies, and recombinant therapeutic proteins. They also discuss the jurisdiction of biologics and how they are regulated by different departments within the FDA. The speaker highlights the criteria for human tissue, cellular, and tissue products, and explains the difference between 361 products and 351 products. They mention some examples of regulated and non-regulated products and the challenges faced by healthcare providers who have used products that were under enforcement discretion. The speaker cautions about the potential dangers of unproven cell therapies and emphasizes the importance of FDA regulation to ensure patient safety. They also mention some examples of FDA-approved biologic products for cartilage repair and the challenges faced in getting these products to market. The speaker provides the AAOS position statement on the use of emerging biologic therapies and emphasizes the need for informed consent and the use of approved biologic products. They encourage healthcare providers to stay informed, document appropriate informed consent, and be skeptical of illegal or unproven products. The speaker concludes by providing resources for further information and offering their assistance for any questions. No credits were mentioned in the video.

Asset Caption

Stephen Weber, MD

Keywords

FDA regulations

biologics definition

enforcement discretion

patient safety

informed consent