December 12, 2024 5pm London, UK time This panel will critically examine the recent FDA approval processes for oncology and Alzheimer's treatments. Can a case be made for “regulatory capture?”  This discussion will highlight specific cases where the FDA's decisions have sparked controversy, focusing on concerns about the accelerated approval pathways, the reliance on surrogate endpoints, and the pressure to approve drugs with limited efficacy and safety data. Experts will dissect the balance between the fear-driven alleged urgency to provide new treatments to patients and the necessity of maintaining rigorous standards to ensure these treatments' safety and effectiveness. By exploring and comparing these high-profile examples, the panel aims to shed light on systemic issues within the FDA's regulatory framework, debating the influence of pharmaceutical lobbying, the potential for conflicts of interest, and the broader implications for public health. This dialogue seeks to provide actionable insights into how the FDA can reform its approval process to better serve patients and the medical community.

Speakers: Chair: Peter Whitehouse, MD, PhD

John H. Powers, MD (George Washington University School of Medicine)

Joel S Perlmutter, MD  (Washington University St Louis)

Antonio Tito Fojo, MD (Columbia University)