"REFILL" | Dr. Brian Miller on FDA Regulatory Reform and the Valley of Death in Medical Innovation (Originally Aired: March 21, 2025)

In this "Refill" episode, Joe Grogan sits down with Dr. Brian Miller to discuss the "Valley of Death" - the gap between FDA approval and CMS coverage - and how regulatory reform can accelerate medical innovation. Miller explains how FDA product review can be made more efficient through automation and algorithmic analysis of routine tasks, allowing highly trained reviewers to focus on clinical interpretation rather than data processing. The conversation covers clinical trial reform, device review modernization, third-party review programs, and CMS coverage decision processes. Miller argues that these are operational challenges that can be fixed with executive leadership, and that transforming FDA and CMS procedures is critical to bringing new medicines and devices to patients faster.

Key Timestamps

1:23 Brian Miller background and AEI role 2:47 The Valley of Death - gap between FDA approval and CMS coverage 5:06 Making FDA and CMS review processes more synergistic 7:43 Example of hypertension drug review and routine tasks 8:26 Data overload in FDA review process 10:40 Supplemental applications and unnecessary information 12:01 FDA reviewer burnout and middle management proliferation 15:30 Automating routine tasks at FDA 17:33 Clinical trial reform discussion and regulatory risk 20:03 Practical approach for new FDA commissioner and DOGE 21:22 Operational changes needed at FDA 22:48 Tobacco regulation at FDA and resource allocation 25:10 Device world getting short shrift in FDA priorities 27:33 Third-party 510k review program and third-party organizations 29:09 COVID diagnostic tests and pandemic review process 30:51 Reforming CDRH through third-party reviews 31:36 70-year comparison of heart attack treatment advances 32:46 CMS coverage decisions and Coverage with Evidence Development 36:02 Medicare Administrative Contractors (MACs) and local coverage decisions 38:12 Practical market-based approach to MAC appeals 39:54 National vs local coverage decisions and reasonable and necessary standard 42:28 Defining reasonable and necessary through algorithms and guidance

Key Topics FDA regulatory reform, Valley of Death, clinical trial reform, FDA product review automation, CMS coverage decisions, Medicare Administrative Contractors, third-party device review, drug development costs, medical innovation, device regulation, regulatory science, operational efficiency

About the Guest (at time of recording, March 2025) Dr. Brian Miller is a physician and non-resident fellow at the American Enterprise Institute (AEI) focusing on FDA regulatory policy and Medicare payment policy. He practices medicine at Johns Hopkins Hospital and serves as an associate professor of medicine and business at Johns Hopkins University. His research and policy work emphasize making regulatory systems more efficient to accelerate the development and approval of innovative medicines and medical devices.

Podcast: DC EKG with Joe Grogan Host: Joe Grogan Guest: Dr. Brian Miller

Sponsor: Survivors for Solutions Executive Producer: John CZ Czwartacki, DC EKG Podcast