"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