The second of two policy briefs exploring the “valley of death” between FDA approval and Medicare coverage, this brief focuses on improving FDA processes to expand access to innovation. It explores three key reforms: product reviewer job redesign through the use of AI to support clinical and scientific evaluation; regulator-prompted clinical trial reform; and center-level organizational restructuring to expand the frontline workforce while reducing administrative overhead.
Key Takeaways:
- Modernizing Product Review: The review process is artisanal, and the use of AI can automate mundane tasks, improving review efficiency and empowering reviewers to function at a higher level, serving as a counselor to product developers to facilitate safe and effective innovation.
- Modernize Evidence Generation: The FDA can lower the regulatory risks for positive creativity in evidence generation, facilitating access to innovation and enhancing the diversity and real-world usefulness of therapeutics.
- Organizational Streamlining: Center-level organizational restructuring to expand the frontline reviewer workforce and redeploy middle management to serve the core mission of product innovation will boost support for small, innovative companies.
Crossing the Valley of Death, Part 2: FDA Reform by Hoover Institution
Cite this essay:
Ted Cho and Brian Miller, “Crossing the Valley of Death, Part 2: FDA Reform,” Hoover Institution, Healthcare Policy Working Group, July 2025.
