In the Know Will Pickering: FDA Under Trump, A New Era of Regulation
Mar 3, 2026
Will Pickering, Senior U.S. biotech analyst at Bernstein Research, gives a concise mini bio and dives into FDA inspection trends, headcount cuts, and shifts in regulatory standards. He outlines five major policy changes under the current administration. Short takes cover inspection types, approval backlogs, and which biotech names face heightened regulatory risk.
AI Snips
Chapters
Transcript
Episode notes
Examples Of Inconsistent Individual FDA Decisions
- Will Pickering cites Unicure, Replimune, and Sarepta as examples of inconsistent FDA decisions reversing prior guidance or issuing rejections.
- Unicure lost pre-study assurances; Replimune got a CRL after breakthrough designation; Sarepta's market pull was handled abruptly.
Approval Rates Rose After Obama But Standards Shift Over Time
- Approval counts rose vs Obama years; 2010s saw regulatory flexibility especially for gene therapy, but current trend appears stricter with higher evidence standards.
- Will argues increased trial volume and a larger application funnel partly explain higher recent approvals.
Leadership Inexperience Is Driving FDA Instability
- Will Pickering finds leadership concerning: Macri and deputies lack large-organization experience, high turnover at CDER, and controversial appointments like Vinay Prasad.
- Reported management style issues include demands for resignations and rapid senior exits (five CDER heads in 2025).