The FDA experienced major upheaval in 2025 with leadership changes, including Commissioner Martin Makary and Vinay Prasad facing criticism for a toxic work environment, staff departures, and inconsistent review timelines.1
Inconsistent standards emerged:
Makary proposed single Phase 3 trials for approvals while Prasad heightened requirements for vaccines and cancer therapies, frustrating biotechs and investors.1
Analysts from RBC and William Blair highlight regulatory unpredictability as a top investor concern, with flip-flopping on submissions and political influences adding to perceptions of chaos.12
Vaccine scrutiny intensified under RFK Jr. and FDA leaders, including stricter approvals and VAERS investigations, leading to policy shifts like reduced childhood shots and eroding trust.1
Despite tensions, some positive FDA moves like redacted response letters exist, but overall consistency is demanded; biopharma regained footing in 2025 amid M&A optimism for 2026.12
Sources:
1. https://www.biopharmadive.com/news/biotech-pharma-outook-2026-trump-rfk-china-fda/808670/
2. https://www.fiercebiotech.com/biotech/2026-outlook-biotech-poised-outperform-bear-markets-21-24-analyst-says