1. A Storm at the Helm: Leadership Shakeups

In early August 2025, Dr. Vinay Prasad—director of the FDA’s Center for Biologics Evaluation and Research (CBER)—resigned following fierce pressure from conservative activists and biotech critics. The controversy stemmed from his decision to halt delivery of Sarepta Therapeutics’ gene therapy Elevidys, meant to treat Duchenne muscular dystrophy, after reports of patient deaths. Public backlash from families and libertarian groups swiftly forced the FDA to reverse its decision, culminating in Prasad stepping down under duress.The Washington PostAP News

Yet just two weeks later, Prasad was unexpectedly reinstated with backing from FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr. While his return initially lifted investor optimism, biotech stocks soon faltered amid ongoing political volatility.Barron’sFinancial TimesPolitico

2. Innovation on the Move: Biotech Losing Confidence

Rampant layoffs, reorganization, and policy ambiguity within the FDA have prompted biotech companies and drug reviewers to reconsider the U.S. as ground zero for early-stage drug development. Some are opting to launch trials in Europe or Australia first, citing more stable regulatory environments abroad.Reuters

The “revolving door” problem is worsening: up to 600 FDA drug reviewers have recused themselves from duties while interviewing with pharmaceutical firms, eroding operational stability and raising conflict-of-interest concerns.STAT