Overview

• Vinay Prasad resigned as CBER director on July 28 after reports that President Trump ordered his removal despite official statements that he left to spend time with his family.
• Prasad had sparked backlash by overruling agency reviewers to limit COVID-19 vaccine authorizations and by moving to suspend Elevidys, a Duchenne muscular dystrophy gene therapy.
• His departure was praised by pharmaceutical investors and patient advocates but alarmed FDA scientists who warned it undercuts evidence-based regulation.
• George Tidmarsh, a biotech entrepreneur with deep industry ties, assumed leadership of the FDA’s Center for Biologics Evaluation and Research (CBER) this week.
• Critics caution that Tidmarsh’s appointment may tilt policy toward faster market approvals and weaken trial standards for emerging therapies.