Peter Marks Steps Down as Head of FDA’s CBER Amid Industry Concerns

Peter Marks, the longtime director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), has reportedly been removed from his position, sparking reactions across the biotech and public health sectors. The decision comes amidst ongoing debates about regulatory policies tied to the “Make America Healthy Again” initiative, which some critics argue lacks a fully informed approach to addressing public health challenges.

Marks’ departure has drawn attention due to his prominent role in overseeing vaccine approvals and biologics regulation during critical periods, including the COVID-19 pandemic. Observers have raised concerns about how this leadership change might impact both the biotech industry and broader public health efforts. Paul Knoepfler, writing for STAT News, characterized Marks’ removal as indicative of deeper tensions within current health policy frameworks. The move has prompted questions about future regulatory priorities at CBER and their potential implications for innovation in biotechnology and vaccine development.

Date: March, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後