Vinay Prasads FDA Appointment Anything but Status Quo
# Vinay Prasad's FDA Appointment:
Anything but Status Quo
Keywords
- FDA Center for Biologics Evaluation and Research (CBER)
- Oncologist
- COVID-19 vaccine critic
- FDA policy criticism
- Regulatory standards
- Placebo-controlled trials
- Biotech industry impact
- Peter Marks replacement
Key Facts
Dr. Vinay Prasad, a hematologist-oncologist and professor at the University of California, San Francisco, has been appointed to lead the FDA's Center for Biologics Evaluation and Research (CBER)12. Prasad becomes just the third person to lead this division, which is responsible for reviewing biological drugs, including cell and gene therapies and vaccines1.
Prasad replaces Peter Marks, who resigned in March after 13 years leading the division. Marks reportedly left after conflicts with Health and Human Services Secretary Robert F. Kennedy Jr. regarding access to the Vaccines Adverse Event Reporting System12.
FDA Commissioner Dr. Marty Makary announced Prasad's appointment, stating that he "brings the kind of scientific rigor, independence, and transparency we need at CBER"4. Makary also praised Prasad's "long and distinguished history in medicine" and highlighted his oncology research2.
Prasad has published more than 500 academic articles and authored books on the medical field in 2015 and 20204. However, he is also known for being a vocal critic of the FDA and U.S. government's response to the COVID-19 pandemic2. He has questioned school closures, mask mandates, COVID booster shots, and vaccine recommendations for children24.
The biotech stock index XBI has fallen approximately 7% since the announcement of Prasad's appointment on May 7, 2025, indicating market uncertainty about his impact on the industry1. Industry executive Audrey Greenberg characterized Prasad as "anything but a status quo appointment"1.
Prasad's appointment comes as the FDA plans to require future vaccines to be tested through placebo-controlled trials, potentially signaling a shift in regulatory approach2.
Sources:
1. https://www.biospace.com/fda/vinay-prasads-fda-appointment-anything-but-status-quo
2. https://www.powershealth.org/about-us/newsroom/health-library/2025/05/07/dr-vinay-prasad-to-head-fda-vaccine-biologics-division
4. https://www.fiercepharma.com/pharma/fda-commissioner-marty-makary-taps-vinay-prasad-head-cber