The Readout Loud
352: A firebrand takes oversight of vaccines, gene therapies
May 8, 2025
Matt Herper, STAT's senior medicine writer with a knack for dissecting the pharmaceutical industry, joins the conversation to discuss the controversial appointment of Dr. Vinay Prasad as head of the FDA's vaccine division. He and Adam delve into how Prasad's unorthodox views could disrupt public health norms. They also explore the implications for gene and cell therapy approvals and the broader challenges facing biotech innovation under new leadership. The dialogue highlights the tension between regulatory reform and maintaining expert oversight in a rapidly evolving landscape.
26:28
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Quick takeaways
- Dr. Vinay Prasad's appointment as head of the FDA's biologics center raises concerns about regulatory impact due to his outspoken history.
- His leadership could shift the FDA towards stricter standards, affecting biotech relationships and possibly hindering market entry for new therapies.
Deep dives
Vinay Prasad's Controversial Appointment at the FDA
The appointment of Dr. Vinay Prasad to lead the FDA's Center for Biologics Evaluation and Research, which is responsible for the regulation of vaccines and gene therapies, has stirred significant discussion. Prasad's history as a vocal critic of the FDA and drug clinical trials complicates his new role, raising concerns about how his past opinions might influence future policies. He has gained notoriety for his sharp critiques of COVID-19 protocols, particularly surrounding vaccines and masking for children, which has polarized public opinion. While many applaud his critical stance, others worry that his abrasive approach on social media could undermine the credibility and integrity of the regulatory process he is now overseeing.
