The Readout Loud 363: What Vinay Prasad’s ouster means for biotech and the FDA
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Jul 31, 2025 
In this discussion, guests Brian Skorney, a senior research analyst at Baird, Ned Sharpless, former acting FDA commissioner, and Robert Califf, former FDA commissioner, delve into the impact of Vinay Prasad's departure from the FDA. They examine the political turbulence influencing FDA operations and the biotech sector, especially regarding drug approvals and leadership changes. The conversation highlights the challenges of regulatory integrity, the evolving landscape of gene therapies, and the urgent need for improved data collection in post-marketing drug safety.
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Vinay Prasad's Controversial Persona
- Vinay Prasad began as an ardent advocate for evidence-based medicine, focusing on rigorous drug efficacy and safety.
- He evolved into a combative online figure whose strong opinions polarized the biotech and regulatory communities.
FDA May Shift To More Flexibility
- Prasad's removal will likely lead to more regulatory flexibility at the FDA, especially for rare and orphan diseases.
- His strict stance caused significant pushback and pressure, indicating a return to a more lenient review approach.
Political Pressure Threatens FDA Stability
- Political pressure and turnover at the FDA create instability and chaos in decision-making.
- This environment hampers the FDA’s competence and threatens timely, consistent drug reviews.