The sudden ouster of FDA official Vinay Prasad from his role running the agency’s biologics division has sparked controversy in the biotech industry. This move comes after a series of decisions on Sarepta’s gene therapy for Duchenne muscular dystrophy, which were met with criticism from conservative voices.
To discuss the implications of this development, we brought in Brian Skorney, senior research analyst at Baird. We also had Robert Califf, former FDA commissioner, and Ned Sharpless, former acting FDA commissioner, share their insights on what this change means for the agency.
For more information on what led to Vinay Prasad’s removal, visit [link]. Adam and Matt also shared their perspectives on the impact of this move – one arguing it may not be beneficial for biotech, while the other worried about its effects on the FDA.
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Source: https://www.statnews.com/2025/07/31/readout-loud-podcast-fda-vinay-prasad-sarepta-duchenne-trump