What Vinay Prasad’s ouster means for biotech and the FDA

Elaine Chen covers biotech, co-writes The Readout newsletter , and co-hosts STAT’s weekly biotech podcast, The Readout Loud . You can reach Elaine on Signal at elaineywchen.70. Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54. This week’s show is focused on a single topic — the ouster of Food and Drug Administration official Vinay Prasad from his job running the agency’s biologics division. This surprising development came after a series of controversial decisions he made on Sarepta’s gene therapy for Duchenne muscular dystrophy and a barrage of political attacks from conservative voices. We bring on Brian Skorney, senior research analyst at Baird, to talk about the implications for the biotech industry. We then have on Robert Califf, former FDA commissioner, and Ned Sharpless, former acting FDA commissioner, to discuss the implications for the agency. Advertisement For more on what led up to Vinay Prasad’s ouster, go here; to read Adam’s perspective on why this development isn’t necessarily good for biotech, go here; and to read Matt’s take on how it could hurt the FDA, go here. Be sure to sign up for “The Readout LOUD” on Apple Podcasts, Spotify, or wherever you get your podcasts.