Exclusive: FDA reviewers didn't get to vote on first priority voucher drug

In major break from precedent, Vinay Prasad, George Tidmarsh, Tracy Beth Høeg, and other top leaders led the decision.

Log In    Subscribe Exclusive   FDA review staff was excluded from voting on whether to approve first priority voucher drug By Lizzy Lawrence Adobe STAT has learned that when the FDA voted on whether to approve the first product from a Commissioner's National Priority Voucher recipient in October, the voting members did not include the review team. Instead, the voting panelists were leaders from the top of the agency, according to three agency sources.    It is not clear what the outcome was. The agency has not yet publicly announced the approval decisions for any of the voucher recipients, but STAT has obtained the list of officials who voted. READ MORE Sign up for Biotech Scorecard Unfiltered, uncompromising analysis on the biotech world. Learn more. More on the FDA How the first nine drug companies won priority review vouchers from Marty Makary's FDA By Lizzy Lawrence Exclusive: How two top FDA officials are quietly upending vaccine regulations By Lizzy Lawrence Exclusive: Inside FDA, career staffers describe how political pressure is influencing their work By Lizzy Lawrence Experts worry FDA's credibility is being shredded by scandal and 'soap opera' By Matthew Herper and Lizzy Lawrence Don't miss out on another STAT investigation Unlock the world of health and medicine with a subscription to STAT+ Learn more STAT, 1 Exchange Place, Boston, MA ©2025, All Rights Reserved. I no longer wish to receive STAT emails Update Newsletter Preferences • Contact Us • Advertise with Us