For years, the wisdom in biopharma was that you don’t pick a fight with the FDA in public. But that’s changed over the last year, as biopharma companies have become increasingly critical of what they see as moving goalposts for trials and approvals.
Today at 12 p.m. ET on Post-Hoc Live, we’ll be discussing whether Tuesday’s news that the FDA was refusing to review Moderna’s mRNA flu vaccine represents a breaking point. You can join us on YouTube to watch live and set a calendar reminder here.
Moderna walked right up to the line of saying the regulator — and its vaccines chief Vinay Prasad — aren’t being fair brokers. There’s some nuance here: Every administration comes with a change in regulatory priorities. But to an outside observer, it’s hard not to see bias, given the very public, very critical prejudgments by current Trump administration health officials about mRNA vaccines and some gene therapies.
I’ll be talking with our very own Zach Brennan and Max Bayer, who have been covering the FDA, the Trump administration’s vaccine approach and Moderna all year, as well as Tom Randall, the head of Endpoints Signal, who just released an analysis of how industry leaders feel about the FDA right now.
See you in a few hours!
— Drew Armstrong, Executive Editor
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