Pricey Vinay: My editors requested me to elucidate your return to the Meals and Drug Administration to readers. However I’m extra , proper now, in giving recommendation to you.
Look, any declare I’ve to clairvoyance is void. I used to be shocked as anybody by each your ouster from the company and your return, and don’t know what you’re planning relating to Sarepta Therapeutics or Covid vaccines or the rest.
However I’ve watched your rise from medical iconoclast to web provocateur to authorities official. I’ve additionally adopted the FDA carefully for 20 years, throughout which era I’ve interviewed numerous company officers, together with a number of commissioners. So right here’s what I feel you missed in your first three months and what I feel you are able to do higher upon your return.
Briefly: It’s good to lead, and to do this you have to hear. And, ideally, you have to fade into the background, making folks take note of what the FDA, and never you, can accomplish.
You’ve gotten this sort of recommendation earlier than, and publicly, from Harvard College researcher Paul Sax, while you first have been named the director of the FDA’s Middle for Biologics Analysis and Analysis.
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