Dear Vinay: My editors asked me to explain your return to the Food and Drug Administration to readers. But I’m more interested, right now, in giving advice to you.
Look, any claim I have to clairvoyance is void. I was surprised as anyone by both your ouster from the agency and your return, and have no idea what you’re planning regarding Sarepta Therapeutics or Covid vaccines or anything else.
But I’ve watched your rise from medical iconoclast to internet provocateur to government official. I’ve also followed the FDA closely for 20 years, during which time I’ve interviewed countless agency officials, including multiple commissioners. So here’s what I think you missed in your first three months and what I think you can do better upon your return.
In short: You need to lead, and to do that you need to listen. And, ideally, you need to fade into the background, making people pay attention to what the FDA, and not you, can accomplish.
You’ve gotten this kind of advice before, and publicly, from Harvard University researcher Paul Sax, when you first were named the director of the FDA’s Center for Biologics Evaluation and Research.
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