Kiss dissent and fade in the background
Dear Vinay: My publishers asked me to explain your return to Food and Drug Administration to readers. But I am more interested, at the moment, to give you advice.
Look, any statement I owe to clairvoyance is zero. I was surprised because anyone who is both by your evidence of the agency and your return, and I have no idea what you plan about Sarepta Therapeutics or comfortable vaccines or anything else.
But I looked at your climb of the medical iconoclast to the Internet provocateur to the government official. I also closely followed the FDA for 20 years, during which I interviewed countless agency officials, including several commissioners. Here is what I think you missed during your first three months and what I think you can do better when you return.
In short: you have to direct and to do this, you have to listen. And, ideally, you must fade in the background, make people pay attention to what the FDA, and not to you, can accomplish.
You have already received this kind of advice, and publicly from the researcher from Harvard University, Paul Sax, when you have been appointed director of the FDA biological assessment and research center.
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