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Decisions Will Be Made on Science Alone

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This transcript has been edited for clarity.

Eric J. Topol, MD: Hello. I’m Eric Topol, editor-in-chief of Medscape, and I have the privilege today to interview Dr Stephen Hahn, the commissioner of the FDA. So, Stephen, welcome. It’s great to have you with us.

Stephen M. Hahn, MD: Well, Eric, it’s great to be here. I appreciate the invitation. And I’m looking forward to our conversation. These are really important topics for the country.

Topol: No question. Just as a way of background. Dr Hahn came on as commissioner of the FDA in December. I don’t think he knew exactly what he was getting into. He has an amazing background. Undergraduate at Rice and Temple for medical school. We actually shared some history at the University of California, San Francisco, where he did his medical residency. He was also trained at NIH in oncology. He went on to have an illustrious career. He was at the University of Pennsylvania where he was chair of the radiation oncology department, and from there he moved to the University of Texas MD Anderson Cancer Center, where he was the chief medical executive. So, quite a pedigree background, Steve, that got you ready for this tough mission ahead.

Hahn: Thank you.

Topol: It’s remarkable how we came together. We didn’t know each other until I sent you a very tough letter back on August 31 about the convalescent plasma decision. Little did I know that it would be a blessing because it would bring us together. Dr Hahn was kind enough to get in touch with me and we’ve actually become friends. I’ve developed immense trust in him and his efforts. We’re going to get into that with respect to vaccines and monoclonal antibodies today.

Let me start off, Steve, with the acronym of the day: EUA. Can you tell us what that is and how it’s become kind of center stage in the midst of the pandemic?

Hahn: Eric, first of all, when you sent the letter — I have to tell you, I learned this in medicine: You run toward friction and you talk to people about things. I very much appreciated your communicating with me. And I feel the same way. So thank you.

It’s hard to believe that EUA, or emergency use authorization, has become part of the lexicon of the United States, maybe the world. After the 9/11 terrorist attacks, we received this authority from Congress to issue EUAs to allow for medical products to get into the hands of providers and patients before the full set of data were available that we would normally use during our regular approval process.

There are two important points of EUA. One is that, from a treatment or a therapeutic point of view, the standard is “may be effective.” There has to be evidence that something may be effective. We have to have data behind that.

The other one is