Trump FDA Chief Was 'Disgusted' by Riots, Stayed to Guide Agency: Q&A

(Bloomberg) -- Stephen Hahn, the outgoing U.S. Food and Drug Administration commission, in a 30-minute interview with Bloomberg talked about whether the FDA should be an independent agency, the Jan. 6 riots at the U.S. Capitol, the pandemic and what he'll do next.

The conversation has been edited and condensed for readability. 

Bloomberg: Are you ready to go?

Commissioner Hahn: I formally submitted my resignation – it was over a week ago. Today is my last official day. My office is packed up. It’s been an honor and a privilege to serve with the men and woman of FDA.

Bloomberg: What about this job went as expected? What was unexpected — either the role, or with this administration?

Commissioner Hahn: This administration could be described as a deregulatory. And of course we're a regulatory agency. So right off the bat there are some issues there. But that aligned with many things I was interested in – how could we use data to be more efficient, how do we spur innovations?

Bloomberg: What was unexpected?

Commissioner Hahn: The powerful influence that a presidential election year would have in decision-making on top of a public-health emergency.  I'm not naïve enough to think there wouldn't have been any influence. But given the fact that we were in a public health emergency and the priority was saving lives, the magnitude of that effect was surprising.

Bloomberg: Can you be specific about that?

Commissioner Hahn: The development of vaccines and the subsequent authorization were groundbreaking achievements. None of the steps were missing. It shows you what — when we put our minds to things and with appropriate resources and alignment — what we can get done. But what I think was surprising was there was pressure to do that even more quickly. There was pressure to push the timetable up.

Of course, it's the way out of this pandemic — so one totally gets that. But I think there was a relative lack of understanding that a lot of that was out of FDA's control. For example, when the data comes to us from a clinical trial is not something that FDA controls. It was a frustration on my part that that wasn't as clear to people.

Bloomberg: Were you ever pressured to make a decision on something that you had to refuse?

Commissioner Hahn: We received an application for an emergency-use authorization for hydroxychloroquine. There were pressures from all sorts of quarters, one, to authorize it, but also to not authorize it. Because much about hydroxychloroquine became political, that pressure was felt. I had to repeatedly tell people: the answer is based on the science and the data.

Bloomberg: Was that pressure from the White House? People there (including President Trump) were big advocates of the drug, despite a lack of evidence that it worked against Covid-19.

Commissioner Hahn: There was some pressure from the White House. There was certainly pressures from the Hill. A doctor’s group sued us.

Bloomberg: There was also a push by the Health and Human Services Department to do regular reviews of professional staff, “term limits,” that would have put in regular reviews of whether people should stay in their jobs, I believe.

Commissioner Hahn: My major concern about that was that it has such far-reaching implications on public health and our mission, but also by the way, the mission of CDC, CMS, etc. That required a discussion. What would industry think about this? What would stakeholder groups, what would patient groups think?

If, for example, an FDA center director knew his or her term was up, and it was a situation like this past year, would there be even subconscious pressure to make a decision one way or the other — knowing that the ultimate authority allowing you to stay in your position rested with the secretary of Health and Human Services?

Bloomberg: Were you consulted about the idea?

Commissioner Hahn: No, I was not.

Bloomberg: When we spoke for the first time in August, I asked you if the FDA should be an independent agency. What do you think about that now?

Commissioner Hahn: We need a discussion now. I would be in favor of that if there was the appropriate balance between oversight and independence.

I think the scientific independence is so important. One thing we've learned from the pandemic is that the public has confidence in the FDA when it believes when it believes that the FDA has scientific independence. That's critical. On the other hand, I think the agencies, even independent agencies, there needs to be accountability. So as long as we can find that balance and have a discussion, I would be in favor of it.

Bloomberg: What happened to form your view on that?

Commissioner Hahn: The president gets to determine the overall approach to policy. That’s what he or she was elected to do. I think that's appropriate. However, when I think about the significance of the decisions that are made at FDA, the fact that they do need to be made on the basis of science and data, it was just heightened by the pandemic. So I’ve evolved in my thoughts about this.

Bloomberg: You’re a cancer doctor by training. Your predecessor proposed removing nicotine from cigarettes as a way to get people to stop smoking. But that policy disappeared from the FDA’s agenda late in 2019. What happened?

Commissioner Hahn: I don't know what happened to it, but it was gone before my tenure started.

I have seen the scourge of combustible tobacco products and how that has affected the health of real people. I think we should be making every effort we can as a country to eliminate nicotine addiction and the use of combustible tobacco products. I realize that may not be a popular point of view.

Bloomberg: What was your personal opinion of the January 6 riots in Washington? Did it make you feel differently about having served in this administration?

Commissioner Hahn: It has been an honor to serve the American people, and it has been an honor and a privilege of my professional career to serve alongside the 18,000-plus FDA employees. They are true heroes in this response to the Covid-19 pandemic and I’m honored to have been with them. That has not changed.

Now, with respect to January 6 — I was horrified and I was disgusted by what happened. We live in a democracy. There is no place for what we saw and those who are responsible for the actions that took place on the physical grounds of the Capitol should be held accountable.

Bloomberg: Did you think about resigning?

Commissioner Hahn: We have a lot of things going on that are important from a public health point of view that required my attention and the senior leadership's attention. Making a statement with a resignation certainly was a topic of consideration. I think our public health mission and the need to provide leadership during a very critical time was more important.

Bloomberg: What will you do next?

Commissioner Hahn: I haven’t decided. I'm going to take some time off. My wife and I are going to spend some time after this  past year, and then I'm going to regroup and think about what I'm going to do. I still have my medical licenses. 

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