In mid-December, Dr. Stephen Hahn, an oncologist who most recently worked as chief medical executive at MD Anderson Cancer Center in Houston, became the twenty-fourth commissioner of the federal Food and Drug Administration, the agency charged with ensuring the safety and efficacy of medical products and food. Hahn emerged as a front-runner for the post in early September after reports that he’d met with President Trump at the White House. Norman Sharpless, who was acting commissioner after Scott Gottlieb resigned from the post last April, had also been a finalist to get the job permanently. But some administration officials, Politico reported, were concerned that Sharpless’s history of donating to Democrats would “subject him to Senate scrutiny.” Hahn, by contrast, has given to GOP PACs and candidates in recent election cycles.
Critics have blasted the FDA in recent years for not doing more to prevent the opioid crisis, for approving drugs and devices based on too little data, and for failing to exercise oversight over potentially dangerous products like those including CBD or THC. During his Senate confirmation hearing in November, Hahn mostly dodged senators’ questions on contentious matters of policy—many of them focused on the Trump administration’s scaled-back ban on flavored e-cigarettes—and he likewise wouldn’t answer questions about policy in this interview with Texas Monthly, his first on-the-record interview as FDA commissioner. (A Department of Health and Human Services spokeswoman interrupted the conversation to decline to respond on his behalf, stating that it’s too early in his tenure for him to weigh in publicly.)
Hahn grew up in Philadelphia and spent the bulk of his career at the University of Pennsylvania, but he earned his bachelor’s degree at Rice University and returned to Texas in 2015 to join MD Anderson as division head for radiation oncology. In 2017, he was asked to help the medical center navigate a leadership crisis by accepting a newly created position, chief operating officer. In that role, he was widely credited for helping the hospital turn around its troubled finances.
Texas Monthly: Why’d you pursue oncology as a specialty?
Stephen Hahn: At the time I entered medicine, oncology was just entering this era of finding new therapies. Oncology was where neurology and neurodegenerative diseases are now—just at the cusp of having more and greater research lead up to better therapies for patients. It intrigued me because there was so much unmet medical need.
The other part I found incredibly compelling was that people told me over and over again, “Don’t go into oncology, it’s depressing.” It wasn’t depressing by any stretch of the imagination because people are scared—people need your help. You try to do your best, and you’re honest with them. You sit across the table and give them the best information that you can. We help them through the journey. You want the outcome to be outstanding, but of course, it isn’t always. But that journey and how you help people face that journey is incredibly compelling as a physician, and I will always treasure those experiences with my patients.
TM: In all your jobs that you took before, even when you took the chief operating officer and chief medical executive roles at MD Anderson, you made time to continue to do clinical work with patients. I assume you can’t do that anymore as FDA commissioner. Is that something you miss, having taken this job?
SH: You’re right. I’m not going to take care of patients in this job. It was a tradeoff. Besides my family, it’s my first love. But when you talk about what the FDA commissioner can do for American patients and the American public, I see this as a natural extension to that. Being able to help as many people as possible, which this agency does, gives me great comfort.
TM: How did you learn your name was being considered to head the FDA? What was your reaction?
SH: A little shock. I’m incredibly honored and humbled, but enthusiastic. I had, throughout my career as a cancer doctor and cancer researcher, depended upon the FDA. I don’t completely understand how it happened. I was contacted by folks from the White House Office of Presidential Personnel to ask if I’d be interested in public service. I had been asked if I would serve on the National Cancer Advisory Board and was going through that process, so I think my name probably became known through that process and had to go through some vetting. It kind of snowballed after that. I went to the Department of Health and Human Services in the spring or early summer of last year and interviewed for the job. Then, as you know, as reported in the press, I went to the White House.
TM: Did the president or anybody else at the White House or HHS give you an idea of why your name had risen to their attention?
SH: That was not a topic of discussion, and I’m not comfortable sharing confidential conversations that I’ve had. I can tell you that I very much enjoyed it. I am incredibly honored to have been nominated by the president for this role, which is, pinch myself, another lifelong dream.
TM: What insight does your experience at MD Anderson, and your career working with clinical trials, give you into how you will lead the FDA?
SH: One of the things that was reinforced for me in my time with MD Anderson is it’s really hard to lead without having frontline experience. At MD Anderson, if you’re not a frontline doctor or staff person, if you haven’t done that, if you don’t understand what that’s like, it’s really hard to get buy-in from the folks who are actually doing the hard work to take care of the cancer patients. So I think the fact that I have experience with FDA—frontline experience that was involved in cancer research, that I performed a number of clinical trials—I think that was helpful, in terms of understanding the importance of FDA’s mission. Now, at any new job there’s a steep learning curve, and there has been here. But the parallels to MD Anderson, from an operational point of view and culture point of view, are pretty similar.
TM: Were you wary about taking the job without government or policy experience?
SH: No, I’m not worried. I can’t imagine anyone coming into this job and not having gaps in their knowledge because of all the vast things that FDA does. I also knew that there was a team here that could help fill in those gaps. So it’s pretty comfortable. At the end of the day, it’s like MD Anderson—you can’t know everything that occurs in every corner of MD Anderson, but you can get up to speed fairly quickly and do your best to have coverage of all those things. I think the parallels here are pretty significant, and it’s very similar.
TM: The job must have been very appealing because you’ve described being at MD Anderson as your dream job. Then you get offered this job, and we do have an election coming up, so it might just last a year. What are the challenges at the FDA that you were excited to take on?
SH: Yes, the American people get to decide—and obviously the president gets to decide—how long I’m in this position, so your point is very well taken. This organization is, again like MD Anderson, amazingly committed to its mission of protecting the public health and ensuring the safety and efficacy of medical products. But 2019 was a difficult year for the agency. One, because of the government shutdown in the early part of the year and then the transitions in leadership that have occurred over the last year. But there is amazing resiliency here, and the incredibly important underlying work of FDA continues. That tells me that no matter what, no matter who’s at the helm, that great work is going to get done. So, from a 30,000-foot point of view, no matter how long I am in this position, how can I leave FDA in a better place than when I got here?
TM: During your Senate confirmation hearing, there was a phrase you repeated many times in responding to senators’ questions about your approach to various policy matters. It was “data-driven and balanced solutions that are congruent with the law.” How can the FDA do a better job of making data-driven decisions than it has?
SH: It’s like being a doctor. You use data. You use the underlying science to make decisions for individual patients. When you think about, programmatically, what you do for a larger group of patients who have a specific disease, it’s the same thing. Thank God, medical advances are happening at a rapid clip. Science is coming to the fore in ways that we never expected it—new gene therapies, the new cellular therapies. Really amazing advances are going to help the human condition.
The FDA needs to be adaptable and flexible for the changes in the data that are coming forward. So, one general example, the use of what’s often called “real-world evidence.” You have existing databases about what’s happening in the world: outcomes, treatments, etc. How can you use those data as a supplement to clinical trial data to make the most efficient and effective decisions for the American people?
The other part of this that’s really important is that our commitment to the gold standard of safety and efficacy at FDA is completely linked to the validity of the science and the data. But as the data sets we’re looking at change—and they must change—they’re going to be more complicated, more interrelated. They’re going to come from different sources. We have to be prepared to actually assess those data and do it in an efficient fashion. We can’t slow down innovation and getting it into the hands of the American people because we aren’t able to assess the data in a robust way.
TM: Isn’t there a tension between more quickly making available products that could potentially help people and not sacrificing safety? Aren’t there tradeoffs when you’re making those decisions?
SH: It’s kind of like being a doctor. The one tradeoff you never make is harming a patient. Now, are there times that patients are harmed by therapy after the risk-benefit ratio gets assessed? Yes. Nobody wants that, but you make the best decision with the information you have. It’s not dissimilar to this. We will never deliberately sacrifice our gold standard of safety and efficacy for efficiency. On the other hand, we live in an imperfect world. We have to live in that world, and we have to be practical and pragmatic and make the best decisions we can. It’s why our people resources are so important and why our commitment to informatics is so important because we’ve got to have the best tools available to us. I hear what you’re saying about tensions. We have to understand that we may need to revisit decisions as data change and as the speed of science and data catch up to those decisions.
TM: So how’s life in Washington? Is your wife already there with you?
SH: My wife is here with me. We live here with our Texas dog, who is the best dog ever. She does not like the weather at all. She’s a Texas dog, for sure. We got her when we were in Houston, but we both are enjoying our time in Washington, D.C. We very much miss Texas. Texas is our home. We still have two children in Texas, and our intention when we’re finished here in Washington is to go back home.
TM: Back to Houston?
SH: Back in Texas. Yeah, I had the opportunity to meet some of our home-state members of Congress, and it’s really been exciting for me. Senator Cornyn introduced me at my confirmation hearing, and I had a terrific meeting with Senator Cruz as well. I really valued their feedback and their perspective from Texas. I’m really looking forward to getting to know them better and really working to partner with them. And the other person that I’m anxious to meet with, Dr. Michael Burgess, who’s a leader in the House and a fellow physician and has been a top leader on the FDA issues. Texas has quite a bit of expertise and input into FDA issues, and it’s another connection to my home state that I’m anxious to continue to have.
This interview has been edited for clarity and length.