Dr. Stephen Hahn
Outgoing FDA commissioner Stephen Hahn says he needs some time to reflect on his future after leading the FDA for a little over a year.
It’s hard to blame him.
Hahn’s brief tenure at FDA has been rocky, to say the least. (News of his temporary replacement broke on Thursday, when the incoming Biden administration named FDA veteran Dr. Janet Woodcock to be interim commissioner until Biden can name a successor to Hahn.)
Sworn in on Dec. 17, 2019, Hahn is President Donald Trump’s second FDA commissioner after the resignation of Scott Gottlieb, who served from May 2017 to April 2019. A radiation oncologist, Hahn was chief medical officer of Houston’s M.D. Anderson Cancer Center and a longtime Republican donor. Hahn backed all of the Republican presidential nominees dating back to Mitt Romney but did not support Trump’s first run for president, according to STAT.
The first U.S. coronavirus case was diagnosed a little over a month after Hahn took office, and Trump has exerted enormous pressure on Hahn during the pandemic. Hahn largely refused to cave, openly defying Trump by telling COVID-19 vaccine developers that the agency needs two months’ worth of safety data before it will consider emergency approvals. Hahn also stumbled in August, stating without enough scientific evidence that convalescent plasma donated by former coronavirus patients could reduce COVID-19 deaths by 35%. Hahn apologized the following day.
Now that his tenure is coming to an end, Hahn told a panel of reporters and the nonpartisan Alliance for Health Policy about his plans for life beyond the FDA, his hopes for the agency and about more immediate issues that will affect the medtech industry. (President-elect Joe Biden hasn’t named a successor, but rumors about former FDA commissioner David Kessler and former FDA official Joshua Sharfstein have appeared in the media.)
This session was moderated by Dr. Reed Tuckson, managing director of consulting firm Tuckson Health Connections and former EVP and chief of medical affairs at United Health Group. We have edited a transcript of the conversation for brevity and clarity.
On the resumption of elective surgeries in 2021
“I absolutely believe that will be the case. I don’t have a crystal ball… Hopefully, we can get to that point sooner rather than later, as we vaccinate more and more people. And of course, when we get to herd immunity, then I think we’ll see a significant acceleration of that, but there are a number of medical procedures that really are going to need to be done beyond the elective ones. And we need to make sure we have the capacity to do that, which is why the mitigation efforts are so important now because we need resilience in the healthcare system to take care of women with breast cancer who need their surgery [and] to take care of the men and women who need heart surgery.”
On the ability of diagnostic tests to screen for variants of the SARS-CoV-2 virus
“I think it’s unlikely that any test is going to be a hundred percent in terms of being able to screen for a variant, but in order to sort of sift through the landscape of positive tests, which of the tests are going to be able to help us detect whether a particular virus that we’ve detected in a person could be a variant and then to use genetic sequencing for that. Because I think we need to step up, if you will, our genetic sequencing to really keep track of this moving forward. So we’re focused on that…. We’ve also spent a lot of time looking at point-of-care antigen tests. And so the question comes, do these variants affect the performance of antigen tests and we’re working on that issue right now. As you can imagine, it’s a little bit different to assess antigen tests than it is the PCR molecular test, because of course, the PCM molecular tests detect the genetic code of the virus, whereas the antigen tests test the protein that’s produced by the virus. So there needs to be a culturing…Those assessments are in the works… So this is work that’s ongoing, very important. Stay tuned over the next couple of weeks as we move forward, looking at those results in partnership with the CDC.”
On the FDA under the Biden administration
“It would be presumptuous of me to tell the incoming administration what to do. I can certainly tell you some of the things that I think would be reasonable. I have had the opportunity to talk to the transition team and I’ve certainly offered my willingness to help after the transition in any way that they see fit. That really [will] be up to the incoming administration. We need to continue our science-based approach to the evaluation of vaccines. We need our evaluation from a regulatory and clinical development point of view, uh, to have these rooted in science. We can’t move from that and make any mistakes with respect to allocating these vaccines based on anything other than the science and the data…. The North Star of FDA, my personal North Star, has been science and data. I would strongly encourage, and I have no reason to think that that won’t be the case with respect to moving forward.”
On vaccine distribution
“I would strongly encourage that we move forward with giving states the opportunity to be more expansive [in] and who they can give the vaccine to, particularly as more supplies become available.”
On the FDA’s independence from political forces
“It is so important for the FDA that we remain an independent regulatory body, that our decisions are rooted only in data and in science and in medicine. So we need to think very carefully of what are the measures we can take to continue to ensure that moving forward. I [am] very much after my tenure looked forward to participating in that conversation. We faced unprecedented challenges this year and we have worked really hard… to maintain the regulatory independence and the science-based approach to our decisions. I think all of these discussions should be on the table.”
On distrust of vaccines and clinical trials among people of color
“Really superb question. What I would recommend is that we continue to number one, acknowledge this is a real issue and acknowledge the fact that there are real reasons behind the mistrust that we see, and we hear. This is not something that’s made up… This is real. It’s legitimate, and we have to acknowledge it, and we have to hit it head-on because to me it’s a moral imperative. Our decisions have to be rooted in, in all of America, not just one group. We need to make sure that they’re generalizable to everyone, including people of [color] and other underrepresented minorities and those from socioeconomic groups that aren’t always represented in clinical trials. And if we don’t do that, I consider it a failure. So engagement, discussion, honest conversations that are sometimes very difficult, and acknowledging the fact that many of these communities that are mistrustful are the very communities that are suffering the most [and] are the very communities that are likely to benefit the most from vaccination and the prevention of this disease… I can tell you personally, um, it is something that I’d like to dedicate to myself moving forward.”
On his year at the FDA
“Our decisions have been guided by what’s been available at the time, and we’ve revised those decisions as more science and data have come down… [On] inspections, transparency and how clinical trials are conducted… I think if we look back, there are ways that we can strengthen and improve our response. But overall I am incredibly proud of the agency and its response, particularly over the last several months when we’ve seen unprecedented challenges to the use of science and decision-making, I’m incredibly proud of how the agency has responded, and, certainly no regrets when it comes to those issues.”
On his future
“I’m gonna take a little time off, spend time with my wife and our kids… Then I’m gonna rethink what I do with my career. I haven’t made any decisions at this point about what I’m going to do. [I’ll] reflect back a bit on what’s happened and then move forward. I can tell you this, um, I am so dedicated to the public health of this nation, to increasing equity, to helping those who have been most affected by this pandemic and trying to help us address the underlying issues associated with that. I’d just like to say to this group and to all of Americans, FDA represents science and action. FDA has 18,000-plus incredible career scientists, doctors, nurses, pharmacists, their mothers, their fathers, their brothers, their sisters. They have also been through this pandemic. They understand on a personal, but also professional level of what this pandemic has meant, and they care deeply about the public health of America. I’m so proud to have represented it. I realized that there have been challenges, and I realized there are things that, that our agency should and could do in a different way. Moving forward, I know the agency is committed to that, and I look forward to working as a private citizen to help in any way possible.”
(This article has been updated with news of Dr. Janet Woodcock’s appointment as interim FDA commissioner under President-elect Joe Biden and with a correction. Stephen Hahn’s title at M.D. Anderson Cancer Center was chief medical officer.)
