LEILA FADEL, HOST:
For more on the resignation of the head of the FDA and what that means for the agency, I'm joined by Dr. Scott Gottlieb. He was commissioner of the Food and Drug Administration from 2017 to 2019 in President Trump's first term. Good morning, and welcome to the program.
SCOTT GOTTLIEB: Good morning. Thanks for having me.
FADEL: So as we just heard, Dr. Makary resigned, apparently because of pressure from the White House to approve flavored vapes, which he did not agree with. What do you make of his resignation?
GOTTLIEB: Look, I don't - I'm not sure that there is one policy issue that drove this. I don't know the details. Marty's a friend. I think there were some constructive things that he did during his tenure at the agency. I think that the biggest challenge that the agency faces and faced was just the loss of senior personnel. If you look at - overall, they lost thousands of staff members, thousands of medical reviewers. You look at the oncology division at the agency, it went from about a hundred medical reviewers at its starting strength to about 50 now. The hematology division that oversees malignant heme went from 21 reviewers to six. They lost an entire breast cancer review team.
That's just the oncology division, which I happen to look at closely. And they also lost a lot of senior career leaders inside both the biologic center and the drug center. There were political appointees put in those positions. And I think ultimately that eroded a lot of the institutional rigor and experience of the agency, and I think that's what's been hobbling the agency.
FADEL: Taken together, all of these departures, plus kind of a tumultuous year - as you said, you called Dr. Makary a friend, and you said he has done some admirable things. But him leaving, how does that affect health policy in the U.S., plus all these other departures you mentioned?
GOTTLIEB: Yeah. I think the continued turnover at the agency is not constructive for FDA. I think what you want in those positions is stable leadership both in the commissioner's office - and there's probably going to be other turnover in the commissioner's office as a result of his departure - but also stable leadership in the different centers that govern the products, oversee different product centers. When I was there, I had - I inherited a core of center directors - from Rob Califf, who had been commissioner before me - and they stayed in place for my entire tenure at the agency. And that was very helpful to me, having senior career leaders with a lot of experience, having stable leadership in those positions.
And if you look at those positions, they've turned over many times in the last couple of years. There's been some divisions inside the drug center that have turned over five or six times. That kind of turnover inside the agency, the loss of very experienced senior career leaders in those positions, that ultimately has a real impact on the review process. And it's not just in the drug center. You're also seeing that in tobacco center. You're seeing it in the food center as well, although, that's been a little bit more stable.
FADEL: What does it mean for public trust in the agency?
GOTTLIEB: I think most people probably are paying very close attention to who's coming and who's going inside FDA, but I think that there is a perception of just consistent and sort of persistent turnover inside FDA, and that has to have an impact on the overall public perception of the agency. And a lot of the senior career leaders who left also were well known outside the agency.
FADEL: You know, the reporting indicates that there was pressure from the White House, at least over this one decision. As a former FDA commissioner, did you ever experience White House pressure, or this kind of White House pressure?
GOTTLIEB: Yeah. And I don't know if that's true, that narrative around White House pressure. I - it does appear that the White House had a different perspective on some of the tobacco-related issues. But, look, I had policy disputes. I had places of disagreement, but I was always able to come to a compromise and didn't feel that the White House forced me into a decision.
FADEL: Former FDA commissioner Dr. Scott Gottlieb. Thank you for your time.
GOTTLIEB: Thanks a Lot.
(SOUNDBITE OF I MARC 4'S "RAY BAN") Transcript provided by NPR, Copyright NPR.
NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.
