As Drama at Trump’s FDA Subsides, Doubts and Damage Linger

Dan Gorenstein (DG): These first 18 months at the Food and Drug Administration under President Trump have been… eventful. 

Newsclip: After a rocky tenure, the head of the Food and Drug Administration is resigning.

DG: The massive agency, charged with protecting the public’s health, has approved controversial products.

Newsclip: For the first time, the agency has authorized fruit flavored e-cigarettes for adults despite evidence that they encourage younger people to smoke.

DG: The FDA has lost thousands of staff, including many long-time senior officials. And the administration has clashed with scientists over critical decisions.

Newsclip: Pres Trump today tried reversing decades of medical advice given to pregnant women.

Trump: Don’t take Tylenol. 

DG: Today, we talk with FDA reporter Lizzy Lawrence about the agency’s recent struggles and where it might be headed.

From the studio at the Leonard Davis Institute at the University of Pennsylvania, I’m Dan Gorenstein. This is Tradeoffs.

*****

DG: Lizzy Lawrence leads coverage of the FDA for STAT News, and she recently won a George Polk Award for her reporting on the agency’s upheaval.

Lizzy joined me by Zoom earlier this week on a muggy Monday in Washington, DC.

 Lizzy, nice to meet you. How are you? 

Lizzy Lawrence (LL): Good. How are you? 

DG: I’m good. Thanks for being on. I just gotta say, this FDA beat seems pretty intense. I mean, the news and the controversies just feel kind of like nonstop here. Do you ever get a day off? 

LL: Yeah, I feel like it at least comes in waves where there’s a few weeks where things are eerily quiet, and then there’ll be a week where everything happens at once. But at least I get those few weeks to kind of take a beat. 

DG: And what do you do to get away from the work? 

LL: Yeah, I try to touch grass, like go to the park near my house. And just hang out with friends and people who don’t know anything about the FDA. 

DG: Real talk for a second, what’s it been like to have this beat during this time? I mean, this is maybe some of the most tumultuous time the FDA has ever experienced. 

LL: It’s been crazy. Because the experts I spoke to when I took on the beat in late 2024, you know, even when Trump won and it was clear that Kennedy was gonna be involved, people really thought that the FDA would be protected because it’s within industry’s interest for the FDA to stay relatively, you know, stay stable and normal. And so people thought they wouldn’t really mess with it that much, and then they, and then they really did. So, it’s been exciting. But, yeah, it was definitely unexpected.

DG: Alright, Lizzy, so let’s get into some of the action that has made these first 18 months of President Trump’s FDA so busy for you. I’d like to start with the recent departure of FDA chief Marty Makary. 

He lasted just over a year in the job.  Your own colleague, Matt Herper, penned a column calling Makary the worst commissioner in the last quarter century.

Before we talk though about some of Makary’s shortcomings, this is a guy who clearly had a vision for change. How would you articulate what that vision was? 

LL:  He came into the position wanting to improve public trust in the agency, encourage innovation, reduce red tape. At the same time, he would talk a lot about increasing scrutiny of vaccines. But his vision, I wouldn’t say it was super cohesive. It was a little bit disjointed. I mean a great example was the FDA at first refused to review a new flu vaccine from Moderna.

Newsclip: One of the companies instrumental during COVID says it has a new flu shot ready to help out but the FDA is shooting it down. 

LL: And this didn’t come from staff. This came from Vinay Prasad, who was kind of more of a political official. Then that got overturned after White House pressure. 

Newsclip: The FDA changing course now saying it will review Moderna’s new mRNA flu vaccine.

LL: And so that was a moment where clearly, like, the right hand was not talking to the left hand. Things were happening that the different groups were not aware of, and it all kind of spilled into public in a messy way. 

DG:  Some of the other things, Lizzy, that I know Makary really pushed on when he was in charge were doing more with AI and big data and getting generic and over-the-counter drugs to market more easily. Do people that you’ve been talking to expect any of these reforms to potentially end up taking hold and lasting?

LL:  Definitely. And, to be clear, I think that Makary and a lot of the leaders he brought in had good intentions, you know, wanted to help the agency change for the better, make it nimbler, cause the FDA certainly had a lot of problems before he came in.

And so some of the ideas he had, I’ve been told new leadership will continue to embrace, like, reducing animal testing, what you mentioned, you know, doing more with AI and big data, getting generic and over-the-counter drugs to market more easily. I think that the challenge is not a lot of it has been codified. He often made these changes through press releases or just kind of momentary changes in enforcement. So we’ll see what sticks.

DG: So here’s Makary trying to do a bunch of stuff trying to make lots of different people happy, which is obviously hard to pull off. In your mind, Lizzy, did anything else get in his way?

LL:  The biggest issue is that he didn’t really listen to staff. 

Obviously when a new commissioner comes in, there’ll be some change. They’ll bring some political appointees in with them, but typically they try to have some continuity and empower the long-term, you know, scientists [and] policymakers who’ve been there, who know the agency very well. Makary didn’t do that. Some of it wasn’t his fault. DOGE came in and laid off a bunch of people, and Kennedy pushed out the vaccine chief, Peter Marks, before Makary got there. 

But even once Makary was in, he tended to pick leaders based on kind of who he was friends with, who was loyal to him rather than trusting or relying on career staff. And so some of these people were pretty bad managers or had, you know, very specific personal or political agendas that sometimes conflicted with public health decisions grounded in science. So that caused a lot of the tumult and distrust between Makary and the people who really make the FDA run. 

DG: You mentioned, Lizzy, the cuts that DOGE made before Makary even arrived. 

But we also saw departures of senior staff continue under his leadership.

Now you recently profiled six officials who left their posts. 

And I’d like to play a clip from one of your interviews with Rick Pazdur, a top cancer drug regulator who was at FDA for more than 25 years.  

Rick Pazdur:  Did I have any intentions of leaving the FDA? No. I thought I would stay there, and they would have to pry me out of my office, okay?

DG: You go on to ask Rick what the public should know about these personnel losses at the agency. 

Pazdur: I think it’s important to realize that it’s not a numbers game. When I hear that the FDA is hiring 1,000 people, it’s kind of like you’re missing the point. It’s about the quality of people that have left the agency and years of regulatory experience decision-making that they have.

The professional staff, whether they be PhD scientists, whether they be physicians, whether they be oncologists, pulmonologists, they’re not just cogs in a factory. These are jobs that require a great deal of intellect, judgment, experience, and once that experience has left the agency, it’s going to take years to really build that up again. 

DG:  So all of this sounds super concerning, and the point that you can’t just sort of like recreate years of experience makes perfect sense. At the same time, Lizzy, have you or other reporters found proof, any examples of all this staffing turnover actually affecting patient safety or access to drugs? 

LL: Not yet. I would say I think that’s a really good point. A lot of this concern is more theoretical ’cause these are changes that will have a long tail and also might be hard to track. I know FDA staff that are there are working really hard to stay on top of all their work, reviewing medications, inspecting manufacturing facilities.

I know that the agency is really trying to hire a lot more people to help fill in the gaps. I would say that the clearest patient impact, um, of, of this turmoil has been kind of in response more to agency rhetoric and communications. 

You know, after I wrote a story about how there was a dispute between career staff and political leadership on a Type 1 diabetes drug had someone reach out who was confused, who, you know, she didn’t know whether her daughter should take that drug, and I tried to help point her to as many resources as I could. That’s kind of the immediate impact I’ve seen, is there’s just been more confusion over, you know, what is the right thing to do, whether certain medications can help or harm you. That’s what’s been harmful, I would say. 

DG: Right I mean I saw a recent study showing that Tylenol use in emergency rooms for pregnant women fell by like 10% right after Makary and Trump held a press conference saying that Tylenol increases a baby’s risk of autism, despite zero rigorous evidence to substantiate that claim. 

That’s clearly some real impact on patients.

Lizzy, what about the pharmaceutical industry? Is any of this confusion or those staffing cuts you talked about affecting drugmakers? 

LL:  I’d heard anecdotes about companies, you know, being unable to secure meetings with FDA to talk about paths forward for their drugs, which can be particularly harmful for small biotechs, which are often the ones working on very innovative cures.

There were also high-profile instances of, especially companies working on rare disease drugs losing out on advisory committee meetings, which the FDA will often convene to discuss more contentious drug decisions, but since there’s been new leadership, I think the ship has steadied a bit, and so companies are not as worried about the FDA anymore. But time will tell.

DG: When we come back, we’ll talk with STAT reporter Lizzy Lawrence about the battle brewing over peptides, a controversial product at the center of a fitness fad, and the FDA’s newest chief.

BREAK

DG: Welcome back. 

We’re talking with STAT News reporter Lizzy Lawrence, who’s had a front row seat to all this upheaval inside the FDA.

Lizzy, before the break, we focused on Marty Makary’s tenure, which ended in May.

Now we’ve got Kyle Diamantas at the helm. 

He’s the interim FDA commissioner. Can you paint a picture of Kyle? Like in terms of some of these ideas that Makary had initiated but did not get codified, is Diamantas expected to carry that forward? 

LL: Yeah, so he is a lawyer. He’s represented food and beverage and tobacco industry clients in the past. He’s been hunting with Don Jr., so I think that proximity to the Trumps helped bring him to the FDA as the leader of the food center.

He’s really impressed a lot of people, people inside the agency and industry and public health groups. They’ve described him as just pretty normal, professional, listens to them. When I was trying to write a profile of him, it was, I was trying to get any kind of, like, interesting anecdotes, and I was struggling. But he is definitely, he does not wanna be permanent commissioner, so I would doubt that he’s going to make any kind of significant changes just ’cause he doesn’t intend to stay. So he’s gonna sort of try to be more along for the ride — keep things steady. 

DG: Substitute teacher vibes.

LL: Yes for sure.

DG: In some ways, your answer reminds me of a conversation that we had with Washington Post reporter Dan Diamond, who’d profiled Chris Klomp, the new deputy over at HHS and Dan told us that Klomp was really driving a lot of the recent hiring decisions behind the scenes with an eye towards dialing down the drama. It sounds like Diamantas is kind of the same mold.

LL: Definitely. And I know that they are close. Klomp has been pretty involved in searching for a new leader of the FDA and, and helping stabilize the agency. 

DG: Based on the chatter you’re hearing, are people expecting someone like a Diamantas, like a Klomp, like that dialed-down drama type person?

LL: Yeah, I think that’s, that’s the kind of person they’re looking for, someone who is, is, yeah, less of a controversial character than Makary became. 

DG: Running the FDA is still running the FDA, right? Like, this is a big deal. This is a big job. Given how tumultuous the scene has been, is that scaring folks away from wanting this job? 

LL: Definitely, just from talking to people that, you know, maybe at one point would have been candidates for the commissioner consistently I hear, you know, “Why would someone want this job? you have, have to earn the trust of career staff, at the same time satisfying HHS and the White House. There’s just, there’s a lot of different people to keep happy and the pressures are high for sure. 

DG: And I mean on this point, Lizzy, about needing to keep a lot of people happy, the degree of political influence — even interference — happening at the FDA seems notable.

That came up in your exit interview with Rick Pazdur, the long-time regulator … someone who’s also been considered a possible commissioner candidate.

Rick told you ‘political influence’ was a main reason he left the FDA.

Pazdur: I never had a commissioner that called me up and said, “Rick, what are you doing with this drug? I want it approved,” or, “I don’t want it approved. What is your thoughts on this drug?” There was really a firewall that existed between the political appointees, uh, and the agents and the review staff, uh, and those people that made decisions, uh, in drug development. And I really felt that this wall was being breached by the political appointees, uh, on many levels.

DG: I guess I’m wondering how unprecedented is this meddling that we’re seeing?

Because I know prior presidential administrations have pushed certain priorities at the FDA too. Like that’s just part of this business.

LL:  It’s pretty unprecedented. I mean, political priorities have always impacted decision-making to a certain extent. But where political leadership was weighing in on individual drug decisions and really trying to get into the science, that is not something that has really happened a lot before, or it’s been very taboo.

There was a taboo example where, during the Obama administration, Kathleen Sebelius, the HHS secretary, vetoed the FDA’s decision to make Plan B over the counter, and she was sued. And the FDA decision stood because it was for political reasons that she vetoed, and that was, you know, frowned upon — but that kind of thing was happening all the time at Makary’s FDA. 

DG:  So whoever Diamantas’ successor is, is gonna face tough decisions that will pit the FDA career staff against political appointees like RFK Jr. or folks inside the White House even. In your mind, Lizzy, what are one or two decisions on the horizon that you’re gonna be watching closely to gauge who’s winning the tug of war — the science or the politics — and what the direction of the agency might be? 

LL: One of the issues I will definitely be watching is the policy decisions around peptides.

Which are a class of drugs that have become very popular online with influencers you know, claiming that various types of peptides can boost energy.

Padzur: I’ve taken all three of these peptides and it absolutely changed my life.

LL: Enhance muscle repair…

Padzur: This is the first time this is coming to market and it is kind of revolutionary when it comes to muscle building.

LL: Reverse aging…

Padzur: Use a peptide serum for anti aging if you have sensitive skin!

LL: All kinds of claims that have very limited clinical data to support them. RFK Jr. has made very clear where he stands on this issue, and he went on Joe Rogan’s podcast and said he wants the FDA to allow US compounders to manufacture these products. FDA staff have made clear in briefing materials that they want to continue to restrict peptides. They don’t think it’s safe.

So this is an issue where certainly that, that could be elevated to the commissioner, and the commissioner will have to make a difficult decision, which is, you know, do you listen to staff or do you listen to your boss, RFK Jr.? 

DG: Final question. For good reason, it’s very easy to dunk on the FDA these last couple of years. How do you think history will remember this time, like a moment when the agency lost whatever remaining sheen it had? Or potentially this paradigm shift when the FDA got shaken up and as a result, we end up with a better, brighter agency?

LL:  That’s a great question. I, I’m an optimist, you know, it’s in all of our interests to have a strong, stable FDA and I do think that leadership understands that. So, for now it’s seeming like, like more of a blip. 

DG: What do you mean more of a blip? Why do you say that? 

LL: I just think that things seem to be returning to normal there. I would say that FDA staff they’re cautiously optimistic. They’re kind of scarred by losing so many people and having their decisions overturned. They’re worried that political interference will continue, but there’s also some hope that there’s genuine innovation that will be encouraged at the agency.

DG:  Thanks, Lizzy, for taking the time to talk to us on Tradeoffs. I appreciate it very much. 

LL: Yeah, thank you for having me. 

DG: I’m Dan Gorenstein. This is Tradeoffs.