I mean, it was kind of hard that first day with RFK when he came to the FDA in person and said to people's faces, 'You're sock puppets of industry.' I mean, that's not a great way to build confidence in the staff about the place that they're working, especially when they know full well how absolutely wrong he was.
Hello, my name is Lori Ellis and I am your host of Open Door Salon, where global healthcare is discussed by the people who build, fund, and fight for it.
And today's guests are incredibly exciting to me. I have the former FDA commissioner who is now a professor at Duke University School of Medicine, Robert Califf. And along with him, I have Vid, who is the first former FDA CIO.
I want to begin the episode by saying as I was preparing for it, my questions have questions and those questions have questions. So much has happened in such a little of time. We've had six different CDER directors, six different CBER directors, we have an acting commissioner right now and this is the FDA alone. So I think the very first question that I have to ask both of you, and we can expand it to NIH if you like as well because it seems like there's a parallel happening. What does that type of turnover do to an agency not just right now but then the long-term effects? And Rob, I'm going to come with you first.
Sure. It probably is no surprise to anyone that I think this is calamitous for the United States and for the FDA, and you know, we can talk about the FDA and the NIH, really HHS, health and human services in general. I think it is useful to take a step back and start out with your philosophical perspective. If you believe that there is value in having a civil service that provides continuity and standards and methods of doing things that are independent of politics, then I think you'd have to believe that we're undergoing a very dangerous time right now. If you believe that having those things is detrimental to the country, then you would be celebrating the destruction of those enterprises the way that they have existed.
And this is very clearly spelled out in Project 2025. And I think, you know, I urge people if you don't have the stomach to read the whole thing, just, you know, put one of your AI agents on it and get the condensed version or you can go to one of the many checklists that are being kept of progress being made towards the goals of Project 2025. But it's clear in the writing that the view is that these agencies, the way they've existed, have been detrimental to the country and they need to be torn down before they can be built up. Although how they're going to be built up is not specified in the document.
You know, just speaking, yeah, I know Vid is out doing some consulting now and I'm interacting with all sectors now from my position in the university and also working with healthcare delivery and development of medical products. So much of what's at stake is really a system of development of standards that lead to the most effective things getting on the market in the US, particularly from the FDA perspective, and then at the NIH it's really the germination of the best science where the US has led the world, which is now jeopardized by the reduction in available funds and the politicization of decision making.
I think Dr. Califf captures the key points of, you know, the institutional knowledge is obviously pretty much gone. Not only that but, you know, even the acting positions, there's turnover there as well. So just yesterday or the day before we heard the acting CIO at the FDA resigned. So, you know, this churn is occurring as we speak. I think the other thing that I'm particularly concerned about is with the changes that OPM has made in terms of hiring and, you know, who's a career employee versus who's a political appointee, that has changed. So now we're in a situation where every administration change, which could happen every four years or so, you have this huge number of civil servants that are going to be turned over.
And, you know, one of the things that's really, really that people don't realize is how difficult it is to hire good people into the civil service. And so the ability to hire literally thousands of new additional employees and then getting them productive. I, you know, I believe and I personally experienced this. It took me six months before I found my feet at the FDA. And so it takes a while to kind of orient yourself towards a new job. And, you know, you've got two and a half, three years to get something done. Just isn't time enough to do anything significant or major. So I'm, you know, as Dr. Califf says, you know, if you want to destroy the civil service, I think the plans have laid out are great. But I worry for our civil service and the institutions that rely on them.
You know, Vid and I used to talk a lot. We haven't talked so much lately, so it's good to catch up. But, Vid, I think it's also fair to say that both of us felt like there was a lot that needed to be done differently in the civil service. It's not that everything was working great. It shouldn't take that long to hire someone into the civil service. There's no good reason for that that I could think of. And the sort of ossification of the system, particularly around HR issues and around acquisition of information technology in particular, was really difficult to deal with.
So, but destroying it, you know, let's just put ourselves in the shoes of someone trying to develop a medical product. Now you have a discovery in a lab. It looks like it might be great. You start meeting with people at the FDA, which is, you know, this is probably one of the most underappreciated parts of FDA. Almost all the action in medical products happens before the time you actually put in that final application for marketing. It's all about every time you start your human clinical trials, something weird happens that you wouldn't have expected because human biology and the mechanics of human existence are so complicated. And people thirst for those interactions with FDA. But if the people at FDA have no experience and they don't understand how the system works, how can you bank on what they say five years later when you have to bring all this to the forefront to put your application in?
One of the questions that I have, and Vid, you've already addressed it. I know that, you know, it took like six months to get your feet wet, but it seems like in some of the positions you had to go through an entire process of learning the institutional knowledge of the FDA, understanding that that's gone now. And Rob, I'm going to start with you. In 2016, you wrote a memo that basically said overruling a center director was exceedingly rare. As you look to the future of the president now, do you see decisions now being overruled for political reasons or just for reasons that they don't understand the institutional knowledge?
Oh, I think, you know, I have no inside knowledge about the current administration, but at least from where I sit, it looks like it's just a different philosophy. It's a view that all these decisions should be political. And so, you know, but it looks even worse than that. It looks somewhat like a kleptocracy, that is, the political oversight is heavily influenced by who's giving money and who's benefiting as opposed to the scientific merit. I still cling to the hope that it'll get back to having it be extremely rare when there's political overruling of the civil service.
I mean, one, you know, I think you know that the way I've tried to describe this is for the most part, the FDA is a referee. It doesn't own the team. It doesn't make the rules of the game. The rules of the game are made by laws passed by Congress and by federal rules which have to go all the way through OMB and the executive branch of the government. Then the FDA applies those rules to individual products. And I think that refereeing should not involve people who can be influenced by political pressure. And in fact, most of the job of FDA commissioners, and you know, we have a group that meets regularly of former commissioners to talk about things, regardless of whether you're a Democrat or Republican appointee, a big part of your job was to protect the civil service from political and financial influences about individual products. Now, making policy, that's a different issue. Making policy is a political issue and that's a major role for the FDA commissioner.
Vid, do you want to chime in?
No, I think again, Dr. Califf, I think captured it really well. You know, the only thing I would add is, you know, I like his analogy of the commissioner position being like a referee. But I would go so far to say that the reason institutional knowledge is so important is the internal civil servants pretty much knew what the rule book was and how to operate within that rule book. And I think again, you know, I made the reference, it takes a while to learn that rule book. So I came in from private industry. I had never worked in government before. And so I had to learn that rule book and the first six months are pretty traumatic. I would say, you know, more than a few times the thought of what am I doing here and why am I here and why shouldn't I leave occurred to me because, you know, the rule book is different. It takes a while to get used to it.
And I think, you know, the referee analogy is good, but I would say it also applies to the reason why losing that institutional knowledge is so difficult. I think right now we're in a situation where the new folks are going to kind of bump around learning the rules and a lot of things that are happening right now I would say are not even sticky. You know, Dr. Califf mentioned that we had a lot of discussions. I would say Dr. Califf and I probably had many discussions that frankly DOGE would be proud of. You know, we talked a lot about efficiency and understood over the years what was causing those inefficiencies and what it would take to fix them and firing people is not the way to fix them. These are things where the funding needs to be rewired. You know, you got to work with the Hill. The user fee discussions need to be brought in in terms of diverting funds for the right activities. Unless you change the funding, fundamentally, nothing changes within the agency and changing that funding takes a lot of work and effort.
And Dr. Califf and I had begun that, we made some success, but that's how you make sticky change. Otherwise, you know, this podium policy stuff, yeah, it gets you a few headlines, but, you know, as soon as oversight comes in, a lot of that will get reverted back or, you know, will have to be changed because again, frankly, we may not be working within the right rules. And changing those rules does take a lot of time and effort, but they're worth doing and need to be done.
Yeah. You know, Lori, I want to be clear on just something, but I don't see the commissioner as a referee. I see the civil servants as referees. I see the commissioner as more like the coach and the coach has to get into the fray. We all have, I don't know whether they call it soccer or football now on our minds, but, you know, imagine that you had referees out there who didn't know about the history of the rules and the nuances of how the calls are made. You could have a lot of bad calls being made and I think that's what's really in play. But when the coach sees a bad call being made by the referee, it's a coach's job to get in there and make the case and maybe change the rules to reduce those number of bad calls.
So, I have a question for you. The national priority voucher, I want to talk a little bit about that. One, since now we have an acting FDA commissioner, do you think that it's sustainable and do you think that it'll survive now that the former commissioner is not there?
Well, it's hard to make a prediction about that. I would just have a couple of comments about my perspective on it. Vid referred to podium politics or podium policies and I think there's a question about almost everything that's been done in the last year and a half as to whether there's an adequate administrative record for it to withstand the scrutiny of lawsuits and judges. I don't know whether to feel sad or be proud of the fact that I was named in thousands of lawsuits as FDA commissioner. Fortunately, you're protected by the civil service laws from personally being at risk from those. But as commissioner, you get named and everyone who wants to sue the FDA.
And I think this group, you know, I was really struck, there was a reversal done by Mike Davis, the current acting CDER director, where his memo, I think people who are interested in FDA history and politics should read it because what he says was basically my predecessor had overruled the civil servants twice but there is no record of why she did it and so I don't need to create a record to change her overrule. I'm overruling what she said and turning it back to what the civil servants want. But the fact that there was nothing to argue about because there was no record just sort of says a lot about the current state.
Now having said that, I do think, you know, there were reasons why cancer and rare disease got the priorities for incentives put into place by the government. I always feel it's important to point out the FDA doesn't give incentives. The FDA applies the rules where Congress passes laws that give incentives. That's the way it works. So, it's your elected officials that set those rules, not the FDA. But, you know, and I think those programs have been effective. We have a lot more cancer and rare disease drug development. But if you look at America, why is it that we're living three to five years shorter than other high-income countries? It's mostly common chronic disease. And we went through a period where there was a huge underinvestment in new therapies for common chronic disease.
And so I'm glad, I'm in favor of having incentives for things that are clearly national priorities. But then you come back to the administrative procedures. How is it being done? I do not believe that a political appointee should make the individual decisions. The commissioner should be involved in setting the rules for how should the priority list be set and then there should be, like everything else in the FDA, civil servants who impartially judge based on those rules who would get priority. But the last thing to say is if we prioritize everything then nothing has priority. So it's, and the worst part of this is when it becomes arbitrary. If Joe Rogan can send a text to the president and the president can call the FDA commissioner and say make this and that a priority, that I would argue is not good.
So Vid, I'd like to talk to you the same type of question. You were on the tech side and obviously CIO. What changes did you start seeing happening that perhaps the FDA wasn't ready to have those changes made or they were more political?
I think one fundamental change that I see that's recently happened is there's again, you know, I use the term, you know, podium policy. There's a lot of announcements being made without the details being thought through. I think in previous administrations or previous times, I think we were more thoughtful and a little bit more conservative in terms of we wanted to make sticky change, change that was going to stick around or wasn't going to be overturned. And, you know, I made some references earlier. To change the culture, to make a change that survives the long term, you need to make sure that the funding, you know, those activities are funded for the long term. And that requires a rewiring of funds or getting approval for funds from Congress or from the user fee programs. So I think we were focused a lot on making those strategic types of changes, which made us look a little bit slower because they take a little bit more time. It's far easier to just go out and kind of, you know, talk about an idea early.
And I think there are some, you know, I'm not saying it's all bad in doing that. I think it's not bad in setting some direction, but I do think that some of the hard wiring, the work that needs to be done, at least the groundwork for that needs to have been laid out before you go and announce it. You know, I find right now that a lot of ambitious things are being talked about, but I've not seen many signs that the fundamental plumbing changes and the strategic work that needs to be done to actually make that happen, that there's been much work done there.
One of the things I wanted to ask you about is ELSA.
And how ELSA was launched and then within two to three months it was discovered that she was hallucinating. Is that the type of changes that you're seeing, that they're being announced, they're being put through, but then they're going to have to step back and rework?
Yeah, let me be clear. The ELSA work was started while Dr. Califf and I were there. So a lot of the groundwork in terms of testing those models, doing the proof of concepts, all that work had started there. We were looking at that. We were having active discussions with the centers and the Oncology Center of Excellence were probably the most enthusiastic in looking at those technologies. So a lot of that work was already done. But like I said, the how are we going to fund it for the long run? You know, AI is great, but it's not cheap. And Dr. Califf and I have had experience in terms of, you know, look, during COVID or during any crisis, you know, the infant food formula, temporary funding is made available to us. And you can do some pretty impressive things with those temporary funds, but eventually those funds go out and then what do you do?
So I suspect a lot of these things like ELSA are funded through HHS has a program called the Non-Recurring Expense Fund, NEF. So those are temporary funds that are made available to kind of, you know, give a surge to cybersecurity or some activities like that. I suspect that some NEF funds were diverted towards making ELSA and some of the AI activities happening, but how do you do that once the NEF funds go away? How do you sustain that? You know, 40, 50% of the initial investment is needed for day-to-day operations. And unless you've had those discussions and you've made plans for how that funding is going to be replaced when the NEF funds run out or when the temporary funds run out, you're going to have to shut things down. And we've seen that happen with many COVID programs. We saw that happening with some of the infant food oversight programs when the funding ran out. We had to make either significant changes or reductions because, you know, we weren't able to get the funds to sustain those programs long term.
And that requires either Congress stepping in or the user fee program stepping in or, you know, we had this wonderful thing that Dr. Califf smiled at, the working capital fund internally to the FDA. You know, you go beat your head against the wall there to try and see if you can get funds through there and literally from an IT perspective, it was like beating your head against the wall. Get funds, you know, kind of donated through the centers to fund some of those longer-term activities. So those are tough, tough things to do. But that's the hard work you have to do to create a long-term sustainable program.
I think we're all trying to figure out what the equilibrium is going to be between our friendly AI agents and the human aspect of work. And, you know, my read on it is we started out from a very conservative position because there was a lot of resistance by the leaders in the centers to moving too quickly because they recognized that if you sort of move along and don't pay attention to those details, things slip through the cracks and errors occur.
On the other hand, you could see the big wave coming and I think Vid and his team were working hard to try to make it happen. And then I think what happened was a lot of pronouncements were made with the thesis that if you just implemented AI agents, you could reduce human labor dramatically. This is an interesting month to be talking about that because we're in the middle of all these industry, across multiple industries, announcements where that assumption was made. They're having to go back and rehire the people that they got rid of before, most notably the Mark Zuckerberg discussion at Meta, but also many other companies.
And so, you know, personally, I believe that the right combination of human labor and AI agent should alleviate the FDA staff from a lot of the sort of very mind-numbing, routine, repetitive work that an AI agent can do better. But I also believe that the FDA has been so underfunded that as that happens, the amount of human work and conversation that's going to need to happen to make progress is just going to grow. It's very similar to the way I see clinical care and medicine. You know, if you get rid of all of the work that doctors and nurses have to do now to submit bills to get paid and now they have more time, there is just a huge pent-up demand of human suffering out there not being attended to right now because everyone's so distracted with the billing systems.
I think the same at FDA. And, you know, a little discussed issue in the previous two iterations of the user fees, which I was very involved in both times, the biggest demand from the mature industries, and I'm talking about mostly drugs and devices, was for more meetings, not for faster timelines. And, you know, we just didn't have enough people to have all the meetings that people wanted to have. They're so important. So I think we're going to be in a period where errors are going to happen. We'll learn from it. But that's not unique to FDA or to government. I think we're all going to go through that.
But ultimately, you know, I'm very hopeful that we'll end up with the right balance of the agent in the background doing the routine work and then the parts that require human interaction will be done by now somewhat liberated staff who can spend time doing what they're professionally expert in.
You know, that was for you. Do you want to...
Just to add, just today, I read a really interesting article, nothing to do with healthcare, but IKEA. Apparently, IKEA did a lot of optimization where they could have laid off staff, but instead they asked themselves, you know, how can we utilize the freed up staff to do something productive? And they looked at the data and what they found was whilst the AI was very good at answering 50% of the normal routine questions that people call their call center for, there were 50% of the calls that they weren't able to answer. So they focused on those and it turns out that most of those questions were people asking for design help. And so they created a new service that offers design help. So retrained the staff and that created, you know, over a billion dollars worth of new revenue stream.
I think that's the right way of implementing AI. It's how do I make better use or provide better services as well. So I think many executives are not asking the right question. You ask AI to basically say, how do I cut costs, it's going to give you an answer. If you ask them, you know, how do I increase revenue as well as increase my profits, you're likely to get a very different answer in terms of here's some new services that you could be doing that you're not doing right now that you could put your freed up staff to do. So I think AI is all about asking the right questions. And I think many leaders have still not learned to ask the right questions.
Then on that, I have a question. Do you see the leaders that are in place now, the acting ones, do you see that there's a potential of them learning what those right questions are, particularly when it comes to the FDA? And then Rob, I will ask that of you as well, from a different aspect.
Having worked with many of the civil servants that are still there, if it's somebody that's been around the agency for a while, I have full trust that they will, these are thoughtful people that would think things through. What I worry about is they're not even asked to make those decisions. Many of these things are coming from higher levels in the HHS. And that's where I think the lack of thought comes from, frankly. But I have full trust that the folks that I interacted with, Dr. Califf interacted with, I mean, the FDA has very smart, very capable people. And one of the unique things about the folks I worked with is they were thoughtful. They would think things through in great detail. You know, they're not the type that are going to make rash decisions.
So, yeah, so, you know, if the acting roles are coming in from the existing civil servants that have been around for a while, I'm very optimistic about that. But, you know, if you bring in somebody from the outside and expect them to start making immediate decisions, like I said, it takes at least six months to find your way around before you can make any thoughtful decisions. I think it's going to take a while for them to learn the environment, the culture, get trust to make a proper decision.
Well, many people have observed that there's much more of a peace across the FDA right now. I think the current acting commissioner, who I don't know and have never met that I know of, has been a judicious and thoughtful person who's listened carefully to the staff and said the right things to encourage the staff about the role that they play. I mean, it was kind of hard that first day with RFK when he came to the FDA in person and said to people's faces, you're sock puppets of industry. I mean, that's not a great way to build confidence in the staff about the place that they're working, especially when they know full well how absolutely wrong he was. I mean, just a stupid thing to say. But, you know, the big question is who's going to be appointed into the permanent roles? And I don't think we know the answer to that.
There's only so much you can do as an acting person knowing that your job will not be there for that long. You can't really put permanent policies into place. So there's a lot riding on who gets those permanent positions.
I will echo what Dr. Califf said. You know, watching, I did get to meet Marty Makary before I left, a couple of meetings, so not in any depth, but from what I've observed in the very short time that he's been in position, I think he does seem thoughtful. Certainly the word on the street is that, you know, he's paying attention to the voice of his key leaders and stuff. And I think the fact that he's in front of a selfie stick every day, I think that's a good sign. So, yeah, I'm cautiously optimistic.
