Transcript
Speaker: Welcome to the Healthcare Theory Podcast. I'm your host, Nikhil Reddy, and every week we interview the entrepreneurs and thought leaders behind the future of healthcare care to see what's gone wrong with our system and how we can fix it.
Speaker: Today's guest has seen the FDA from almost every angle. Dr. Sandra Kueter joined the agency in 1988 as a young medical officer in a brand new division created to fight the AIDS epidemic.
Speaker: She then went on to spend over a decade as deputy director of the Office of New Drugs, the office that decides which new medicines reach patients. In her job there, she got to see high-level disputes, understand why and when the FDA should change, and she eventually became the FDA's liaison to the European Medicines Agency in London.
Speaker: And today, we really use her career as a lens on why does the FDA change? From activists at its stores, to the user-fee deal that transformed drug review, to Congress and Europe and politics, there's so much to go into it, and today we get our candid take on the agency, and I can't wait to get into it.
Speaker: Hi, Dr. Kreeter. Thank you so much for coming on the Healthcare Theory. It's great to have you. And it's great to be here. And you sent me some really interesting questions that I'll be happy to entertain and see where the conversation goes. It's really a delight to be here.
Speaker: Yeah, i'm I'm also really excited. And I find it especially interesting because i think when a lot of people picture the FDA, they picture like paperwork, process, this whole monotony of regulation and government.
Speaker: um and And you had the training to go into clinical practice, like work with real people every day. And of course, you do to some extent at the FDA. yeah But yeah, you kind of chose the regular regulatory path alongside being a clinician at the same time, where the impact is is still, it's much bigger in some ways, but it's also much harder to see and much more opaque.
Speaker: And um you stayed for decades, and and some of those moments were like the most important moments in the agency's history. And I think that's not really a choice people make by accident and will just stumble in the FDA and then stay for 30 years.
Speaker: So I'd be curious, like what pulled you in at the start? And what was that really like in your first moments? And what's kept you there all these years? okda That's a great question. And I mean, I have to say, I never envisioned myself, you know, look I wasn't growing up wanting to work at FDA. Yeah.
Speaker: That was not in my view in the grand scheme of things. I really thought that I was going to be, you know, a full time clinic clinician. And when I was a medical student, I had ah a scholarship, a public health service scholarship.
Speaker: And i thought I was going to be going to the public health service hospitals, which were in wonderful places, Staten Island, New York, Seattle, Louisiana. And they closed during the Reagan administration.
Speaker: And so those options for my training and future careers went out the window. And the public health service was having, once I finished my medical training, ah the public health service was having trouble finding a place for both my husband and I to be assigned. And I won't go into the details of that, but a formal faculty faculty member at our medical school was Now the head of FDA Center for Drugs.
Speaker: And he heard about our situation and he said, wait a minute. He said, I have this brand new division, Sandy. I know you really like, you know, to think about clinical trials and all kinds of things. You enjoy that. He said, I could really use some, I really need new medical officers for h iv with the HIV, because there's a plethora of drugs being studied for HIV, which we called AIDS at the time.
Speaker: um And would you be willing to come? And, you know, I thought, desk job, you know, well, I went and I, it was absolutely amazing.
Speaker: It was just, um I was a medical officer during the AIDS epidemic. And, you know, I got there right after about three months after AZT had been approved.
Speaker: And my work was more in the opportunistic infections world, but it was completely drinking out of a fire hose, trial by fire.
Speaker: um Activists were calling me at home on the phone. um Um, but it was amazing. I learned so much.
Speaker: I had the opportunity to really think about things from, you know, changes that had to be made and how to deal with an epidemic like that was being faced in the context of regulations.
Speaker: It was difficult. It was exciting. And, uh, I went thinking that I was going to go there, go to FDA for a few years And then yeah go off to go to clinical medicine. Well, I i so ended up being able to do clinical medicine because that was the deal I made that they'd let me continue to see patients and teach while I was there. No problem.
Speaker: And so I stayed.
Speaker: And it almost sounds like perfect looking back. It seems like a good mix of like you like that clinical trial, like the regulatory aspect. We can combine that with being a clinician, too. But I mean, you almost hinted at it yourself when you came into the FDA, like right as the AIDS epidemic was like basically at its worst or at least yeah some of its peak. Absolutely. um Absolutely. Yeah.
Speaker: And there's only like there's only one drug at the time, like patients were dying. And in that moment, i've I saw the movie like Dallas Buyers Club like a few yeah weeks ago. And I think it really emphasizes how a lot of patients wanted access to these drugs. But of course, we wanted to make sure they were safe. But there was a real like moral dilemma here. And I was found it funny that activists were calling you because, i mean, they were right outside the FDA's front door all the time. Oh, yes, they were.
Speaker: yeah Yeah. So there's like this whole idea that like patients want access to drugs and then the FDA wants to make sure it's safe. It's a really, like really interesting debate. And I imagine as a young physician then, especially in this department, you're kind of like wondering what's what's going on here.
Speaker: um But what was that like tension debate like at the time? Like, where did you stand? How did you feel about this like whole idea of exp speed versus certainty and where the FDA should take a stance? Well, I think that, you know,
Speaker: Prior to that time, it was interesting. FDA was so much smaller then. and a really? Yeah. Oh, my gosh. Yes. Oh, my goodness. It was small. And in many respects, there were a lot of sleepy corners, I would say. FDA was not in the habit of being publicly visible. And there they found the agency found itself suddenly, you know, in the spotlight, not something it was had historically been comfortable with. um
Speaker: And the pressure was enormous because people were dying all over the place. And it was very clear that the regulatory framework needed to um not be departed from from a scientific perspective, but that we needed to find novel ways of implementing the regulations in a way that still held to showing that the medicines were effective and safe.
Speaker: At the same time, right in parallel with that, there was a big expansion of development in oncology. It was kind of the roots of it. So while I was paying attention and, you know, trying to get to my car without being harassed by HIV activists necessarily, you know, the buildings weren't locked. There was no security. Oh, really? Oh, wow. Okay. what's none right then Yeah. ah The same thing was happening in the oncology space.
Speaker: ah Yeah. A little less, you know, ah maybe equal emotion, but a little less, um, intense sometimes because it was in small pockets, but people who were desperate for treatments and in oncology, particularly willing to take immediate risks in order for potential benefit. And I don't think that has changed.
Speaker: You know, I think that's a a lesson that ah the clinical practice community, the research community and the regulatory community learned In those times to think about people who have a lot to lose are willing to to think about risks differently.
Speaker: And it was an important lesson. It still applies today. Yeah. And how did you think, cause like it makes sense to some extent that but i think both sides have valid arguments and like, course the fda wants to protect people, protect their own institutional credibility and their job is to keep people safe. But, and then for people themselves, like what might be safe is actually to take that drug and take that risk because yeah other outcome could be like a terminal illness with no good options. So it's like, there's no really, it's hard to align incentives here because they're kind of poking in different directions. So
Speaker: Maybe could you walk me through like, what was like, was there a big debate at the time? i know we eventually moved into like some ways of fast tracking, letting patients get access to such medications to some extent, but what did it look like from your perspective and how or why did things end up changing a little bit from there?
Speaker: i think, you know, what, what I think was really wonderful was the importance of having clear heads in the room and,
Speaker: really being able to articulate the fact that um there is no such thing as absolute safety. There's no such thing as absolute effectiveness or efficacy.
Speaker: And that those decisions are complicated and need a lot of perspective brought to them. you know I can remember being presenting at an FDA advisory committee It was first when I presented that.
Speaker: Yeah. And it was for Ganciclovir, an old treatment for cytomegalovirus retinitis was an opportunistic infection that still an opportunistic infection that caused blindness.
Speaker: um And among other things, but blindness was what was the big issue. And you had these people with AIDS, they had so many things happening and then they go blind.
Speaker: And um you couldn't reverse the disease, but you could slow it. And thinking about how to measure that um and what was enough data to allow that treatment to be to be on the market, you wasn't something that, you know, the primary care doc was going to prescribe on Tuesday to set the patients. You know, I mean, this was pretty specialized and I can remember
Speaker: having to present an advisory committee and saying what I thought. um And I almost got in trouble becauses ah because I said what I thought.
Speaker: And I realized that I had to say, my give my assessment on, you know, my perspective with respect to the advisors because many of them were afraid to openly say, yeah, we should take this risk.
Speaker: Have we proved absolute efficacy for life beyond a doubt? No, but that wasn't called for. These are people who are only likely to be alive for five years and they want to take this risk. But I remember it was, I, I wonder if I'd have a job, but I had a division director yeah who was really courageous and she just said, do it, do it.
Speaker: And I've got your back. And yeah, I think we did good work. I think we did good work. And I think it takes like leaps of change like that to kind of, or leaps of faith like that to kind of change an organization in the first place, because i mean, I can imagine the the pressure there because how could you really, the whole idea of the FDA before that wasn't really about like, there was a dilemma like this. it kind of forced the picture really quickly.
Speaker: And i mean, after the f after like the HIV years, like things changed like a little bit. I mean, you moved into leadership, you oversaw the antiviral and antimicrobial drugs and helped run the office there, which I thought was really cool.
Speaker: um But that happened just as Congress was basically rewriting some of the rules, like obviously absolutely in the 90s. yeah they They passed a major law creating fast track designation. So it seems like to some extent the FDA had this predicament. They adapted as much as they reasonably could to allow some access to drugs when needed. So the FDA, as a regulator a regulatory body, was able to adapt. But then there's some congressional pressure.
Speaker: um Also, and i was curious, I mean, now you're having these rules be written to drugs in terms of like how fast things can get approved and it's like a more institutional thing than just like the FDA quickly pivoting when things got really pressured. It's now like something that was a part of a long-term vision.
Speaker: um What was it like at that time? Like what was the FDA thinking? and What was the real trajectory of the FDA around like the nineties, two thousands when like they're positioning themselves to be a quicker moving agency? Like how are they trying to adapt to all these like pressures they've been facing? um You know, I mean, FDA has a way of doing business. The ship turns slowly is what I always say. Yeah. um But you know, there are, you try things, you try something new. So for example,
Speaker: um One of the early shifts was ah the idea of what we now know as accelerated approval. Okay. Allowing a product to show benefit, safety and benefit in in sort of with an early marker that you think may well have be a ah good marker. At the time it was viral load.
Speaker: You're being able to measure the virus. Yeah. um And then because to wait for people to for the survival data that you really wanted to understand that was going to take too long. And the best access is the market. There were enormous expanded access programs, but the best access is the market because sometimes going through these, you know, company sponsored programs is very cumbersome for patients and for companies.
Speaker: So, and And that set the path for the, for the regulations that followed and some of the standards around, what do we mean when we say a surrogate, what does that look like? The other thing that was happening was at the same time that Congress started to pay attention to was the fact that the process of review at FDA took an extraordinarily long time, you know an application review took sometimes took years.
Speaker: Oh, wow. Oh, my gosh. It was the first of all, it was all on paper. OK, first of all, it was all paper. That tells you something right there. OK, there was no such thing as you know sitting at your computer looking at a file that was did not exist. It came in on paper. um And um second of all, the staff was tiny.
Speaker: compared to what exists today. And the agency didn't have the resource didn't have much in the way of resources. There was no way that government appropriations could keep up with the growth in staff that was going to be needed to address what Congress and the public wanted, which was faster turnaround on reviews.
Speaker: So some of it was staffing, but also it was the idea that FDA would have deadlines for a review. We didn't have deadlines. You got to it when you got to it. You might get and new drug application and you might not even touch it for nine months because you had too much other work to do.
Speaker: Now, you know, team team attacks it. Everybody's got an assignment. You need to make the decisions A, B, C on a clock. But that needed to come with resources.
Speaker: And that was the Prescription Drug User Fee Act. which in itself was controversial. But it was because ah in other regions, in other countries, there were these medicines were getting approved much more rapidly than in the US, much more rapidly. So they called it the drug lag.
Speaker: And FDA took a lot of heat for that. um I'll tell you a ah little story I remember. I had an application. It was for an influenza drug.
Speaker: And I was a reviewer and it needed to be signed off a couple levels above me because it was a new kind of entity. And the guy who had to sign it was really busy. He was taking applications from multiple directions. Yeah. Not getting to it.
Speaker: And he would. I knew that he was carrying it around in his car. Okay. he's He's gone now, so I can talk about this. Yeah. And I also knew and was my, I'd send him an email and say, Hey, how about that? Okay. You know, and I did this for weeks on end. And finally, one day knew.
Speaker: i knew that he went down to the parking garage to smoke cigarettes. Because we had a new anti-smoking rule in the building. So I went down to the garage and knocked on his window. yeah remind him just tell er he got to it yeah but it was there you go you know i mean that was kind of how it was um so and i think we had that application in house for almost three years that's crazy wow that is crazy so yeah congress took that seriously and worked out this whole process for the prescription drug user fee act
Speaker: where industry would provide funding through in the way of um facility fees, application fees, the staff would never see the money.
Speaker: You know, it never there was never a direct link to who paid and where the money went. it was It's a big cut. And most of the staff, we didn't even want to know what the fees were. You know, it like we just didn't want to touch it. but it brought resources with some restrictions.
Speaker: And in the beginning, those user fee dollars were restricted because the industry insisted that the money could only be used. And this was put into the legislation could only be used to work on efficacy issues, New York applications and effectiveness.
Speaker: Yeah. Could not use funds for the safety work or inspections. And a few rounds into renewal of the user fees, they have to be renewed every five years. It has to be renewed in terms adjusted every five years. That was finally fixed because it had created in the agency the haves and the have-nots.
Speaker: And you really needed that safety piece. And that's where the renewed focus on safety came.
Speaker: Yeah, because because now I really feel like the trials are a mix of safety and efficacy, but I can imagine that- always hope The trials have always been. But we would have we had a staff that was really focused on assessing effectiveness of new products. But when you got to post-marketing safety, following up on that, good manufacturing practices and manufacturing inspections, which is an enormous component of safety.
Speaker: Those people had no money. They had these like skeleton stuff. yeah Meanwhile, we're, you know, we're churning out these applications and they can't keep up. Yeah. It's you have like a full like train going full speed with efficacy stuff. And the moment you hop off the train, it's like little horse running And totally shooting for the pit, which is not a good thing.
Speaker: And what was your role like during this time? Because at this time you stepped into the role of the Office of the New and the office of the new Drugs. You're working pretty high up there, a Deputy Director. know you're Acting Director for a little bit. So what was that? Like, what does the role actually look like? Like, yeah you're dealing with all these changes. You had big, almost like big news breaking events with the FDA yeah at that time.
Speaker: And then you also had, on the other hand, like ah changes with the FDA, you had the actual congressional changes. and a whole bunch of other things that were going on. And then you also had like, much many breakthroughs in science too. So all these different things happening in once.
Speaker: What was your role like at the Office of the New Drugs? What did that actually mean? And what was your position? It was fun. Awesome. I loved it. I absolutely loved it. You know, at the time that I was, you know, got into that role, we were growing.
Speaker: um We were expanding our divisions. hiring you know new people, you know, a lot of people. um And what I, but I had had a lot of experience, you know, in the review trenches overseeing, you know, product groups and mostly in the anti-infectives world. I also spent a couple of years overseeing drug safety.
Speaker: So I had that perspective as well. um And, but in, in O and D office of new drugs, we were overseeing all of the therapeutic review divisions. yeah And, you know, each of those divisions, um, had their own culture, you know, they had, you know, some of them, the newer divisions were really known as kind of the rabble rousers. You could always count on them to come up with something, you know, you know, really creative on, Well, here's what they've got.
Speaker: Here's what they proposed. We don't think that'll get them through, you know, meet the terms of the regs, but we think if they collect the data this way, it will, you know, and, you know so the antivirals division was notorious for that. You know, they just kind of always just open-minded, creative thinkers, um, willing to, uh, take risks to address important patient needs. But at the same time, if, if it was for a condition, that wasn't one of those, you know, it was just like, oh, yeah yet another to treat, you know, an effect infection on your, infected cut on your finger. You know, you you don't apply that kind of flexibility, but they really, I think they were real trailblazers. Other groups were um very uncomfortable with that, with that kind of an approach.
Speaker: And so it took John Jenkins and I, to work with them. And I always say, i tell them you need to, you need to kind of get on board with these ideas. It doesn't mean that apply in every situation, but first of all, think creatively.
Speaker: Second of all, talk to the companies, talk to the patients, get out of your four walls. and listen and hear what they have to say, what they're thinking. You will learn a lot and you can't know everything. So learn from them and then you'll see, you'll see windows open.
Speaker: um But that was hard for a lot of people. You know, um um ah I've always said people tend to take jobs that keep them in their comfort zone. Okay.
Speaker: and if you're And if you're initially attracted to being a regulator, which I never was, um way back in the beginning, i' was like, what? yeah um You kind of like the idea of the rules.
Speaker: The idea is, oh, the regs will tell me what to do. In fact, the regs don't tell you what to do. They give you some guideposts, but they don't tell you what to do. But there's a comfort in that. I feel like, okay, I've got this cover and I don't have to stick my head over the parapet. I just have to kind of stay in here.
Speaker: Um, and that sometimes leads to getting pretty stuck in your ways. And I spent a lot of time listening to colleagues and talking about how to think more openly about things.
Speaker: It was really, it was really great. And in addition, starting to see that there were threads across the different review groups that needed very focused expertise and attention to help them.
Speaker: So a pediatrics and maternal health team, for instance, because the pediatricians were few and far between. We set up a whole division of pediatrics and maternal health to help the divisions.
Speaker: um Everybody doesn't think like a pediatrician, and it's important to understand that that world. They're not just little adults. There's a whole science there that needs to be brought to the table. Yeah. um Another good example is biomarkers andert and and patient reported outcomes. And how do you measure how do you measure pain?
Speaker: What's the difference between pain, bone pain and a headache, you know, things like that. Um, so we put together a lot of special teams and that would, were there to help the divisions provide consultation.
Speaker: And, uh, really what I think was enriching the review process. Wow, it's actually really interesting. So seems like I saw that, I mean, you led the FDA's effort to overhaul um drug labels on pregnancy and breastfeeding, which is kind of what you talked about. But it seems like you had a lot of like ad hoc special things that you guys did that were like specific tasks with. And it also seems like a lot of it was a culture thing then too, like reshaping the organization so that people are willing to think on their feet, have the ability to adapt while still like working within regulations. Was that something that how you kind of characterize it? And how often were you really looking at
Speaker: like the individual like drug applications i assume more like a bigger picture you know what was really kind of interesting was you know ah we would know up at the office of new drugs level what the big ones were that the group the the individual divisions were working on and we would hear along the way you know if they were big controversial issues that were coming up you know there's the usual push and pull of you know have they shown effectiveness are they well with But sometimes there were really tough, tough decisions to be made, you know, um fence sitters. And how do you decide that? You know, FDA is um an organization that's very collugi collegial.
Speaker: People talk. if it's There's, an you know, equal voice was a thing. Everybody wanted to have their opportunity to have a say, you know, regardless of your discipline, which made it really interesting.
Speaker: um Yeah. And um but there's always one decider. There's always one decider. And yeah um that made things pretty interesting. And it's a so ah helping sometimes the decider think through, know, walk through their rationale, bounce it off of us.
Speaker: And for us to be prepared if it was going to, there was going to be a big splash, you know, ah in the press or public, based on with which way a particular decision went.
Speaker: Yeah. And it's really interesting because I know just around this time in the 2000s, there's a lot of like really high profile whiplash within the FDA for like some, especially at the congressional level, which is kind of what we talked about earlier, like giving the FDA more ability to like take care of safety and and then pharmacovigilance, like after the drug is released.
Speaker: I'm giving them those powers so that we have staffing there, not just in the efficacy area. But what I find really interesting in your career is that you've essentially later on became the FDA's diplomat in Europe. I didn't even know that was a thing. I think a lot of people don't realize that the FDA has a role like that and that the world's like major regulators work together behind the scenes. But when you think about it, it almost makes perfect sense that they do and that they should.
Speaker: You helped run like more than 20 working groups there. And what's interesting is that the two agencies can look at the exact same data, yet they can reach different conclusions on different timelines and really work through things in a totally different process. So it's just that regulation isn't purely just science and like checking the box, like does the science work? There's a bigger...
Speaker: cultural legal and like system systemic issues like that go into how this works so like what was this position like and how were these interactions like between the fda yeah and ema at the time um i find it really fascinating that there's even like a whole institution or system built around this but it really there should be some global idea working together together of an idea of working together but what was that like Oh, it was, you know what?
Speaker: I for six years, I woke up up every day and said, Oh, I'm gonna pinch myself. I can't believe I get to do this job. You know, yeah it was really interesting. um The two organizations are they honestly, they could not be more different.
Speaker: They just as organizations. And I, think you know, my observation is that one of the reasons they're different is because their origins are different.
Speaker: EMA, you know, FDA has grown over the years in in response to big public health and legislative and, you know, even political sometimes shifts, but more ah you know historically. to address the needs of public health and science.
Speaker: And that's its origins. And, you know, put you know, there's shifts along the way, of course, but it has created this very, as I mentioned, kind of a hierarchical structure in the organization of decision making.
Speaker: um And EMA exists because of the European Union. It was established over, you know, what, 50 years of negotiation for to get these member states to come together at max, they had 28 of them, you know, and then the UK left that while I was there um to come together and find common ground to address the broad needs of all of those member states in the way of medical product regulation.
Speaker: Each of those member states still has their own, you know, like regulatory body that does certain things, but over time, the role of EMA has grown. They staged in what needed to be sent reviewed centrally over time.
Speaker: Um, and so the way it works is the staff at EMA aren't making the decisions. It's not like FDA where the staff are working on the decisions are made by committees of experts.
Speaker: And there are seven major ones. Um, and they each have they have a representative or a rap they call it a rapporteur and a co-rapporteur, two representatives, a representative and an alternate that sits on that committee for a x number of years.
Speaker: The committees meet they and they come from the regulatory bodies of all those member states. So they're big. And they spend at least one week a month at EMA working doing on meeting as a committee.
Speaker: um They are the ones who make the decisions. The application assignments are shifted around to different represent representatives over time. There's a repertoire and a co-repertoire.
Speaker: They come back to the committee, get input. They go back. They do the assessment. They come in at the end and the committee votes. And that's how the decisions are made. Yeah.
Speaker: Now, ultimately, those have to be signed off at the EU level, but they almost always are. I mean, it's really there's not much change in that. um And that's just how it works. The staff are remarkably well informed.
Speaker: They have views. They can help. They can help the assessors. um That's their job. They keep the train moving, but they don't make the decisions. Uh-huh. So I will tell you for FDA, for someone coming from FDA, that was, that was really interesting. And yeah I found it fascinating.
Speaker: And while they're tight, they don't have the same kind of timelines that we do. They do tend to be slower than their regulatory tools. Their framework for authorizations are a little different than ours. um What I found most remarkable is that most of the time they come to the same decisions.
Speaker: Mm-hmm. Now, it may take a little longer. They may you know need to tweak some things a little. So, for instance, one of the things that is absolutely taken into account in EMA decisions is from what they call their health technology assessors or their payers in the country that may want some additional measures in the clinical studies to be able to assure that there's potentially value added for this medicine. because my company, my country is going to have to pay for this, you know, and you can have drugs or ships and you can't have as many, you know, paid for, you got to yeah to make those decisions. So um that's, it was, you know, it's a little bit of a different twist while I was there, a couple of colleagues and I actually looked back over a cohort of three years.
Speaker: and apple drug applications and looked that went to both agencies and look to see what the congruence rate was in approvals and non approvals.
Speaker: It was like 97% over
Speaker: over three years. That's insane. Yeah. And we could only do that because and and and understanding, you know, when there were non approvals, why they didn't get approved, we could only do it because we had access to the inside internal files.
Speaker: We could dive in and look. um So most people found that really interesting because, you know, the mindset is, oh, they make really different decisions. Actually, no, they don't.
Speaker: Uh huh. Yeah, that is actually really interesting because, of course, they would it is it is really cool how the EMA, because the way that EU's healthcare system largely works in different countries, is that they're often the ones paying for it too. So they also, I i know to some extent, looked at like price and like well how what was like this willing to come out at to fit that into the regulatory framework also, which that was really interesting.
Speaker: Well, the FDA, of course, that wasn't really in their hands as much. And I mean, getting to today a little bit, and of course, we don't have too much time to talk about it. um i mean, the FDA seems to be like changing in a lot of ways still. like Back then, as we've talked about, it's changed in reaction to large health crises. When you have the AIDS at epidemic, you'd want to get drugs quicker. And of course, in the two thousand with the um we wanted to make sure we have safety and other areas that we can keep drugs safer when those issues came up and in that time.
Speaker: And now it seems to be changing for a lot of reasons. um It's going through probably one of its most dramatic periods of change. Yes, I would say so part of the Part of that's in reaction to science, like post-COVID, and part of that's just because of a new administration has been um creating a lot of changes. I mean, candidly, it seems like there's been a lot of instability there. The drug center has had, I think it seems like five leaders in about a year.
Speaker: um The commissioner resigned himself in spring, which is sounds like maybe somewhat normal. the companies have changed. But I mean, you were there as a study number two at the office for a well over a decade. So when you look at that and you compare that to how things are today, it does seem surprising that we're seeing all these changes.
Speaker: Um, Especially with like Unicure and things like that, that have all been high profile. But I'll leave it open-ended to you. I mean, what are you, what keeps you up at night? Whether you're excited or you're worried about the FDA, like what what what are you really thinking about in terms of where this organization goes in the future? Of course. Yeah, I would say, Nikhil, that has evolved in the future. And you're right, you know, when you work for a government agency, that's visible particularly a publicly visible one, you it's, it's expected that with a new administration, there will be change.
Speaker: That's our system. You know, yeah, that's how it is. You know, you get a new administration is it's their prerogative to make changes. And for the most part, um there are shifts that they're mostly shifts in emphasis.
Speaker: Okay. Over historically. And they have lessened because probably 20 years ago or so there was a a decided effort in FDA to, you know, keep the politics way only up at the top at the very highest level of the agency and not be Dipping in down into the trenches with political appointees.
Speaker: And I think in this administration that has been completely upturned. Well, yeah, so there it is. um i think There is no question that the the mass exodus that came with Doge was awful.
Speaker: Absolutely. awesome And it, you know, I will say from watching my colleagues there, it really seemed obvious that, you know, pain was the point.
Speaker: um And yeah I had a lot of survivor's guilt. I got over it. Yeah. oh and I think, yeah you know, in a place that values collegiality, that values teamwork, that values internal transparency,
Speaker: that was just the, the, that values scientific rigor to just be said, we don't need you anymore. Um, yeah. Um, was really demoralizing and in many ways frightening who was left to do the work. Right.
Speaker: Um, I think that, and, and there was a spillover from that because, many people tried to tough it through and um they ah they still just couldn't get past it you know, they had no resources to work with. Excuse me.
Speaker: My ID is in there. No, I'm Yeah. ah They couldn't. It was just too hard. It was just too hard.
Speaker: I think things have steadied. You know, the staff had to live through, you know, and I saw the whiplashes, you know, one new podium policy after another. The staff knew nothing about no plans to implement it. How are we going to do that? yeah Who's going to do that? Well, actually, we don't need you. We're going kind of decide. And then you just kind of pick up and it. You know, that is for people who have spent a long time in a career and have some maturity and scientific and regulatory thinking.
Speaker: They're open to new ideas. hu but having somebody come in and say, and here's how we're going to do it. And that's not in a way that's not thought through. That's just, that's just really painful.
Speaker: I think that's changing. And what I think is um I hope that FDA will come out changed it in a good way, but maintain that commitment to scientific rigor, true science, not pseudoscience, not pseudoscience, not stacked expert panels that come in with a view that they want to espouse for everybody else, which we saw for a while.
Speaker: oh yeah But really, the the tools, the scientific thinking to truly examine a circumstance or a situation or the um and render some advice.
Speaker: And the other thing is, it's by bringing in some new people, the the thing to do is not just tell everybody what to do, but give them what I call the shoulders to have the courage to try some new things, you know, kind of like way back in the HIV epidemic and the AIDS epidemic.
Speaker: We needed people, I needed a strong division director, a strong center director who helped put some guardrails around a thing so you didn't go totally off the rails and hurt people, but adapt to the needs of the time. And I think the needs of our time are around a lot of the innovations and scientific tools that are becoming available that don't necessarily neatly fit into the current regulatory framework. And we're going to have to find a way collectively to adapt to that.
Speaker: That's a good thing. I think that's a really exciting thing. It makes, it's what gets people to come to work because they're, they're learning, they're trying new things and they see it in in a way that they feel like is a benefit to patients and that really matters.
Speaker: Yeah, and I think it's really interesting because when people think of the FDA and the government, they think of like a regulatory body that should stay consistent. But really, I mean, as you've seen through this conversation, it's an agency that has aspects of culture and organization that change, that meets like outside needs all the time and adapts. And I think it'll be extraordinarily interesting to see with AI, like a wide range of new modalities, um like a lot of new ways of finding like therapeutics and and even like researching and presenting data. Even those things are all changing all at the same time so quickly that I think it's interesting to see that like the FDA does and can adapt. And that's kind of the ethos is like scientific rigor, but also being willing to reflect on like, how can we do things better in the future? So of course, like change isn't always good. It isn't always bad. And as you've seen some change recently has been
Speaker: hard and frustrating for some members of the organization but i think generally you can still be very excited that in the next like five years that things will probably change in the organization and new interesting problems and yeah that's a good thing it shouldn't always be the same um yeah and i think the important and you know most people in industry will tell you they need a strong fda They want a strong FDA. They want an FDA that listens, that learns, but is and but helps them interpret the regs and keeps them out of trouble.
Speaker: okay Because every company, every investigator thinks that their drug is beautiful. yeah I mean, again, in that world, I understand that. I totally understand that. you know This cake I made is amazing and everybody's going, oof.
Speaker: Yeah. But but they need that back and forth, that discourse, that reality check. And it's what, you know, you can have all the science and the AI in the world, but at the end of the day, it's judgment. It's um saying, yeah, maybe this fits the statistical model, but you know what? The statistical model can't take into account this particular factor over here. And I think we need to weigh that more heavily.
Speaker: whatever that may be. And I'm going to take a risk and say, yes, we need to do that or no. Yeah, it's statistically significant. And the safety the safety data look reasonably okay, except for these two cases and my God, they're awful. And if there's two in the trials, there's going to be many more. you know Those kinds of things, those take the those take judgment.
Speaker: hu And I think it's really, yeah, it's really, it's a people-focused organization, right? or It's an organization that's really built on its people, I should say. So I think that's going to be increasingly interesting to see how they are able to like really keep that, keep that going.
Speaker: But I really do appreciate the conversation today. We've talked through so much and there's honestly so much more we can even talk to. So thank you much, Greeter, for coming on today. I've never a shortage of things to say, as my family tells me. Yeah. But thank you so much for the time. It was really great to have you. Okay. Thank you for inviting me, Nicole. I really enjoyed chatting with you.
Speaker: Thanks for listening to The Healthcare Theory. Every Tuesday, expect a new episode on the platform of your choice. You can find us on Spotify, Apple Music, YouTube, any streaming platform you can imagine.
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Speaker: Repeat, thehealthcaretheory.org. Again, i appreciate you tuning in I hope to see you again soon.
