Special Edition: Califf Transcript
On February 10, 2023, the Alliance for a Stronger FDA hosted an online, fireside chat
with FDA Commissioner Dr. Rober Califf. In light of public interest in the topics discussed,
we are posting a transcript of that event as a special update below.
Emily Holubowich: Good afternoon, everyone. I am Emily Holubowich, National Senior Vice President for the American Heart Association and President of the Alliance for Stronger FDA. I’m pleased to be joined today by my co-moderator, fellow Alliance board member and former FDA Chief of Staff, Tom Kraus of the American Society for Health System Pharmacists, or ASHP. Tom and I welcome Alliance members, the media, Alliance guests to today’s webinar with Dr. Robert Califf, Commissioner of the Food and Drug Administration.
Before we begin, a quick word about the Alliance for a Stronger FDA. We are multi-stakeholder coalition that advocates for increased appropriated resources for FDA. We’ve been an important force in doubling the FDA’s budget authority from 1.6 billion dollars to 3.5 billion dollars. Our other mission is to educate policy makers, the American people, and the media about the FDA’s growing mission and responsibilities. We are also the only advocacy organization focused on resources for both food safety and medical products, as well as other components of the FDA mission.
Our members include consumer and patient groups, research advocates, health professional societies, trade groups, and industry. With about 150 members, we welcome new members to further strengthen our advocacy and educational efforts. If you are interested, please feel free to follow up with me or our Executive Director, Steven Grossman.
The format of today’s fireside chat will be familiar to those who have joined us previously. Tom will lead our fireside chat and during this time we encourage you to submit your questions through Zoom’s Q&A function. Make sure to use that Q&A box as we will not be monitoring the chat function. Our session today is being recorded and a summary will be available in a future edition of the Alliance’s Friday Update, which many of you already receive. If you aren’t signed up for it, please visit us at strengthenFDA.org to do so.
Now, it’s my distinct honor and pleasure to introduce our speaker, Dr. Robert Califf, FDA Commissioner. Dr. Califf is coming up on his second anniversary of his second time as Commissioner of FDA. He first led the agency during the Obama administration from February 2016 to 2017. Dr. Califf also served as FDA’s Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as Commissioner in February 2016. He was a professor of medicine and Vice Chancellor for Clinical and Translational Research at Duke University. He also served as Director of the Duke Translational Medicine Institute and Founding Director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science with more than 1200 publications in peer reviewed literature.
Dr. Califf, welcome! We are so pleased to have you with us today to celebrate Heart Month and your second anniversary next week. With that, Tom, I will turn it to you.
Tom Kraus: Yeah! Thank you, Emily, and thank you Dr. Califf for joining us again on this sort of upcoming anniversary. You’re a year into the job the second time around. Maybe just to get started, how does the agency compare to the agency you inherited back in 2017? How does this compare and what are you noticing as the differences? Obviously, the way we work is different but can you just tell us a little bit about how the agency compares?
Dr. Califf: Sure. First of all, thanks, Emily and Tom. It’s great to see you all. You seem like a much friendlier audience than the Congressional Oversight Hearing I met with on Wednesday. This is a welcome chance to chat a bit.
What I’d say is first of all, amazing the number of familiar faces when I came back. It speaks to the mission at FDA that people are really dedicated even at levels at which you’re under fire every day. Even through this pandemic where the FDA has had to do its usual job with all the to and fro of all the products that normally are dealt with plus all of the extra load of the pandemic. So, that was very noticeable. I’d say the environment, however, is very different. I would say 2016 was a genteel environment. I don’t know how you felt, Tom. It didn’t necessarily feel that way day to day but in comparison to what we experience now, I think it’s a much more difficult environment. We have a divided country. There is a sea of misinformation, and it just seems a lot less collegial on the outside than it was in 2016.
I don’t think that’s unique to FDA but since the FDA is at the tip of the spear of a lot issues that affect society, I think we may feel it more than everyone else. Finally, I’d say just an observation I’ve been thinking a lot about because of other things going on with the agency. You remember in 2016 we had 21st Century Cures. There was a sense that the medical products side of the FDA needed a shot in the arm that would be good for all of us. I think when I came back it was obvious that that had worked, that the medical products side were pretty well supported. It could always be better. Performance could always be better but basically was working.
The food side of the FDA, I’d gotten a lot of calls saying gotta pay attention to the food side. It’s not gotten what it deserved. I think that’s been validated in our experience so far, a lot of hardworking people under resourced with many very difficult issues to deal with. I think I’d say the unevenness is something that we’re really having to deal with across the agency. I don’t think that’s totally new either. This is a long-standing issue that’s been germinating, but it’s come to a head and we’re dealing with it.
Tom: Well, why don’t we jump right into that topic then? The agency has recently proposed a new approach to organizing that food safety program. Can you talk a little bit about that, in particular how the reorganizing ORA to be more responsive to those food safety needs how you see that?
Dr. Califf: Yeah. You threw a lot of words in there that are really very important the words that we use, I think. First of all, we can only propose because as you know we have a lot of bosses and we have a lot of collaborators, including all of the employees and the unions that represent them. We can only propose ideas now for then discussion about how we make final decisions and implement. In addition, when I say a lot of bosses, we’ve got the executive branch of the government and the Congress.
Tom: Sure.
Dr. Califf: It seems like everybody’s interested in what is being done here. So, our proposals are nowhere near the final word. I would argue that armed with the Solomon Report from the infant formula situation and the Reagan Udall Report led by Dr. Haney, esteemed former commissioner, that basically we have all the information we need to propose very significant changes that I think will make a big difference and respond to what was said. So, number one, the use of the word food safety, Tom, no. It’s not just food safety. It’s the human foods program. Food safety is critical. Contamination of food by bacteria and viruses is something that we need to do better and better on. But we’re a nation with a declining life expectancy that’s profound going on right now. Not just because of COVID but common chronic disease driven with a nutritional underbelly that we’ve got to deal with more effectively.
In addition to wanting food that’s safe from contamination and good nutrition, we want food that’s safe from chemicals. That is an area that’s gonna grow a lot. Not because the chemicals are getting worse necessarily, but because we can measure things so much better. So, all of these have to be taken into account, so a unified program with a single leader. The job will be posted soon. We’re gonna do an executive search. If you happen to know anybody out there that would like to take on the chance of a lifetime to prepare for the regulation of the food system of the future, this is it.
A second thing I’d point to is we heard a lot from people about something that’s really an obvious issue but needed more work. That’s FSMA is a great basic template for what needs to be done. The FSMA rules have been hard work that the FDA has done. The community has weighed in a lot, but if you say have we enacted FSMA I think there’s pretty broad agreement that we’re only partway down the road. A very big part of that is the realization that we’re regulating over 600,000 entities. Every entity is in a state. Every state his its own regulatory system for food. So, the proposal is to separate out the FDA, State, and the other entities that we deal with, Tribal, etcetera, and put that into a program that would be very specific and very out front in terms of working together. Because all told, the states do more inspections than we do. I think in the report and in all of the discussions that I’ve had with people, there are all sorts of issues that need to be resolved about transfer of information and such and the way the contracts work. Those are really important.
There’s the elevation of nutrition into a center. Congress gave us the Office of Essential Foods as a mandate, which we were really glad to get. That deals with infant formula but also this very important growing area of specifically using food to prevent or treat diseases, which is gonna be a hot area over the next 10 to 20 years. Then you have the integration of the subject matter experts with the inspectorate, which gets into the ORA issue, the last part of it that you mentioned. Very important that we have this working more effectively together across these different parts of the FDA. As people know, we made the decision not break apart ORA as many people had recommended and still are recommending in the response to what we’ve laid out, but I think if you work inside the agency you realize that across the spectrum for commodities there’s a real need for an infrastructure that delivers there.
At the same time, we’ve got to have compliance functions and communication functions which are more efficient and streamlined and lead to better decision-making. That’s where the Human Foods Program with a single leader is really gonna be important as we envision. I’ve gotta stress again, if I was private business or in a university, I’d move a lot more quickly, but we have a lot of interested people that we have to make sure that we get it right. I’m not kidding when I say the chance of a lifetime. I think the issues of the past have been brewing for many years, but if we look at the future we’ve got climate change. We’ve got multiple supply chain disruptions. I’m proud of my quote that the only commodity in which we’re not seeing supply chain disruptions unfortunately is tobacco. In every other commodity we regulate there are really critical issues that are gonna need policy correction, and we have international strife that we thought we were past but that’s having a big affect on raw materials.
So, getting this right so that we can feed America and feed the world nutritious food that’s plentiful and not contaminated, that’s a big charge. We’ve gotta put a system together for that future.
Tom: Rob, you mentioned implementation of FSMA and talking about kind of progress towards that. Some folks who are on the line may not be familiar with what that was. Can you just say a few words. That was intended to apply a more risk-based approach to regulation of food. Can you just talk a little bit about that?
Dr. Califf: Sure. I think one view of regulation and enforcement is that it’s sort of like you wait for something to happen. Then when it goes bad, you come in and give citations and fines and tell people they have to correct their behavior. I think we all agree the better approach to anything that we do in life is to prevent the problem rather than waiting for it to happen. Again, if you look at 600,000 entities, we can’t have an inspector in every entity that we’re regulating every day. So, the plan which is clearly laid out in FSMA also is document the new era of smarter food safety that was authored out of the FDA. It just makes a point. You need a much more digitized system, more information-based, use of algorithms, and also the phrase educate before you regulate.
There aren’t many people who are involved in the food industry that want to be producing or selling contaminated food. What we need to do is to work together. Of course, the FDA does have an enforcement function which much like in medical products, we’ve always got to keep that in mind as a part of what we do. So, what’s really called for in FSMA is working together, education, making the whole system better, and then risk-based inspections. Again, this is where the states and FDA really need to come together. Because if you’ve got a bunch of people living in the state doing inspections, having that information and putting it in the algorithms is gonna enable us to make the best use of the limited number of people we have working at FDA.
Tom: So, maybe actually let’s take that concept and kind of broaden it out to the agency as a whole. How are you thinking about the role of data and technology modernization across the agency?
Dr. Califf: Well, you know me. My whole career, it really started for me I was as I like to say a country doctor from South Carolina. I was seeing patients with heart attack at a time when we didn’t have a treatment. There were a lot of ideas about what to do. For those who were around in 1980, remember we had a lot of mostly men in their 50s that were dropping over dead from heart attacks, a lot of cigarette smoking. Then we discovered it was a blood clot in the artery that caused the immediate problem. There were hundreds of ideas about the best way to treat it but no one really knew. We developed systems to do global clinical trials to sort it out. The result is the reduction in the risk. If you have a heart attack, I don’t wish this upon you, Tom, but if you had one today your risk of dying would be half of what it was in 1980 because of these interventions.
So, throughout my whole career it’s good to have knowledge. It’s good to have opinions but as I like to say, I’d much prefer evidence-based intervention to imminence-based intervention. Smart people are better than not having smart people. Smart armed with evidence is really the way to go. Unfortunately, not all elements of the entities that we regulate have the sophistication of data systems that we have for example for human clinical trials, but it’s really coming along. As you know, I spent five years at Google. I see the potential in where things are headed. It’s really critical for the FDA to be prepared as society becomes more digitized to take advantage of that on behalf of the good part of what digitization can do. That’s a big focus.
We are intensively working now with a more enterprise-wide approach to ORA. Because if you think about it, and it shows up in the diagrams in our report, the inspector at ORA is linked to every center in the FDA. So, make that more modernized, I think it’ll have big implications for other sections.
Tom: Great. So, that modernization and kind of digitizing within ORA is one function. Now, I recall that we had a list probably 30 items long of kind of operational improvements that we were working on in the background that maybe weren’t as visible as the kind of headline grabbing policy issues. You had a concept of leaving the agency better of than you found it. What’s on that list this time around?
Dr. Califf: We’re down to 24 I think, Tom.
Tom: Okay.
Dr. Califf: It’s a little less infrastructure oriented per se. For example, I think advisory committees is an area where we need to do a lot of work. I’ve come to think of many things in government as sort of like artificial intelligence algorithms. If you develop one and you just leave it in place, it deteriorates over time. It veers in directions you don’t expect, and you need to be maintaining it. We still have the core issues that everyone knows. We have to hire people. I would say the federal personnel management system, it’s dealing with all kinds of things that are not so pertinent to FDA. So, it’s suboptimal for FDA but 21st Century Cures has made a huge difference. Thanks to everybody’s hard work, we now have the authority on the food side. We really need it for tobacco, I must say. The sophistication of the tobacco industry begs that we have sophistication on the regulatory side that’s at least as good and matching.
I think what’s really come along since 2016-2017 that we sort of take for granted now is digital platforms have gotten to the place where we just take for granted how much our work is gonna be supported by the digital systems. I think where the FDA excelled because we had to, I remember with you we had to go virtual because we didn’t have enough offices to put people in. So, the FDA was already set up with home technology. I think we compare with any business I’ve seen in terms of Zoom at home and those sorts of things. But at the workplace, we’re behind because there was no reason to focus on it during the pandemic when people weren’t here. Things that people take for granted in their jobs in digital support for their workflow is a big activity.
Again, the main focus here is ORA because we’ve got the inspectorate all over the country and the world. I think you know. I think you may have gone with me on some of the trips to see the difference between taking a picture of an item and having AI categorize it and catalogue it vs having to hand enter characteristics of the item because we have to defend what we do in court. You’ve gotta have the data. That’s like a huge difference in the work. So, I’d say that’s a big focus. I’m glad Janet is around. She’s very focused on the same thing. I think we’re getting a better and better internal group at working on that.
We have another 20 something areas of focus. I think the theme now rather than just being infrastructure, these are things that are cross-cutting across the agency. Things that individual center can do and needs to be focused on, I feel like people are doing a great job. I’m very happy with that, but in today’s world you gain a lot by having enterprise-wide activities where there’s economy of scale and thinking. That’s where I’m focused.
Tom: You mentioned the advisory committee process. I think obviously advisory committees have probably been more public visibility in the past few years than ever, but people may not realize some of the challenges with recruiting experts that are able to participate in those committees. Can you just say a few more words about kind of your vision for the advisory committees?
Dr. Califf: Sure. It was interesting that it came up in the hearing on Wednesday. I think the comment that advisory committees are like democracy, they’re messy, is something that we really need to embrace. Because people say FDA decidedly differently than the advisory committee or there were advisory committees that were unhappy. All of those kinds of things are gonna happen. If you have advisory committees where everyone agreed and everybody was happy, you wouldn’t need to have a committee meeting.
Tom: Right.
Dr. Califf: You could just spend your time doing something else. I used to be an advisory committee chair back in what I call the good old days of advisory committees. The amount of paperwork, the difficulty of dealing with potential conflicts, if we think about rare diseases as an example, show me an expert in a rare disease who’s not spending time working on therapeutics for that disease. Then you automatically have what traditionally is a conflict. Yet, if you look inside the FDA the main thing that employees want out of advisory committees is expert opinion from the outside. There’s also value, of course, in the patient perspective and non-expert opinion people, people that are general experts, but all of these things need to be melded together I think in a much better way.
I think evidence of the frustration was what’s pointed out in the two Reagan Udall reports. The food advisory committees were disbanded somewhere around 2018 and the TPSAC for tobacco hadn’t met in two years. I think it’s essential in a public agency that you have public advisory committees. To be fair, the food side started depending on the science board, but I would argue the science board is really constituted for a different reason than we need. So, we’re gonna start back up the food advisory committee.
Across the FDA, we need to make it easy. A review group needs an advisory committee. It ought to be the easiest thing they do, not the hardest thing they do. It’s so important to get that interaction with people on the outside.
Tom: Let’s shift gears. We had a couple of other topics that I know Congress has been interested in. One of those is the accelerated approval process. There was some legislation included at the end of the year. Do you have any kind of perspective yet on how the changes to the accelerated approval process will be implemented?
Dr. Califf: Well, you know, I can’t resist coming at this problem as a clinician, which is how I grew up. So, as I like to say, I’m a fan of accelerated approval when it’s a situation where there’s not an effective treatment for a significant unmet need for serious illness. What’s been missing, I think, is an adequate follow on to that accelerated approval. I think the new Omnibus bill added some things in that are really important and give us more ability to deal with the follow on studies and even to require enrollment if needed before the approval is given. Remembering that in my world of large cardiovascular diseases, it’s not uncommon to get a cholesterol lowering drug on the market in a rarified population of people with a condition like familial hypercholesterolemia, which is not really all that rare but it’s much more rare than the entire population which is at risk for coronary disease. It was the norm to get the big trials started before the approval for the more rare population.
I think that’s a good way to do it. It wouldn’t always work so it’s not always gonna be that way. Then I think when companies don’t do the studies or they do the studies…I don’t like the term the trial fails because it’s not the trial that is failing. It’s the treatment that is failing. If you do a good trial and the treatment doesn’t work, then it doesn’t seem like there’s much basis to be on the market. I think we’ll have a streamlined process to make that happen. So, I think we’re moving in the right direction on accelerated approval.
Tom: Great. Another question tangentially related to Congress, obviously the government, Congress, put forward an approach to negotiation of drug prices. FDA is not involved in that process, but there is some discussion about how that might shift incentives for manufacturers, whether they might shift investment away from small molecule products. Some of that was already happening but do you have a sense of kind of how that shift impacts the agency, if that is a shift?
Dr. Califf: There are parts of that question that you know I can’t talk about because it’s under consideration. One of the points of emphasis for me has been work across agencies. I feel like for all of the issues that exist inside a big place like FDA, a lot of what’s lost for societal good is when the ball gets dropped between agencies. So, with regard to CMS, we’ve really stepped up our communication and interchange. We’ve had folks from FDA helping out at CMS as they’re trying to figure out how to implement the IRA. I can’t talk about exactly what the decisions are. That’s a CMS decision.
I would just say sort of an analogy. I think one of the great things about the food and drug and cosmetic act is that it gets tuned up on a regular basis. The user fee must pass legislation gives an opportunity. It kind of worked out in a weird way this year, but we got many of our improvements in with the Omnibus. I think IRA is a big law. There will be unanticipated consequences. There will be repair work that’ll need to be done to make it right. We’re all gonna watch with interest and track things. One thing I’m also sure of, we’ll hear from the constituents about what’s happening with the incentives.
I can’t stress how important I think understanding what the incentives are doing on the medical products side. We really just can’t ignore the impact of incentives, but it gets tough. Because once something is incentivized, it’s hard to stop incentivizing it, but the needs vary. I’ll just say, we had a meeting today about smoking cessation. Where is the industry on developing new products to help prevent 500,000 people a year from dying? We have a vaping industry. We could have a long discussion about its role in combustible tobacco cessation, but to me it’s not an issue that there aren’t enough good ideas that might be out there. There’s just not a market for this huge human need. I mean, our leading reversible cause of death, and we’re not seeing much from the industry. It’s just to make the case, we’ve gotta be aware of what incentives are doing. IRA will produce a set of incentives and we’ll have to see how that works. Then I hope the government can respond by aligning the policy with the incentives.
Tom: So, another sort of area of the industry that the FDA regulates, you mentioned the cosmetics part of the Food Drug and Cosmetics Act. Obviously, there’s new authority there. Can you tell us about that new authority and why it’s important and how the agency is approaching implementation of the new law?
Dr. Califf: Sure. Like a lot of things, I regard the new authority as a start of what’s gonna be a longer journey. Obviously, what’s happened to the cosmetics industry is dramatic. It’s an enormous, growing industry. The issues have so many variations from what happens with hair straightener to the skin is actually an organ. We frequently have to remind people that when you put things on the skin, it’s actually configured to both block and absorb. The start is really being able to catalogue what’s being sold and what’s in what’s being sold. As all too often happens, we got authority but no budget to go with it. So, we’re gonna do it. Where cosmetics will reside is a frequently asked question, and the answer right now is we’re not sure. It seems unlikely its final place will be in the food area, but we’re gonna make sure it gets the attention it deserves.
Like a lot of things, as we get the program started and the funding needs become obvious, we’ll have to make the sale that the funds need to be there and there’s a good reason for them to be there.
Tom: We’ve talked about cosmetics. We’ve talked about the Foods Program. We’ve talked about medical products and tobacco. Does the agency need any additional tools kind of across those from Congress? That could be authorities. It could be infrastructure. It could be dollars. What’s kind of a global perspective on the agency’s needs?
Dr. Califf: Of course, we need dollars, but I do know that in order to make the case for dollars we’ve gotta clean up our kitchen. We’ve gotta have things in order. We’ve gotta be able to show people in the budget where things that society needs are not being met because there aren’t the people there to do it. As you know, I worry. Despite my saying all the good things about technology platforms, I worry a lot about it because the way this would be handled in business would be to raise a bunch of money and make it as a capital investment off of the P&L type analysis to configure the entity for the future. We can’t do it that way. Incrementalism here is better than nothing but it’s not really the best approach to the problem.
You know, there was a good discussion at the hearing about the needs for data in the setting of a pandemic. It’s every bit as true for just everyday life. If you have a good sense of what’s going on with diseases and outcomes, in the case of food with where technology is, what crops are being grown, we could go on and on. Having a data platform that gives you the information you need to be smart is something that we really, really need to think through and work on.
Tom: Clearly, implementing a data strategy with a budget a year at a time without some certainty is a challenge. Let me turn to Emily to draw on some questions coming from the audience.
Emily: Thank you, Tom, and thank you, Dr. Califf. We have a lot of questions in the Q&A box, some of which were answered during your fireside chat. One that’s coming in, a follow on I think to one of the questions, is there were several provisions and reforms that were left out of the User Fee Bill and that end of year Omnibus package. Of those that didn’t quite make the cut, Dr. Califf, what would you like to see included in upcoming packages, for example, [inaudible] [00:38:13] like the prop [inaudible], some old plug user fees, etcetera?
Dr. Califf: Well, there are a couple of big ones, one of which almost made it called VALID which is dealing with laboratory testing. Kind of like what’s happening in animal biotechnology or plant biotechnology, we’ve got increasingly sophisticated tests being developed, often in laboratories of academic medical centers. There’s smart people involved. I’m an academician. I love academic medical centers, but when you begin to take those tests out to a broader population, it’s really important that you do the basic things that ensure a quality system with a reliable, interpretable result. The only way you really know how to interpret most tests is to do basically studies in relevant populations to generate the operating characteristics, like sensitivity, specificity, and the other more sophisticated measures.
So, I’m hoping we’ll get the framework fixed so that innovation will be highly rewarded and supported, but we also will have reliable tests that you can depend on. That if you go to Place X or Place Y to purportedly get the same test, that you’ll get a result. Particularly for things that are for example directing you to a particular chemotherapy, where we have evidence it’s just not the case now in many situations.
Then we have supplements which has been a point of discussion ever since DSHEA. I don’t regard that quite at the same readiness level as VALID which I think is right…we almost got it through this last time. Supplements, we’ve got a lot of work to do but it’s such an enormous industry and so many people are spending so much money. It just seems to me that we ought to know what’s being sold and what’s in what’s being sold. I think with real world evidence over time, we’re gonna have more and more studies that demonstrate the benefits and the risks of supplements just like with drugs because the cost of doing the studies will come down.
Then we have a lot of smaller fixes that didn’t get through like the catalyst. I’m sorry, the issue with orphan drugs that when you go for multiple indications the implications of that. I think we can patch those things up over time. Don’t be surprised as we go through the Human Foods Program we end up seeing a lot of things that need fixes to make them part of the ongoing system of the future.
Emily: Great. Thank you so much for that. You talked about the importance of data and data modernization, especially in context of the pandemic. I think the pandemic also underscored the importance of testing. We had a question from our audience on what is the FDA working on or is the FDA working on a strategic diagnostic plan that could be implemented on a national scale to be more prepared for the next pandemic?
Dr. Califf: Yeah. I’ve got a beautiful playbook from Dr. Shuren and his CDRH colleagues that they’ve developed from the lessons learned as we have gone through several emergency needs for tests, of course with COVID being the big one but also the M-pox situation. I think we know that the basics of the playbook would be develop a test as quickly as possible. Make reagents are shared. I think is we look at the societies that have done the best with rapid deployment of testing, the solution is not to have 100 different entities developing their own test but to have a more limited number who develop scalable, reliable tests that can be distributed at a reasonable cost across the country.
Now, because you’ll be dealing with an unknown almost by definition in a outbreak pandemic type situation, of course you need multiple people working on it. It’s not to cut out people but we learned with COVID that initially it took too long to get the testing out there to the country. Once the gates were opened, a lot of bad tests got out there that probably shouldn’t have. So, I think we’ve got a pretty good strategy now for how to operationalize a more efficient, effective testing system.
Emily: That’s great. Thank you for that. Another question from one of our board members actually is if you could share more about how FDA will approach the women’s health roadmap update that was required in the Omnibus passed last December. Do you anticipate there being a focus on innovation?
Dr. Califf: Well, women are half or more of our population. There’s a lot to do. There are so many specifics. I won’t through them all but I think there’s so many examples. I talked about the incentive thing. We obviously have things that are in the headlines today having to do with issues like abortion and birth control, but we also have this embarrassingly high and tragic maternal and fetal mortality issue. We don’t have a lot of new therapies coming along to deal with it. I do think innovation has gotta be a critical part of what we do. It gets back to this how do we – it’s not that the biology of pregnancy and fetal growth hasn’t moved along. We know a lot more about it but there are a lot of reasons why this is not a big area of investment, mostly having to do I think with risk of clinical trials.
That’s just one example of many. There will be a roadmap and we’re happy to have the impetus to do it.
Emily: That’s great. Thank you for that. Thanks for your work on that. A lot of questions in the chat, you mentioned VALID and the hopes that will eventually get over the finish line. To kind of follow up more specifically, what approach do you see the agency taking toward the regulation of LDTs between now and perhaps a hopeful enactment of VALID sometime in the near future?
Dr. Califf: We’ve already publicly said we’re looking at rule making as a possible strategy. I can’t go into any more detail because it’s a regulation under consideration. I’ll just say that there has to be a way that we can agree to a framework of quality in laboratory testing that assures Americans that when they go and get a test they’re gonna get a reliable answer. I’ll also add, it’s sort of like with drugs and devices in general there’s a swim lane for FDA that a lot happens when things get on the market. We still have accountability for post-market safety. I think in laboratory testing there’s a whole lot else besides just a reliable test. There’s also and interpretable test and a lot of work to do in the future on that. The basic groundwork is making sure we have the framework for reliable tests.
Emily: Great. Thank you for that. Also, we have a couple more questions about AI and any more detail you can share about how the agency will be moving forward with guidance on handling premarket submissions for medical products using AI and anything you can share. You probably can’t talk about what’s in it but some more on timing, especially around products that receive the EUAs during COVID public health emergency.
Dr. Califf: Well, let me make sure I know which question you’re asking.
Emily: It’s both.
Dr. Califf: It’s both. Okay. On the AI, obviously the predicted exponential growth of AI is happening. Having worked at Google, I could see it was happening already. It’s just that it was happening in areas that we don’t think about as regulated areas. Like we all talk to our cars now and things like that. Those things are just being now incorporated into medicine. Dr. Shuren just hired a new head for the digital component of what FDA is working on. We’re gonna have to be flexible and learn as we go because of the pace at which this is going. Chat GPT is an example and all of the big tech companies have comparable technology. It’s gonna change a lot of the fundamental operations of diagnosis and treatment, and clinic visits, and all those things. We’re just gonna have to be adaptive. I’ll just say I think that the FDA was wise way back when it said when it comes to algorithms and AI there’s a lot of work to do premarket, but the biggest bulk of work is in post market.
If you leave an algorithm sitting there in a clinical setting, it will deteriorate over time and it will veer in ways that are unexpected because it’s very dependent on the underlying characteristics of the people who happen to come into contact with the algorithm. So, people think about premarket. That’s fine. They’d better be thinking about an algorithm as a living entity that needs to be tended continuously during its lifespan.
On the COVID, it’s actually pretty straightforward. If there’s a useful product out there that has an EUA, whether it’s a drug device or vaccine or diagnostic test, it’s gonna be EUAed until it can be converted to a regular approval. There are some that were EUAed that turn out probably not to be so good when all the data comes in, so that will be evaluated too. It’s important for people to realize that the EUA is not dependent on the public health emergency declaration. We can continue the EUA independently even when the emergency declaration is ended. We’ll handle all of this through guidance and also a federal register notice. Everyone will know.
Now, paying for all of these products when they’re back in regular circulation, that’s a whole other issue which is not FDA’s primary issue.
Emily: Right. Thank you for that. I’m looking at the time. I know we’re getting close but we do have a few more questions if that’s all right.
Dr. Califf: Sure.
Emily: You’ve spoken previously about the affect of climate change on the food supply and the spread of infectious disease. Maybe you could elaborate on what role you see FDA playing in helping to reduce covered emissions and respond to climate change more generally.
Dr. Califf: Well, sure. I would start with one that people on the human side don’t think much but they probably should, animal feed which we regulate. It turns out cows are the biggest source of CO2 according to some experts. It turns out what you feed an animal has an affect on that. There are also big potential changes due to biotechnology in plants and animals that could enable much more resilient species that are much more carbon friendly. That gets into just a fascinating set of issues and science issues that we’re very involved in. As you may know, we’re about to announce the new head for the Center for Veterinary Medicine which is a key player. With the Human Foods Program, I’m thinking we’re gonna have this new group of people who are gonna lead into the future in ways that will be very exciting.
Part of it is reducing the rate of climate change, but another huge part of it is just we’ve gotta feed people even as the climate is changing. Crops and animals are not gonna do so well if they’re in an unstable climate environment, but we can help them become more stable through smart use of technology.
Emily: Thank you for that. Of course, I would be remiss if I didn’t thank you for yours and the agency’s leadership in what you’re trying to do to improve nutrition. So, thank you for the work you’re doing there. If I can, a personnel question. I think all of us, large employers large and small inside and outside the government are trying to figure out how we get back to the back to jobsite initiatives. What policy has FDA adopted on getting back and how is it going so far?
Dr. Califf: Well, I think as all of you know as I mentioned with Tom, even back in 2016 we were hybrid because we didn’t have enough office space. Most FDA people by rule spend a day a week working from home and had a nice home setup to make that possible. Obviously, during the pandemic people that worked in labs etcetera came to work every day as needed. People that were just working with computers mostly stayed home. We did a pilot that Janet led right as I was coming back, and we confirmed that people actually like working from home for the most part. We’re not in a hybrid phase. I think the way to think about this, we’re now not thinking about COVID as the driver of what we do. It’s really what’s the workplace of the future? We’re measuring productivity, satisfaction of the employee, satisfaction of our constituents, and finance. Remember we that we rent a lot of space. If we can reduce the amount of space we rent, we can hire more people.
I think the optimal work environment for most people now is gonna some period of time in the office but a good bit of the time working from home to reduce commute time and all that, but we will have time in the office. We are now going to face to face meetings with industry, for example, which I know has been a hot topic.
Emily: You’re right. Thank you for that. Well, as we’re coming to close I have to ask. Reflecting on your first year of your second term at FDA, what are you most proud of over the last year? Maybe looking ahead, what’s keeping you awake at night?
Dr. Califf: First of all, nothing keeps me awake at night. I was an ICU doc for 25 years. The first 10 of those, I was on call 12 out of 14 nights at a time when we were figuring out how to treat heart attacks. If you told me to go to sleep now, it would take me about 30 seconds. Nothing keeps me awake at night. What I’m proud of is that we’re taking on hard issues. I’ve gotten entire lectures from people about how to kick the can down the road and not deal with it. I didn’t come back at age 71 to kick the can down the road. As hard as it may be and as much criticism as it may engender, we’re gonna take on these issues.
I wanna point to cannabis as an issue that we’re taking on. We’ve learned a lot in the last four year but frankly the briefing I got when I came in 2022 is almost identical to the one I got in 2016. So, it’s time to create a new regulatory pathway for the 30 something derivatives of the cannabis plant that end up in everything from animal feed to cookies. We’ll deal with that. I’m shocked, Emily, that you haven’t mentioned tobacco at all in this. I’m very proud of –
Emily: I’m trying to not take my privilege of moderator, but you brought it up so I’ll let you go there!
Dr. Califf: Yeah. 500,000 people will die this or almost 500,000 in the US. We’ve got a new director for the Center of Tobacco Products. Mitch Zeller, after distinguished service, retired having paved the way. As you’ll see as we respond to the Reagan Udall Report, we’re into a new era where I hope we’ll accelerate the reduction in combustible tobacco product use and the associated death and disability that occurs with it. I think taking on the longstanding issues on the food side, getting ORA in a situation where it’s better linked with the centers and prepared for what’s gonna be a really exciting future, and taking on the tobacco issues are right up there.
Of course, I’m a doc so I love the medical products side. I don’t mean to play it down, but I think medical products side has gotten a lot of attention and still gets a lot of attention. We need to do a lot of work on the other side of the house.
Emily: Well, Dr. Califf, we’re coming up on time. I can’t thank you enough for being with us today and sharing your insights and for all of your leadership. It’s great to have you back. I also wanna thank your team for making themselves available and always being so helpful to the Alliance. We’re here for you. We’re excited to dive into budget and appropriation season. We’re looking forward to seeing the budget on March 9th and hopefully future conversations about your priorities there. I wanna, of course, also thank my co-moderator Tom Kraus for his incredible questions, for you in the audience for your participation and being with us today. As a reminder, if you’re not yet a member of the Alliance for a Stronger FDA, we’d love to have you. Please contact me or Steve Grossman, our Executive Director.
With that, I wish everyone a wonderful Friday afternoon. Hopefully, Dr. Califf, you can take a break and get some rest. I know it was a busy week.
Dr. Califf: No rest this weekend.
Emily: Thank you for being here.
Dr. Califf: I’ve gotta work on reports this weekend, but let me just say, Emily. I got the old tired question in the hearings, “When are you people gonna show up for work?” I just enjoyed answering that question. I mean, people have worked so hard at the FDA. We’re not perfect. We should get criticized when we don’t get it right. That’s fine. But I’m very proud to be representing this group of hardworking people. Thanks, and have a great weekend.
Emily: They’re at work and they’re still working. They’re gonna keep working! Thank you again. Thanks, everyone, for joining us today. Take care!
Dr. Califf: See you, Tom.
Tom: Thanks, Dr. Califf. Thanks.
[End of Audio]
Duration: 60 minutes