Interview: FDA’s Califf talks with Focus about 2023 priorities

Regulatory NewsRegulatory News | 21 December 2022 |  By 

FDA Commissioner Robert Califf toured the exhibit floor at the 2022 Medtech Conference in Boston. (Source: Ferdous Al-Faruque)

It’s been almost a year since Robert Califf returned to the helm at the US Food and Drug Administration. The commissioner talked to Focus about his unfinished work, his hopes and concerns for the future, and more in a year-end review.
Focus: When you stepped into the commissioner's office again, what unfinished business did you want to prioritize from your previous tenure at the agency? 
Califf: There was a long list of things that I thought could be made better. I think a lot of them have to do with supporting the internal workings of the agency, the employees and the systems in which they work, hiring the right people, and improving their ability to get their work done through better information technology.  
Those were internal things that I think people tend to undervalue that pay off in many, many ways for all the many areas in which the FDA works. But I think it's also fair to say that in my lifelong career has been spent on evidence generation and we got a lot of things started. The 21st Century Cures Act is a good example of major legislation that's bolstered the evidence generation system. But I had a real desire to take advantage of the opportunity to help make the evidence generation system better. And that was a big part of what I was thinking coming into the job.  
We also started some things on the opioid crisis and unfortunately that hasn't gotten better since 2016. There was a lot to do there that we were starting to work on that I thought could be enhanced and that continues to be a major priority.  
We did much of the deeming with tobacco in 2016. Now we're in a very different period in tobacco regulation. Some of the newer things which are now in play with the menthol rule and the flavored cigar rule and other approaches to tobacco, I thought, were very important.  
Vaping didn't exist when the [Family Smoking Prevention and Tobacco Control Act was enacted] 13 years ago and so there was a question, ‘Are vaping products considered under the authority of the tobacco legislation?’ And we made that clear through rulemaking. 
Focus: What new priorities are you focusing on? 
Califf: As I was going through confirmation, I got a number of calls from both inside and outside the agency that the food part of the FDA needed more support and attention. And indeed, I discovered that that was correct.  
Remembering back to 2016 that when I came in as commissioner, Steve Ostroff was serving as acting FDA commissioner and also deputy commissioner for food and veterinary medicine, so I had a person in charge of that area who was highly qualified and so I was not aware of all the details of what had gone on for years in the food program.  
One way to think about it is the user fees have really bolstered the medical products side of the FDA in terms of just funding and resources so there are enough people to do the work. The food side of the FDA doesn't have user fees and its funding has stagnated so that there's really a difference between the two that's quite significant. 
And of course, the infant formula crisis – the recall from Abbott – happened the day I was confirmed, so I stepped right into it and that's become a big priority. We commissioned an independent evaluation that just came out, and that's work that’s underway.  
Another one that I was thinking about a lot in 2016 but has become what I think is a major crisis is misinformation. That affects every part of the FDA. I've been quoted as saying, ‘It's a leading cause of death in America.’ And I believe that's true.  
What I'm really trying to say there is that many of the people who don't do well with their health it happens because they didn't get the right information, or they got information that influenced them to make bad decisions about health. The big example, of course, is the pandemic.  
Some of the guidances about emergency use, for example, were completed during my tenure in 2016, but were very theoretical at the time. And of course, while I was not commissioner the pandemic hit and whether we're talking about many decisions about vaccines or the use of antivirals or other ancillary interventions, tests, etc., all are a huge part of what the FDA does, and a major priority.  
I will note that mpox became a big priority and I think we did a good job of dealing with that. It's still an important issue, but under much, better control in this country now, in no small part due to the efforts of the FDA to make sure there was vaccine and antiviral therapy that was available for people.  
Then of course we had the issue of the workplace environment in the midst of the pandemic where we've done a lot of work to try to optimize the situation.  
The productivity of the FDA I think has been phenomenal. If you think about it, all the usual work that has to be done is getting done, but on top of that, all the pandemic work with essentially the same workforce. Keeping that system going has been a big priority. 
Focus: Looking back, how do you think you fared? How would you score yourself on those goals so far? 
Califf: I've learned my best answer to that question is others will have to decide how it should be rated. I'm not going to rate myself.  
I would just say that we've made significant progress. This next year is going to be a really big year to solidify some of the progress that's been made and take further steps. For example, we now have a basic plan for the food side of the FDA – a human foods program – but the implementation of that plan and the crystallization into the exact strategies we're going to use is work to be done in this upcoming year.  
Similarly, in tobacco we've got the proposed rules from menthol and flavored cigars out the door. The comments are coming in. Now we need to finalize those this year.
I think we've made significant progress. We've definitely held our own. But we've got a big job ahead of us in this coming year. 
Focus: During your confirmation hearings, you highlighted some of the issues and challenges the FDA and its commissioners were facing. Do you feel you have enough support from the current administration and Congress to do your job? 
Califf: I feel like I have enough support to do my job. I'd also add, as many people have pointed out, that for many things in our society, the FDA is sort of the bottom line since our job is to make decisions that are very hard decisions, often with a timeline and in the face of uncertainty.  
We are constantly criticized, and that's part of the job here that everybody understands. I think we have enough support to do the job but being critiqued is just an everyday occurrence at FDA from all sides. People have opinions about the decisions that we make, and they tend to let those opinions be known. 
Focus: What are some new priorities you have set for yourself for 2023 and what are some long-term priorities you'd like to set beyond 2023? 
Califf: Let me go back to food and tobacco. You know the ‘F’ in FDA does stand for food. We always have to remind people of that.  
But let's look at what's happening with our food today. We have climate change, which is significant. That's going to dramatically change the need for resilient plants and systems for protein that don't result in so much carbon dioxide in the environment and contribute to climate change.  
We have international strife which is disrupting supply chains in a major way. We need to design and develop a food system that enables the production of safe and nutritious food and its distribution in a very different way than it is currently being done. You know the other negative side of this is right now if you look at Americans as a people, we have a shorter life expectancy by five years than the average of other high-income countries. And at least according to some reports, China bypasses us in life expectancy this year and much of that is rooted in dietary habits that start early in life with poor nutrition. 
On the positive side, the same biology and bioengineering which is leading to cures for rare diseases in children, can also be used to make resilient plants and opportunities on the protein side to produce meat at a much lower cost to the environment.  
To help the food system get to where it needs to be we’ve got to have really smart regulation and use of technology and information. That brings up data science and information.  
We have almost 600,000 entities that we regulate on the food side when you think about all the farms, the grocery stores, distribution centers and import sites. There's no way you can do that by physical hands-on inspection. So we have a lot of work going on to improve our information technology base and data science that we use. 
We're going to lose almost 500,000 Americans this year to tobacco-related illness. We have made steady progress in reducing the use of tobacco but we’ve got about 30 million people using tobacco today and a couple of million or more teenagers addicted to nicotine because of vaping.
Particularly for adult smokers, as we have better and better approaches to reducing the use of tobacco, many of these people need a care package, a way to support as they try to stop smoking because nicotine addiction is very hard to shake and it's a lifelong struggle for these people.  
I'd also say in the area of medical products, gene and tissue engineering is a huge growth area. The user fees that were negotiated have a big boost for (the Center for Biologics Evaluation and Research) in terms of increasing the workforce there, and we're very focused on that part of it.  
In the long term, on the drug side, I think things are really looking good for rare disease and cancer. Of course, we could do even better than we're doing now, but we are seeing steady reduction in mortality and morbidity from cancer and more and more rare diseases being either cured or converted to chronic disease instead of death by effective interventions.  
The big chronic diseases like heart disease, pulmonary disease, Alzheimer's disease have been actually stagnant or are going backwards in many cases. That's what accounts for at least a significant part of our decline in life expectancy. These areas have been disincentivized in the system, and we have to figure out how to improve those areas in terms of the pipeline.  
We have areas where the pipeline is still thin, like alternatives to opioids for pain. It's been talked about a lot, but if you look at what's actually in the drug pipeline, it's not been a successful area up until now and a lot of work needs to be done there.  
We are seeing some success perhaps with the Alzheimer's disease drugs, we'll see what all the data shows when the trials come in and also in the area of obesity with several new classes of drugs that look very promising.  
We have to work across the federal agencies, particularly with (the Centers for Medicare and Medicaid Services), to make sure the hand-off from FDA to CMS is most effective so that when effective new treatments come into play that access is enabled for everyone who needs it, not just those who are more privileged in our society.  
With obesity drugs we now have an official shortage but they're very expensive and a lot of people that are using them are not people that need them for serious comorbidity-related obesity but people that are looking just for a cosmetic approach which is not a part of what FDA should be focused on. We want to make sure these treatments are available to people that need them.  
We don't control the cost, that's not our swim lane, but if we do a better job at evidence generation and developing better evidence generation systems then the insurers and CMS and health systems will have better data so they can make better decisions about allocation. 
Focus: As you know, the (Verifying Accurate Leading-edge IVCT Development) Act wasn't included in the omnibus spending bill, and you've said you'll consider using rulemaking to regulate laboratory developed tests. Are you planning to propose a rule on this issue? 
Califf: I can't comment on the VALID Act right now, so we'll have to talk about that later.  
Much of my career early on, 30 years ago, was in the development of methods for assessing tests. It was in the area of cardiology. It's something I'm very interested in, but I can't really talk about what our strategy will be. We're still digesting what's happened this week. 
Focus: How long do you plan on staying in the commissioner’s job and what are some mile markers for you for success? 
Califf: I serve at the pleasure (of the president) so I could be gone any day. In terms of the mile markers, there'll be an election coming up in a couple of years from now and I had a distinct experience with the election in 2016 that had an effect so we'll see how it goes. I'm 71 years old now, so I don't plan on doing this forever. But as long as I feel like I'm contributing and I'm asked to stay, I'm in the game and will do another assessment for sure when the next election comes along. 
Focus: What does the future of regulatory science in terms of people, education, job prospects look like to you? Do you think there needs to be more done to ensure we're headed in the right direction? 
Califf: There's always more to be done. But I think it's obvious regulatory science, that is the applied science of the way we use technology and scientific knowledge to advance the practical development and assessment of products, it's just a burgeoning area. Whether you're doing it from working inside the FDA or at one of the state agencies, for example, that deals with food or working in one of the many industries, it's just a huge area of growth that creates jobs that pay pretty well and make a big difference. What more could you want? 
Focus: Our readers are regulatory professionals, both in the industry and in government, many of them are in your agency. Do you have any words for them? 
Califf: We're privileged to do the kind of work that we do, and this area is interesting and exciting and has consequences for people. In this sea of misinformation that we're living in, our diligence and professionalism and honesty has never been more valuable to society. That mission is really clear and something that's very important to be a part of. 

Commissioner Califf’s comments were edited lightly for clarity and brevity.


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