> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# New AI Tools Will Require FDA Flexibility: Califf
- URL: https://www.fdaweb.com/new-ai-tools-will-require-fda-flexibility-califf/
- Published: 2023-02-10T12:00:00.000Z
- Updated: 2026-09-14T18:15:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153753

FDA commissioner **Robert Califf** says that while new artificial intelligence (AI) advances are quickly becoming revolutionary and transformative, the agency is going to have to be flexible and learn as it goes because of the pace at which this is going. Speaking at a 2/10 Alliance for a Stronger FDA fireside chat, Califf cited the potential of the new AI [ChatGPT](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjPoLiJjoz9AhVQEVkFHXFhBhQQFnoECAsQAQ&url=https%3A%2F%2Fopenai.com%2Fblog%2Fchatgpt%2F&usg=AOvVaw07ciM%5FLkSe6efpFVXLmYhu) and similar natural language processing tools being developed by other technology companies that will “change a lot of the fundamental operations of diagnosis, treatment and clinic visits …, and so we are just going to have to be adaptive.”

Califf said that when it comes to algorithms and AI, there's a lot of work to do pre-market, but the biggest bulk of work is in post-market setting. “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,” he told the Alliance. “They better be thinking about an algorithm as a living entity that needs to be tended continuously during its lifespan.”

Asked about the role of data and technology modernization at FDA, Califf noted disparities across the industry and how important it is for the agency to have more modernized systems. “I spent five years at Google and I see the potential in where things are headed,” he said. “So 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. So that's a big focus and we are intensively working now with a more enterprise-wide approach to ORA. If you think about the inspectors at ORA, they are linked to every Center in the FDA. If we make that more modernized, I think it’ll have big implications for other sections.”

Califf said advisory committees are another area that needs a lot of work, and he reiterated some of his concerns conveyed at a House Energy and Commerce subcommittee hearing earlier in the week ([see story](https://www.fdaweb.com/califf-sails-through-1st-covid-oversight-hearing/)). “Many things in government are like artificial intelligence algorithms,” he said. “If you develop one and you just leave it in place, then it deteriorates over time and veers in directions you don't expect and you need to be maintaining it.”

The commissioner shared his vision for advisory committees as being one of the easiest things a review group should be able to take care of and not the hardest thing in a review. He reminisced about his days serving as a committee chair and the difficulties with paperwork and conflicts of interest. “As an example, show me an expert in a rare disease who is not spending time working with therapeutics for that disease, which automatically becomes a traditional conflict. And yet if you look inside the FDA, the main thing that FDA 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 that are general experts, but all these things need to be melded together I think in a much better way.”

Asked about legislative reforms that the agency would like help from Congress in implementing, Califf said regulating lab-developed tests under the VALID Act is a big one. FDA is worried that increasingly sophisticated tests that are being developed, often in laboratories of academic medical centers, are being introduced into broader populations. “It’s really important that you do the basic things that ensure a quality system with a reliable interpretable result,” he said, “and the only way you really know how to interpret those tests is to do 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.”

Another legislative fix Califf would like to see is dietary supplement listing authority. “Supplements is such an enormous industry and so many people are spending so much money,” he said. “It just seems to me that we ought to know what's being sold and what’s in those products being sold. I think with real-world evidence over time, we will get 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.”

In lieu of a legislative fix, Califf said FDA continues to look at rulemaking as a possible strategy for lab-developed tests. “I can’t go into any more detail because it’s regulation under consideration, but I’ll just say that there has to be a way that we can agree to a framework of quality and laboratory testing that assures Americans that when they go and get a test, they're going to get a reliable answer.”