Commissioner Califf Talks About AI

During the Alliance’s August 22, 2023 with FDA Commissioner Califf, he was asked about the application of artificial intelligence to the FDA regulatory process and how that can support the FDA staff.

The full webinar transcript with Dr. Califf can be found here. 

He replied (answer condensed and edited): I think about this in three spheres.  

If you think about the work that people do inside the FDA, a lot of it deals with documents and documentation. I think we can free up our FDA staff a lot from tasks that can be more efficiently done, not replaced by AI but aided by AI. I want them to use their brains as much as possible to make better decisions and spend as little time as they have on repetitive documentation of things. 

The second sphere is the industries that we directly regulate. And I think we're making pretty good progress there.  And I'll give hats off to CDRH, five years ago, for developing a fundamental schema that I think is really good for what I'll call predictive AI, that is if you're using AI to make a prediction. There's a lot that's known and unknown in the way we regulate that requires you to document the operating characteristics of your prediction and predictive model and keep it updated. [Of course, we need to measure] outcomes over time, because otherwise, the algorithms are going to go off course and get into trouble.

And then we've got this sort of scary area. I'll just link together generative AI and the role of the FDA in a much larger world of how to regulate AI, where we have those who own the AI coming to us and saying, please regulate it, but we don't know how to do it. Usually, industries have a pretty good idea of how they think they ought to be regulated. 

And there's a lot of concern at the highest levels of government about this because of the risks that are inherent in other areas like politics and international competition, and we're part of that, so stay tuned. 

In that regard, it is something that is going to need a response; the FDA is not the driver there. Within that context, I feel like the regulation of medical things will be something that people keep coming back to because it's easier to understand than some of the other areas that they're talking about. 

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For more on FDA and AI, sign up for an upcoming Alliance webinar with MiRa Jacobs, PhD., who is Acting Assistant Director of Digital Health Policy. 

September 19 from 11 to noon. Please register here!

Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.