AI Has Saved FDA 17,000 Hours: Makary
FDA commissioner Marty Makary says the artificial intelligence (AI) tools the agency has implemented have saved its 14,000 staffers some 17,000 hours of human work time in the measurement period the agency has assessed since implementation at the end of 6/2025. In an online interview with Healthcare Brew, Makary said his goal is to implement AI in a way that the agency’s scientists find that it is using common sense and should not be dismantled down the road.
“Let me give you an example,” he said. “There’s a 60-day filing period when you submit a drug application to FDA. So it takes 60 days just for FDA to tell you that the application is complete. Once we get up and running with this new system, it’s going to be hard for someone in the future to come in and say, ‘Hey, you’ve got this down to two minutes, let’s go back to 60 days.’”
He stressed that AI is not deciding whether to accept or reject a drug. Rather, he said, what it is doing is performing the tedious tasks that humans do, like ensuring all the parts of the application are complete. “AI can do that very well,” Makary said, “and it’s extremely low risk.”
Asked how the technology can make an FDA process more efficient and potentially cheaper, Makary cited the computational modeling and organ-on-a-chip technology to replace animal testing for monoclonal antibodies. “You’re reducing research and development time, and you’re reducing R&D costs,” he said. “For smaller drug development companies, time is money because they’re running their operation. That’s burning cash as they’re waiting for FDA.”
Makary said FDA asked its developer community to think creatively about any workstream that could be improved with AI. The agency received 181 submissions that are being reviewed and socialized. Currently in use are the two tools that were initially introduced, he said, an AI reviewer tool and agentic AI for the reviewers with specific buttons for certain tasks.
Asked about the current state of AI in healthcare, Makary said, “We have a construct at FDA that comes from before the AI revolution, and it’s not working. It’s stifling innovation, so we’ve got to modernize it, which means we have to ask ourselves, what risks can we tolerate? We, as a society, have decided we can accept the risks of a Google search or ChatGPT giving you, on occasion, medical information that may not be accurate. We have decided that that is a lion we can’t outrun, and we cannot try to protect the public from an answer to a question that may not be in their best health interest in order to enable this technology to develop, grow, and learn as it grows. We have to think differently about what’s realistic.”