AI Forcing FDA to ‘Rethink Everything’: Califf
FDA commissioner Robert Califf says FDA is “entering an era where we’re going to have to rethink everything we do because of the technology changes that we’re seeing, which affect every single industry that we’re dealing with.” As reported by Chief Healthcare Executive, Califf spoke to the 2024 HLTH Foundation conference and said the agency is dealing with the difficulties in the rapid growth in artificial intelligence (AI) technology. “We’re a regulatory agency,” he said, “but we’re also a public health agency.”
Califf said that some of the challenge involves finding the best balance between providing enough regulatory oversight without imposing too much regulation.
He said that if entities want to know that their AI is doing what they think it is doing, they need to validate it in the situation in which it is being released. “I’ll just say right now,” he declared, “I don’t know that a single health system in the U.S. is capable of doing validation.” He said organizations can’t unleash AI algorithms and hope for the best, but conceded it’s problematic to regulate.
“We’re sort of the referee of the system,” Califf said. “But the first line of defense is the industry doing what they’re supposed to do in the first place.” While such an approach works well for drugs and medical devices, he said, for FDA to monitor everything in AI would require the agency to be two to three times bigger.
Asked about the potential of AI to improve health equity, Califf offered the blunt assessment that “right now it’s furthering the divide. I’m very worried health systems are using AI honestly to segregate patients into those that are profitable and those that are not. It seems to be the biggest use of AI right now in American healthcare. What we need is for AI to bring up the people that are currently disadvantaged. It’s so obvious that can happen, but you have to focus on doing that.”
On the issue of drug shortages, Califf said the less expensive a drug is, such as generic drugs, the more likely it is to be in shortage. “In America, we want to make money,” he said. “So if the price has gotten so low, there’s not a profit for companies to be interested in making these products. We don’t control prices at FDA, but we have to deal with the shortages when they occur.”
The remedy Califf sees would require congressional action. He says it’s necessary to create a set of financial incentives that would cause American companies to be in the business and have a profitable situation.