FDA commissioner talks about AI, drug shortages, and rethinking everything | HLTH 2024

Las Vegas – With the growth of artificial intelligence and other technologies evolving so rapidly, Robert Califf says the Food and Drug Administration is going to have to change as well.

FDA Commissioner Robert Califf talked about AI, drug shortages, drug prices and more at the HLTH conference Monday.

The FDA commissioner outlined the challenge during a 20-minute conversation at the HLTH conference Monday.

“We're 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,” Califf said.

The FDA is dealing with the difficulties of the rapid growth in AI technology. As Califf said, “We’re a regulatory agency but also a public health agency.”

Some of that challenge involves striking a balance between providing enough regulatory oversight without imposing too much regulation.

Califf described the thorny task of AI tools that are billed as providing “decision support” for healthcare organizations.

If the tools make recommendations for patients, the FDA must weigh its responsibility to the public.

“As you begin to make recommendations for patients where there's significant risk, then you're in an area where there's a lot of discretion by the FDA on what to regulate and what not to regulate,” Califf said.

Califf says it’s especially difficult because “what happens before an AI product goes on the market is relatively insignificant compared to what happens after it goes on the market. … if you put an AI out in practice, it's going to evolve and it can evolve to get worse, and it can evolve to get better.”

“If you want to know that your AI is actually doing what you thought it was doing, you actually need to validate it in the situation which it is being released,” he said. “And I'll just say right now, I don't know that a single health system in the U.S. which is capable of doing validation.”

Califf said organizations can’t unleash AI algorithms and hope for the best, but also 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 is doing what they’re supposed to do in the first place.”

That approach works well in areas like drugs and devices, he said. But he said for the FDA to monitor everything in AI, the agency would likely have to be two to three times larger.

AI and health equity

John Brownstein, senior vice president and chief innovation officer of Boston Children’s Hospital, moderated the conversation and also asked about the prospect of AI technologies improving health equity.

Califf offered a blunt response.

“I feel like right now it’s furthering the divide,” he said. “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,” he said. “It’s so obvious that can happen, but you have to focus on doing that.”

Brownstein also asked Califf about the growing use of consumer devices aimed at healthcare. Califf said he is enthusiastic about such technologies, but says they need to live up to their billing.

“I'm a cardiologist. I love gadgets and I love the developments on the consumer side,” he said. “But when you begin to get consumer products that are used for people who have significant health problems, then you're in a whole different sphere of accountability.”

In the discussion on the advances of AI, Califf said there needs to be a greater emphasis on fundamental problems with the nation’s healthcare delivery system. He noted that the lifespan of Americans lags behind other nations.

“Our fundamental problems are blocking and tackling,” Califf said. “It's like we're trying to throw the touchdown, but we're not even doing the basic blocking and tackling. The primary care in this country is a disaster, right? And so people are not getting the fundamental things they need.”

Drug and supply shortages

Califf was also asked by Brownstein about the shortage of certain drugs, and he talked about the shortage of highly popular weight loss drugs. He also bemoaned the high prices that keep those drugs out of reach of many Americans.

“The profit margin, especially in the U.S. is outrageous,” Califf said. “They should be ashamed of themselves for what they’re charging Americans.”

“Because what's happening in America is people like you and I are getting the weight loss drugs. Poor people are not, and it's not right.”

Califf said that he expected the situation to improve, given the enormous demand for the medications.

But Califf noted the ongoing shortage of hundreds of generic drugs.

“The less expensive, the greater the risk of shortage of drugs,” he said. “In America, we want to make money, and so 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 the FDA, but we have to deal with the shortages when they occur.”

Califf said there’s a remedy, but it requires legislative support.

“We’ve got to create a set of financial incentives, which will take Congress, that will cause American companies to be in the business and have a profitable situation,” he said.

The healthcare industry continues to deal with other shortages, including the shortage of IV fluids due to the flooding of a key plant in North Carolina from Hurricane Helene. Analysts expect hospitals and healthcare providers to deal with shortages for some time, and some hospitals have postponed non-emergency surgeries.

Califf bemoaned the lack of visibility in the supply chain, including companies who have resisted calls to allow regulators to get a better sense of potential inventory problems.

“In these complex supply chains, we should be able to do stress testing,” Califf said.

He said the FDA should be able to get better insights into potential risks of shortages of key medical supplies, which would allow for better planning. Califf said this is one area where evolving technologies could help.

“That's a great use of AI,” he said.