Califf: FDA will be a ‘more activist’ agency

US Food and Drug Administration (FDA) Commissioner Robert Califf said he hopes to see several priorities unfold in the coming years, including reorganizing the Office of Regulatory Affairs (ORA), more effectively harnessing real-world evidence (RWE) and taking an active role in combating misinformation.

During a wide-ranging virtual chat with the Alliance for a Stronger FDA on 22 August, Califf touched on several topics that are important to him. He also discussed the agency’s plans for its proposed unified human foods program (HFP) ahead of its hiring of James Jones to lead the effort (RELATED: FDA updates on proposed foods reorganization, shifting some of ORA’s functions, Regulatory Focus 23 August 2023)

“I'm told this is the biggest reorganization in the history of the FDA. We're not doing it to win the Guinness [World Record] of reorganization size,” said Califf. “We're just really trying to equip the FDA to be ready for the next decade, which is predictably going to be a decade of tremendous change in the external environment.”

‘Activist’ FDA

The commissioner noted that as Earth’s population grows and climate change continues to have detrimental effects on people, FDA needs to play its part in tackling public health issues. One way the agency can do this, he said, is by developing new pathways to get treatments to patients more efficiently.

“What we need to do is to very intelligently use regulation to help the industry meet these demands that are coming from the outside world,” said Califf. “How do we create regulatory pathways that enable the industry to innovate on a pathway that leads to benefit and to stop things that are not going to be beneficial.”

“In that sense, it's a more activist FDA, which is looking to the future rather than just sitting back and waiting for applications to come in from the industry.,” he added.

Artificial intelligence

Califf talked about how artificial intelligence (AI) can improve FDA’s workflow. He noted that agency staff deal with a lot of documentation and said that AI could be used to improve workflows.

“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,” he said. “Our most precious element at FDA is our people and 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 that can be better done if assisted.”

Califf gave kudos to the Center for Devices and Radiological Health (CDRH) for developing an AI framework that sponsors can use when developing what he called predictive AI products. He noted that when companies use AI to make a prediction, FDA requires them to document the operating characteristics of their predictive model and keep it updated. That information can then be used to measure RWE outcomes over time to improve patient care.

On the topic of generative AI, Califf also said that the technology is so new that sponsors are coming to FDA to figure out how they should be regulated.

“We have those who own the AI coming to us saying, ‘Please regulate it,’ but we don't know how to do it,” said Califf. “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.”

Supply Chain

Califf also touched on supply chain issues and drug shortages, which have been an area of heightened scrutiny in recent years. FDA has asked for additional authorities from Congress to require different industries to report manufacturing and distribution data to address potential product shortages. While Congress has acted to give FDA additional reporting authorities during public health emergencies, other asks have gone unfulfilled.

“I did not come back to FDA to spend all my time on supply chain, but that's what's happened,” said Califf. “I'm pretty fired up to do something about it.”

When it comes to drug shortages, Califf said the fundamental problem is that the US has two drug industries. One is the innovative industry, where he thinks drugs are priced too high. The other is the generic industry, where he thinks drugs have been priced so low that companies are halting manufacturing because products are often not financially viable.

“Even in India, companies are saying they can't invest in the manufacturing because there's not enough of a margin, if any, to attract investors to go into it,” said Califf. “I think we need a modification now in the market so that the industry can be sustained.”

He noted that in other industries, there are market mechanisms to respond to shortages by fixing the pricing, but he also added that it’s not the FDA’s job to try to fix the market. For now, the agency is trying to use its limited authority to make it easier for generic drugs to come to market or find alternative treatments. But ultimately, the commissioner said something more needs to be done to address the “national security risk.”

“What we do need to plug the holes better is better information from the industry,” said Califf. “A more complete picture of what's in the supply chain so that we can help and respond … It's as if we're running a country with railroad tracks where every company has its own set of railroad tracks. They intersect, but no one knows exactly where they intersect, and there's no switching mechanism between the companies.”

“That's good when things are flush because they're competing. They shouldn't know each other's secrets,” he added. “I think, like the banking industry, ultimately, over time, we're going to need to have a way for a government agency to delve in and do stress testing and, when there's an impending shortage, intervene.”

LDT Reform

Another big issue that Califf has championed in the past year has been to ask Congress for additional authorities to regulate laboratory-developed tests (LDT) and baring that authority, he said he plans to use the agency’s rule-making process to ensure oversight of LDTs.

The commissioner said that it shouldn’t matter what medical center a patient goes to get a diagnosis, they should all provide reliable tests where the operating characteristics of the tests are widely understood. Right now, however, he is concerned that patients are getting different diagnoses for life-threatening conditions depending on where they are being diagnosed.

“We're going down the pathway of an [LDT] rule, let me just be clear about that,” said Califf. “My great hope is that Congress will pass legislation that's badly needed and will be a much better solution to the problem.”

Califf: FDA will be a ‘more activist’ agency

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