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Pink Sheet – ‘Stop Fighting Us’ On Inspections, US FDA’s Califf Tells Industry; Foods Modernization Will Bring ‘Big Change’ To Drug Quality Systems

Pink Sheet – ‘Stop Fighting Us’ On Inspections, US FDA’s Califf Tells Industry; Foods Modernization Will Bring ‘Big Change’ To Drug Quality Systems

US Food & Drug Administration Commissioner Robert Califf is touting the modernization of food safety inspections as an important initiative of his second stint at the helm of the agency – and is underscoring that the “new vision” for foods will have ripple effects for drugs and biologics.

The modernization work that FDA is undertaking for its food safety oversight has “a lot of implications for the drug side of the house” when it comes to inspections, Califf said at the Prevision Policy/Friends of Cancer Research Biopharma Congress in February.

“You’ll see much more movement to digital technologies, the use of algorithms to help us figure out where to go. That’s already happening, but it can be a lot better.”

FDA announced a redesign of its food safety program to better coordinate field operations to respond to quality issues like those seen recently with infant formula. While the details are still in flux, upcoming changes to the operating structure of the Office of Regulatory Affairs will include activities related to drug and biologic facilities. (Also see “US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections” – Pink Sheet, 2 Feb, 2023.)

Enterprise-wide information technology can improve things “so that people’s work is more efficient, they’ll enjoy it more, they’ll also be better at what they do,” Califf said in announcing the changes with Principal Deputy Commissioner Janet Woodcock in late January.

“With the IT investments and the reorganization,” Califf said at the time, “the system of safety and inspections will be much more preemptive. … That’s really what we’re doing is realizing that vision so that we can catch these things earlier.” (Also see “Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate” – Pink Sheet, 2 Feb, 2023.)

During the Biopharma Congress, Califf reiterated he is “pretty excited” about the inspections system for foods and its implications for drugs and biologics – going so far as to describe the “integration of the subject matter experts with the inspectional regime and the surveillance regime” as “one of the biggest changes in the history of FDA.”

On post-pandemic inspections, Califf says that FDA is “making really good progress in catching up.” But he also underscored the importance of staying on top of regular visits. Using his experience with big data software from his experience at Verily/Google as an analogy, Califf pointed out the necessity for continuing process checks.

“If you put an AI algorithm out there in real life and let it sit there, it will deteriorate almost 100% of the time and become less predictive. You have got to keep it tuned up. And if people think they’re not going to get inspected for a while, they sort of lose their edge and we’ll likely discover some of those things.”

“The solution is really a whole different system of quality.”

Califf urged sponsors to support the efforts to move toward a quality management maturity rating system. “Frankly, we need the industry to stop fighting us every step of the way, when what we want to know is do you have a quality system.”

“We also need to return more of the industry to the U.S. Just simply offshoring to get arbitrage on a lower price, I think historically is going to be looked at as an enormous mistake.”