https://issuesinsights.com/2023/04/19/the-fda-needs-bold-reforms-instead-of-kicking-the-can-down-the-road/
When Dr. Robert Califf was selected by President Joe Biden for a second stint as Food and Drug Administration commissioner, we called it a safe but uninspired choice. Unfortunately, we have been proven right.
Califf is a distinguished academic cardiologist who specializes in clinical trial design, but the day-to-day regulatory decision-making happens at organizational levels below the commissioner, and he seems unwilling to engage with them. He has also made it clear that he’s not interested in criticism from the public, even though the FDA is required by law to consider public comments as part of the rulemaking process.
Dr. Califf did give some reason for hope last summer when he commissioned a review of the agency’s food and tobacco regulatory programs. We suspected that the report, prepared by the Reagan-Udall Foundation, would be a whitewash. But we are pleased to say we were partly wrong.
On the food front, the report echoed criticism from members of Congress, industry and public interest groups that there isn’t a single chain of command among various human food oversight offices, including the Center for Food Safety and Applied Nutrition and the Office of Food Policy and Response.
Now, a diverse group of stakeholders is unhappy with the reorganization plan the FDA announced in January and fleshed out further in late February, because it doesn’t fully integrate the all-important food inspection work into the new Human Foods program.
At a House Oversight Subcommittee hearing in March, Frank Yiannas, who resigned earlier this year as the FDA’s deputy commissioner for food policy, testified that the agency’s ability to protect food safety is hindered by staff turnover, a siloed culture, and a lack of decision-making power. Roberta Wagner, the Consumer Brands Association’s vice president of regulatory and technical affairs, noted that an external study of the FDA has found the agency’s food regulation suffers from “constant turmoil” and “little motivation.”