FDA Commissioner Robert Califf, already grappling with the infant formula crisis, told lawmakers Thursday the agency lacks the leadership and staff to properly regulate food safety and appealed for more funding.
“I was very well aware coming in that we need to do major improvements on the food side of the FDA, not because the people are bad, but there is a need for consistent leadership and the right resources for people to get their work done,” Califf told the House Agriculture Appropriations Subcommittee, which writes FDA's annual budget.
Ahead of the hearing, Califf announced that he was assigning the agency’s principal deputy commissioner, Janet Woodcock to provide “strategic counsel” for planning improvements to the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine and other food-related FDA offices, according to a note to FDA staff.
He provided little detail on what her assignment would entail, except that she would help “advance key initiatives and most importantly, continue our efforts to modernize the entire agency.”
Woodcock, like Califf, is a physician and her background is in drug evaluation. She served as acting commissioner of the FDA until Califf’s confirmation by the Senate in February.
A coalition of agriculture, food industry and consumer groups concerned that FDA is giving short shrift to food safety issues appealed to Califf last month to create a position that would have authority over food programs. The groups said there needs to be a deputy commissioner for foods, who would have “direct line authority” over the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and food-related components of the Office of Regulatory Affairs.
House Appropriations Committee Chairwoman Rosa DeLauro, D-Conn., blasted FDA during the hearing, both over its oversight of the food industry as well as its handling of the infant formula shortage under Woodcock’s leadership.
“At the FDA, food safety is not a priority,” DeLauro said. “There needs to be a restructuring of the food safety (side) with people who know food safety.”
She also demanded to know from Califf who was responsible for the agency’s inaction on a whistleblower report FDA received in October 2021 in connection with an Abbott Laboratories formula manufacturing facility in Michigan.
“Whomever looked at that report felt there was no reason to respond. … That was a dereliction of duty in my view,” DeLauro said.
Califf said he was not prepared to answer questions yet about FDA’s handling of the Abbott plant, but he said consumers should start seeing improvement in formula availability “within days.”
He warned that the shortage would continue to be a problem in rural areas especially. “We’re going to have to pay special attention to that,” he said.
During the hearing, Rep. David Valadao, R-Calif., pressed Califf to implement a process for approving feed additives that could reduce emissions of methane from cattle. Califf said FDA’s work on the issue was “moving along well.”
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