Tag: FDA

“But the short answer is no one’s going to be reassigned or fired because of the infant formula situation,” Califf told reporters.

Scrutiny of the FDA’s foods division increased after advocates and lawmakers accused the agency of failing to rapidly and effectively address an infant formula contamination event that had a major impact on U.S. supply. The actions unveiled by Califf on Tuesday follow an external review of the foods division that found “constant turmoil” within its ranks, and a complex leadership structure that left staff “wondering which program is responsible for decision-making.”

Baby formula supplies have bounced back since the widespread shortages triggered by a recall that sent parents scrambling for supplies last year. But some families — especially those with medically vulnerable children — are still struggling to find formula.

Top FDA officials were warned about food safety concerns at a key infant formula plant months before the agency’s inspectors found strains of a bacteria that can be deadly to babies. Months after those warnings, Abbott, the company at the center of the formula crisis, issued a recall of some formula products and shut down the facility, triggering widespread shortages across the country. The company, which maintains there is no connection between the bacteria found at the plant and the deaths of several babies, is now under criminal investigation by the Justice Department.

“Where there could have been better performance, that’s reflected in the performance evaluation system. And, of course, that’s confidential information between supervisors and employees,” Califf said in response to the question from POLITICO.

Califf said the proposed foods division reforms included streamlining reporting structures; clarifying the relationship between the Office of Regulatory Affairs, which is the lead for field food safety inspections, and the food oversight division; and creating a Center for Excellence in Nutrition. Califf also proposed unifying much of the foods program under a single leader who reports directly to him, which would mean “removing redundancies” and “enabling the agency to oversee human food in a more effective and efficient way.”

FDA Principal Deputy Commissioner Janet Woodcock told reporters on Tuesday that FDA’s formula response was “a systems problem, not an individual problem.” She also noted an internal review of FDA’s infant formula supply chain response last year. As POLITICO reported, the report didn’t name any specific teams responsible for breakdowns at FDA and surprised stakeholders with its lack of accountability.

“And so the system fixes that we are putting in place, both the information technology support as well as many of the changes, will address all the different issues,” Woodcock said.

“This was a failure of the systems — to the extent there was a failure — to provide the information to the right people at the right time,” Woodcock added.

Califf and other top FDA officials, despite acknowledging to lawmakers a string of internal breakdowns that contributed to the crisis, have pushed back against claims that there were any major failures at the agency. That includes a breakdown in internal FDA communication that some senior FDA officials said prevented them from knowing about the food safety issues until just weeks before the recall.

Califf and Yiannas said a whistleblower report alleging food safety problems at the plant, which was mailed in October 2021, did not reach the FDA’s highest ranks until mid-February 2022. Califf, in testimony to lawmakers, said senior officials didn’t receive the whistleblower report due to pandemic “mailroom issues.”