‘I know firsthand they failed’: Parents slam FDA’s lack of action on infant formula safety

There is still no single, clear food manager at the FDA, and the agency suffers from serious organizational and cultural problems that make it painfully slow to do just about anything, such as revealed a POLITICO investigation earlier this year. Those findings were confirmed this month in a major external review of the FDA’s food program, triggered in part by POLITICO’s reports on the FDA and the infant formula disaster, which was led by the Reagan-Udall Foundation. , a nonprofit organization that supports the FDA.

“The absence of a single, clearly identified person to lead the human nutrition program has had a negative impact on organizational culture and has led to overlapping roles and competing priorities that result in what is perceived as a constant turmoil,” concluded the panel, led by Jane. Henney, who served as commissioner of the FDA during the Clinton administration.

FDA Commissioner Robert Califf, who last summer called for an outside review of the food program, said this month he was considering structural changes within the agency and planned to set a ” new vision” for the food side of the FDA at the end of January.

In the case of infant formula, the Reagan-Udall Foundation sign determined that these organizational issues hampered the agency’s response: “A review of events indicates that lack of communication and engagement across the agency explained, in part, the missteps.”

“Although it appears that staff at all levels sought to follow rules and procedures within their division, there was little motivation, and apparently no obligation, to share information and interact in the across the agency to facilitate critical thinking and proactive decision making,” the panel found. “This is particularly problematic in a crisis, where decisions need to be made quickly and controlled properly.”

These findings follow numerous reports from POLITICO of a slow response from the FDA. The first infant hospitalization was reported to the FDA in September 2021. The following month, a whistleblower warned multiple FDA officials about food safety issues at the Sturgis plant, but the warnings did not were not heard. It would take four months before the FDA visits the factory to perform a reasoned inspection in late January and nearly five months before the products are recalled on February 17. Meanwhile, three other illnesses have been reported, including two infant deaths.

Coincidentally, FDA inspectors visited the Sturgis plant the same week in September that the first illness was reported by health officials in Minnesota, one of only two states that require all cases of Cronobacter sakazakii are reported. Inspectors, who were not made aware of the sick infant’s existence, found problems at the plant, but nothing serious enough to warrant regulatory action. When inspectors returned in late January, they found numerous food safety violations and five strains of Cronobacter in 20 different locations, although the agency said none matched the two cases for which they had DNA evidence. . The agency has yet to explain why these issues had not been detected during its routine inspection four months earlier.

In its statement, the FDA placed the responsibility for safety on manufacturers: “Ultimately, when issues are found, the onus is on the company to correct those issues to ensure consumer safety, because FDA investigators FDA may not always be present.”

Infant formula factories are usually inspected at least once a year.

The FDA also conducted its own internal review of the agency’s handling of the infant formula situation, finding that the agency needed more resources, better technology and better communication to manage a such urgency, although the report is devoid of specific details about what went wrong.