By Alice Seeley
On May 25, the head of the Food and Drug Administration (FDA), Robert Califf, testified before a House subcommittee concerning the nationwide infant formula shortage, which has forced the U.S. to begin airlifting infant formula from Europe.
Califf testified that the FDA’s efforts to investigate problems at an Abbott Laboratories formula plant in Sturgis, Michigan, were delayed by months due to COVID, scheduling conflicts, and “mailroom failure.” The agency first became aware of problems at the plant in September 2021 while tracking several bacterial infections in infants who had consumed formula from the facility but did not shut down the plant until February of this year. He admitted that the FDA’s response was “too slow and there were decisions that were suboptimal along the way.”
According to Califf’s testimony, the FDA received a whistleblower complaint in October reporting safety violations at the plant, including employees falsifying records. Senior officials at the agency were not aware of the complaint until February due to “an isolated failure in FDA’s mailroom, likely due to Covid-19 staffing issues,” according to Califf’s prepared remarks. Then acting FDA commissioner Dr. Janet Woodcock never received a copy of the complaint, according to the FDA.
FDA staffers reviewed the complaint in late October, and the agency requested an interview in early December. However, due to scheduling conflicts, the interview did not occur until December 22. After the interview, the FDA planned to begin inspecting the plant on December 30, but nearly a dozen of the plant’s employees tested positive for COVID at this time. As a result, the FDA did not begin its inspection until January 31. After detecting positive bacteria samples in multiple parts of the plant, the FDA closed the plant, and Abbott announced a massive recall of its formula on February 17.
Lawmakers questioned Califf about why the agency did not anticipate the shortage.
“We knew that ceasing plant operations would create supply problems, but we had no choice given the insanitary conditions,” Califf stated.
The FDA requested new authorities, funding, and staff to track supply chain data that could have helped prevent the shortage, according to Califf, but has not received them from Congress.
“Until regulatory agencies have digital access to critical supply chain information and personnel to do the work, we’ll continue to react to disruptions rather than prevent them,” Califf said.
