WASHINGTON — The head of the U.S. Food and Drug Administration told Congress on Wednesday that he’s found no evidence of intentional delay or malfeasance within the agency — though it took months to act on a whistleblower report of what he called “egregiously unsanitary” conditions at an infant formula plant in Michigan.
FDA Commissioner Robert M. Califf, however, did say the agency’s response “was too slow and there were decisions that were suboptimal along the way.” He also told lawmakers there was a “lack of coordination” regarding the whistleblower report the FDA received in October 2021.
Members of Congress have repeatedly criticized the FDA for its slow response to reports of unsanitary conditions at the Abbott Laboratories manufacturing facility in Sturgis, Michigan, where Cronobacter was detected during an inspection earlier this year.
Cronobacter sakazakii is “a germ found naturally in the environment,” according to the Centers for Disease Control and Prevention.
It’s not often that people get ill from Cronobacter, though infants can die from the bacteria. “Cronobacter infections in infants less than 12 months old are often linked to powdered infant formula,” according to the CDC.
Califf described for lawmakers the unsanitary conditions at the Abbott plant, including:
Standing water.
Cracks in key equipment that could have allowed bacterial contamination to persist.
Leaks in the roof.
Previous citations for inadequate hand-washing.
Bacteria growing from multiple sites.
“A disappointing lack of attention to the culture of safety.”
“Frankly, the inspection results were shocking,” Califf told the Energy and Commerce Subcommittee on Oversight and Investigations, headed up by Colorado Democratic Rep. Diana DeGette.
Consent decree
The plant has remained shut down since mid-February, despite Abbott and the U.S. Department of Justice reaching a consent decree earlier this month that should allow the formula facility to reopen once it’s clean and can safely produce infant formula.
Califf said during the hearing that the plant isn’t yet ready to reopen “but they will be in the next several weeks.”
“I’m very optimistic that over time we’ll have plenty of formula, but I don’t want to make light of the fact it’s going to be days to weeks until we get there,” he said.
Democratic and Republican members of the panel repeatedly questioned Califf about whether they could tell their constituents baby formula produced at the facility would, in fact, be safe.
“Given what we saw, the only way we could have confidence was through a consent decree where we literally have oversight of every single step,” he said.
Califf said FDA officials met with Abbott officials on Tuesday to go over where the company was in terms of complying with FDA regulations, including the hundreds of steps the company needs to take ahead of reopening.
