FDA chief cites ‘egregiously unsanitary’ conditions at Michigan baby formula plant

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.

FDA officials, he said, plan to be in the plant every step of the way until they’re comfortable the plant is clean, has the right systems in place to keep it sanitary and the right people working there.

Within the FDA itself, Califf told lawmakers that Steven Solomon, director of the Center for Veterinary Medicine at the agency, is conducting an after-action review.

Califf reiterated he didn’t believe there was any malfeasance within the FDA regarding the Abbott facility inspections or the whistleblower report, but said the agency had systems that were “failing.”

Califf said he believes the issues within the FDA are a combination of problems within leadership, staffing, money and technology.

“The day that I was confirmed was the day that the recall made the news,” he said. “And we’ve been engrossed in that, trying to take care of this problem for the first three months of my time.”

The U.S. Senate voted 50-46 on Feb. 15 to confirm Califf as FDA commissioner.

Once stores are fully stocked with infant formula, Califf said, he wants to review how the FDA handles food safety.

He would also like Congress to give the FDA additional authorities to track food shortages, noting there’s currently no requirement that infant formula manufacturers alert the agency if they are running low.

The industry, however, has fought “tooth and nail” against the FDA gaining insight into its supply chains, Califf said.

Abbott leader testifies

The U.S. House panel later heard from Abbott President of U.S. and Canada Nutrition Christopher J. Calamari, who testified that the “current infant formula shortage is heartbreaking,” though he disagreed there is a cultural problem at the plant regarding safety and cleanliness.

“On the culture problem — I don’t think it’s a problem,” he said. “We were there last week. And I saw generations of employees who work in Sturgis with pride, who feed their own families, and they are committed to making steps to improve.”

Calamari told the committee Abbott officials are “working rigorously” to address the FDA’s concerns about the facility.

“We as a leadership team are fully committed. All resources against it,” he said. “We are aligned as leaders to make sure we put the necessary steps and sustained actions in place so that this doesn’t happen again.”

New Jersey Democratic Rep. Frank Pallone, chair of the full Energy and Commerce Committee, said during the hearing he’s frustrated that just three companies control roughly 90% of the infant formula market in the United States.

“We’re too reliant on too few companies to do the right thing,” Pallone said. “And if just one of those companies cuts corners we spiral into an emergency. So there needs to be more competition, so these few manufacturers don’t have a monopoly.”

Pallone said Wednesday’s hearing would “lay the groundwork for what we have to do legislatively.”

He said specifically that “additional legislation will be necessary to improve transparency and reporting requirements” and noted that the “industry must also do its part to ensure robust internal controls are in place and prevent contaminated products.”