Abbott Nutrition’s Michigan plant that closed in February created a widespread baby food shortage crisis, had a leaky roof, water on the floor and cracks in key manufacturing equipment that allowed bacteria to get in and out, Dr. Robert Califf, the head of the Food and Drug Administration told a House panel on Wednesday.
He told lawmakers at a hearing about “extremely unsanitary” conditions at the Sturgis, Michigan plant, but he also acknowledged his agency’s response was too slow.
“Frankly, the inspection results were shocking,” said Dr. Califf. “We had no confidence in the integrity of the quality program at the facility,” noting that the agency was working with Justice Department officials to prescribe steps the company should take to improve the facility.
That effort is expected to result in the facility reopening on June 4, said Jonathon Hamilton, an Abbott spokesperson, with a formula expected to roll out on June 20. Officials hope new shipments will hit store shelves within six to eight weeks, although full factory production will take longer to resume.
Abbott has replaced the factory’s leaking roof and floor, said Dr. Califf.
Members of the House of Representatives Subcommittee on Oversight and Investigation opposed the agency’s claims that it was difficult to recognize in real time the extent of the contamination and the resulting nationwide disruption in supplies. The Abbott plant had produced one-fourth of the country’s infant formula, including custom formulas for those with specialized nutritional needs.
“There was a life-and-death crisis in front of the FDA, but they didn’t see the gravity of the situations,” said Representative Cathy McMorris Rodgers, a Washington Republican. “We need to fix the immediate problem and also make sure we take action so that this situation never happens again.”
In the opening remarks, Christopher Calamari, a senior vice president of Abbott Nutrition, said little about conditions at the Michigan plant, but said he had “deep, deep regrets” about the shortages. He said the company was coordinating 50 flights a week from its formula plant in Ireland to a dozen US airports to support supplies.
Understand the supply chain crisis
“We are committed to ensuring that this never happens again,” said Mr. Calamari, noting that the company will add redundancy to its operations.
He later said the company is currently verifying that every step has been taken to ensure quality controls are working in a sustainable manner in the 700,000-square-foot facility.
The agency discovered a series of problems at the factory last fall. At the same time, there were reports of babies being hospitalized with a rare bacteria. Cronobacter sakazakii, which can be deadly to infants, was found in four babies who had consumed formula from the plant, according to the Centers for Disease Control and Prevention.
Testimonials at the hearing made it clear that it took the FDA months to try and match the bacteria that sickened the first baby with bacteria later found throughout the plant.
Cronobacter strains linked to two of the babies did not match samples of the bacteria taken later at the factory, although Dr. Califf said the agency deems these results “inconclusive” given shortcomings with genome sequencing.
The diseases set the recall in motion. The factory shutdown began on Feb. 17, leading to shortages that left parents struggling, driving hundreds of miles to find baby food, and sometimes improvising to feed hungry babies.
dr. Califf also acknowledged that the FDA had made a mistake: The January follow-up inspection should have started earlier, and, he said, the agency took too long to distribute a whistleblower report that arrived in October but didn’t let top officials until later. reached February.
“It was too slow and there were decisions that weren’t optimal along the way,” said Dr. Califf.
He told lawmakers that the agency did not immediately receive notification when a formula factory found the deadly Cronobacter bacteria. Nor does the agency have access to the supply chain information held by each of the three major US baby food manufacturers.
The report of an anonymous whistleblower who said he worked at the Sturgis factory came up repeatedly during the hearing. The whistleblower alleged that security personnel there “celebrated” the FDA overseeing issues after a 2019 inspection and did not destroy enough product when it found Cronobacter in finished products. That top agency leaders didn’t see those claims until February “is astonishing to me,” said Representative Gary Palmer, an Alabama Republican.
Details in the report suggested there was “corruption” at the factory, accused Washington Democrat Representative Kim Schrier. dr. Califf said he could not confirm or deny whether there could be criminal proceedings in the future.
How the supply chain crisis unfolded
The pandemic caused the problem. The highly complex and interconnected global supply chain is in turmoil. Much of the crisis has been traced to the Covid-19 outbreak, which led to an economic slowdown, mass layoffs and a shutdown of production. This is what happened next:
Last week, the Justice Department announced a decree of approval with Abbott on the terms needed to reopen the Sturgis plant, and the company could face heavy fines if it doesn’t follow the rules. In a complaint supporting the decree, officials described contamination with Cronobacter bacteria in finished baby powder formulations as early as 2019 and 2020.
Abbott officials “were unwilling or unable to take sustained corrective action to ensure the safety and quality of food for infants,” the complaint concluded.
Cronobacter sakazakii bacteria thrive in dry conditions, such as powdered food preparation. Only one state, Minnesota, requires doctors or labs to report cases of foodborne illness from the bacteria to public health authorities, who are in turn expected to alert the CDC, DailyExpertNews has reported.
Illinois Democrat Senator Tammy Duckworth urged the CDC to change protocols. “Our country’s inadequate reporting system results in critical data gaps that undermine our ability to understand the true extent of Cronobacter infections in infants,” the letter she sent Wednesday said.
During the subcommittee hearing, Dr. Califf agrees that cases involving the bacteria should be reported.
Last week, President Biden invoked the Defense Production Act to increase formula production and authorized the use of airplanes to expedite the shipment of infant formula to the United States from abroad. The first military plane carrying 500,000 bottles of formula arrived in Indianapolis from Europe on Sunday, and another was expected to land in the Washington DC area on Wednesday.
The FDA said last week it has established a streamlined process for foreign baby food manufacturers to ship their products to the United States. On Tuesday, it announced it had approved a company’s application to ship two million cans.
Mr. Biden has also signed legislation that expands the types of formulas that can be purchased using benefits from the federal women’s and infants’ food aid program, which both houses of Congress passed with few objections. However, a $28 million emergency measure approved by the House to increase staffing for the agency has stalled as some senators question whether the money will sufficiently address the deficit.
“We don’t want anyone to be short of baby food or anything like that,” said Alabama Senator Richard Shelby, the top Republican on the Senate Appropriations Committee. Let’s see if we need it – the answer isn’t always money. The answer is good governance and market forces.”
It is unclear what other legislative steps Congress will take. But when pleas from desperate parents seeking a formula flooded Capitol Hill, lawmakers hastily scheduled hearings to bring both Dr. Califf as top industry executives to question the failures that led to the shortage. Two more hearings are scheduled for this week, with House Appropriations subcommittees convening a panel of experts on Wednesday and Dr. Califf will appear before the Senate Committee on Health, Education, Labor and Pensions on Thursday.
Emily Cochrane contributed to this report.
