FDA Chief Details ‘Shocking’ Conditions at Baby Formula Plant

The Abbott Nutrition Plant in Michigan that was shut down in February, sparking a widespread baby formula shortage crisis, had a leaking roof, water pooled on the floor and cracks in key production equipment that allowed bacteria to get in and continue, Dr. Robert Califf, head of the Food and Drug Administration, told a House panel on Wednesday.

He detailed “egregiously unsanitary” conditions in the Sturgis, Mich., Plant to lawmakers during a hearing, but he also acknowledged that his agency was too slow to respond.

“Frankly, the inspection results were shocking,” Dr. Califf said. “We had no confidence in the integrity of the quality program at the facility,” noting the agency worked with the Justice Department officials to dictate steps the company needed to take around the facility.

That effort is expected to result in the reopening of the facility on June 4, Jonathon Hamilton, an Abbott spokesman, said, with some formula expected to begin rolling out June 20. Officials hope new shipments will reach store shelves within six to eight weeks, though resumption The plant will take longer to produce.

Abbott has replaced the leaking roof at the plant as well as the floor, Dr. Califf said.

Members of the House Energy and Commerce Subcommittee on Oversight and Investigations pushed back against the agency’s assertions that it was difficult to recognize in real-time the scope of contamination and the resulting nationwide breakdown in supplies. The Abbott plant had produced one-fourth of the nation’s infant formula, including tailored formulas for people with special nutritional needs.

“There was a life-and-death crisis in the front of the FDA, but they failed to see the severity of the situations,” said Representative Cathy McMorris Rodgers, a Republican from Washington. “We must resolve the immediate issue and also ensure that we are taking action so this situation never happens again.”

In opening remarks, Christopher Calamari, an Abbott Nutrition senior vice president, said there was little about conditions at the Michigan factory but said he was “deeply, deeply sorry” about the shortages. He said the company was coordinating 50 flights per week from its formula plant in Ireland to help bolster supplies to a dozen US airports.

“We are committed to ensuring that this never happens again,” Mr. Calamari said, noting that the company will add redundancy to its operations.

He later said the company is currently verifying that every step is in place to ensure quality checks are operating in a 700,000 square-foot facility in a sustainable way.

The agency discovered a battery of problems at the plant last fall. At the same time, reports began emerging of babies who had been hospitalized with a rare bacterium. Cronobacter sakazakii, which can be deadly to infants, was found in four babies who consumed the formula from the plant, according to the Centers for Disease Control and Prevention.

During the hearing that Testimony made it clear that the FDA took months to try to match the bacteria that became the first baby to the bacteria that was later found throughout the plant.

Cronobacter strains related to two of the babies did not match the samples of the bacteria later taken at the plant, although Dr. Califf said the agency considers those results “inconclusive” given the shortcomings with genome sequencing.

The illnesses set the recall in motion. The plant shutdown began Feb. 13. 17 and led to shortages that left parents struggling to find hundreds of miles of baby formula and, at times, improvising to feed hungry infants.

Dr. Califf also acknowledged that the FDA erred: its follow-up inspection should begin sooner, and, he said, the agency took too long to circulate a whistleblower report that arrived in October but did not reach top officials until February.

“It was too slow and there were decisions that were suboptimal along the way,” Dr. Califf said.

He told lawmakers that the agency didn’t receive an immediate notice when a formula plant found dead Cronobacter bacteria. Nor does the agency have access to the supply chain information that each of the three main US baby formula manufacturers have in-house.

The report of an anonymous whistleblower who said he worked in the Sturgis plant came up repeatedly during the hearing. The whistleblower alleged that safety staff there “celebrated” the FDA overlooking problems after a 2019 inspection and did not destroy enough product when it found Cronobacter in finished products. That top agency did not see those claims until February, “is stunning to me,” said Representative Gary Palmer, a Republican from Alabama.

Details in the report suggested there was “corruption” at the plant, Representative Kim Schrier, Democrat of Washington, charged. Dr. Califf said he couldn’t confirm or deny there might be criminal proceedings in the future.

Last week, the Justice Department announced a consent decree with Abbott on the conditions required to reopen the Sturgis plant, and the company could face heavy fines if it does not. In a complaint supporting the decree, officials described contamination with Cronobacter bacteria in the finished baby powder formula as long as 2019 and 2020.

Abbott officials have “been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants,” the complaint concluded.

Cronobacter sakazakii bacteria thrive in dry conditions, like powdered foodmaking. Only one state, Minnesota, requires doctors or labs to report cases of food-borne illness to the bacteria to public health authorities, who, in turn, are supposed to alert the CDC, The New York Times has reported.

Senator Tammy Duckworth, Democrat of Illinois, urged the CDC to change the protocols. “Our nation’s inadequate reporting system results in critical data gaps that undermine our ability to understand the true scope of Cronobacter infections in infants,” according to a letter she sent on Wednesday.

At the subcommittee hearing, Dr. Califf agreed that reporting should be required for cases involving the bacteria.

Last week, President Biden invoked the Defense Production Act to increase formula production and allow the use of aircraft for speed shipment infant formulas from the United States. 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 that it would set up a streamlined process for foreign baby formula manufacturers to send their products to the United States. On Tuesday, it announced that it had approved a company’s application to send two million cans.

Mr. Biden has also signed legislation broadening the types of formulas that can be used to benefit the federal food aid program for women and babies, which cleared both chambers of Congress with few objections. A House-passed emergency measures $ 28 million to boost staffing for the agency, however, as some senators question whether the money will adequately address the shortage.

“We don’t want anybody to be short of baby formula or anything,” said Senator Richard Shelby of Alabama, the top Republican on the Senate Committee on Appropriations. “Let’s see if we need it – the answer is not always money. The answer is good government and market forces. “

It is unclear what other legislative steps Congress will take. But as pleas from desperate parents seek formula flooded for Capitol Hill, lawmakers havetily scheduled hearings to interrogate both Dr. Califf and top industry executives over the failures that led to the shortage. Two more hearings are scheduled for this week, with House Appropriations subcommittees summoning a panel of experts on Wednesday and Dr. Califf set to appear before Senate’s Health, Education, Labor and Pensions Committee on Thursday.

Emily Cochrane contributed to this report.

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