The FDA chief details the “shocking” conditions at the baby formula plant

The Abbott Nutrition plans in Michigan that closed in February, triggering a widespread formula shortage crisis, had a leaking roof, water accumulated on the floor, and cracks in key manufacturing equipment that allowed bacteria to enter and persist. said Dr. Robert Califf, the head of the Food and Drug Administration, told a House panel Wednesday.

During a hearing he detailed the “extremely unsanitary” conditions in the Sturgis, Michigan plan to lawmakers, but also acknowledged that his agency was too slow to respond.

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

This effort is expected to lead to the facility’s reopening on June 4, said Jonathon Hamilton, a spokesperson for Abbott, with a formula that is expected to begin rolling out on June 20. Officials hope the new shipments will hit store shelves within six to eight weeks, though resuming full production at the plant will take longer.

Abbott replaced the leaky plant roof and floor, Dr. Calif said.

Members of the Chamber of Energy and Commerce’s Subcommittee on Supervision and Investigation have rejected the agency’s claims that it was difficult to recognize in real time the extent of contamination and the resulting disruption of supplies nationwide. The Abbott plant had produced a quarter of the nation’s infant formula, including formulas tailored for people with specialized nutritional needs.

“There was a life-or-death crisis before the FDA, but they failed to see the gravity of the situation,” said Washington Republican Rep Cathy McMorris Rodgers. “We have to solve the immediate problem and also make sure we act so that this situation never happens again.”

In the keynote address, Christopher Calamari, senior vice president of Abbott Nutrition, spoke little about the conditions at the Michigan plant, but said he was “deeply, deeply sorry” about the shortages. He said the airline was coordinating 50 flights a week from its formula facility in Ireland to a dozen US airports to help strengthen supplies.

“We are committed to ensuring this never happens again,” 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 controls are functioning sustainably throughout the 700,000-square-foot facility.

The agency uncovered a number of problems at the plant last fall. At the same time, reports began to emerge of children who had been hospitalized with a rare bacterium. According to the Centers for Disease Control and Prevention, Cronobacter sakazakii, which can be deadly to babies, was found in four babies who consumed the plant’s formula.

Testimony at the hearing made it clear that it took the FDA months to try to match the bacteria that made the first child sick with the bacteria that were later found throughout the plant.

The Cronobacter strains from two of the children did not match the bacteria samples subsequently collected at the facility, although Dr. Califf said the agency considered those results “inconclusive” given the deficiencies in genome sequencing.

Diseases set the call in motion. The closure of the plant began on February 17 and led to shortages that left parents in trouble, driving hundreds of miles to find formula and, at times, improvising to feed hungry babies.

Dr Califf also acknowledged that the FDA made a mistake: its follow-up inspection in January should have started earlier and, he said, the agency took too long to circulate a whistleblower report that arrived in October. but it did not reach senior officials until February.

“It was too slow and there were decisions that weren’t optimal along the way,” said Dr. Calif said.

He told lawmakers that the agency did not receive immediate warning when an artificial plant found the deadly Chnobacter bacteria. Nor does the agency have access to the supply chain information that each of the three major U.S. baby formula manufacturers own internally.

the relationship an anonymous informant who claimed to have worked at the Sturgis plant emerged repeatedly during the hearing. The whistleblower said security personnel “celebrated” the FDA by neglecting the issues after a 2019 inspection and did not destroy enough product when they found Cronobacter in finished products. The fact that leaders of major agencies didn’t see those claims until February “is astounding to me,” said Alabama Republican Rep. Gary Palmer.

Details in the report suggested there was “corruption” at the plant, Washington Democrat Representative Kim Schrier accused. Dr Califf said he could neither confirm nor deny whether there could be criminal prosecutions in the future.

Last week, the Justice Department announced a consent decree with Abbott on the conditions necessary to reopen the Sturgis plant, and the company could face heavy fines if it fails to comply. In a complaint supporting the decree, officials described contamination with Cronobacter bacteria in finished batches of baby formula as early as 2019 and 2020.

Abbott officials “were unwilling or unable to take sustainable corrective actions to ensure the safety and quality of food produced for children,” the grievance.

Cronobacter sakazakii bacteria thrive in dry conditions, such as producing powdered food. Only one state, Minnesota, requires doctors or labs to report cases of foodborne illness caused by the bacteria to public health authorities, which, in turn, should alert the CDC, The New York Times has reported.

Senator Tammy Duckworth, a Democrat from 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 extent of Cronobacter infections in children,” according to the letter he sent Wednesday.

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

Last week, President Biden invoked the Defense Production Act to increase formula milk production and authorized the use of airplanes to accelerate the shipment of formula milk to the United States from overseas. The first military aircraft carrying 500,000 bottles of formula arrived in Indianapolis from Europe on Sundayand another was due to land in the Washington, DC area on Wednesday.

Last week, the FDA said it has instituted a streamlined process for foreign infant 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.

So did Mr. Biden law signed in law expanding the types of formulas that can be purchased using the benefits of the federal food aid program for women and children, which cleared both houses of Congress with few objections. A Emergency measure approved by the $ 28 million house to increase staffing for the agency, however, stalled as some senators question whether the money will adequately address the shortage.

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

It is unclear what other legislative steps Congress will take. But as pleas from desperate parents looking for a formula flooded Capitol Hill, lawmakers hastily scheduled hearings to question both Dr. Califf and senior industry executives about the failures that led to the shortage. Two more hearings are scheduled for this week, with the House appropriations subcommittees convene a jury of experts Wednesday and Dr. Calif set to appear Thursday before the Senate Committee on Health, Education, Work and Pensions.

Emily Cochrane contributed to this report.

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