FDA chief says Covid outages in mailroom hampered formula response

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The Food and Drug Administration commissioner is expected to tell members of Congress Wednesday that the agency’s delayed response to reports of contamination at a Michigan baby formula plant was the result of a Covid-19 outbreak at the facility and a ” FDA failure” was mail room.”

As a result, the FDA did not begin its inspection until Jan. 31, more than three months after learning of the first Cronobacter infection in an infant who reportedly consumed powdered infant formula produced at Abbott Nutrition’s Sturgis, Michigan facility , FDA Commissioner Robert M. Califf says in prepared observations.

Califf will make the statement at a hearing Wednesday morning before the House Energy and Trade Committee, which focuses on a nationwide baby food shortage that has left many parents scrambling to find food for their infants and medically vulnerable children. Some children had to be hospitalized due to lack of food.

Among those scheduled to testify are FDA officials directly involved with food safety and executives from the country’s three largest baby formula companies — Abbott President Christopher Calamari, Gerber Vice President Scott Fitz and Reckitt President of Nutrition Robert Cleveland.

The hearing comes amid mounting criticism of the FDA’s handling of the crisis, largely stemming from a recall and the closure of Abbott’s Sturgis manufacturing facility in February. The plant produced most of the nation’s supply of powdered Similac and some specialty formulations.

The closure followed reports that four infants became ill or died after consuming formula made at the facility, and an FDA inspection found allegedly unsanitary conditions. But nearly four months later, the facility remains closed, severely limiting supplies.

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The Abbott facility had a troubled history, receiving 16 complaints from 2019-2021 about infants becoming ill after consuming Abbott products.

Abbott said in a statement that the bacteria found in non-product contact areas at the facility have not been linked to any known childhood illnesses. Genetic sequencing of the two available samples did not match the strains found in the plant. And samples from sick infants did not match, meaning there was no link between the two cases.

In an op-ed for The Washington Post on Saturday, Abbott’s chief executive Robert Ford apologized for the company’s role in the crisis and pledged to provide financial support to families facing medical bills as a result of the shortage. “We regret every family we have let down since our voluntary recall exacerbated our country’s infant formula shortages,” he said.

The situation erupted into a full-blown emergency in Washington last week when Congress passed two bills and President Biden invoked the Defense Production Act in hopes of rapidly increasing supplies. The Biden administration launched Operation Fly Formula, using DoD planes to transport up to 1.5 million 8-ounce bottles of three hypoallergenic formulas from Zurich to Plainfield, Indiana, in a crackdown on price gouging or unfair sales practices.

“We are pleased to have the opportunity to discuss the conditions at Abbott Nutrition’s Sturgis, Michigan facility that led to the recall that contributed to the current supply disruption; our monitoring and mitigation efforts in the infant formula supply chain; and additional tools needed if we are to prevent, monitor and mitigate future infant formula supply disruptions,” read Califf’s prepared comments.

Even as access to infant formula is improving in many parts of the country, some lawmakers blame the FDA itself for the slow national response to the shortage.

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House Appropriations Committee Chair Rosa L. DeLauro (D-Conn.) said she received a detailed report from a former Abbott employee who submitted a litany of complaints to the FDA last October about conditions at the Sturgis plant have registered.

But the agency didn’t interview the whistleblower until late December, DeLauro said at a hearing in April. The FDA didn’t begin its inspection at the facility until January 31, and the recall wasn’t issued until February 17.

“Why didn’t the FDA take action? Why did it take four months to get this formula off the shelves?” DeLauro said at a hearing in April.

At a hearing last week, Califf told lawmakers his agency was still investigating. He said FDA officials have been “working tirelessly” to increase shipments of baby formula nationally, and he expects the Abbott plant to be back up and running in a week or two.

Some lawmakers and advocates have expressed frustration that the FDA has been lax in responding to reports of childhood illnesses and has been slow to review whistleblower claims of unsafe operations. But they say the agency also seemed flat-footed to understand that recalling and closing the facility of Abbott Sturgis — one of the country’s largest formula makers and the largest for low-income families — would result in a national shortage that the lives of American infants.

The US Department of Agriculture’s Supplemental Nutrition Program for Low-Income Mothers and Children purchases half of the infant formula in the United States.

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The FDA should have asked how its actions might affect supply, said Jerry Mande, a senior USDA official during the Obama administration.

“The formula has to be absolutely safe,” he said. “But this is a complex issue, not just for infants but for others who rely on specialty nutrition products where shutting off supplies can also result in fatalities. You must carefully consider both and the steps you will take.”

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