Covid, post office failure has hampered the FDA’s official response, the director said.


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The Food and Drug Administration (FDA) director is expected to tell lawmakers on Wednesday that the FDA’s delayed response to the Michigan milk powder factory’s contamination reports was the result of the facility’s COVID-19 outbreak and “FDA mailroom errors.” .”

As a result, the FDA Commissioner conducted an inspection by January 31, more than three months after learning of the first Chronobacter infection in an infant reported to have consumed powdered infant formula produced at Abbott Nutrition’s Sturgis, Michigan facility. didn’t start. Robert M. Caliph said prepared speech.

Califf will explain Wednesday morning before the House Energy and Commerce Committee hearings about a nationwide baby formula shortage that has left many parents busy finding livelihoods for infants and medically vulnerable children.

The hearing came as criticism grew over FDA’s handling of the crisis caused by the recall and closure of Abbott’s production facility in Sturgis in February. The company produced most of the national supply of similac powder and some special formulations.

The closure came as an FDA inspection suspected of unsanitary conditions following reports of four infants ill or died after consuming factory-produced formula. However, nearly four months later, the facility continues to close, severely limiting supply.

The FDA director said the infant formula plant could open in less than a week.

The Abbott facility has a troubled history, with 16 complaints of infants who became ill after drinking Abbott products between 2019 and 2021.

Abbott said in a statement that the bacteria found in non-product contact areas of plants were not associated with any known infant disease. Gene sequencing of the two available samples did not match the strains found in the plants. And the samples of sick infants did not match each other, so there was no association between the two cases.

In an article in the Washington Post on Saturday, Abbott’s CEO Robert Ford apologized for the company’s role in the crisis and promised to provide financial assistance to families whose shortages are causing medical bills. “We apologize to all the families we have let down since the voluntary recall exacerbated the milk powder shortage in our country,” he said.

The situation escalated into an all-out emergency in Washington as Congress passed two bills last week and President Biden invoked the Defense Production Act in hopes of a rapid increase in supplies. The Biden administration launched Operation Fly Formula using a Pentagon aircraft to transport up to 1.58 ounce bottles of three hypoallergenic formulas from Zurich to Plainfield, Indiana. President Biden has also directed ingredient manufacturers to prioritize supply to official companies and said there will be crackdowns on price increases or unfair selling practices.

“We appreciate the opportunity to discuss the current condition of the Abbott Nutrition facility in Sturgis, Michigan, which has led to the recall that contributed to the current supply disruption. monitoring and mitigation efforts in the infant formula supply chain; “An additional tool needed to prevent, monitor and mitigate future infant formula supply disruptions,” Califf’s prepared remarks said.

Although access to formula is improving in many parts of the United States, some lawmakers are blaming the country’s slow response to the lack of the FDA itself.

FDA agrees to resume production with milk powder mills

House Appropriations Committee Chairman Rosa L. DeLauro (D-Conn.) said: long report In the words of a former Abbott employee who filed a complaint with the FDA last October about the condition of the Sturgis plant.

However, the agency did not interview the whistleblower until the end of December, DeLauro said at a hearing in April. FDA did not begin an inspection of the plant until January 31, and the recall was not issued until February 17.

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

At a hearing last week, Califf told lawmakers that his agency was still under investigation. He said FDA officials have been working “tiringly” to increase milk powder supplies across the country and expect the Abbott plant to be up and running again in a week or two.

While some lawmakers and advocates have expressed frustration that the FDA has been slow to review whistleblowers’ allegations of negligent reporting of infant disease and unsafe plant management, as is common with Abbott’s understanding of the Sturgis recall and facility closures. It looked. America’s largest producer of formula, and the largest manufacturer of supporting low-income families, will create a national shortage that continues to put the lives of American infants at risk.

The USDA’s WIC program for low-income mothers and children buys half of infant formula in the United States.

About 200 Republican senators voted against a bill to ease the milk supply shortage.

Jerry Mande, a senior USDA official during the Obama administration, said the FDA should be asking how the FDA’s action will affect supplies.

“The formula has to be absolutely safe,” he said. “However, this is a complex issue not only for infants, but also for other people who depend on specialty formula products that can be fatal if cut off. You have to carefully balance the two with the steps you will take.”

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