US President Joe Biden on Wednesday invoked the Defense Production Act to speed up infant formula production and authorized flights to import supplies from abroad, as he faces mounting political pressure over domestic shortages caused by the shutdown. related to the safety of the nation’s largest formula manufacturing plant. .
The Defense Production Act order requires suppliers to formulators to fill those companies’ orders before other customers, in an effort to eliminate production bottlenecks. Biden is also authorizing the Department of Defense to use commercial aircraft to fly supplies of formula that meet federal standards from abroad to the US, in what the White House is calling “Operation Fly Formula.”
Baby formula supplies across the country have been severely reduced in recent weeks after Abbott Nutrition recalled in February and exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on shelves. from stores and increasingly anxious parents struggling to find nutrition for their children.
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The announcement comes two days after the Food and Drug Administration said it was streamlining its review process to make it easier for foreign manufacturers to start shipping more formula to the US.
In a letter sent Wednesday to the Department of Health and Human Services and the Department of Agriculture, Biden directed the agencies to work with the Pentagon to identify supply of formula abroad that meets US standards. USA
“Baby formula imports will serve as a bridge to this accelerated production,” Biden wrote.
Regulators said Monday they had reached an agreement to allow Abbott Nutrition to restart its Sturgis, Michigan plant, the nation’s largest formula plant, which has been closed since February due to contamination concerns. The company must review its safety protocols and procedures before resuming production.
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After getting FDA approval, Abbott said it will take eight to 10 weeks before new products start hitting store shelves. The company did not set a timetable for restarting manufacturing.
Abbott’s voluntary recall was prompted by four reported illnesses in infants who had consumed powdered formula from its plant. All four babies were hospitalized with a rare type of bacterial infection, and two died.
After a six-week inspection, FDA investigators released a list of problems in March, including lax health and safety standards and a history of bacterial contamination in various parts of the plant. Under Monday’s agreement, Abbott must regularly consult with an outside security expert to restart and maintain production.
Chicago-based Abbott has emphasized that its products have not been directly linked to bacterial infections in children. Samples of the bacteria found at his plant did not match strains collected from two babies by federal investigators.
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But FDA officials pushed back on that reasoning Monday in a call with reporters, the first time they’ve publicly addressed the company’s argument. FDA staff noted that they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match.
“From the beginning, our ability to determine with a causal link whether the product was related to these four cases was limited because we only had sequences in two,” said Susan Mayne, FDA food director.
Fixing the violations discovered at the Abbott plant will take time, according to former FDA officials. Companies must thoroughly clean facilities and equipment, retrain personnel, repeatedly test, and document that there is no contamination.
As part of the FDA’s new import policy, regulators said companies would have to provide documentation of their factory inspections.
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