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FDA Says Baby Formula Factory Could Reopen As Soon As Next Week

FDA Says Baby Formula Factory Could Reopen As Soon As Next Week

The head of the Food and Drug Administration (FDA) told lawmakers Thursday that a baby formula factory that had been shut down could be up and running as soon as next week, although he sidestepped questions about whether his agency should have intervened earlier to address problems at the plant that have triggered the national shortage.

FDA Commissioner Dr. Robert Califf faced a bipartisan panel where Republican House lawmakers grilled him over the baby formula issue that has angered American parents and become a major political liability for President Joe Biden, although the problems stem from Abbott Nutrition’s Michigan formula plant, the largest in the U.S., which has been closed since February due to contamination problems.

Abbott shut its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. All four were hospitalized and two died. The first case was reported to the FDA in September, but agency staff didn’t begin inspecting the facility until late January.

 

Consolidation in the U.S. formula market makes it highly vulnerable to disruption. Only four companies produce an estimated 90% of U.S. formula, including Abbott, Gerber, Perrigo, and Reckitt. Those companies also dominate federal contracts that provide about half of all U.S. formula through the supplemental WIC program for low-income mothers, infants, and children.

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After complaining about the shortage and blaming it fully on President Biden, twelve Republican lawmakers bucked their party on Wednesday in votes on two separate bills aiming to address the nationwide baby formula shortage causing rising concern for parents across the country.

 

The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending safety upgrades and certifications.

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