The FSA's leaders are testifying before a House committee looking into its response to a formula recall that exacerbated shortages
Robert Califf testifies before a Senate Committee on Health, Education, Labor and Pension in Washington, on Dec. 14, 2021. | Manuel Balce Ceneta, File/AP PhotoThe FDA’s top official will acknowledge a string of failures that contributed to the current infant formula shortages when he faces lawmakers on Capitol Hill on Wednesday.
The FDA timeline laid out in the prepared testimony acknowledges the FDA didn’t hold interagency discussions about potential supply chain disruptions until Feb. 14, three days before the Abbott Nutrition plant at the center of the current shortages shut down and issued a formula recall.
The FDA timeline does say other FDA officials overseeing infant formula and regulatory affairs received a copy of the 34-page report last October. Mayne and Frank Yiannas, FDA’s deputy commissioner for food policy and response, will testify alongside Califf on Wednesday. As POLITICO has reported,Senior leaders at Abbott and two other major formula manufacturers will also testify before Congress on Wednesday.
Califf’s testimony also addresses why it took the FDA until the end of January to begin its inspection of Abbott’s Sturgis plant, despite receiving warnings last fall. For several months after the initial reports of bacterial infections, Califf says the FDA struggled to match formula samples to the specific bacterium, which is known to grow in infant formula and cause rare but potentially fatal illnesses in babies.
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