House Appropriations Chair Rosa DeLauro today asked the Health and Human Services office of the inspector general to investigate whether the FDA “took prompt, appropriate, and effective action” in the lead up to the massive recall of Abbott Nutrition infant formula last month, POLITICO has learned.
How we got here: The request comes after POLITICO reported that FDA, CDC and Abbott were told of the first infant with a Cronobacter sakazakii infection in September. FDA has not answered key questions about the several-month gap between the first reported case, the subsequent reports of four more illnesses — including two infant deaths — and the agency’s decision to inspect the plant on Jan. 31 and then recall formula on Feb. 17.
“Based on reports, I am concerned the agency acted too slowly in pulling potentially dangerous infant formula off store shelves, which may have resulted in additional illness and death,” DeLauro wrote.
Timeline questions: POLITICO has repeatedly asked FDA to explain its timeline in the investigation, but the agency has declined to do so.
“We know there have been questions about the timeline,” FDA said in a statement to POLITICO, eight days after first being asked about the timeline. “However, this remains an open inspection with many moving parts. Our top priority is ensuring that any recalled product produced at this facility is taken off the market. We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available.”
The agency said it would conduct a review when the investigation is complete.
DeLauro asked the HHS OIG to look into several questions as it conducts its investigation, including explanations of why it took FDA months to inspect and then recall product as reports of illnesses trickled in, what all was found during the agency’s inspections of the plant, and whether FDA had seen records that the plant had in June 2020 destroyed product over the presence of Cronobacter sakazakii, among other things.
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