


The House Oversight Subcommittee on Health Care and Financial Services is calling for transcribed interviews from eight top Food and Drug Administration officials relating to the infant formula shortage.
"The more the Oversight Committee uncovers in our investigation into internal failures at the FDA which led our nation into an infant formula crisis, the more questions we have for the FDA," Subcommittee Chairwoman Lisa McClain (R-MI) said.
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A whistleblower filed an FDA complaint in October 2021 regarding hazardous bacteria at the Abbott Laboratories plant in Michigan that produced the majority of powered baby formula in the U.S. FDA regulators, however, did not respond to the complaint until December 2021, and the plant did not stop operating until February 2022.
The subcommittee heard testimony from the director of the Center for Food Safety and Applied Nutrition at the FDA, Susan Mayne, in May regarding this marked delay in action. At that time, Mayne stated that the FDA had received the whistleblower's report, but the report was not elevated to senior leadership in a timely fashion to take appropriate action.
Mayne said in her testimony that streamlining "the reporting and decision-making" process as well as "organizational changes could make a more efficient or effective program."
"We believe where there is smoke, there is fire," McClain said in Wednesday's announcement. "We need to hear from more officials directly involved at the FDA about the lack of structures in place to prevent a crisis like this, and about actions that have or have not been taken to prevent a similar crisis from happening again."
Among those contacted for interviews are the director of the Office of Security and Emergency Management, Lionel Carter, assistant commissioner for criminal investigations in the Office of Regulatory Affairs, Justin Green, and the medical director for the infant formula and medical foods division, Andrea Lotze.
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McClain told reporters that the FDA has been "consistently delayed" in providing information about the infant formula shortage to Congress but has not yet conducted its own independent review of the crisis.
"We are going to ensure agencies are held accountable and find solutions to better protect American families in the future," she said.