The audit assessed how FDA responded leading up to the 2022 formula shortage.
The Food and Drug Administration failed to heed warning signs that there were mounting concerns with one of the nation's largest infant formula makers, as a series of babies' severe illnesses and whistleblower complaints began to accumulate ahead of a critical shortage in 2022, the agency's watchdog has found.
"What happens when you don't immediately address risks is that you can't mitigate and address them timely. And that's what we were seeing," Lewis, Assistant Inspector General for Audit Services, said. "We know that millions of babies each year may rely on infant formula as their sole source of nutrition.
"We are committed to implementing the OIG's recommendations for strengthening our program," the FDA said, adding they have already "begun several steps to improve policies and procedures for complaints, recalls, and infant formula inspections." The FDA "did not have adequate policies and procedures" for crucial oversight systems, the IG's report found-mechanisms meant to identify risks to infant formula, such as whistleblower and consumer complaints red-flagging issues.
And when it came to whistleblower complaints, IG's report found, FDA "did not develop an organizational structure or assign responsibilities to enable the organization to operate in an efficient and effective manner." Amid scrutiny over their process in May of that year, the FDA released a "timeline of infant formula related activities" which admitted that a second whistleblower complaint wasn't received by FDA leadership "due to an isolated failure in FDA's mailroom, likely due to COVID-19 staffing issues."
"I was just surprised that something like that hadn't been elevated," Yiannas said of the monthslong mislaid whistleblower report, noting the issues at Abbott had already been brewing for months by the time he "found out about the series of events" ensuing.
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