FDA Commissioner Robert Califf laid out a series of setbacks that delayed the government's response to the worsening problem, caused by persisted supply chain disruptions and the shutdown of a baby formula manufacturing plant run by Abbott Nutrition.
"Our oversight is critical but make no mistake about it - the return to normal will only occur when Abbott takes the steps to resume production in a safe manner," Califf announced.
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He further could not give a straightforward answer when questioned when conditions would be back to normal.
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"This is a crisis, we're fully aware of it - families should not be searching for formulas, but they have to do it now until we fill in," he stated.
"Several weeks out, we'll have a surplus of formulas. When I say 'several,' I can't say exactly how many weeks."
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The Biden administration has been deflecting blame for the shortage by highlighting the part Abbott's product recall and voluntary shutdown earlier this year played in the depleted supply - pointing out the inherent weaknesses in a supply chain so fragile that it could be severely disrupted by one manufacturer's matters.
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"About a month ago, the reports of shortages on the shelf proliferated - although there was not a drop in production. This increase in consumption most likely represents heightened concern of parents and caregivers about shortages - leading to an understandable effort to purchase ahead to ensure adequate supply at home," Califf stated.
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"This type of cycle has happened with other products throughout the pandemic, and we realize that the only solution is to have adequate supply to make sure shelves are stocked."
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However, he did admit the FDA was "too slow" to inspect Abbott's Michigan plant despite receiving a whistleblower complaint regarding conditions at the facility in September last year.
The bacteria was reportedly linked to Cronobacter sakazakii infections in four babies who consumed formula made there.
Califf's pre-planned opening comments state that the complaint was made to a district office yet failed to reach FDA leadership in a timely manner "due to an isolated failure in FDA’s mailroom."
Officials did not request an interview with the whistleblower until December. It did not take place until December 22 due to scheduling conflicts on the whistleblower's part.
Califf further told the House panel that a spate of COVID-19 infections at the plant delayed an FDA inspection into the matter until January 31.
In the meantime, both Republican and Democrat lawmakers grilled the government officials on the Biden administration's handling of the shortage as well as the market monopoly that contributed to the failure.
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