The ongoing COVID-19 pandemic and ‘mailroom failures’ are at least two contributing factors to a nationwide shortage of baby formula, the Food and Drug Administration said on Thursday. Private.
FDA Commissioner Robert Califf has laid out a series of setbacks that have delayed the government’s response to the deepening crisis, fueled by prolonged supply chain disruptions and manufacturing plant closures. infant formula operated by Abbott Nutrition.
“Our oversight is important but make no mistake – a return to normal will only happen once Abbott takes steps to safely resume production,” Califf said.
He was also unable to give a definite answer when asked when conditions would return to normal.
“This is a crisis, we’re fully aware of it – families shouldn’t be looking for formula, but they have to do it now until we fill it out,” he said.
‘In a few weeks, we’ll have a surplus of formula. When I say “a few”, I can’t say exactly how many weeks. ”
The Biden administration has blamed the shortage by highlighting the role Abbott’s product recalls and voluntary closures earlier this year played in dwindling supplies – pointing to flaws inherent in a string of Supply is so fragile that it can be severely disrupted due to manufacturer problems. .
FDA Commissioner Robert Califf admits his regulator has been ‘too slow’ to respond to signs that are ultimately leading to a shortage of baby formula
He testified before a Hybrid House hearing about the crisis, which was linked to multiple reports of children being hospitalized
‘About a month ago, reports of stock shortages on shelves increased – although there was no drop in production. This increase in consumption most likely represents the growing anxiety among parents and carers about shortages – leading to an understandable attempt to buy in advance to ensure adequate supplies at home. ,’ Califf said.
‘This kind of cycle has happened to other products throughout the pandemic, and we’ve realized that the only solution is to have enough supply to ensure shelves are always stocked.’
However, he admitted the FDA was “too slow” to inspect Abbott’s Michigan plant despite receiving a complaint about its condition last September.
The bacteria are thought to be associated with Cronobacter sakazakii infection in four infants who drank formula produced there.
Califf’s pre-planned opening remarks stated that the complaint was sent to a county office but did not reach FDA leadership in a timely manner ‘due to an isolation failure in the FDA’s mailroom. ‘
Officials did not request an interview with the whistleblower until December. It didn’t happen until December 22 due to scheduling conflicts on the part of the whistleblower.
Meanwhile, the shelves of baby food stores at many supermarkets across the country continue to be empty
Califf also told the House panel that a series of COVID-19 infections at the plant delayed the FDA’s inspection of the matter until January 31.
Meanwhile, both Republican and Democratic lawmakers have grilled government officials over the Biden administration’s handling of shortages as well as market monopolies that contributed to this failure.
‘The tragic situation is unacceptable and worse, it is completely preventable. This shows a disturbing pattern of negligence,’ Colorado Democratic Representative Diane DeGette said of Abbott.
She said: ‘There were increased incidents to the domestic supply of formula in the months leading up to the reported infant illness, and the subsequent recall of Abbott products, but the recall official again. The U.S. formula supply became a difficult affair. ‘
‘The efforts of the Biden administration to coordinate this response to get families out of the immediate crisis have been extensive and I think we will soon see them work. But we cannot ignore the need for longer-term solutions,’ she said.
First Lady Dr Jill Biden and Surgeon General Vivek Murthy on Wednesday welcomed a shipment of baby formula at Dulles International Airport
President Joe Biden has authorized the transfer of tens of thousands of pounds of baby formula from Europe to the US under ‘Operation Fly Formula’
Republican Representative Morgan Griffith of Virginia stated: ‘The big question I ask today is, why did the Biden administration allow the shortage to become so severe before urgent action? “
He has criticized the Democratic administration for being caught ‘by foot’ in ‘what should have been a foreseeable event.’
‘Why has the Biden administration received intense national media attention when it has acted with the sense of urgency needed to adequately address the infant formula shortage?’ required by the legislator.
On Tuesday, Abbott said it would restart production at the plant in early June, the same day the Federal Trade Commission announced it was opening an investigation into a baby formula shortage.
Meanwhile, as part of President Joe Biden’s Operation Bay Formula, tens of thousands of pounds of baby food are being transported by commercial military aircraft from Europe to the United States.
