Abbott Laboratories and the U.S. Food and Drug Administration are on track to reopen Abbott’s baby formula manufacturing plant in Sturgis, Michigan, within one or two weeks, FDA Commissioner Robert Califf said on Thursday.
Abbott, the biggest U.S. supplier of powder infant formula, including Similac, on Monday agreed with the FDA on steps needed to resume production at the plant.
“I’m pleased to say today we’ve already made significant progress and I think we are on track to get it open within the next week to two weeks, most likely at the outer bound two weeks,” Califf told a U.S. House of Representatives panel.
The company recalled infant formula products and closed the plant in February after reports of Cronobacter sakazakii infections in four infants, worsening a shortage among multiple manufacturers that began with pandemic supply-chain issues. The FDA launched its investigation following the consumer complaints.
The agency cannot conclude whether the cases of ill babies are directly related to the Abbott plant until its investigation is concluded, Califf said.
“Abbott has remedied a number of issues,” after three days of working closely with the FDA, Califf said.
The FDA is confident more product “can quickly hit U.S. stores,” he said, but it will be weeks until formula supplies are back to normal. People are buying more formula now than before the recall, making distribution harder, he added.
The nationwide shortage has left parents scrambling to feed their babies and the U.S. government searching for short-term fixes while grappling with longer-term solutions.
President Joe Biden invoked the Defense Production Act on Wednesday to help manufacturers obtain ingredients to ramp up supply.
Biden also directed U.S. agencies to use Defense Department-contracted commercial aircraft to bring formula into the United States from overseas, calling it Operation Fly Formula.
The White House on Thursday announced Operation Fly Formula’s first shipment. The equivalent of 1.5 million 8-ounce bottles of Nestle formula will be flown from Zurich, Switzerland, to Plainfield, Indiana. The three formula brands being shipped are for children with cow’s milk protein allergy.
The House on Wednesday passed two bills, including one providing $28 million in emergency FDA funds, supported by 219 Democrats and 12 Republicans. It was opposed by 192 Republicans.
A second measure, which passed 414-9, would guarantee low-income families can continue using their benefits to buy formula under a federal program for women, infants and children known as WIC.
Both bills still face votes in the closely divided Senate.
‘Dereliction of Duty’
House Appropriations Committee Chair Rosa DeLauro grilled Califf, who appeared before an Appropriations subcommittee to discuss the FDA’s budget request for the 2023 fiscal year, over its response to the shortage.
The FDA said on Monday it would allow baby formula imports from foreign makers that do not usually sell their products in the United States to help ease the shortage.
“I remain concerned about the safety of the formulas that end up on our shelves,” said DeLauro, adding she was worried “the FDA’s recently released guidance does not go far enough to ensure formula is safe.”
Califf said formula would only be imported after the FDA determines it is safe.
DeLauro also criticized the FDA for acting too slowly, having received a whistleblower report in October. DeLauro cited the report last month when she sought a government probe.
“Whomever looked at that report felt that there was no need to respond at all from October to February until there was a recall. That is a dereliction of duty, in my view,” she said.
Califf said the United States had been facing stress on the formula supply chain before the Abbott recall in February because of the pandemic and other factors, but said there was room for improvement on how quickly the FDA responds to such issues.
“We could do better than we did.”
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