US FDA says Abbott infant formula factory set to reopen in 1-2 weeks

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By Ahmed Aboulenein and Susan Heavey

WASHINGTON (Reuters) – Abbott Laboratories and the U.S. Food and Drug Administration are on track to reopen the baby formula manufacturing plant in Sturgis, Michigan, within the next week or two, a FDA Commissioner Robert Califf said Thursday.

Abbott, the largest U.S. supplier of powdered infant formula, including Similac, on Monday agreed with the FDA on steps needed to resume production at the manufacturing facility.

“I am happy to say today that we have already made significant progress and I think we are on track to open it within the week to two weeks, most likely within the two outer weeks. Califf told the U.S. House of Representatives. Panel of representatives.

The company recalled infant formula and closed the factory in February after reports of serious bacterial infections in four infants, exacerbating a shortage among several manufacturers that began with pandemic supply chain issues.

The FDA was investigating Abbott after it reported that four babies who were fed formula made there fell ill with Cronobacter sakazakii infections.

The agency cannot conclude whether the sick baby cases are directly linked to the Abbott plant until its investigation is complete, Califf said.

“Abbott has resolved a number of issues,” Califf said after three days of working closely with the FDA.

The FDA is confident that more products “can get to U.S. stores quickly,” he said, but it will still be weeks before supplies of formula return to normal. People are buying more formula now than before the recall, making distribution more difficult, he added.

The nationwide shortage has left parents scrambling to feed their babies and the US government looking for short-term solutions while grappling with longer-term ones.

President Joe Biden on Wednesday invoked the Defense Production Act to help manufacturers secure ingredients to boost supply.

The House on Wednesday passed two bills, including one providing $28 million in emergency funding from the FDA backed by 219 Democrats and 12 Republicans. He was opposed by 192 Republicans.

A second measure, passed 414-9, would ensure that low-income families can continue to use their benefits to purchase formula under a federal program for women, infants and children known as WIC. .

Both bills must also pass the tightly divided Senate.

‘DERELICTION OF DUTY’

House Appropriations Committee Chair Rosa DeLauro questioned Califf, who appeared before an appropriations subcommittee to discuss the FDA’s fiscal year 2023 budget request, about its response to the shortage.

The FDA said Monday it would allow imports of infant formula from foreign manufacturers that don’t typically 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,” DeLauro said, adding that she was concerned that “the guidelines recently released by the FDA do not go far enough to ensure the safety of the formulas.”

Califf said the formula would only be imported after the FDA reviewed it and determined it was safe.

DeLauro also criticized the FDA for moving too slowly, after receiving a whistleblower report in October. DeLauro cited the report last month when she called for a government investigation.

“Anyone who looked at this report felt that there was no need to respond at all from October to February until there was a recall. This is a dereliction of duty, in my view,” she said.

The United States had faced formula supply chain strains before Abbott’s recall in February due to the pandemic and other factors, Califf said, but there was room for change. improvement in the speed with which the FDA responds to these issues.

“We could do better than we did.”

(Reporting by Ahmed Aboulenein and Susan Heavey; Editing by Chizu Nomiyama and Lisa Shumaker)


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