WASHINGTON – Abbott Laboratories and the U.S. Food and Drug Administration are set to reopen the company’s Stargis, Michigan, Baby Formula manufacturing plant in a week or two, FDA Commissioner Robert Calif said Thursday.
Abbott, the largest U.S. supplier of powdered baby formulas, including Similac, on Monday agreed with the FDA on steps needed to restart production at the manufacturing plant.
“I’m glad to say today that we’ve already made significant progress and I think we’re on track to open it in the next two weeks from next week, probably on the outer border in two weeks,” Callie said. Representative panel.
The company recalled the baby formula products and shut down the plant in February after reports of serious bacterial infections in four children, exacerbating the deficit among multiple manufacturers that started with epidemic supply chain problems.
The FDA was investigating Abbott after reports that four children who were fed formula there had contracted the Chronobacter Sakazaki infection.
Until an investigation is completed, the agency will not be able to decide whether it is directly related to the Abbott plant in the case of sick children, Calif said.
“Abbott has fixed a number of issues,” Caliph said, after working closely with the FDA for three days.
The FDA is confident that more products could “quickly hit US stores,” he said, but that it would still take a few weeks until supply could return to normal. He added that people are now buying more formulas than before withdrawing, making distribution more difficult.
Nationwide scarcity has shaken parents to feed their children, and the U.S. government is searching for short-term solutions while fighting long-term solutions.
President Joe Biden on Wednesday called on the Defense Manufacturing Act to help manufacturers get ingredients to increase supply.
On Wednesday, the House passed two bills, including one that provided 21 28 million in emergency FDA funding backed by 219 Democrats and 12 Republicans. It was opposed by 192 Republicans.
A second measure, 414-9 passed, would guarantee that low-income families could continue to use their benefits to purchase formulas under a federal program for women, infants and children known as WICs.
Both bills must be passed in a closely divided Senate.
‘Neglect of duty’
Rosa Delauro, chairman of the House Appropriations Committee, grilled Calif, who appeared before an Appropriations Subcommittee to discuss the response to the FDA’s budget request deficit for fiscal year 2023.
The FDA said Monday that it would allow the import of baby formulas from foreign manufacturers who do not normally sell their products in the United States to help reduce the deficit.
“I’m concerned about the safety of the formulas that end up on our shelves,” Delaware said.
Calif said the formula would be imported once the FDA reviews it and determines it is safe.
Delaware also criticized the FDA for being too slow after receiving a whistleblower report in October. Delaware cited the report last month when he called for an official inquiry.
“Those who have seen the report feel that there is no need to respond until it is withdrawn from October to February. In my view, this is a violation of duty, “he said.
The United States was under pressure in the supply chain before Abbott’s withdrawal in February due to epidemics and other factors, but there was room for improvement in how quickly the FDA responds to such issues, Calliff said.
“We can do better than us.”
(Reporting by Ahmed Aboulenin and Susan Heavy; Editing by Chizu Nomiyama and Lisa Schumacher)