WASHINGTON – Abbott Laboratories and the U.S. Food and Drug Administration are set to reopen Abbott’s baby formula factory in Sturridge, Michigan in a week or two, FDA Commissioner Robert Calif said Thursday.
Abbott, the largest U.S. supplier of powdered baby formula, including Similac, on Monday agreed with the FDA on the steps needed to resume production at the 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 withdrew infant formula products and shut down the plant in February after reports of Chronobacter Sakazaki infection in four children, exacerbating the deficit among multiple manufacturers that began with epidemic supply-chain problems. The FDA has launched an investigation into the allegations.
Until the investigation is completed, the agency cannot conclude 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 it will take weeks for formula supply to 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.
Biden has instructed U.S. agencies to use the Department of Defense’s contracted commercial aircraft to bring the formula to the United States from abroad, called Operation Fly Formula.
The White House on Thursday announced the first shipment of Operation Fly Formula. The equivalent of 1.5 million 8-ounce bottles of Nestle SA Formula will be shipped from Zurich, Switzerland to Plainfield, Indiana. Three formula brands are being shipped for babies who are allergic to cow’s milk protein.
On Wednesday, the House passed two bills, one with an emergency FDA funding of $ 28 million, backed by 219 Democrats and 12 Republicans. It was opposed by 192 Republicans.
A second measure, which passed 414-9, would ensure 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.
The two bills still face a closely divided Senate vote.
‘Neglect of duty’
House Appropriations Committee Chair Rosa Delauro Griffiths, 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 only after the FDA determines whether 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.
Calliffe said the United States was under pressure in the supply chain before Abbott withdrew in February due to epidemics and other factors, but said there was room for improvement in how quickly the FDA responds to such issues.
“We can do better than us.”
(Reporting by Ahmed Abulinin and Susan Heavy; Editing by Chizu Nomiyama, Lisa Schumacher and Leslie Adler)