WASHINGTON (AP) — Baby formula maker Abbott said Monday it has reached an agreement with U.S. health regulators to restart production at its largest domestic plant, though it will take far more than a month. months before new products ship from the site to help alleviate the national shortage facing parents.
Abbott did not immediately detail the terms of the agreement with the Food and Drug Administration, which has been investigating safety issues at its Sturgis, Michigan plant since earlier this year. The consent decree amounts to a legally binding agreement between the FDA and the company on the steps necessary to reopen the plant.
An FDA spokeswoman did not immediately respond to a request for comment on the announcement late Monday.
After production resumes, Abbott said it will take between six and eight weeks before new products start hitting stores. The company has not set a timetable for restarting production.
The FDA is expected to announce additional measures on Monday to allow more foreign imports into the United States to address supply issues. It comes as President Joe Biden’s administration faces intense pressure to do more to ease the shortage that has left many parents seeking formula online or at food banks.
Abbott’s factory came under intense scrutiny earlier this year after the FDA began investigating four bacterial infections in infants who consumed powdered formula from the factory. Two of the babies died.
In February, the company halted production and recalled several brands of powdered formula, reducing supplies that had already been tight by supply chain disruptions and storage during COVID-19. The shortage has led retailers like CVS and Target to limit the number of containers customers can buy per visit.
Outrage over the issue quickly snowballed and gave Republicans a new talking point to use against Biden ahead of November’s midterm elections.
Abbott is one of four companies that produce about 90% of US formula, and its brands account for nearly half of that market.
After a six-week inspection, FDA investigators released a list of issues in March, including lax safety and health standards and a history of bacterial contamination in several parts of the plant.
Chicago-based Abbott stressed that its products were not directly linked to bacterial infections in children. The bacteria samples found at his factory did not match the strains taken from the babies by federal investigators. The company has repeatedly said it is ready to resume manufacturing, pending an FDA decision.
Former FDA officials say fixing the kind of problems found at Abbott’s plant takes time, and infant formula facilities face more scrutiny than other food facilities. Companies must thoroughly clean the facility and equipment, retrain personnel, test repeatedly, and document that there is no contamination.
On Monday, FDA Commissioner Robert Califf told ABC News that an announcement was forthcoming regarding the importation of infant formula from overseas. The key issue is making sure the instructions for the formula are in languages that mothers and caregivers can understand, he noted.
Pediatricians say infant formulas produced in Canada and Europe are roughly equivalent to those in the United States. But traditionally, 98% of the infant formula supply in the United States is made domestically. Companies seeking to enter the United States face several major hurdles, including stringent research and manufacturing standards imposed by the FDA.
San Diego father Steven Davis faced harrowing challenges finding a formula for his medically fragile daughter, who was on an Abbott formula but had to change with the recall and subsequent shortages at other brands.
Zoie Davis was born 19 months ago without a kidney, a rare life-threatening condition that requires dialysis and a feeding tube until she weighs enough for a kidney transplant. She’s four pounds lighter than that milestone, said Davis, a mortgage lender and her daughter’s caretaker.
“His life depends on his gaining weight,” he said.
Davis said he was using an overseas organic brand until costs and customs hurdles made it too difficult. Friends and strangers from out of state have sent her other brands, but each time she changes, she requires more blood tests and monitoring, Davis said.
Despite her challenges, Zoie walks, talks and is “doing pretty well” on other stages of development, Davis said.
“She is a shining light in my life,” he said.
AP Medical Writer Lindsay Tanner contributed to this story from Chicago.
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