WASHINGTON –
Infant formula maker Abbott says it has reached an agreement with US health officials to restart production at its largest domestic plant, a key step towards reducing nationwide shortages related to factory shutdowns earlier this year.
Abbott did not immediately detail the terms of an agreement reached with the Food and Drug Administration, which is investigating safety issues at the Sturgis, Michigan, facility. A consent decree is a legally binding agreement between a company and the federal government.
Once production resumes, Abbott said it will take at least eight weeks to begin shipping the new product to stores.
Over the past week, the Biden administration has come under intense pressure to do more to alleviate a formula shortage that has forced parents of babies to spend a lot of time feeding their babies.
Abbott’s factory came under scrutiny earlier this year after four infants fell ill with a bacterial infection after consuming infant formula from the Michigan factory. Two of the infants died.
In February, the company halted production and recalled several brands of formula. Those steps have squeezed supplies already strained by supply chain disruptions and parents stocking up during COVID-19.
THIS IS A BREAKING NEWS UPDATE. The AP’s previous story follows.
Under opposition from parents and politicians, the administration of President Joe Biden is expected on Monday to announce an agreement to reopen the country’s largest baby formula factory and eased import regulations to allow supplies from abroad, amid a nationwide shortage fueled by the Michigan factory. discontinued earlier this year due to safety issues.
Brian Deese, director of the White House’s National Economic Council, said a decree agreed between the manufacturer, Abbott, and the Food and Drug Administration to pave the way for factory reopenings. He added that the agency will also take steps on Monday to allow more imports from abroad into the US to address pressing supply constraints.
It’s been the past week that the Biden administration has come under intense pressure to do more to alleviate the formula shortages that have forced parents of babies to spend a lot of time feeding their babies. .
Over the weekend, the White House asked formula manufacturers and retailers to assist with shipping and logistics, and worked with all major formula manufacturers to boost production, including including contacting their suppliers to encourage them to prioritize the production and distribution of formula ingredients.
Deese said the administration “has made it clear to all of them that federal resources, including transportation and logistics resources, are available and on-demand and we are ready to move assets in coordination with them when and when we identify a need.”
The shortages stem from a February recall by Abbott, the nation’s largest formula maker, that closed the company’s Michigan plant and exacerbated ongoing supply chain disruptions. among formula manufacturers, leaving stores across the country with fewer options. Shortages have led retailers like CVS and Target to limit the number of boxes customers can buy per visit and forced some parents to barter and sell formula online.
On Monday, FDA Commissioner Robert Califf told ABC News “Good Morning America” that the federal agency is “working really closely with Abbott” to reopen the closed Michigan plant, and he hopes Hopefully “in a very short period of time, we will have an announcement on the way forward.”
Califf said an announcement on the import of infant formula from abroad is coming soon, noting that the key is making sure the recipe instructions are in a language that mothers and caregivers can understand.
The FDA has warned families against making their own infant formula because it has 30 separate ingredients that must be dosed correctly, or the formula could be dangerous to consumers.
Abbott’s voluntary recall was triggered by four cases reported in babies who drank infant formula from the Michigan factory. All four infants were hospitalized with a rare bacterial infection and two died.
Abbott is one of four companies that make about 90 percent of U.S. formula, so the shutdown has reduced an already tight supply.
After a six-week inspection, FDA investigators released a list of issues in March, which included lax safety and hygiene standards as well as a history of bacterial contamination in certain areas. factory parts.
But Chicago-based Abbott has stressed that its products are not directly linked to bacterial infections in children. Bacterial samples found at its factory did not match bacterial strains collected from infants by federal investigators. The company has repeatedly stated its willingness to resume production, pending an FDA decision.
The terms of the consent decree were not immediately clear, including what steps Abbott is taking to fix the problems raised by the FDA or how quickly production at the plant will be restarted. .
Former FDA officials say fixing problems discovered at Abbott’s plant takes time and baby formula facilities receive more oversight than other food facilities . Companies need to clean entire facilities and equipment, retrain employees, test multiple times, and document that there is no contamination.
Even if the facility reopens soon, the FDA will still face scrutiny over its handling of problems at the plant.
FDA inspectors visited the plant in September for routine checks, around the time when the first bacterial infections were reported in infants. Although inspectors discovered a number of violations — including standing water and unsanitary conditions — the FDA did not close the plant or issue any official warnings.
Only after several other illnesses were reported did the FDA return to the plant in January, this time finding a history of bacterial contamination in certain parts of the plant. Abbott then closed the facility and recalled some infant formula in mid-February.
Congressman Rosa DeLauro reported last month that a whistleblower contacted the FDA in October about unsafe conditions and practices at the plant, including falsifying factory records and failing to inspect correct formula for contamination.
She and other lawmakers will question FDA Commissioner Califf about that and others at a hearing scheduled for Thursday.
