Abbott (ABT) has reached an agreement with the U.S. Food and Drug Administration (FDA) that could allow it to get baby formula products, currently in shortage, to customers in about two months, once it restarts a Michigan plant which shut down in February.
A nationwide shortage of baby formula has been growing in recent weeks as a domino effect of Abbott's plant closure and ongoing supply chain constraints has left store shelves bare.
Abbott announced a potential timeline of two weeks to restart the plant and six to eight weeks before products make it back on shelves.
FDA Commissioner Dr. Robert Califf said Monday evening he believes these goals are doable.
"We believe those timeframes are reasonable," he said, but added that he cannot commit to a timeline.
But, he said, the FDA expects overall supply to improve "in the next couple of months."
Califf added that the FDA was working with outside consultants to gain realtime updates on the company's progress to resolve the safety concerns, and the agency would give the green light as soon as Abbott meets all the requirements.
Abbott voluntarily shut down its plant and recalled some of its infant formula products after reports of four cases, including two infant deaths, following the use of its formula. The company has maintained that the subsequent investigations show that the strains found by the FDA did not match the strains of infection in the babies.
FDA officials told reporters on Monday that there were many types of strains found at the plant, but because Cronobacter sakazakiior is not a reportable disease, except in Minnesota, the data do not exist for a definitive conclusion. The FDA only had two samples from the four cases to work with, and the database of the bacteria only has 238 strains identified.
"We simply don't have the evidence to demonstrate that causality. But again, the data are so limited with sequencing only available for two out of the four cases," said Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition.
The U.S. government has taken several steps in the past week in efforts to alleviate the situation.
Last week, the White House met with major retailers and manufacturers to determine how to increase production domestically. Meanwhile, the FDA has been looking abroad to find supplies that meet regulatory requirements, as well as increasing flexibility to add more domestic production partners.
A White House official told reporters on background Monday that since President Joe Biden's calls with manufacturers and retailers last week, there have been follow-ups to help determine how to get products in areas of critically-low formula supply.
That includes production and distribution from manufacturers like Abbott, the largest maker, and Rickett, Mead Johnson, Nestlé/Gerber, and Perrigo, which make the in-house brands for Amazon (AMZN) and Walmart (WMT). Those retailers and Target (TGT) have also been contacted by the president about helping with distribution to ensure supplies are reaching where they need to as well, officials said.
The White House said last week that the U.S. produces 98% of the baby formula it consumes, both for infants and for adults with certain health issues. The remainder comes from overseas including, The Netherlands, Chile, Mexico and Ireland.
In addition, two U.S. House committees have sent letters to the product makers to understand what has caused the severe shortage in addition to pandemic-related supply chain constraints. The companies have until next week to reply.
The FDA is also working on ways to diversity the infant formula supply in the U.S. going forward.
Califf said the topic will be "much discussed and needs to be considered" in light of the last few months' events.
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