FDA and Abbott Reach Baby Formula Deal to Try to Ease Shortage

The Food and Drug Administration reached an agreement Monday with Abbott Laboratories on steps needed to reopen the company’s shuttered baby formula plant, which could begin to ease an infant formula shortage that has scared and exasperated consumers. parents across the country.

The FDA has yet to grant approval once the company has taken steps to resume production at the Sturgis, Michigan plant. It has been closed since February after several babies who had consumed formula that had been produced there became ill and two died.

Abbott described the agreement with the FDA as a “consent decree” and said it would require federal court approval. Once the agency allows the plant to reopen, the company said production could begin in about two weeks and could translate to more formula on shelves in six to eight weeks. The company said it will continue to transport formula from a plant in Ireland.

It was unclear how soon the FDA would approve the plant’s reopening.

The Abbott plant has been out of action since February, when the FDA discovered a deadly bacteria, called cronobacter, while taking samples in and near production lines. Abbott disputed that characterization, saying the bacteria were found in “high care” areas indicating proximity to open produce, but not necessarily in or on production lines.

The same type of bacteria has been linked to four recent childhood illnesses and two deaths in Minnesota, Texas and Ohio. Abbott said “there is no conclusive evidence linking Abbott formulas to these childhood illnesses.”

The plant closure exacerbated an existing supply crisis, as parents scrambled to stock up on formula. With store shelves empty in some communities, some have been so desperate that they have fed their babies powdered oatmeal and fruit juice, despite pediatricians saying formula or breast milk is a source. crucial piece of nutrition from birth to the first birthday.

In addition to the FDA’s actions, Rep. Rosa DeLauro, a Democrat from Connecticut, said in an interview Monday that she planned to introduce a bill that would make it easier to import infant formula from FDA-regulated foreign plants. She also said she plans to hold House hearings to review what went wrong in the lead up to the discovery of the bacteria and the shortage.

“Both the company and the FDA have to be held accountable moving forward,” Ms. DeLauro said. She said she had called for an investigation by the Health and Human Services inspector general and invited Abbott to testify at a hearing scheduled for May 25.

The problems at the Abbott Sturgis plant surfaced in September during the FDA’s first routine inspection there since the Covid-19 pandemic began. Inspectors discovered standing water inside the plant and staff working directly with formula without proper hand hygiene, according to agency documents.

The following month, a whistleblower who worked at the plant filed a complaint under the Food Safety Modernization Act alleging that plant leaders celebrated withholding information from the FDA and withheld key information from official documents.

The FDA returned to the plant on Jan. 31 and discovered persistent problems, including the presence of cronobacter bacteria near production lines, according to agency records.

The FDA and Abbott shut down manufacturing and issued a wide-ranging recall of Abbott’s infant formula on February 17. Since then, supplies have dwindled in stores, sending parents on frantic trips to find formula to feed their babies, some of whom reject a new or unfamiliar flavor.

On Monday morning, FDA Commissioner Dr. Robert. M Califf, told CNN that the agency was working on the supply chain to get the necessary formula back on store shelves.

“We really anticipate that, within a few weeks, things will be back to normal,” said Dr. Califf.

Dr. Califf also dismissed reports of the extent of the shortage. He described the events since the production’s shutdown as “relatively unpredictable consequences.” He also said supply figures cited in some reports, which showed formula supplies at 56 percent of normal, were “incorrect” and said the White House had more accurate figures. White House officials pointed to data from retail research firm IRI showing the stock rate is approaching 80 percent.

Neither figure seemed relevant to Angela Coleman, 32, of Sacramento, who on Monday found the shelves of a local Target completely devoid of infant formula. She said the only item in stock was toddler formula. She drove 16 miles to a store near her parents’ house to buy the last two cans of her nine-month-old son’s favorite formula.

“You want to buy it every time you see it because you don’t want to be at that point where you run out of it,” he said. Most outlets have placed limits on formula purchases.

Dr. Califf is expected to appear before a House Appropriations subcommittee on Thursday to answer questions from lawmakers. He said in the CNN interview that the agency has nine staff members focused on baby formula and received funding for four more.

“We’re going to need more than that,” Dr. Califf said. “This is a huge part of the well-being of Americans and our most vulnerable young children, so we’re very concerned about it.”

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