The Food and Drug Administration on Monday reached an agreement with Abbott Laboratories on the steps needed to reopen the company’s shuttered baby formula plant, which could begin to ease the shortage of infant formula that has frightened and exasperated parents nationwide.
The F.D.A. must still grant approval, once the company has taken the steps, for production to resume at the plant in Sturgis, Mich. It has been shut down since February after several babies who had consumed formula that had been produced there fell ill and two died.
Abbott described the agreement with the F.D.A. as a “consent decree” and said it would require federal court approval. Once the agency permits the plant to reopen, the company said production could begin within about two weeks and could translate to more formula on shelves in six to eight weeks. The company said it will continue flying formula in from a plant in Ireland.
It was unclear how soon the F.D.A. might approve the plant reopening.
Abbott’s plant has been offline since February, when the F.D.A. discovered a deadly bacteria, called cronobacter, while swabbing in and near production lines. Abbott disputed that characterization, saying the bacteria were found in “high care” areas that indicate proximity to open products, but not necessarily in or on the production lines themselves.
The same type of bacteria has been linked to four recent infant illnesses and two deaths in Minnesota, Texas and Ohio. Abbott said “there is no conclusive evidence to link Abbott’s formulas to these infant illnesses.”
The plant shutdown exacerbated an existing supply crisis, as parents rushed to stock up on formula. With store shelves bare in some communities, some have been so desperate they have fed their infants powdered oatmeal cereal and fruit juice, even though pediatricians say formula or breast milk is a crucial source of nutrition from birth to the first birthday.
In addition to the F.D.A.’s actions, Representative Rosa DeLauro, a Democrat from Connecticut, said in an interview on Monday that she planned to introduce a bill that would ease the process of importing infant formula from F.D.A.-regulated foreign plants. She also said she plans to hold hearings in the House to review what went wrong in the run-up to the discovery of the bacteria and shortages.
“Both the company and the F.D.A. have got to be held accountable in order to move forward,” Ms. DeLauro said. She said she had called for investigation by the Health and Human Services inspector general, and invited Abbott to testify at a hearing set for May 25.
Problems at the Abbott Sturgis plant surfaced in September during the F.D.A.’s first routine inspection there since the Covid-19 pandemic began. Inspectors discovered standing water inside the plant and personnel 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 claiming that plant leaders celebrated concealing information from the F.D.A. and omitted key information from official documents.
The F.D.A. 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 F.D.A. and Abbott shut down manufacturing and issued a wide-ranging recall of Abbott’s infant formula on Feb. 17. Since then, supplies have dwindled in stores, setting parents on frantic trips to find formula to feed their babies, some of whom reject a new or unfamiliar taste.
On Monday morning, the F.D.A. commissioner, Dr. Robert. M Califf, said on CNN that the agency was working on the supply chain to get the needed formula back on store shelves.
Navigating the Baby Formula Shortage in the U.S.
“We really do anticipate that within, you know, a few weeks we will have things back to normal,” Dr. Califf said.
Dr. Califf also pushed back on reports about the degree of the shortage. He described the events since the production shutdown as “relatively unpredictable consequences.” He also said the supply numbers quoted 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 the retail research firm IRI showing the in-stock rate at closer to 80 percent.
None of those figures seemed relevant to Angela Coleman, 32, of Sacramento, who found the shelves at a local Target completely stripped of infant formula Monday. She said the only item in stock was toddler formula. She drove 16 miles to a store near her parents’ home to get the last two cans of the formula favored by her nine-month-old son.
“You kind of want to buy it whenever you see it because you don’t want to be at that point where you run out,” she said. Most retail outlets have put limits on formula purchases.
Dr. Califf is expected to appear before a House Appropriations subcommittee on Thursday to answer lawmakers’ questions. He said in the CNN interview that the agency has nine staff members focused on baby formula and was given funds 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.”
Source : Nytimes