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FDA and Abbott Agree On Infant Formula To Try To Make It Easier


The Food and Drug Administration reached an agreement with Abbott Laboratories on Monday on the steps needed to reopen the company’s baby food factory, which was shut down. lack of baby food This scared and infuriated parents across the country.

After the company takes steps, the FDA must approve the resumption of production at the factory in Sturgis, Mich. It has been shut down since February after several babies fell ill and two babies fell ill after consuming formula produced there. died.

Abbott described the deal with the FDA as a “consent decision” 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, with more formulas on the shelves in six to eight weeks. The company said it will continue to fly the formula from a factory in Ireland.

It was unclear when the FDA would approve the reopening of the facility.

Abbott’s facility has been offline since February, when the FDA discovered a deadly bacteria called cronobacter as it crawled in and near its production lines. Abbott disputed this characterization, saying that bacteria are found in “high maintenance” areas that indicate affinity for open crops, but need not be inside or on production lines.

The same strain of bacteria has recently caused four infant illnesses and two deaths in Minnesota, Texas and Ohio. “There is no conclusive evidence to link Abbott’s formulas with these infant diseases,” Abbott said.

As parents rushed to stockpile formula, the factory closure exacerbated an existing supply crisis. In some communities, store shelves were empty, while others were so desperate that they fed their babies oatmeal and juice, even though pediatricians said formula or breast milk was a crucial source of nutrition from birth to first birthday.

In addition to the FDA’s actions, Representative Rosa DeLauro, a Democrat from Connecticut, said in an interview Monday that she plans to introduce a bill that would ease the FDA-regulated process of importing baby food from foreign plants. She also said she plans to hold hearings in the House to review what went wrong in the process leading up to the discovery of bacteria and famines.

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

Problems at the Abbott Sturgis facility surfaced in September during the FDA’s first routine inspection there since the Covid-19 pandemic began. Investigators discovered staff working directly with the formula without waterlogging and proper hand hygiene inside the facility, according to agency documents.

The next month, a informant An official at the factory filed a complaint under the Food Safety Modernization Act, alleging that factory leaders celebrated withholding information from the FDA and removed important information from official documents.

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

The FDA and Abbott ceased production on February 17 and issued a wide-ranging recall of Abbott’s infant formula. Since then, supplies in stores have dwindled, with parents taking wild trips to find formula to feed their babies, with some turning down an offer. new or unfamiliar taste.

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

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

Dr. Califf also turned down reports about the extent of the famine. He described the events since the shutdown of production as “relatively unpredictable consequences”. He also said there are also supply numbers cited in some reports that indicate formula supplies at the moment. 56 percent of normalHe said they were “wrong” and the White House had more accurate numbers. White House officials pointed to data showing the retail research company IRI’s stock ratio close to 80 percent.

None of those numbers seemed relevant to Angela Coleman, 32, of Sacramento, who found shelves at a local Target completely free of baby food on Monday. She said the only product in stock was baby food. She drove 16 miles to a store near her parents’ house to get the last two boxes of her nine-month-old son’s preferred formula.

“Every time you see this you want to buy it because you don’t want to be at the point where you run out,” she said. Most retail outlets have placed limits on formula purchases.

Dr. Califf is expected to appear before a House Appropriations subcommittee on Thursday to answer MPs’ questions. He said in a CNN interview that the agency has nine employees focused on infant formula, with funding for four more.

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



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