FDA and Abbott reach infant formula deal to try to ease shortage

The Food and Drug Administration on Monday reached an agreement with Abbott Laboratories on the steps needed to reopen the company’s shuttered infant formula plant, which could begin to ease the infant formula shortage that has frightened and infuriated parents. in all the countries.

The FDA said it expected Abbott to restart production in about two weeks and was set to review progress at the plant in Sturgis, Michigan. It has been closed since February after several babies who had consumed formula produced there fell ill and two died.

The deal stems from a complaint from the US Department of Justice and a consent decree with the company and three of its executives. These court records indicate that the FDA found a deadly bacterium, called cronobacter, in the plant in February and that the company found more slices of the bacteria later that month.

According to the complaint, the same Sturgis plant also produced two batches of formula in the summer of 2019 and 2020 on different production equipment that tested positive for the bacteria.

Abbott staff “unwilling or unable to implement lasting corrective actions to ensure the safety and quality of foods manufactured for infants,” necessitating legal action, according to the documents.

In a statement, Abbott said “there is no conclusive evidence to link Abbott’s formulas to these childhood illnesses.”

The company said Monday that production could begin in about two weeks and could see more formulas on shelves in six to eight weeks. The company said it would continue to transport formula from a factory in Ireland.

The agreement stipulated that Abbott was to hire a qualified surveyor to oversee various improvements at the Sturgis plant.

As frustration on the side of nurseries and grocery store aisles grew, the agency embarked on a race to replenish depleted inventory that has become political fodder for Republicans against the Biden administration.

The factory 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 they gave 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 first birthday.

Susan Mayne, one of the FDA’s top food regulators, said late Monday that the agency has issued guidelines to encourage international formula makers to ship their products to the United States. She said the eased import restrictions would be in place for 180 days and the effort could take weeks to bring more products to shelves.

In addition to the FDA’s actions, Representative Rosa DeLauro, a Connecticut Democrat, said in an interview Monday that she plans to introduce a bill that would ease the process of importing infant formula from factories. foreign regulated by the FDA. She also said she plans to hold House hearings to consider what went wrong in the run-up to the discovery of the bacteria and the shortages.

“Society and the FDA need to be held accountable moving forward,” Ms. DeLauro said. She said she had requested an investigation by the Inspector General of Health and Human Services and invited Abbott to testify at a hearing set for May 25.

Problems at the Abbott Sturgis plant emerged in September during the FDA’s first routine inspection since the start of the Covid-19 pandemic. Inspectors found standing water inside the plant and staff working directly with infant formula without proper hand hygiene, according to agency documents.

The following month, a whistleblower who worked at the plant filed a lawsuit under the Food Safety Modernization Act, claiming that plant executives celebrated the withholding of information from the FDA and omitted information. key information in official documents.

The FDA returned to the plant on Jan. 31 and found lingering issues, including the presence of cronobacter bacteria near the production lines, according to agency records.

The FDA and Abbott halted manufacturing and issued a wide-ranging recall of Abbott’s infant formula on February 17. Since then, stocks have dwindled in stores, forcing parents on frantic journeys to find formula to feed their babies, some of which reject a new or unfamiliar taste.

The agency’s agreement with Abbott requires the company to notify the FDA if it discovers contamination and to store any cronobacter samples it finds for three years. Violations of the agreement could result in daily fines of $30,000 capped at $5 million per year, according to court records.

“We know millions of parents and caregivers depend on us and we are deeply sorry that our voluntary recall has exacerbated the nationwide formula shortage,” Abbott chief executive Robert Ford said in a statement. . “We will work hard to regain the trust that moms, dads and caregivers have placed in our formulas for over 50 years.”

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

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

Dr Califf also pushed back on reports of the degree of shortage. He described events since the production shutdown as “relatively unpredictable consequences”. He also said supply figures cited in some reports, which showed formula supplies at 56% 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 inventory rate was close to 80%.

None of those numbers seemed relevant to Angela Coleman, 32, of Sacramento, who found a local target’s shelves completely stripped of infant formula on Monday. She said the only item in stock was toddler formula. She drove 16 miles to a store near her parents’ house to get the last two cans of her nine-month-old son’s favorite formula.

“You kind of 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,” she said. Most retail outlets have placed limits on formula purchases.

Dr. Califf is scheduled 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 who specialize in infant formula and has received funding for four others.

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

Abbott has opened a hotline for medical professionals with urgent formula needs to make requests. The phone number is 1-877-293-9145.

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