Abbott Laboratories reached a pact with U.S. authorities that would allow it to begin making baby formula again at a troubled plant in Michigan, a move that could help ease a supply shortfall that has rattled many parents.
Under the terms of the agreement, which was filed on Monday by the Justice Department in a federal court in Michigan, Abbott must take steps prescribed by the Food and Drug Administration to assure it can safely make formula.
The plant has been shut since February after four children who had been fed formula made there were sickened by cronobacter bacteria, and two died. No further cases of children being sickened by formula have since been reported, according to the Centers for Disease Control and Prevention.
Abbott said its products are not to blame for the illnesses and deaths. Top FDA officials said on a call with reporters Monday evening it was too early to tell.
The agreement is still subject to the approval of the court, the FDA said in a statement. Abbott must meet the agency’s food standards, among other measures, when it decides to resume production, the agency said.
The shutdown of Abbott’s plant helped make an already-existing shortage of baby formula much worse, and the crisis has intensified in recent weeks, with stores seeing inventories exhausted by panic buying. Top state and federal law-enforcement officials say they are on the lookout for price gouging.
Growing attention to the shortage has caused the Biden administration to step up efforts to untangle it. In addition to the accord with Abbott, the FDA laid out standards for importing formula made by overseas companies on Monday. And the White House has also vowed to help smooth logistics to get formula back on shelves faster.
At the same time, Republicans are seizing the issue to dial up pressure on the president. Top GOP lawmakers on the House Energy and Commerce Committee on Monday pushed the panel’s Democrats' call for FDA Commissioner Robert Califf to testify about the shortage.
It’s unclear how much restarting the Abbott plant will do to ease the wider deficit of formula. Before the shutdown of the facility in Sturgis, Michigan, Abbott and competing formula makers including Nestle SA’s Gerber and Mead Johnson were having difficulties in their supply chains they attributed to the effects of the COVID-19 pandemic.
Meanwhile, Gerber has increased the amount of its formula available for sale in the U.S. by 50% in March and April, the FDA said, while Mead Johnson owner Reckitt Benckiser Group Plc has boosted its supplies by 30% so far this year.
The FDA said Monday it’s moving on other fronts to increase the supply of formula, and would shortly take further steps that would make it easier to import it. The agency published a guidance document late Monday that lays out information it needs from manufacturers who haven’t previously been cleared by the agency before their products can be sold in the U.S.
“We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants,” Califf, the FDA commissioner, said in a statement.
Abbott said in a statement that it could resume work at the plant within two weeks. It said it would first begin making EleCare, Alimentum and metabolic formulas, and then resume production of the widely used Similac and other formulas. From the time the plant is reopened, Abbott said it will take six to eight weeks for product to become available in stores.
Larry Biegelsen, an analyst at Wells Fargo, wrote in a note to clients that since Abbott had indicated that it had already begun to take corrective steps, “we expect FDA approval to restart the plant in the next few weeks.”
Califf said the agency agrees that Abbott’s timeline of two weeks to restart production is “reasonable.”
The agreement forces Abbott to hire an outside expert who will ensure any actions that the company takes comply with FDA standards. It also outlines stepped-up environmental testing and tracking that could detect cronobacter bacteria at the plant, and puts in place immediate shut-down procedures if cronobacter is found in finished formula.
The expert is also tasked with reviewing the violations the FDA found during an inspection at the Abbott plant earlier this year and verifying the company has addressed the issues found by inspectors.
FDA inspectors spotted the potential for formula made at the plant to become contaminated during an inspection in September. Abbott said on Monday that regulators found “no conclusive evidence” of a link during their investigation.
The company specifically pointed to the fact that sequencing of available cronobacter strains hasn’t been able to match the ones found in patient samples from two sickened infants and those found in Abbott’s plant where FDA inspectors identified five different strains of the bacteria.
“We had multiple strains of cronobacter that were isolated in the environment from the Sturgis plant so there certainly is possibility that other strains that we didn’t detect at time of inspection were in there,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition.
Abbott said it has been working to implement improvements and corrective actions, including better education, training and safety procedures as well as updated protocols for water, cleaning and maintenance.
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