Abbott under federal investigation for baby formula: Here’s how the pharmaceutical giant got here

Abbott under federal investigation for baby formula: Here’s how the pharmaceutical giant got here

top line

The Justice Department opened a criminal investigation Friday at an Abbott Laboratories plant in Michigan for unsanitary workplace conditions at its baby formula production — the latest investigation into one of the nation’s largest baby formula makers. after the plant’s closure last year fueled a nationwide shortage.

Chronology

October 19, 2021A whistleblower who previously worked at the facility submitted a 34-page document to the Food and Drug Administration alleging lenient cleaning protocols and falsified records intended to keep the FDA in the dark about problems at the plant, which was made public by the representative Rosa DeLauro. (D-Conn.) in April 2022.

February 17, 2022Abbott Laboratories announced a recall of its products manufactured at its Sturgis, Michigan plant, including its flagship line of Similac infant formula, as well as Alimentum and EleCare, following four consumer complaints about two reported cases of bacterial infections in infants. after drinking the powder. formula (the company said it found no evidence of the bacteria in its routine testing).

February 17, 2022The FDA, as well as Canadian officials, warned parents and other consumers against using facility-made infant formula following the Abbott recall, and Canadian officials warned that formula containing Cronobacter sakazakii bacteria “may not be seen nor smell bad, but it can still make you sick.”

February 28, 2022The FDA reported that two infants were hospitalized and later died after contracting a bacterial illness from Cronobacter sakazakii after consuming the formula, saying the illness “may have contributed to the infants’ deaths.”

March 18, 2022An FDA inspection found standing water at the facility, as well as instances of employees who work directly with the formula not washing their hands thoroughly, while the company said it is working with the FDA on “corrective actions.”

April 28, 2022Abbott denied that its formula contained the bacteria following the results of routine tests it conducts before distributing the formula, saying its focus “has been, is, and always will be ensuring safe food for families.”

May 10, 2022Major retailers including CVS, Target and Walgreens limited customer purchases of baby formula as shortages across the country intensified and made worse by supply chain issues, while Abbott said it was “doing everything possible” to fix the shortage.

August 26, 2022Abbott announced it would restart production of Similac at its Michigan plant, including 8 million pounds of formula that month, and CEO Robert B. Ford acknowledged that the shortage had been “difficult for the families we serve” and called the reopening as a “major milestone”. ”

Against

An Abbott Laboratories spokesman said Forbes on Saturday, the company is “fully cooperating” with the Justice Department’s investigation, but did not provide further details on the matter. The company had previously denied any link between its products and reported deaths from infant formula, saying routine testing showed that “no Abbott formula distributed to consumers” contained Cronobacter sakazakii or Salmonella.

chief critic

In a statement last April, DeLauro criticized the FDA for waiting two months after the whistleblower released information about the facility to interview them, and for not issuing a recall until last February, four months after she said she the complainant came forward. “How many babies were fed contaminated formula during this time?” she asked.

big number

43% That’s the share of baby formula market sales made up by Abbott, according to a 2011 USDA report, with Mead Johnson, the maker of Enfamil, accounting for another 40% and Nestlé another 15%.

what to observe

Market reactions to the news of the investigation, which the Wall Street Journal first reported, citing Biden Administration officials, after markets closed on Friday night. Shares of Abbott Laboratories closed Friday at $112.82, up nearly 1% on the day, though its shares have been hit since their December 2021 high of $140.74. Abbott shares are down nearly 7 % since the withdrawal was issued, when the shares were $120.58.

Other reading

Abbott under criminal investigation for baby formula crisis (Politico)

Baby formula shortage: How safety concerns at an Abbott facility fueled a crisis (Forbes)

Justice Department Investigates Troubled Infant Formula Plant (New York Times)

Justice Department opens investigation into Abbott over baby formula (The Washington Post)

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