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Blumenthal Calls on HHS Inspector General to Investigate Previously Unreported Infant Deaths as Part of FDA Review

“The FDA didn’t do any disclosure until a year after the whistleblower report, and we’re just now learning the dimensions of this disaster,” said Blumenthal at a Senate hearing today

[WASHINGTON, D.C.] – Amid alarming reports that illnesses and deaths related to the infant formula recall were higher than originally disclosed, U.S. Senator Richard Blumenthal (D-CT), Chair of the Senate Commerce, Science, and Transportation Subcommittee on Consumer Protection, Product Safety, and Data Security, called on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) to investigate previously unreported infant deaths as part of its ongoing review of the Food and Drug Administration’s (FDA) actions related to the contamination and ongoing nationwide formula shortage.

“More information has come to light that necessitates a special review from the Office of the Inspector General,” wrote Blumenthal to HHS Inspector General (IG) Christi Grimm, citing documents showing nine children have died, an increase over the two deaths that were originally reported. “I remain concerned about the FDA’s failure to adequately track the illnesses and deaths linked to the formula, and failure to be transparent with the public. I would ask that throughout your investigation into the recall…you pay special attention to the circumstances that led to these additional infant deaths, and why they were not originally reported by the FDA.”

Blumenthal raised additional concerns about possible health and safety implications that may arise from FDA efforts to allow increased and expedited imports, especially as the FDA’s relevant office remains small and underfunded. In today’s letter, Blumenthal joined U.S. Representative Rosa DeLauro (D-CT) in calling for an additional investigation into how applications are reviewed and accepted.  

“I am concerned that with the pressure to restore stock and approve products, warning signs could be missed,” wrote Blumenthal to Grimm. “It is essential that, while addressing this urgent crisis, we do not put more infants at risk…While we focus on getting formula on shelves, we must also focus on ensuring enforcement discretion is applied in an organized and safe manner with the health and safety of all infants and families at the forefront.” 

At a Senate Judiciary Antitrust Subcommittee hearing earlier today titled, “Baby Formula and Beyond: The Impact of Consolidation on Families and Consumers,” Blumenthal echoed these concerns, saying:

“What outrages me most here is in fact the Food and Drug Administration’s delay in catching this problem,” said Blumenthal. “We’re just getting the truth and it’s coming to us literally a year after, more than a year after the first whistleblower report in February 2021… The FDA failed to act. It betrayed its trust.”

The full text of the letter can be found here.