WASHINGTON—Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain (R-Mich.) today released a statement on a Department of Health and Human Services (HHS) Inspector General audit of the FDA’s handling of the 2022 infant formula crisis.

“The long-awaited audit by HHS’ OIG confirms findings by the House Oversight Committee that the 2022 nationwide infant formula crisis was exacerbated by dysfunction and delay within the FDA. This audit confirms testimony by multiple former FDA officials before the subcommittee that the FDA’s failure to heed whistleblower warnings, failure to conduct adequate inspections, and slow responsiveness had serious implications. We are going to continue to use the tool of oversight to ensure that the FDA implements the recommendations in this report, makes necessary adjustments to their policies and procedures, and finally holds affiliated parties accountable” said Subcommittee Chairwoman McClain.

Subcommittee Chairwoman McClain revealed documents obtained by the Committee during a recent hearing with FDA Commissioner Califf that the Biden Administration know about the infant formula crisis months before they took action.

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