WASHINGTON—The House Committee on Oversight and Accountability Subcommittee on Health Care and Financial Services held a hearing today titled “FDA Oversight Part 1: The Infant Formula Shortage.” At the hearing, subcommittee members asked Frank Yiannas, Former Deputy Commissioner of the Food and Drug Administration (FDA) about the FDA’s failure to respond to the infant formula crisis. Members asked Mr. Yiannas about how the FDA failed to heed to whistleblowers, respond quickly, conduct an objective review, and take ownership of the crisis.

Key Takeaways:

The FDA failed to conduct adequate inspections and ignored a whistleblower report of a Cronobacter sakazakii bacteria outbreak in Abbott Nutrition’s powdered infant formula production facility for months.

The FDA failed to conduct adequate inspections and ignored a whistleblower report of a Cronobacter sakazakii bacteria outbreak in Abbott Nutrition’s powdered infant formula production for months.

• In his opening testimony, Mr. Yiannas said, “As we all now know, FDA’s response to a series of reports of multiple infants infected with Cronobacter, along with the letter received from a whistleblower, spanned a period of several months beginning in September of 2021. It wasn’t until January 31^st of the following year – four months later – that the FDA began an official inspection of the Abbott Sturgis facility. Had the agency responded quicker to some of the earlier signals, I believe this crisis could have been averted, or at...

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