FDA’s Delay in Addressing Baby Formula Shortage Crisis Criticized at Congressional Hearing

The recall of Similac, Alimentum, and EleCare baby formula products by Abbott Nutrition in 2022 led to a shortage of baby formula throughout the US, causing panic among parents and caregivers. The pandemic supply chain problems, extreme market concentration, and delayed response by the US Food and Drug Administration (FDA) further exacerbated the crisis.

Delayed Response by FDA Acknowledged at Congressional Hearing

According to Frank Yiannas, former FDA deputy commissioner for food policy and response, the agency failed to take timely action despite receiving a whistleblower complaint about the plant’s safety on October 26, 2021. Yiannas testified at a congressional subcommittee hearing on the infant formula crisis of 2022, held by the U.S. House of Representatives Subcommittee on Health Care and Financial Services.

Blame Placed on Abbott Nutrition

While Yiannas admitted that the FDA could have averted or mitigated the crisis if they had acted more quickly and efficiently, members of the committee put most of the blame in the hands of Abbott Nutrition. Internal mailroom problems at FDA kept the whistleblower report out of Yiannas’ hands for four months, but Abbott received an inspection report on November 10th that cited multiple violations related to quality control.

Issues with FDA’s Management Structure Highlighted

The hearing also exposed structural issues within the FDA that hampered efforts to resolve the situation. Committee Chair Lisa McClain criticized FDA Commissioner Robert Califf for ineffective management and turning a blind eye to the agency’s turmoil. Yiannas pointed out that while food safety is a priority for the agency, its food programs operate within silos without effective communication or coordinated efforts.

Suggestions for Avoiding Future Crises

Witnesses and committee members suggested several measures to prevent future crisis, including making Cronobacter infections a reportable disease and requiring manufacturers to report positive findings of bacteria in their plants. Ranking Member Katie Porter stated that everyone involved should be held accountable, including the lawmakers, the FDA, big business, and Abbott Nutrition.

FDA’s Strategy to Strengthen Infant Formula Supply

The FDA has announced its preliminary strategy to boost and strengthen the management of the US’ supply of infant formula to prevent similar crises from occurring. The proposed national strategy aims to improve communication and coordination with overseas producers, help companies identify possible supply chain problems through redundancy risk management plans, expedite review of pre-market submissions for new products, and work closely with the US Department of Agriculture to make its WIC program more resilient.

Resiliency in Infant Formula Supply Chain is Necessary

Yiannas warns that while the FDA’s new strategy is a step in the right direction, the US remains one natural disaster or cyber attack away from finding itself in a similar situation as February 17, 2022. The surveillance for the pathogen that caused the recall is still insufficient, and the infant formula supply chain continues to lack resilience. He believes that more structural changes are necessary for effective flow of information and organization of responsibilities.

In conclusion, while the FDA’s response was criticized at the congressional hearing regarding baby formula shortage crisis in 2022, it has taken some steps towards resolving these issues. However, more comprehensive strategies will be necessary to ensure adequate resiliency in baby formula supply chain for future generations.

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