The Food and Drug Administration has no plans to fire or reassign any agency employees after internal communication breakdowns helped lead to the monthslong baby formula shortage that plagued the U.S. market last year.
Commissioner Robert Califf unveiled the agency’s new “transformative vision” that seeks to modify the FDA’s internal processes and resources to ensure a more robust organization. The redesign comes in response to an external review that found a number of issues surrounding the agency’s culture, structure, and resources, Califf said.
DOJ INVESTIGATING ABBOTT LAB AFTER INFANT FORMULA SHORTAGE
As part of its new structure, the FDA will seek to modernize its data systems, provide increased resources to streamline agency communications, and improve emergency response systems.
“The proposed structures for both groups will have clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment,” Califf said in a statement.
The FDA’s announcement did not mention the agency's response to the infant formula shortage last year, but Califf told reporters during a press conference on Wednesday that he had no plans to fire any officials involved in the communication breakdowns.
The revamp of the FDA systems comes nearly a year after Abbott Labs shut down production at its formula plant in Sturgis, Michigan, due to a recall of several of its products. The federal agency issued the recall after reports of at least two infants dying from possible bacterial contamination stemming from the facility’s formula products.
The Sturgis plant temporarily halted operations for a month, causing a severe shortage of infant formula nationwide.
The FDA opened an investigation into the facility in June after reports of nine infants dying after consuming the facility’s formula. However, the agency was unable to identify a link between the facility and the source of the bacterial contamination.
Several lawmakers criticized the FDA for its handling of the shortage after it was reported that a whistleblower tried to warn the agency of problems at the Abbott facility in the fall of 2021, according to the Wall Street Journal. Officials did not respond to the warnings until months later, raising concerns that the slow response helped lead to the nationwide shortage.
The review of the agency by the Reagan-Udall Foundation found that a “lack of communication and engagement across the agency” contributed to the formula shortage.
“While it appears that staff at all levels sought to follow the rules and procedures within their division, there was little motivation, and apparently no requirement, to share information and interact across the Agency to facilitate critical thinking and proactive decision-making,” the report stated. “This is especially problematic in a crisis, where decisions should be made quickly and be vetted properly.”
In response, Califf will appoint a deputy commissioner for the Human Foods Program, which allows the agency to regulate safe and nutritious food while ensuring the agency remains updated with advancements in science, technology, and nutrition.
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The Sturgis plant was later permitted to resume production in May 2022 to ease the formula shortage. Under that deal, the facility is required to work with third-party experts to keep the Sturgis plant in proper condition.
The Justice Department said last month it would also be opening a criminal investigation into the shortage. It’s not yet clear whether that inquiry could result in charges.