Going before a congressional panel on Tuesday, former Food and Drug Administration Deputy Commissioner Frank Yiannas said the FDA waited four months to act on potentially contaminated infant formula.
The recall of Abbott infant formula in February 2022 was blamed, in part, for a massive formula shortage that made it difficult for parents to find products.
Abbott issued the recall and closed a Michigan facility after two infants died and two others were treated for cronobacter infections.
Yiannas told the House Oversight Committee that the FDA received a complaint alleging egregious conditions and practices at the Sturgis, Michigan, facility on Oct. 26, 2021.
“While FDA did conduct notifications to the company of the illness reports as they came in and did slowly take steps to follow-up on the whistleblower complaint, it wasn’t until January 31, 2022, four months later, that the FDA began an official inspection of the AN’s Sturgis facility and it wasn’t until February 10, 2022, that I personally became aware of the series complaints, the whistleblower report, and the findings from FDA’s January inspection that resulted in multiple environmental swabs being found positive for Cronobacter sakazakii in the facility,” Yiannas told the committee.
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Yiannas noted structural problems within the FDA prevented leaders like himself from becoming aware of critical incidents.
“With siloed groups in the FDA’s decentralized Foods Program, it is impossible for leaders, even leaders like me that had titles that might indicate otherwise, to have clear line of sight on what was happening or to set processes in place to help catch these critical public health concerns,” he said. “The current structure results in regular communication breakdowns, and results in the potential for food safety concerns to fall through the cracks altogether.”
With the U.S. coming out of the pandemic, supply chains were being disrupted for a number of products, with infant formula being no exception. When one plant shut down, that was enough to make it difficult to have enough supply.
“One should wonder, how does the shutdown of one of 21 infant formula plants serving the U.S. market cause such a shortage and disruption?” Yiannas said. “And what were the factors that led to the creation of such an inelastic and fragile infant formula supply chain system? The reality is that the FDA has had minimal authorities and levers to affect the system, other than the safety and nutrition standards they create and their ability to approve new market submissions in a quick manner.”
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As questioning got underway, the FDA released a new strategy to combat supply chain issues with infant formula. The strategy includes developing risk management plans, enhancing inspections, expediting product reviews and developing a forecasting model for supply shortages.
“Safety and supply go hand-in-hand. We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage. That’s why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible,” said FDA Commissioner Robert M. Califf.
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