The U.S. Food and Drug Administration listed more than a dozen factors that contributed to the national infant formula shortage earlier this year, but it stopped short of blaming a single individual or agency.
An internal review of how the agency handled the crisis cited a lack of training and outdated information technology as two of the 15 reasons behind the severe shortage of infant formula. The report said it was unable to find “a single measure” to explain why the formula crisis occurred.
The internal review was conducted by Stephen M. Solomon, director of the FDA’s Center for Veterinary Medicine, who said in a statement that he identified five key areas that need in his review: Development of information technology for sharing data during emergencies. modernization of personnel, training and equipment; updated emergency response systems; assessment of the infant formula industry; And a better scientific understanding of cronobacter – the bacteria that caused the deficiency.
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Solomon said other factors that led to the formula crisis — such as the limited number of formulation manufacturers and issues with the ingredient supply chain and product distribution — need to be addressed outside the Food and Drug Administration.
“Simply put, if the FDA is expected to do more, it needs more,” Solomon said in a statement. “While the agency is assessing workforce needs related to infant formula regulation and monitoring, we recommend that the appropriations process be used to help secure the necessary authorities and resources.”
In February, infant formula manufacturer Abbott began a voluntary recall after consumers reported cases of strep, a bacterial infection particularly dangerous to infants, in products manufactured at a facility in Sturgis, Michigan. Shortages forced parents to search for formula, markets and retail stores, as stores struggled to keep up with demand.
Abbott said in a press release in August that it has resumed production at the Sturgis facility, and that products should begin shipping in late September or early October.
The FDA also acknowledged in its findings that it – and other federal agencies – “do not have the authority, expertise, or resources to manage critical supply chain and food product shortage issues.” In order to address this, Solomon recommends government work with federal agencies to define roles and responsibilities for managing critical food product supply chains.
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