New FDA Review Details Roadmap For Infant Formula Shortage Recovery And What Went Wrong Following Initial Product Safety Reports

First, the FDA was urged to upgrade to modern data systems. The review found that the agency utilized outdated technology that lacked coordination– which may have contributed to the FDA’s delayed response to the baby formula safety complaints.

Additionally, the FDA was encouraged to “optimize its emergency response capabilities”– including the clarification of command structure– as well as “focus on industry accountability.” The recommendations ultimately reveal that the FDA needs additional authorities and resources to ensure consumer protection. And Califf claims the administration is already working on it.

“The agency has already updated some existing processes and procedures that will allow the agency to respond more quickly during a public health emergency,” he said.

Some of these “immediate changes” include streamlining how community members can contact the FDA about food product concerns and improving the FDA’s emergency response structure.

However, Califf also underscored how the FDA is not suited to tackle the baby formula shortage alone– and he called on industry leaders to review the latest report and lend a hand.

“The situation at the Abbot Sturgis facility has highlighted just how little authority the FDA has to compel many companies to ‘do the right thing’ without intervention. The long-term resiliency of the infant formula supply chain will rely on greater diversification of manufacturers,” Califf said.

This includes new stakeholders entering the U.S. marketplace and the investment in new manufacturing facilities by infant formula producers.

“I encourage those who have an interest in strengthening the U.S. food supply and supporting the agency’s ongoing efforts to read this report,” Califf added.

In the meantime, the statement underscored the FDA’s commitment to doing everything possible to avoid future shortages and ensuring that caregivers have access to infant formula. To read the FDA’s complete statement, visit the link here. Or, to view the agency review, visit the link here.

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