The FDA announced its initial strategy to boost and strengthen the management of the country's supply of infant formula.
came just ahead of a hearing of the House Oversight and Accountability Committee about what went wrong during last year's infant formula shortage.
"The nation remains one outbreak, one tornado, flood or cyberattack away from finding itself in a similar place to that of February 17, 2022." "Clearly, I really wish, and I should have been notified sooner, so I could have initiated containment steps earlier. Had that happened, I believe we might not be here today," Yiannas said Tuesday. "Had the agency responded quicker to some of the earlier signals, I believe this crisis could have been averted or at least the magnitude lessened."
The agency said it will work with the industry on redundancy risk management plans that will help companies identify possible supply chain problems. It will also continue to enhance inspections of infant formula plants by expanding and improving training for agency investigators. The new strategy is just a first step; the long-term strategy is expected to be released in early 2024.
One positive development that came out of the crisis is that manufacturers are reporting formula volume to the FDA on a weekly basis even though there is no legal requirement to do so, he said.
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