FDA Chief Struggles to Explain Slow Response on Baby Formula |
Califf said the agency had been trying to monitor formula supplies since 2020 when COVID-related disruptions first emerged, but regulators have limited visibility into company supply chains.
The FDA planned to begin inspecting the Sturgis, Michigan, plant on Dec. 30, according to Califf's testimony. But Abbott warned that about a dozen plant employees had tested positive for COVID-19 and requested a delay. As a result, the FDA didn't begin its inspection until Jan. 31. Abbott and the FDA have reached an agreement to reopen the plant next week, under which the company must regularly undergo outside safety audits.
Senior FDA officials eventually received the complaint via email, but not until February due to “an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the FDA testimony. A mailed copy addressed to then-acting commissioner Dr. Janet Woodcock has still not been located.
Califf said the FDA requested new authorities, funding and staff to track supply chain data that could have helped get ahead of the problem, but noted Congress has not provided them.
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