Food and Drug Administration Commissioner Robert Califf on Wednesday will answer questions from the US House about the nationwide baby formula shortage as lawmakers seek details of what led to the shortage.
According to prepared testimony from Califf, the FDA’s plans to investigate the Sturgis, Michigan, Abbott Nutrition plant associated with the shortage were stalled by a COVID-19 outbreak, scheduling conflicts and other logistical problems.
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The facility was closed in February following complaints that four babies who consumed products made by the Michigan plant became sick with a bacterial infection. Two of the babies died, although Abbott said in a recent statement that the infections are not connected to the company’s formula. The infections occurred between September and January.
Congress will hear Califf deliver the first detailed account of why it took the FDA months to probe the plant after becoming aware of potential contamination issues in the fall.
An Energy and Commerce subcommittee will also hear testimony from a top Abbott executive and two other baby formula manufacturers.
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Califf is expected to tell lawmakers his agency began preparing for a visit to the plant in early December and that inspectors were slated to arrive at the end of that month, but that Abbott had said about a dozen of its employees had recently tested positive for the coronavirus and requested a delay. The FDA did not begin its inspection until January 31 due to the setback.
The FDA shut down the facility after positive samples of bacteria were detected in different areas of the plant, and Abbott issued a voluntary recall of its baby formula in mid-February.
Abbott and the FDA have agreed to reopen the facility next week, but with the requirement that the company be subject to regular outside safety audits, but Califf’s prepared remarks suggest that the FDA’s attempts to reopen the plant were delayed because of negotiations with Abbott.
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“Because it was a negotiation process with a regulated firm, the US government did not completely control the timeline,” Califf’s testimony reads.
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An Abbott executive is planning to tell the committee that the company will invest in additional capacity and supply chain safeguards in an effort to avoid similar shortages in the future. According to the executive’s prepared testimony, the company will be able to produce more baby formula than before the recall after it resumes production next month.
The Associated Press contributed to this report.