The head of the FDA is preparing to tell lawmakers about events that led to a months-long gap before inspecting the plant at the center of a nationwide baby formula shortage.
Michelle Saenz of Santee, Calif. buys baby formula at a grocery story across the border, Tuesday, May 24, 2022, in Tijuana, Mexico. As the baby formula shortage continues in the United States, some parents are opting to cross the border into Mexico, where the shelves are still stocked with options to feed their babies.
Members of an Energy and Commerce subcommittee will also hear from three infant formula makers, including a top executive from Abbott.FDA staff began honing in on Abbott's plant last year while tracking four bacterial infections in infants who had consumed formula from the facility. The cases occurred between September and January, causing four hospitalizations, including two deaths.
Abbott and the FDA have reached an agreement to reopen the plant next week, requiring the company to regularly undergo outside safety audits. But Califf's testimony suggests FDA efforts to reopen the plant were slowed by negotiations with Abbott, which had to be codified in a court agreement.“Because it was a negotiation process with a regulated firm, the U.S. government did not completely control the timeline,” states Califf's written testimony.
Senior FDA officials did not receive copies of the whistleblower complaint until February due to “an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the prepared remarks.Califf is the only administration official who has testified thus far on the shortage, which has become a major political liability for President Joe Biden.
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