In April, we reported that a former employee at Abbott Nutrition sent a detailed complaint to the US Food and Drug Administration (FDA) months before they took their baby formula off the shelves. The whistleblower sent the complaint in either September or October 2021, and Abbott initiated its recall in February 2022. Now, the FDA has finally responded about the complaint.
An FDA top official, Commissioner Robert Califf, will be questioned Wednesday by a House committee about its actions and inactions that led into the current crisis where American parents have not been about to find baby formula on store shelves, reports Politico.
The FDA prepared what it will say, releasing its statement a day ahead of the hearing. Regarding the whistleblower’s complaint, the FDA leader said that the whistleblower’s complaint didn’t get to top officials at the FDA due to “mailroom failures.” This, despite it having been “sent directly to then-acting Commissioner Janet Woodcock and others,” reports Politico.
Politico reports that the prepared FDA statement states that the FDA shut down Abbott Nutrition’s Michigan plant in February due to contamination. Then the prepared statement gives the “first detailed account of why it took [Califf’s] agency months to inspect the plant after learning of potential problems as early as September.”
This is the first time the FDA has commented as to why it took them months from the first notification about contaminated and potentially deadly formula it received in September or October, the FDA’s first inspection of the Abbott plant on the last day of January, and the baby formula recall and plant shut down in February.
ABC News reports that the FDA claims it “began planning to visit the Sturgis, Michigan, plant in early December, with inspectors set to arrive on Dec. 30. But Abbott said that about a dozen of its employees had recently tested positive for COVID-19 and requested a delay. As a result, the FDA didn’t begin its inspection until Jan. 31.”
Speaking about the whistleblower report from last fall, the FDA statement says “several FDA staffers reviewed the complaint in late October, but officials didn’t request an interview until early December. Because of conflicts with the whistleblower’s schedule, the interview didn’t take place until Dec. 22,” reports ABC News. ABC News further reported that the prepared statement says that “Senior FDA officials eventually received emailed copies of the complaint, but not until February due to “an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the prepared remarks. A mailed copy addressed to then-acting commissioner Dr. Janet Woodcock has still not been located.”
A Twitter user’s response to the FDA’s excuses: “Another federal bungle by the Biden administration. Unsurprising[.]”
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You know what this sounds like? It sounds like a big cluster and a lot of lame excuses for incompetency all around. This at the expense of our tiniest citizens and their parents who can’t find the food they need to feed them. How should the FDA be held accountable?
