An Inspector General from the Department of Health and Human Services (HHS) will investigate the Biden administration’s response to the nationwide shortage of baby formula.
The ongoing formula shortage finds its roots in an Abbott Nutrition facility in Sturgis, Michigan. Last fall, the Food and Drug Administration zeroed in on the Michigan Abbott facility while tracking several bacterial infections in infants who had consumed formula manufactured by the company. The four cases being tracked by the FDA occurred between September 2021 and January 2022. Two of the infants being tracked died, and the others were hospitalized.
The FDA was scheduled to begin a series of inspections of the Sturgis-based facility, but according to Abbott, the investigation was postponed due to an outbreak of COVID-19 among the company’s employees.
Previously, Brian Deese, the director of the National Economic Council, told CNN that the Biden administration was working around the clock to “tackle the issue from every angle possible,” and that the Biden administration was aware of the impending shortage since this past February.
Deese confirmed that the Biden administration became aware of the impending shortage “when the FDA had to take its action back in February.”
In response to the Biden administration’s delayed reaction to the crisis, having not responded to the shortage until several months after it first became aware of it, HHS is going to investigate whether the FDA appropriately handled a baby formula recall from Abbott that has left shelves empty.
According to a statement from the White House, President Joe Biden invoked the Defense Production Act to “ensure that manufacturers have the necessary ingredients to make safe, healthy infant formula here at home” and launched Operation Fly Formula to “speed up the import of infant formula and get more formula to stores as soon as possible.”
Axios reported that in a prepared statement the HHS’s Office of the Inspector General said, “We will determine whether the FDA followed the inspections and recall process for infant formula in accordance with Federal requirements.”
Reportedly, the investigation will specifically look at whether the FDA’s actions preceding the February recall of potentially tainted formula from the Abbott facility in Michigan followed the correct policies and procedures when conducting inspections at the manufacturing facility in question.
The FDA is still unable to reach a conclusion as to whether the infant infections were caused by products made in the Michigan Abbott facility.