Federal investigation is underway into the Food and Drug Administration’s compliance with policies and procedures regarding the recall and contamination of baby formula, which led to a national shortage and potentially fatal outcomes for infants.
On Thursday, the Department of Health and Human Services stated that it would review whether the FDA conducted correct inspections of Abbott’s Sturgis (Mich.) manufacturing facility. It will also examine if the FDA properly oversaw Abbott’s initation of the infant formula recall.
Abbott recalled some baby formula products in February after one of its plants was suspected to have been contaminated with Cronobacter Sakazakii. This bacteria caused four deaths and two more infants. Certain lots of Similac, Similac Alimentum, and EleCare formula products were included in the voluntary recall.
All over the country, stores were left with empty shelves of baby formula due to the recall.
Rosa DeLauro (D-Conn.) applauded the decision to investigate and called for answers from the FDA about why inspections were delayed.
DeLauro stated in a statement that “I commend OIG for taking the critical step to obtain answers as to why this unreasonable delay occurred aEUR”, especially considering that a product we feed our babies was the subject of allegations of wrongdoing.” “I hope that the OIG quickly uncovers answers to prevent this crisis from happening again.”
The Defense Production Act was invoked by the Biden administration in May to accelerate domestic infant formula production. HHS also put into place measures to increase imports of baby formula from foreign countries. Additionally, the administration issued flexibility in the WIC program (the government program that largely relies on Abbott for its contracts)
Questions remain about how government officials communicated the threat to food security and why no action was taken sooner.
Karine Jean-Pierre, White House press secretary, was unable to reveal to reporters who told President Biden about possible shortages during a Thursday afternoon briefing.
“He is briefed on many priorities. Jean-Pierre stated that he receives regular briefings from his senior White House staff. He also noted earlier that the FDA was slow to act. “I don’t know who it is.”
The communication snafus have also been overlooked in recent congressional hearings. The October whistleblower report detailing problems with food safety inspection at the Michigan plant was not received by Janet Woodcock, then acting Commissioner, and other FDA officials until February.
Robert Califf, FDA Commissioner, testified before the House Appropriations Committee that “mailroom issues” were to blame.
