Written by Kara Morris, HealthDay Reporter
WEDNESDAY, Sept. 21, 2022 (HealthDay News) — In a report released Tuesday, the U.S. Food and Drug Administration acknowledged several shortcomings in its response to infant formula shortages earlier this year.
Robert Califf, commissioner of the US Food and Drug Administration, told News agency. “That’s pretty much what happened here.”
Among the problems the report highlighted were outdated data-sharing systems, while staffing and training for food inspectors was less than usual. The agency also had a poor view of supply chains and manufacturing procedures for infant formula.
The 10-page report comes eight months after the agency closed the Abbott Infant Factory in Michigan amid safety concerns and reports of infant illness. The review was led by a senior official who interviewed nearly 60 agency employees.
Although a whistleblower attempted to warn the FDA about the problems in September 2021, the agency did not investigate until the following February.
By that time, four children were sick and two had died. The Food and Drug Administration is still investigating whether there is a relationship between these babies and the formula, and AP mentioned.
Dr. Stephen Solomon, director of the Center for Veterinary Medicine and the person who oversaw the review, told AP. “One of the actions we’ve already taken is to make sure that regardless of their access to the agency, they are categorized and escalated to the right levels of leadership.”
Mail delays were one reason the Food and Drug Administration didn’t learn about the complaint earlier, according to information the agency provided to Congress. Another was the failure to escalate the whistleblower’s allegations.
It’s possible that “inappropriate FDA processes and lack of clarity regarding the whistleblower complaint” contributed to the delay, according to the report.
Shipping problems faced by “third-party couriers” also caused delays in testing bacterial samples and the agency struggled with its ability to test for rare but potentially lethal samples. Chronobacter Bacteria that has been linked to outbreaks of infant formula.
The pandemic continues to cause more problems, the report said, both when the agency missed inspections after the inspectors were taken out of the field and also because of COVID cases among agency staff.
The US Food and Drug Administration plans to search for a new authority that will require companies to provide samples and records about manufacturing supply chains, quality and safety.
The report also called for funding from Congress to improve inspections and standards for infant formula. This will increase funding and hiring authority for new experts in the FDA’s Food Division, as well as improve technology for sharing data about FDA inspections, consumer complaints and test results.
However, Scott Faber, of the Environmental Working Group, said in a statement that the report did not go far enough.
“This internal evaluation treats the symptoms of the disease rather than providing a cure,” Faber said. “Nothing in this assessment addresses the fragmented command structure that has led to serious communication failures.”
Problems at Abbott’s factory in February caused a massive shortage of formula and led to the United States moving about 80 million bottles of formula from other countries.
More on the US Centers for Disease Control and Prevention Chronobacter .