FDA acknowledges shortcomings in response to infant formula shortages

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By Cara Murez HealthDay reporter


Health Day Reporter

WEDNESDAY, Sept. 21, 2022 (HealthDay News) — In a report released Tuesday, the U.S. Food and Drug Administration acknowledged numerous shortcomings in its response to the infant formula shortage earlier this year.

“For things that are critical to public health, if you don’t understand how all the pieces fit together, then you have a real problem when you hit a crisis or shortage,” said FDA Commissioner Robert Califf Associated Press. “To a large extent, that’s what happened here.”

Issues highlighted in the report included outdated data exchange systems, while food inspectors had subpar staffing and training. The agency also had poor visibility into infant formula supply chains and manufacturing processes.

The 10-page report comes eight months after the regulator closed Abbott’s Michigan infant formula plant due to safety concerns and reports of infant illness. The review was led by a senior official who interviewed about 60 agency employees.

Although a whistleblower tried to warn the FDA of problems in September 2021, the agency didn’t investigate until the following February.

By then four infants had become ill and two had died. The FDA is still investigating whether there is a link between these infants and the formula AP reported.

“Whistleblower complaints come to the agency in many different ways and from many different sources,” said Dr. Steven Solomon, Director of the Center for Veterinary Medicine and the person who oversaw the review AP. “One of the actions we’ve already taken is to ensure that regardless of whether they come into the agency, they’re triaged and escalated to the right levels of leadership.”

Postal delays were one of the reasons the FDA didn’t learn about the complaint sooner, according to information the agency gave to Congress. Another reason was the failure to escalate whistleblower allegations.

According to the report, FDA’s “inadequate processes and lack of clarity surrounding whistleblower complaints” likely contributed to delays.

Shipping issues at “third-party suppliers” caused further delays in testing bacteria samples, and the agency struggled with its testing capabilities for the rare but potentially deadly bacteria Cronobacter Bacteria linked to the infant formula outbreak.


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Even more problems have been caused by the pandemic, both as the agency missed inspections after they removed inspectors from the field and because of COVID cases among agency staff, the report said.

The FDA plans to apply for a new agency that would require companies to provide samples and records of supply chains, quality and safety of manufacture.

The report also asked for financial support from Congress to improve infant formula inspections and standards. This would increase funding and hiring skills for new experts in the FDA food department and improve technology to share data on FDA inspections, consumer complaints and test results.

Still, the report doesn’t go far enough, Scott Faber of the Environmental Working Group said in a statement.

“This internal assessment addresses the symptoms of the disease rather than offering a cure,” Faber said. “Nothing in this review addresses the fragmented leadership structure that has led to critical communication failures.”

Trouble at Abbott’s plant in February caused significant bottlenecks in infant formula and caused the United States to airlift about 80 million bottles of infant formula from other countries.


More information

The US Centers for Disease Control and Prevention has more on it Cronobacter .





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