FDA admits flaws in response to infant formula shortage

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 infant formula shortages earlier this year.

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

Among the issues highlighted in the report were outdated data-sharing systems, while food inspector staff and training were below par. The agency also had a poor understanding of infant formula manufacturing supply chains and procedures.

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

Although a whistleblower attempted to notify the FDA of the issues in September 2021, the agency did not investigate until the following February.

At that time, four infants were sick and two had died. The FDA is still investigating whether there is a link between these infants and formula, PA reported.

“Whistleblower complaints come to the agency in different ways, from different sources,” said Dr. Steven Solomon, director of the Center for Veterinary Medicine and the person who oversaw the review. PA. “One of the steps we’ve already taken is to make sure that regardless of how they come into the agency, they’re sorted and escalated to the right levels of management.”

Mail delays were one of the reasons the FDA was not made aware of the complaint sooner, according to information provided by the agency to Congress. Another was the failure to escalate whistleblower claims.

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

Shipping issues experienced by “third-party delivery companies” have further caused delays in testing bacterial samples and the agency has struggled with its testing capacity for rare but potentially deadly species. cronobacteria bacteria linked to infant formula outbreak.


Still other issues were caused by the pandemic, both when the agency missed inspections after pulling inspectors from the field and also due to COVID cases among agency staff, the report said.

The FDA plans to seek a new authority that would require companies to provide samples and records on manufacturing supply chains, quality and safety.

The report also called for congressional funding to improve infant formula inspections and standards. It would increase funding and hiring power for new experts in the FDA’s food division, as well as improving 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 task force said in a statement.

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

Problems at the Abbott factory in February triggered major formula shortages and led the United States to airlift about 80 million bottles of formula from other countries.

More information

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

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