Federal investigators to audit FDA response to baby formula recall

Health

CHICAGO (NewsNation) — Federal investigators have launched an investigation into whether the U.S. Food and Drug Administration property inspected the Abbott Laboratories Michigan plant and whether the agency safeguarded the United States’ critical supply of baby formula.

The review will be conducted by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG). They’ll investigate the FDA’s actions leading to the recall that led to severe U.S. shortages.

“We will determine whether FDA followed the inspections and recall process for infant formula in accordance with federal requirements,” OIG said.

Lawmakers grilled FDA officials last week over what they saw as a lack of urgency in the agency’s response to complaints about possible baby formula contamination at the Michigan plant. 

The FDA started inspecting the plant in late January following reports of bacterial infections in babies potentially linked to Abbott’s formula.

However, experts say Abbott’s Michigan plant has issues dating back to 2021 due to cleanliness.

“Between October of last year and February of this year, there was radio silence. There was nothing communicated back to Abbott on a course of action or requirements for a course to clean up,” said Robert Kelley, a supply chain expert.

He says that’s when the FDA should have notified leadership.

“There were protocol problems caused by COVID and people not working, or working from home, and that caused part of the communication issues,” Kelley said.

On Thursday, President Joe Biden said he wasn’t notified about the issue until just weeks ago. He since invoked the Cold War-era Defense Production Act to shore up supplies, and manufacturers have been importing baby formula.

“Well, here’s the deal, I became aware of this problem some time in — after April — in early April, about how intense it was,” Biden recalled.

In February, Abbott subsequently closed the plant and recalled baby formula made there after bacterial infections were found in infants, leading to two deaths.

That deepened a nationwide shortage that left parents scrambling to feed their children, babies hospitalized and parents in sheer desperation.

“I remember going to Costco one day to find formula and I couldn’t find any at all and I remember panicking not knowing what I was going to feed him,” Hannah Frierson, a South Carolina mom, recalled.

Now it will take weeks to get the product back on the shelves.

73% of baby formula products are out of stock nationwide as of May 22, according to data firm Datasembly. The FDA said on May 19 that it expects the plant to reopen within one or two weeks.

Meanwhile, Kelley said he believes this FDA audit will lead to recommendations and ultimately improvements. The review is expected to be completed in 2023.

Reuters contributed to this report.

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