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An Abbott whistleblower tried to alert the FDA of a baby formula shortage 4 months before crisis—the mail wasn’t delivered

May 25, 2022, 9:11 PM UTC

Drastic actions, like the president invoking emergency powers and calling on federal planes to fly product in from abroad, have not yet been enough to end the baby formula shortage that’s been tormenting American families since March.

According to the FDA’s commissioner, missteps at the agency over half a year ago contributed to the crisis the country is in now.

On Wednesday, Dr. Robert Califf along with other high-ranking FDA officials provided a timeline of the agency’s recent history with the baby formula industry as part of a written testimony submitted before Congress.

He said mailroom issues were partly to blame for the baby formula shortage catching the country unawares.

That timeline starts with the World Health Organization declaring COVID a pandemic on March 11, 2020. Shortly afterward, according to the testimony, the FDA identified baby formula supply chain weaknesses and submitted a legislative proposal to address them to Congress.

In late 2021, the issue began to heat up. In October, a whistleblower submitted a report to the FDA about unsanitary conditions and potential contamination at Abbott Nutrition’s Sturgis, Mich. plant. The report came alongside several reports of illness and death in children who had consumed Abbott products from the Sturgis plant, caused by a bacteria known as Cronobacter sakazakii

The whistleblower’s mail just didn’t get delivered, Califf said.

“26 October 2021—FDA District Detroit Office receives a hard copy of a complaint from a confidential informant,” reads the testimony. “FDA leadership do not receive direct copies of the complaint due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.” 

It wasn’t until February 14 that the whistleblower report reached the FDA’s then-acting commissioner Dr. Janet Woodcock, though it had cycled among other officials at the agency, who had already interviewed the informant and had begun an inspection of Abbott’s facility.

Because of the reports of illness and death, Abbott voluntarily recalled its Sturgis-produced formula products and shut down the plant for its own internal investigation on February 17.

One plant shutdown makes a huge impact

With the baby formula industry dominated by only three major players—Abbott, Mead Johnson, and Nestlé—closing just the one facility and recalling its products had an immediate and devastatin domino effect. With Abbott products like Similac nowhere to be found, consumers scrambled to buy anything they could from limited other brands.

The FDA identified several health and safety compliance issues during its own inspection of the Sturgis facility, which it did not complete until mid-March: “The totality of evidence obtained during our inspection caused FDA to conclude that infant formulas produced at this plant were produced under unsanitary conditions and may be contaminated with Cronobacter.”

As a result of those findings, Abbott’s facility remains shut down, pending court approval of a settlement between the company and the FDA submitted last week. But even after reopening, it could take weeks before its products are available.

“From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves,” the company said in a press release.

Without formula coming from the plant, the FDA has been working with other major manufacturers, including Mead Johnson and Nestlé, to increase their own production. The agency has also loosened restrictions for foreign formula products to enter the U.S. 

Meanwhile, President Joe Biden invoked the Defense Production Act (DPA) and initiated Operation Fly Formula last week to further alleviate the shortage. The former is aimed at easing supply chain bottlenecks as production speeds up among all manufacturers, while the latter is set to bring in foreign formula using federal planes.

A $28 million emergency resource package for the FDA passed the House last week but remains stalled in the Senate. The bill is aimed at addressing the current shortage while equipping the agency to take steps to avoid similar debacles in the future.

“I have no problem faulting the FDA for what they have done, but we cannot compound the problem by not providing resources in this moment for much needed inspection personnel,” said Sen. Rosa DeLauro (D-Conn.), chair of the House Appropriations Committee, at a second hearing on Wednesday.

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