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May 25, 2022

FDA's Top Official Will Acknowledge They Did Not Even Begin Discussing For the Impending Baby Formula Crisis Until Mid-February-- and Did Nothing About It Until the Last Several Weeks

The Adults Are Back in Charge, Baby.

The FDA's top official will acknowledge a string of failures that contributed to the current infant formula shortages when he faces lawmakers on Capitol Hill on Wednesday.

In their prepared testimony released Tuesday evening, FDA Commissioner Robert Califf and several senior officials for the first time lay out a timeline of the agency's response to reports last fall that infants had been hospitalized after consuming formula made at an Abbott Nutrition plant in Sturgis, Mich. ...


Up until now, however, FDA officials declined to comment on why it took months between the first report of a bacterial infection linked to the plant last September, their inspection this winter, which turned up a range of food safety problems, and the recall. But the new details aren't likely to tamp down the criticism of the agency, rather, they are already fueling further outrage from lawmakers.


"The FDA, at every step of this process, dropped the ball," Rep. Rosa DeLauro (D-Conn.), chair of the House Appropriations Committee, told POLITICO in an interview about the new details revealed in the testimony. "It put infants at risk."

The FDA timeline laid out in the prepared testimony acknowledges the FDA didn't hold interagency discussions about potential supply chain disruptions until Feb. 14, three days before the Abbott Nutrition plant at the center of the current shortages shut down and issued a formula recall. And the agency didn't notify the Agriculture Department, which oversees a critical federal nutrition program that purchases about half of the nation's infant formula, about potential disruptions until a week before the Abbott plant shut down. The program, known as WIC, serves 1.2 million infants from low-income families. Abbott supplies nearly half of all infant formula provided through WIC state contracts.

The testimony also blames "mailroom issues" for the fact that senior FDA officials, including Woodcock and FDA's top food safety official, Susan Mayne, did not receive hard copies of the whistleblower report from last October detailing alarming concerns about the Abbott plant, including poor food safety practices and that officials there had falsified documents and intentionally information from FDA inspectors. The FDA did not interview the whistleblower until December.


According to Califf's testimony, Woodcock and Mayne eventually received the whistleblower report via email from another FDA staffer on Feb. 14, three days before the recall. The agency says copies of the whistleblower report sent to Mayne and another FDA official were found in the FDA's mailroom in May, but officials have yet to locate the copy sent to Woodcock. It was "likely due to COVID-19 staffing issues" and "a mailroom analysis is underway," the prepared remarks state.

...

DeLauro was not satisfied with the agency's explanation for its slow response to the whistleblower report. "Take responsibility. If you are the director, if you are the acting director, then you have to know what the hell is going on," said DeLauro, who has criticized the FDA for allowing Woodcock to also lead the internal review of its response.

...

Califf's testimony also addresses why it took the FDA until the end of January to begin its inspection of Abbott's Sturgis plant, despite receiving warnings last fall.

...

Despite the delays detailed in the timeline, the testimony argues that FDA "since the first day...has worked tirelessly with U.S. government partners to mitigate the supply chain disruption for both regular and specialty formulas." But lawmakers have questioned why it wasn't until May 16 that the FDA and Abbott agreed on a deal to reopen the Sturgis plant.

So it was shut down for months -- with no plan for reopening it, and no plan for what would replace the supply of baby formula it was supplying.

White House and USDA officials have privately complained about the FDA's decision not to warn other parts of the administration earlier, while allowing the situation to grow into a food security crisis for American families and a political crisis for President Joe Biden, just months ahead of the November midterms.

Oh, the White House is complaining about the political aspect of it, not the fact that babies might literally die from malnutrition, or face permanent developmental losses.

Unrelated: Media "journalists" conspire with Robert Francis "Beto" O'Rourke to allow him a place at a press conference to "confront" Greg Abbott.

Obviously the "journalists" should be stripped of any official credentials and never permitted on state grounds again, and the media organizations they work for banned as well.


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posted by Ace at 06:39 PM

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