FDA says senior officials didn’t receive infant formula whistleblower report due to 'mailroom issues'

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. And they say a whistleblower report alleging food safety problems at the plant, which was mailed in October, did not reach the FDA’s highest rungs until mid-February, despite being sent directly to then-acting Commissioner Janet Woodcock and others.

The Abbott plant was temporarily shut down in February, after an FDA inspection in January found five different strains of a potentially deadly bacteria known as Cronobacter sakazakii, the bacteria that sickened the four infants. Two of those infants died. At the same time, Abbott also issued a recall of some formula made at the plant, exacerbating a shortage of infant formula that began during the pandemic.

The FDA now finds itself at the center of a political firestorm over the shortages, which have sent parents scrambling for alternative sources. The need is particularly acute for infants and children who rely on specialty formulas due to health conditions — a growing number of infants with special dietary needs have been hospitalized.

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.

The FDA timeline does say other FDA officials overseeing infant formula and regulatory affairs received a copy of the 34-page report last October. Mayne and Frank Yiannas, FDA’s deputy commissioner for food policy and response, will testify alongside Califf on Wednesday. As POLITICO has reported, Mayne and Yiannas do not get along and it’s created tension at the senior levels of an agency already struggling to make decisions.

But Woodcock, whom Califf assigned to help oversee the agency’s food divisions in the midst of the formula fallout, will not appear before the committee.

Senior leaders at Abbott and two other major formula manufacturers will also testify before Congress on Wednesday.

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.

“Who told staff that they could interview the whistleblower? You know what, let me step back a second, who's in charge?” DeLauro added.

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. For several months after the initial reports of bacterial infections, Califf says the FDA struggled to match formula samples to the specific bacterium, which is known to grow in infant formula and cause rare but potentially fatal illnesses in babies. A Covid-19 outbreak among the plant’s staff in early January further pushed back the inspection’s launch.

When the FDA’s inspection team finally entered the plant on Jan. 31, they “observed significant operational deficiencies,” according to the testimony.

“The totality of evidence obtained during our inspection caused FDA to conclude that infant formulas produced at this plant were produced under insanitary conditions and may be contaminated with Cronobacter,” the testimony says. When the FDA got back positive samples of Cronobacter from the January inspection, Califf says they alerted Abbott and told the company it should issue a recall.

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.

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.

The White House has also ducked questions about its own timeline in responding to the recall and ensuing shortages. Asked by POLITICO about when the FDA told the White House of the issues at the Sturgis plant and any concerns about potential shortages, a senior administration official said they would not comment on “internal communications.” “The recall became public on February 17 and we certainly have been very public about our activity in this space since then,” the official added.