FDA official: Baby formula whistleblower report got lost in mailroom for months
A top official at the Food and Drug Administration acknowledged that he didn’t see a copy of a whistleblower’s report about an Abbott Nutrition plant in Michigan for four months because it was apparently lost in the mail room.
The anonymous whistleblower sent the 34-page report to the FDA in October 2021 alleging a number of unsanitary conditions at the baby formula plant in Sturgis, Mich., but Frank Yiannas, the deputy commissioner for food policy and response, said he didn’t get his hands on it until February, according to a report.
In that four-month span, four infants had become ill and two may have died after ingesting formula made at the Michigan facility.
“It wasn’t sent to me and it wasn’t shared with me internally. How does this happen?” Yiannas admitted to The Washington Post. “There were early signals and in any safety profession you want to take those seriously to stop the domino effect. That didn’t happen.”
“Why didn’t we act more quickly on the complaints and the whistleblower report? Who knew what when?” Yiannas told the newspaper. “Those are going to be some of the tough questions that will have to be answered.”
According to documents the FDA provided a House committee, which held a hearing on the administration’s response to the shortage on Wednesday, the complaint was lost in the mailroom.
“Hard copies addressed to these individuals were not forwarded from the FDA mailrooms, likely due to COVID-19-related mail routing issues,” the FDA said told the House panel.
Copies of the complaint sent via mail to Judith McMeekin, the associate commissioner for regulatory affairs, and Janet Woodcock, the then-acting FDA commissioner, still have not been found.
The current FDA commissioner, Robert Califf, during a hearing of the House subcommittee, called the snafu a “technical issue” in the mailroom that is now being fixed.
Asked if it was a lack of coordination or a breakdown among leadership at the FDA, Califf agreed that it was “coordination for sure.”
Yiannas confirmed the delay in his receiving a copy of the whistleblower complaint.
“I’m not sure why the report wasn’t shared with me and how it didn’t get escalated,” he said.
The timeline of events surrounding inspections of the Abbott Nutrition plant to when the facility was shut down in February is critical to understanding the Biden administration’s response to the crisis.
Parents searching for baby formula to feed their children have encountered rows of empty store shelves, and the shortage prompted bipartisan political outrage over why the Biden White House failed to anticipate problems.
“Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required to address an infant formula shortage?” Rep. Morgan Griffith (R-Va.) asked at the hearing.
Califf earlier in the hearing told lawmakers the FDA response was “too slow and there were decisions that were suboptimal along the way.”
But he said inspections of the Michigan plant — four between September 2021 and February — uncovered “egregiously unsanitary” conditions, including cracks in equipment, standing pools of water, leaks in the roof and bacteria in several locations.
Abbott issued a massive recall of several baby formula products on Feb. 17 and shut down the Michigan plant.
Califf, who was sworn-in as head of the FDA the same day, said his agency had no choice but to shutter the facility — even though only four companies account for 90% if the market.
“We knew that ceasing plant operations would create supply problems but we had no choice given the insanitary conditions,” he said.
Last week, the Biden administration invoked the Defense Production Act to allow US baby formula makers to access the material they need and launched “Operation Fly Formula” to import formula from Europe.
The first shipment arrived on Sunday and the second landed in Washington, DC on Wednesday.
First lady Jill Biden and US Surgeon General Vivek Murthy welcomed the baby formula shipment when it arrived.
”I am here today to say to parents: You aren’t alone. At the highest levels of Joe’s administration, he and his team understand what you are going through. They won’t stop until every parent can get the formula their child needs,” she said.
Christopher Calamari, Abbott’s North American president of nutrition, said Wednesday that the Michigan plant will open the first week of June, but warned that formula will not get to stores shelves for several weeks.
“By the end of June we will deliver more product in June than we did in January before the recall. And from there we’re going to continue to sustain those efforts,” Calamari told the House committee.
