A senior Food and Drug Administration official admitted that he did not see a copy of a whistleblower’s report on an Abbott Nutrition plant in Michigan for four months because it appeared to have been lost in the mail room.
The anonymous whistleblower sent the 34-page report to the FDA in October 2021, alleging a series of unsanitary conditions at the baby formula plant in Sturgis, Michigan, but Frank Yiannas, the deputy commissioner for food policy and response, said he did didn’t get their hands on it until February, according to one report.
In that four-month period, four infants had become ill and two may have died after ingesting formula manufactured at the Michigan facility.
“It wasn’t sent to me and it wasn’t communicated to me internally. How does that happen?” Yiannas admitted to the Washington Post. “There were early signals and in any security 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 whistleblower report? Who knew what and when?” Yiannas told the newspaper. “Those are going to be some of the tough questions that need to be answered.”
The complaint was lost in the mailroom, according to documents the FDA provided to a House of Representatives committee holding a hearing Wednesday on the administration’s response to the shortage.
“Printed copies addressed to these individuals were not forwarded by FDA mailrooms, likely due to issues with mail forwarding related to COVID-19,” the FDA told the House panel.
Copies of the complaint, which was mailed to Judith McMeekin, the deputy commissioner for regulatory affairs, and Janet Woodcock, the acting FDA commissioner at the time, have still not been found.
Current FDA Commissioner Robert Califf called the snafu a “technical issue” in the mailroom during a House subcommittee hearing that is now being addressed.
When asked if it was a lack of coordination or a breakdown in leadership at the FDA, Califf agreed it was “certainly about coordination.”
Yiannas acknowledged the delay in receiving a copy of the whistleblower’s complaint.
“I’m not sure why the report wasn’t shared with me and why it wasn’t escalated,” he said.
The timing of events surrounding the Abbott Nutrition plant inspections through the February plant closure is critical to understanding the Biden administration’s response to the crisis.
Parents looking for baby food to feed their children have encountered rows of empty store shelves, and the shortage has sparked bipartisan political outrage over why the Biden White House failed to anticipate problems.
“Why did the Biden administration need a rush of national media attention to act with a sense of urgency needed to address an infant formula shortage?” Rep. Morgan Griffith (R-Va.) asked at the hearing.
Califf told lawmakers early in the hearing that the FDA’s 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 — had uncovered “extremely unsanitary” conditions, including cracks in equipment, stagnant puddles of water, leaks in the roof and bacteria in several spots.
Abbott issued a massive recall of several baby formula products on Feb. 17 and closed its Michigan plant.
Califf, who was sworn in as head of the FDA the same day, said his agency had no choice but to close the facility — even though just four companies account for 90% of the market.
“We knew that shutting down plant operations would cause supply problems, but we had no choice given the unsanitary conditions,” he said.
Last week, the Biden administration invoked the Defense Production Act to give US baby formula makers access to the materials 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 food delivery as it arrived.
“I’m here today to say to parents: You are not 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 gets the formula their child needs,” she said.
Christopher Calamari, Abbott’s North American nutrition president, said Wednesday the Michigan plant will open in the first week of June, but warned the formula won’t hit store shelves for several weeks.
“By the end of June, we will ship more products in June than in January before the recall. And from there, we will continue to sustain that effort,” Calamari told the House Committee
https://nypost.com/2022/05/25/fda-official-whistleblower-report-on-baby-formula-got-lost-in-mailroom/ Baby food whistleblower report lost in mail room