An official with the Food and Drug Administration (FDA) claims that the reason the agency didn’t find a shocking whistleblower’s report on the baby formula shortage because the report was lost in the mailroom for at least four months.
The New York Post reports that the 34-page document had been sent to the FDA back in October, claiming that an Abbott Nutrition plant in Sturgis, Michigan was experiencing a shortage in product primarily due to increasingly unsanitary conditions. The FDA’s Frank Yiannas, Deputy Commissioner for Food Policy and Response, admits he didn’t actually see the report until February.
“It wasn’t sent to me and it wasn’t shared with me internally. How does this happen?” Yiannas said in an interview. “There were early signals and in any safety profession you want to take those seriously to stop the domino effect. That didn’t happen.”
During those four months when the report went missing, at least four infants became ill, possibly as a direct result of the conditions at the Michigan plant. The deaths of two infants is being attributed to problems with the plant in question.
“Why didn’t we act more quickly on the complaints and the whistleblower report? Who knew what when?” Yiannas continued. “Those are going to be some of the tough questions that will have to be answered.”
In testimony before the U.S. House of Representatives, the FDA tried to blame COVID-19 for the temporary loss of the whistleblower’s report.
“Hard copies addressed to these individuals were not forwarded from the FDA mailrooms,” the agency explained, “likely due to COVID-19-related mail routing issues.”
In addition to the delayed report for Yiannas, additional copies of the report that had been sent to Associate Commissioner of Regulatory Affairs Judith McMeekin, and then-acting FDA Commissioner Janet Woodcock still have not been recovered.