From Fortune.com…
Drastic actions, like the president invoking emergency powers and calling on federal planes to fly product in from abroad, have not yet been enough to end the baby formula shortage that’s been tormenting American families since March.
According to the FDA’s commissioner, missteps at the agency over half a year ago contributed to the crisis the country is in now.
On Wednesday, Dr. Robert Califf along with other high-ranking FDA officials provided a timeline of the agency’s recent history with the baby formula industry as part of a written testimony submitted before Congress.
He said mailroom issues were partly to blame for the baby formula shortage catching the country unawares.
That timeline starts with the World Health Organization declaring COVID a pandemic on March 11, 2020. Shortly afterward, according to the testimony, the FDA identified baby formula supply chain weaknesses and submitted a legislative proposal to address them to Congress.
In late 2021, the issue began to heat up. In October, a whistleblower submitted a report to the FDA about unsanitary conditions and potential contamination at Abbott Nutrition’s Sturgis, Mich. plant. The report came alongside several reports of illness and death in children who had consumed Abbott products from the Sturgis plant, caused by a bacteria known as Cronobacter sakazakii.
The whistleblower’s mail just didn’t get delivered, Califf said.
“26 October 2021—FDA District Detroit Office receives a hard copy of a complaint from a confidential informant,” reads the testimony. “FDA leadership do not receive direct copies of the complaint due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.”
It wasn’t until February 14 that the whistleblower report reached the FDA’s then-acting commissioner Dr. Janet Woodcock, though it had cycled among other officials at the agency, who had already interviewed the informant and had begun an inspection of Abbott’s facility.
