It’s been previously reported that a whistleblower sent a complaint to the FDA in October 2021. The Journal’s reporting reveals that Abbott was aware of a whistleblower complaint eight months before. The same person, who was a former Abbott employee that was terminated in August 2020, filed the complaints both times, according to the Journal.
The Labor Department sent the February 2021 complaint to Abbott and the FDA during the same month, and Abbott submitted a response two months later, the Journal reports.
The news is the latest revelation in the Abbott baby formula saga that’s shut down the company’s Sturgis plant and contributed to a nationwide baby formula shortage. The company was able to reopen the Sturgis plant this month under strict regulatory oversight after the FDA shut down the plant in February 2022. During an inspection earlier in the year, the FDA discovered “egregiously unsanitary conditions” and the agency received complaints of infants becoming ill with a bacteria called Cronobacter sakazakii after consuming Abbott formula. The FDA opened an investigation into four hospitalizations and two deaths.
While the FDA has found evidence of Cronobacter sakazakii in the Sturgis plant, FDA Chief Dr. Robert Califf said at a May 25 hearing before lawmakers that the agency has been unable to directly link Abbott’s formulas to the reported illnesses and deaths.
Christopher Calamari, senior vice president of Abbott’s U.S. nutrition business, testified at last month’s hearing and apologized, as CEO Robert Ford also did recently. Calamari told lawmakers that Abbott is correcting conditions at the plant by improving traffic patterns and providing additional worker training to prevent future contaminations.
Abbott’s baby formula brands, including Similac, Alimentum and EleCare, are part of its larger nutrition business, which also makes adult and elder products like Ensure. Nutrition generated 19% of Abbott’s $43 billion in sales last year, making it the company’s third-largest business, after diagnostics and medical devices.
But since the recalls, Abbott’s nutrition sales have sagged. In the first quarter of this year, pediatric nutrition sales declined 20.6% to $847 million, contributing to a 7% sales decline to $1.9 billion for the nutrition segment. Analysts don’t expect nutrition to recover until at least next year. Abbott’s stock has dropped 17% since the beginning of the year.