The Food and Drug Administration (FDA) was dangerously slow to respond to multiple complaints about conditions at an Abbott Nutrition facility that contributed to a nationwide shortage of infant formula in 2022, according to a government watchdog. report.
The FDA did not have adequate — and in some cases completely nonexistent — policies and procedures for identifying risks to infant formula and then responding to those risks effectively, the report from the Department of Health and Services’ Office of Inspector General (OIG) concluded. Humans.
For example, it took the agency more than 15 months to follow up on a whistleblower report about dangerous conditions at the Abbott plant, first filed in February 2021.
The Department of Labor received the complaint and forwarded it to the FDA three days later, but the FDA did not identify the complaint until June 7, 2022.
“The complaint alleged that Abbott facilities engaged in practices that violated laws, regulations, and other guidance administered and enforced by the FDA,” the report said.
“At the time of the initial filing of the February 2021 whistleblower complaint, FDA did not have adequate policies and procedures in place to identify and investigate whistleblower complaints received in FDA’s dedicated email inbox.”
The agency received a second warning from the same whistleblower several months later in October 2021.
But according to the report, the FDA “has not stepped up [the October 2021] whistleblower complaint to senior leadership, resulting in a delay of nearly 4 months before senior leadership was made aware of the complaint.”
The agency ended up conducting inspections that revealed a series of problems at the factory, but it took more than 100 days from the October whistleblower complaint to inspect the factory.
During the waiting time to inspect the factory, the agency received two complaints from consumers about babies consuming formula manufactured there. One was due to illness and the other due to death, both due to cronobacter – but the formula samples were negative.
The inspection found unsanitary conditions, a leaky roof, lax safety practices and multiple strains of a bacteria that can be deadly to children.
Several children became ill and two died from a rare bacterial infection after being fed powdered formula made at the factory. But the agency was unable to definitively link the infections to the formula.
The FDA took some action during facility inspections and conducted follow-up inspections, but “more could have been done before the Abbott powdered infant formula recall,” the OIG report said.
The FDA closed the plant for several months and the company issued a nationwide recall for all brands of powdered formula manufactured at the facility, including popular brands like Alimentum, EleCare and Similac.
Just four companies are responsible for 90% of the formula market. When the Abbott plant closed, the effects rippled through a supply chain that was already strained by the pandemic, causing a nationwide shortage.
The report noted that the FDA did not have the authority to require individuals and manufacturers to provide information that might have helped the agency identify and respond to risks in providing infant formula.
“If the FDA had adequate policies and procedures and the authority to obtain information, it could have identified underlying problems at Abbott facilities and required Abbott to correct them,” the report concluded.
The FDA said it “strongly agrees that adequate policies, procedures, and authorities are necessary and that delays due to inadequate procedures are unacceptable and must be corrected.” The agency added that it agrees with all recommendations and has initiated several steps to improve policies and procedures for infant formula complaints, recalls and inspections.
This story originally appeared on thehill.com read the full story
