The inspector general for the Department of Health and Human Services says the Food and Drug Administration's response to the 2022 infant formula crisis was seriously deficient, citing problems including inadequate or nonexistent policies and procedures. The agency says it is taking action to address the problems.
The Office of Inspector General found — as FDA itself has acknowledged previously — that the agency failed “to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes.”
The OIG also said FDA “did not have the authority to require individuals and manufacturers to provide information that may have helped FDA to identify and respond to risks to the infant formula supply."
The outbreak led to the temporary closure of an Abbot Laboratories’ production facility in Michigan and a voluntary recall of infant formula products. The plant supplied around 40% of the nation’s infant formula before the shutdown, contributing to later shortages of the product.
After the recall was initiated in February 2022, FDA recorded 148 complaints related to the Abbott facility. The crisis sparked congressional hearings, an internal FDA review, and ultimately, a reorganization of the human foods program at the agency.
The report concluded that FDA met “applicable inspection and recall processes for infant formula,” but the agency’s inadequate policies and procedures hindered its ability to find and correct the “underlying problems at the Abbott Facility.”
The report noted FDA officials did not see a whistleblower complaint about the facility that was sent to the Labor Department in February 2021 for more than 15 months. During that time, no person was permanently assigned to oversee the email inbox for whistleblower complaints; instead, those duties were handled by employees in other positions with their own duties, the report said.
When another whistleblower complaint was sent to seven FDA employees later that year, it took nearly four months for it to get to the hands of senior leadership, according to agency officials interviewed by the inspector general.
An investigator who evaluated the Abbott plant reviewed the facility's consumer complaint history before beginning his investigation, but was not alerted when the agency entered a new complaint of an infant who got a cronobacter infection after drinking formula created at the plant, the report said.
The staff who reviewed the complaint did not know the inspection was occurring at the time the complaint was submitted, the report said, adding that the agency's electronic system did not alert agency investigators when new complaints were added to the system while they conducted facility inspections, the report said.
Additionally, investigators did not know how to initiate a for-cause inspection during the public health emergency, the report said.
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The recommendations include cross-training staff on whistleblower policies and procedures, submitting regular reports to senior leadership on the status of open whistleblower complaints, creating future FDA policies to conduct timely inspections during future public health emergencies and creating policies centered around the agency’s ability to recall infant formula.
"If FDA had adequate policies and procedures, it could have identified underlying problems at the Abbott facility and required Abbott to correct them,” the report said. "Although FDA took some action during the facility inspections and conducted follow-up inspections in accordance with federal regulations and internal policies and procedures..., our audit results demonstrate that more could have been done leading up to the Abbott powdered infant formula recall."
FDA "strongly" agreed with the inspector general's findings regarding its policies and procedures, saying “delays due to poor procedures are unacceptable and must be corrected," according to the report.
FDA, however, disputed the report’s initial assessment that at least four of the reported illnesses — including two that led to infant deaths — were preventable, noting that its investigation of the outbreak found no evidence demonstrating a direct link between those cases and the Abbott facility.
The inspector general, citing FDA’s response, removed that statement, acknowledging that the laboratory analysis did not find a genetic match to the strains of cronobacter. It also noted, however, that a health hazard evaluation signed by an FDA official “supports a conclusion that this was a case series linked to a common production facility.” In addition, “timely and effective identification and response to risks is essential to protecting public health.”
The report said inspections of infant formula facilities are too predictable.
During the four years from fiscal 2019 through fiscal 2022, OIG said FDA planned to inspect 19 of “during the same two-week span of the same month annually,” the report said.
“By scheduling inspections at facilities during the same week each year, FDA is not responding to the risks that a facility could predict and prepare for an FDA inspection,” the report said. “FDA may need to formalize a policy that ensures that a manufacturer is not able to reliably predict when its annual inspections will occur."
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