Staff Reports
A congressional subcommittee found that a recent audit of the Food and Drug Administration’s response to the 2022 infant formula crisis confirmed their earlier concerns that the agency mishandled the situation. The Inspector General of the Health and Human Services Department produced the report two years after the FDA’s investigation into the Abbott baby formula contamination, which led to nine infant deaths and a nationwide formula shortage in 2022.
The subcommittee, led by Rep. Lisa McClain, a Michigan Republican, stated that the audit supported their previous findings about dysfunction and delay within the FDA during the crisis. They also released documents obtained during a hearing indicating that Biden administration officials were aware of the infant formula shortage months before taking action.
Rep. Lisa McClain says watchdog’s report on FDA handling of infant formula crisis confirms panel’s findingshttps://t.co/RPvDWv1Ugk pic.twitter.com/YJHvD1rWY0
— The Washington Times (@WashTimes) June 18, 2024
The HHS Inspector General’s report highlighted several shortcomings in the FDA’s handling of the crisis, including lacking or inadequate policies and procedures to identify risks to infant formula and respond effectively. The report also pointed out that the FDA failed to handle whistleblower complaints efficiently and take timely action on inspection and recall processes. The Inspector General made nine recommendations to the FDA to address these issues.
In response, the FDA acknowledged the inadequacies in its policies and procedures and agreed with the Inspector General’s recommendations. Meanwhile, Senator Gary Peters, a Michigan Democrat, introduced legislation to prevent similar crises in the future, known as the “Protect Infant Formula from Contamination” (PIFCA) Act.
The report and subcommittee findings reflect the ongoing concerns about the FDA’s response to the infant formula crisis, and the proposed legislation suggests a bipartisan effort to prevent similar incidents from happening in the future.
