Lawmaker says watchdog’s report on FDA handling of infant formula crisis confirms panel’s findings

A House Oversight subcommittee says a federal watchdog’s audit of the Food and Drug Administration’s handling of the 2022 infant formula crisis verifies the panel’s findings that the agency bungled its response.

The report by the Inspector General of the Health and Human Services Department comes two years after the FDA’s investigation into the Abbott baby formula contamination that caused nine infant deaths and triggered a nationwide formula shortage in 2022.

“The long-awaited audit by HHS’ OIG confirms findings by the House Oversight Committee that the 2022 nationwide infant formula crisis was exacerbated by dysfunction and delay within the FDA,” said Rep. Lisa McClain, Michigan Republican and chair of the subcommittee on Health Care and Financial Services.

“This audit confirms testimony by multiple former FDA officials before the subcommittee that the FDA’s failure to heed whistleblower warnings, failure to conduct adequate inspections, and slow responsiveness had serious implications,” she said.

Ms. McClain released documents obtained by the committee during a recent hearing with FDA Commissioner Robert Califf indicating that Biden administration officials knew about the infant formula shortage months before they took action.

Following the temporary closure of Abbott Nutrition in Sturgis, Michigan, a panic set in across the country when mothers sought baby formula for their infants, only to come across empty store shelves or sold-out website pages.

According to the report released last week by the HHS IG, the FDA either lacked policies or had inadequate policies and procedures to identify risks to infant formula and respond effectively through its complaint, inspection and recall processes.

The IG says the FDA had not developed an organizational structure or assigned responsibilities to handle whistleblower complaints in an efficient and effective manner, and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint.

Additionally, the FDA did not push forth an October 2021 whistleblower complaint to senior leadership, resulting in a nearly four-month delay before senior leadership was aware of the complaint.

The IG also found that the FDA did not have policies and procedures to establish timeframes for the initiation of “mission-critical inspections.”

The IG made nine recommendations to the FDA, including that it conduct better staff training on whistleblower policies, require periodic reporting to senior leaders about whistleblower complaints, and implement policies specific to the agency’s authority to recall infant formula.

The FDA, according to the IG report, agreed with the IG’s recommendations and findings that the agency had “inadequate policies and procedures or lacked policies and procedures to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes.”

The agency told the IG it 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 and that it “strongly agrees that adequate policies, procedures, and authorities are needed.”

Sen. Gary Peters, Michigan Democrat, in an effort to prevent another crisis, introduced legislation in early June called “Protect infant formula from contamination,” or the PIFCA Act.