FDA Chief Takes Heat Over Infant Formula Shortage

Whistleblower's warning apparently languished in a mailroom
By Bob Cronin,  Newser Staff
Posted May 25, 2022 6:20 PM CDT
FDA Chief Takes Heat Over Infant Formula Shortage
Food and Drug Administration Commissioner Robert Califf testifies on video during a House Commerce Oversight and Investigations subcommittee hybrid hearing Wednesday.   (AP Photo/Kevin Wolf)

House members of both parties pressed the head of the Food and Drug Administration on Wednesday about how the infant formula crisis could have gotten this bad. "Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required to address an infant formula shortage?" asked Republican Rep. Morgan Griffith. Commissioner Robert Califf acknowledged that the agency acted slowly and gave several reasons for that, the AP reports, including a delay caused when a report apparently became lost in the agency's mailroom.

It was months before the FDA got around to inspecting Abbott Nutrition's plant in Michigan after unsanitary conditions were reported. A 34-page report was sent by a whistleblower to the FDA, per the Washington Post, but didn't reach the official in charge of food safety for four months. "It wasn't sent to me and it wasn't shared with me internally. How does this happen?" Frank Yiannas said. The FDA says a breakdown of some sort in its mailroom, as well as a COVID-19 outbreak at the plant, delayed a plant inspection. By the time inspectors arrived in Michigan, an infant who'd had formula from the plant had died, and two were hospitalized.

The FDA closed the Abbott plant on Feb. 17, and the company announced a recall. "We knew that ceasing plant operations would create supply problems, but we had no choice given the insanitary conditions," Califf told the committee. "Suboptimal" decisions by the agency contributed to the slow response, Califf conceded Wednesday. He said the FDA has sought new powers, funding, and staffing to monitor supply chain data that might have helped the agency get ahead of the problem with Abbott but hasn't received approval from Congress. "Until regulatory agencies have digital access to critical supply chain information and personnel to do the work," he said, "we'll continue to react to disruptions rather than prevent them." (Read more infant formula stories.)

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