Describing inspection findings at an infant formula plant as “shocking,” the head of the FDA on Wednesday told a U.S. House panel that the formula maker had failed, but admitted that the agency also could have done better.
The hearing with the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce found FDA Commissioner Robert Califf in the hot seat, flanked by FDA Deputy Commissioner for Food Policy and Response Frank Yiannas and Susan Mayne, Director of the FDA’s Center for Food Safety and Applied Nutrition.
Califf by far fielded most of the questions and said upfront that the Food and Drug Administration could have done a better job of handling the investigation into problems at an infant formula manufacturing plant operated in Sturgis, MI, by Abbott Nutrition.
The plant is associated with an outbreak of cronobacter illnesses that hospitalized at least four babies, two of whom died. Abbott is the maker of Similac and other brands of infant formula and has 40 percent of the U.S. infant formula market share.
The FDA got the first report of a sick baby in September 2021, but it wasn’t until January 2022 that the agency began inspections, and not until mid-February that Abbott recalled formula and closed the Sturgis plant. The recall sparked a nationwide shortage of infant formula that continues to see parents driving from store to store for hours to find food for their infants. Califf answered questions about the shortage and talked about how the recall contributed to it. But, the commissioner said, agency officials stand by the closure of the production plant, which won’t reopen until June 1 at the earliest.
“The inspection results were shocking,” Califf told the House members, adding that the FDA has had “no confidence in the cleanliness of the plant” and could therefore not allow it to reopen yet.
Califf asked the subcommittee members to imagine a house with roof leaks causing pools of water to accumulate on the kitchen floor and countertops and then imagine a roofer with dirty boots walking around in the kitchen. He said that was only part of what FDA inspectors found at the infant formula plant.
There is hope that the 700,000-square-foot plant will be able to reopen soon, but “hundreds of steps” must be taken to ensure its safety before the government can allow it to resume production of baby formula, Califf said. Some of those steps include replacing floors, repairing the roof, establishing new procedures, and training employees. The plant will also have to be completely cleaned three times, with pathogen testing done after each cleaning.
One subcommittee member, Rep. Kim Schrier agreed with Califf’s characterization of the plant.
“(The) conditions in the plant make me really worried,” she said. “It feels like corruption from the top down (at Abbott). How are you addressing it?”
Califf said the FDA is doing what it can to make sure the plant reopens safely but made a cautionary comment about the company and its officials.
“I can’t say whether there will be criminal proceedings,” the FDA commissioner said.
FDA’s response to the situation
Running alongside the questions about the condition of the production plant were questions about how and when the FDA handled the situation.
Members of the subcommittee wanted to know why it took from September 2021 until January 2022 for the FDA to begin inspecting conditions at the Abbott production plant. That timeline has been under scrutiny by individual members of Congress for months.
The FDA was conducting a routine inspection at the plant in September 2021 when a report from officials in Minnesota was filed about a baby infected with cronobacter. The baby had been fed infant formula from the plant and the opened can of formula tested positive for cronobacter, according to state officials. However, the FDA inspection team was not notified and finished their work.
Susan Mayne, director of the FDA’s Center for Food Safety and Nutrition, said there is a process that must be followed when a complaint comes in and that the final test results related to the Minnesota illness were not available until Oct. 6.
In the meantime, in September 2021, a former employee of the Abbott sent a whistleblower document to several people at the FDA reporting numerous food safety problems at the plant including many of those discovered by FDA investigators after the first of this year. The whistleblower also reported falsification of records and hiding of test results that showed contamination at the plant.
That 34-page whistleblower document was not shared with top FDA officials until months later. Mayne said she thought it was a lack of communication and coordination that led to the lag.
Frank Yiannas, Deputy Commissioner for Food Policy and Response, said he did not receive a copy of the whistleblower document until Feb. 10. When Rep. Frank Pallone Jr. asked why it took so long Yiannas said he did not know. Under questioning by Rep. Janice Schakowsky, Commissioner Califf said: “We are on the record as saying it took too long.”
One of the contributing factors to the slow movement by the FDA, according to Califf, is the fact that cronobacter infections are not “reportable” — meaning that there is no law requiring doctors to report such infections to state health agencies or for state agencies to report them to federal officials. That lack of information meant that the FDA was “flying blind” because it was not immediately known when other babies became ill.
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