A congressional subcommittee hearing Tuesday on the infant formula crisis of 2022 not only explored how the crisis occurred but also examined how the structure of the FDA hampered efforts to resolve the situation and how ineffective management from the top continues to plague the agency.
The hearing Tuesday before the U.S. House of Representatives Subcommittee on Health Care and Financial Services included two witnesses: Frank Yiannas, former FDA Deputy Commissioner of the Office for Food Policy and Response; and Peter Lurie, President and Executive Director for the Center for Science in the Public Interest.
Committee Chair Lisa McClain, blasted FDA Commissioner Robert Califf in her closing remarks, saying that he is “turning a blind eye that the agency is in turmoil.”
She also slammed the agency for failing to send a whistleblower report about the infant formula crisis at Abbott Nutrition’s manufacturing plant to appropriate officials in a timely manner, citing the fact that Yiannas was not made aware of the report until February 2022 even though it had been in FDA hands since October 2021.
McClain also dismissed Commissioner Califf’s recently unveiled plan to reorganize the FDA, saying “it doesn’t go far enough.”
A similar sentiment was related by many House members during the hearing, which mainly investigated the infant formula crisis that came when the detection of bacteria in an Abbott Nutrition plant shutdown operations and resulted in a massive recall in February 2022. The recall vastly worsened a shortage of infant formula, including Similac and other brands, that lasted the rest of the year.
The investigation that resulted in the finding of cronobacter bacteria in the Abbott plant in Sturgis, MI, came as the result of an outbreak of Cronobacter sakazakii infections that saw at least four babies sickened with two deaths. Although the investigators did not find the specific outbreak strain of cronobactor in the plant, they found several others in the manufacturing facility and in finished product.
Members of the committee and the witnesses alike put square blame for the crisis in the hands of Abbott Nutrition. However, the committee members asked pointed questions about how the situation could have been better handled by the Food and Drug Administration.
In his opening remarks and repeatedly during questioning Yiannas said that the four-month delay for information to reach him made the situation much worse that it needed to be.
“Problems at the FDA added to the problem,” Yiannas said. Internal mailroom problems have been blamed for keeping the whistleblower report out of Yiannas’ hands for four months.
Among the problems at the FDA were — and still are — a fractured chain of command on the food side of the agency that created silos without effective communication or coordinated efforts, said Yiannas and Lurie.
During a congressional hearing in May 2022, Commissioner Califf said there were nine staff devoted to reviewing infant formula premarket submissions for safety and
nutrition. Yiannas said Tuesday there were dozens of people working on the situation after he became aware of the problems at the Abbott facility.
An internal FDA report about the situation after the fact downplayed the problems during the infant formula crisis and the months leading up to it, according to Yiannas when he was asked about the so-called Soloman Report.
“It didn’t go far enough. It was an internal report,” Yiannas said. “(It was written) with rose-colored lenses. . . I wish I could have written that report.”
The infant formula situation
Two things that could have helped identify the problems at the Abbott infant formula manufacturing plant involve reporting. Yiannas and Lurie said: making cronobacter infections a reportable disease so public health officials know when and where babies are getting sick; and making it a requirement for manufacturers to report to the government when they find the bacteria in their plants would make huge differences.
During internal testing, Abbott found cronobacter bacteria in the Sturgis, MI, plant, but did not report it to the government. Yiannas said being able to hide under the radar in such a manner is obviously a problem. Lurie said the best place to start laying blame is with Abbott officials because they kept the test results from the FDA.
With only two states — Michigan and Minnesota — requiring that cronobacter infections be reported, the identification of problems, including outbreaks, is greatly hampered said Yiannas. He repeatedly called for the infections to be made reportable in his testimony and in written comments submitted to the subcommittee.
At this point, because of a consent decree with the federal government, only the Abbott plant in Sturgis must report positive cronobacter findings to the FDA. No other plants are under such requirements.
That consent decree is helping to keep things on track at the Abbott plant, where inspectors found what Yiannas described as “egregious” problems. Those problems included broken and worn out equipment including one piece that had been installed in the early 1960s. There was also standing water, evidence of roof repairmen walking through manufacturing areas with muddy boots and dirty clothing, and of course the cronobacter bacteria.
A major contributing factor to the infant formula supply crisis, Yiannas and Lurie said, remains today — about 50 percent of infant formula is sold through the federal WIC program which relies on state contracts. Those state-by-state contracts set up what amounts to monopolies and hampers consumers abilities to buy non-WIC approved formula when supply shortages occur. With the WIC program being under the jurisdiction of the U.S. Department of Agriculture, there is virtually nothing the FDA can do to resolve this problem, Yiannas said.
Subcommittee members asked what can be done to avoid another infant formula crisis, some wondering if money could solve the problem. Neither Lurie nor Yiannas said money is the sole solution.
Lurie said three things are needed to begin to fix the problem. The FDA needs the authority to require companies to report positive findings of cronobacter bacteria. More funding would be helpful, too, he said because the agency is operating with the same number of FTEs as it has in the 1970s. Finally, Lurie said structural changes at the agency are needed to improve the flow of information and organize responsibilities.
Yiannas, too, said more funding is needed for the food program at the Food and Drug Administration, but that may not be the biggest problem. He said agreed with a subcommittee member that the food side of the agency is an afterthought behind the drug operations.
“It takes a back seat,” Yiannas said.
Ranking Member Katie Porter was pointed in her closing remarks, saying there was enough responsibility to go around.
“No body gets a pass today, not FDA, law makers, big business, Abbott,” Porter said. “. . .(except) a pass for our witnesses.”
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