A former top Food and Drug Administration official testified Tuesday that last year's infant formula supply crisis was a “preventable tragedy,” and the Food and Drug Administration’s proposed reorganizational changes fall short of the needed overhaul to improve FDA’s ability to prevent and respond to food safety concerns.
Frank Yiannas, former FDA deputy commissioner in the Office of Food Policy and Response, departed the FDA in January in part over frustration about its leadership structure. On Tuesday, he told a House Oversight Committee hearing the current oversight system is still short of what is needed.
“The nation remains one outbreak, one tornado, flood or cyberattack away from finding itself in a similar place to that of February 17, 2022,” Yiannas said.
It took four months between the first whistleblower report and FDA’s eventual voluntary recall of potentially contaminated product with the deadly pathogen Cronobacter. “There is no question that FDA’s siloed and decentralized foods program structure and culture contributed to and exasperated these delays,” Yiannas said.
Yiannas said FDA's decentralized nature prevented the flow of critical data and information to those individuals who needed to act on it quickly. He said FDA Commissioner Robert Califf’s proposed new Humans Food Program is merely a reorganization and fails to implement a needed change in vision and strategy.
“While I believe Dr. Califf’s plan is well-intentioned, I don’t think it will completely solve the issues at hand,” Yiannas testified. Yiannas said a clear and transparent understanding of what took place leading up to the recall and the contributing factors that allowed it to occur “have remained elusive.”
As it relates to directly addressing the shortfalls that were revealed in the infant formula supply chain, Yiannas said Cronobacter sakazakii should be added to the nationally notifiable disease list. FDA released a national strategy Tuesday morning that more thoroughly evaluates the pathogen and calls for additional research to close knowledge gaps. FDA said it plans to release a long-term strategy next year with input from the National Academy of Science, Engineering and Medicine.
The plan said FDA intends to “work with federal, state and local partners to strengthen the ability of public health officials and firms to identify and investigate illnesses of Cronobacter spp. including increased genomic surveillance and supporting elevation of Cronobacter sakazakii infection among infants as a nationally notifiable disease.”
Yiannas said the state of the infant formula industry is not improved today and the public health surveillance systems for the pathogen remain “insufficient.” In addition, he said “the infant formula supply chain continues to lack serious resilience.”
Key elements of the immediate strategy laid out by FDA include expediting the review of premarket submissions for new infant formula products; developing a forecasting model to enable FDA to prepare for and mitigate future supply chain disruptions; and continuing to enhance inspections of manufacturers. Yiannas called for the reevaluation of the thoroughness and frequency of FDA inspections at infant formula manufacturers.
FDA's strategy also called for the improvement of the agency’s consumer education materials and partnerships with health care providers and professionals to expand education. Yiannas’ recommendations also called for the need to “dramatically improve consumer and physical education on the appropriate use and handling of [powdered infant formula] in hospitals and homes.”
Yiannas disagreed with Peter Lurie, president and executive director of the Center for Science in the Public Interest, who also testified at the hearing. Lurie said he believed FDA’s proposed reorganization will elevate the Human Foods Program and provides a “pretty good balance” of acknowledging the way the agency is currently structured while increasing the prominence of the foods program.
Ag and food industry stakeholders have called for the establishment of a deputy commissioner of foods at FDA with direct authority to act quickly. Yiannas said FDA’s proposed reorganization doesn’t provide this new deputy commissioner with as much authority as previous deputy commissioners once had.
Yiannas suggested a total of 11 solutions to prevent a future situation in critical foods such as infant formula, including a specific recommendation addressing the organizational issues at FDA. “Congress should address the cultural, siloed, structural and leadership issues in the FDA Food Program that contributed to a less than desirable response to this incident,” Yiannas outlined in his written testimony.
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Yiannas praised the Reagan-Udall report, which emphasized the need to address cultural issues at the agency, but argued FDA’s proposed actions fall short of what was called for in the report. “You can’t fix FDA or strengthen FDA by just doing a reorg; you also have to address cultural issues,” he told legislators.
During his time at FDA, Yiannas shared he had six different bosses, and he made each aware of the cultural and leadership structural issues at the agency.
When asked whether FDA needed more resources to more aggressively inspect facilities, Yiannas said he believes FDA can do more with the existing resources.
Rep. Lisa McClain, R-Mich., chair of the House Subcommittee on Health Care and Financial Services, said FDA is “guilty of neglecting its inspection duties” and the agency has not been held accountable.
“The FDA wants Congress to reward its negligence with more money to the tune of $372 million for not doing their job,” McClain said.
She continued that FDA is now “trying to hide behind a weak proposed restructuring plan to distract from their failure and deflect blame.”
McClain also said the subcommittee has invited FDA officials to appear in an April 19 follow-up hearing.
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