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–Helena
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Frank Yiannas resigns from FDA post
Frank Yiannas today announced his resignation as deputy commissioner for food policy and response at FDA, citing a problematic decentralized leadership structure at the agency. His last day at the agency will be February 24.
The move comes just days before FDA Commissioner Robert Califf is expected to unveil a new vision for the agency’s foods program in response to outside pressure and numerous reviews and reports finding that it is not functioning properly.
In a resignation letter addressed to Califf, which Yiannas shared via email with stakeholders and colleagues today, he throws his weight behind a growing call for the creation of a deputy commissioner role that operates as a single leader on foods.
Yiannas said in the letter that he had been thinking about leaving for nearly a year over concerns about the agency’s fractured leadership structure, but stayed to help address the infant formula crisis.
“In February 2022, as you rejoined the agency, I shared with you that I was considering leaving, expressing my concern that the decentralized structure of the foods program that you and I both inherited, significantly impaired FDA’s ability to operate as an integrated food team and protect the public,” Yiannas wrote in a letter to Califf.
“It was also in February of 2022 that I first learned of the infant formula incidents the had been reported to various parts of the FDA several months before, so I postponed this decision and dedicated myself and my staff to doing all we could to help tackle this crisis,” Yiannas wrote.
In the letter, Yiannas said that now that Abbott’s Sturgis, Mich., plant has reopened, infant formula availability has improved, and “the necessary monitoring, data systems, and insights,” to help prevent a similar disaster from happening again have been put in place, “the time is right for me to leave and vacate this position.”
Unempowered deputy commish: While Yiannas, who’s been at FDA since December 2018, technically holds a deputy commissioner title, the post has little authority and operates with a small staff. In practice, Yiannas often operated as the lead on food safety issues, while Susan Mayne, director of the Center for Food Safety and Applied Nutrition, led on nutrition, but this messy structure set up a highly dysfunctional and sometimes ugly power struggle.
This setup has meant that no one is really in charge of food at FDA, an agency that’s long been more focused on drugs and other medical products.
Backing central leader: Yiannas publicly backing a strong deputy commissioner role on his way out only increases the odds FDA will be forced to actually do this, despite internal resistance to the idea, particularly from FDA Deputy Commissioner Janet Woodcock. Food leaders remain extremely wary of Woodcock’s involvement in trying to fix the foods program because of her lack of experience on food issues, having spent most of her career in drug oversight.
In his resignation letter, Yiannas said he believes the agency “would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods.”
He also urged the commissioner to consider moving his “small, yet exceptional staff” to a newly-created office for the deputy commissioner for foods.
Reading between the lines: This line from Yiannas’ letter caught my eye: referencing the infant formula saga, he said he hopes parents “never again have to face this type of preventable situation.” But he also suggests that a truly independent review that documents the failures and how to prevent them in the future might only come from the HHS Office of the Inspector General. (I wrote here about how the agency’s own internal review lacked answers.)
“It is incumbent on any public organization that has undergone a crisis of this magnitude to undergo an independent and thorough review to understand how the crisis happened, what can be done to prevent it from happening again, and that the findings be transparently shared with the public,” Yiannas wrote. “I am grateful that Congressional leaders have demanded that this happen and that the Office of the Inspector General has initiated its own investigation.”
What’s next: As I reported yesterday, Califf is expected to unveil a new vision for the foods program Jan. 31, with more details expected in February.
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