Letter from the Editor: An independent food safety board is far better than anything FDA Commissioner does on his own

— OPINION —

How food safety is best organized in a country this big and this populous is the question we should be asking. Instead during the past confusing year, we’ve come to focus only on the internal organization of the Food and Drug Administration.

We now know the timeline for food safety developments at FDA that captured so much attention during the past year.  We know from Frank Yiannas that before it became a media issue, the “decentralized structure” of the FDA’s food program “impaired the FDA’s ability to operate as an integrated food team and protect the public.”

Around the February 2022 confirmation of Dr. Robert Califf for his second stint as FDA Commissioner, it was Deputy Commissioner Yiannas who raised those issues and said he was quitting.

Because of the infant formula shortage and the issues FDA had pending with the nation’s largest formula plant, Yiannas agreed to stay on the job for an extra year, resigning finally as he just did on Jan. 24, 2023.

In April, Politico reminded us that both Yiannas, the deputy FDA Commissioner for Food Policy and Response, and Susan Mayne, director of the Center for Food Safety and Applied Nutrition (CFSAN), report directly to the FDA Commissioner. Mayne did not go through Yiannas as was required under the previous structure.

The report also said the two fought over how to respond to foodborne illness outbreaks, which if true likely meant that one of them would likely have to go.

As recently as when Mike Taylor was the FDA’s Deputy Commission, CFSAN reported to the Deputy Commissioner. Former FDA Commissioner Scott Gottlieb is the one who carved up the food safety structure.

Meanwhile, in July,  FDA Commissioner Califf sought an external evaluation of the U.S. Food and Drug Administration’s Human Foods Program, including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA). 

That work was conducted by an expert panel facilitated by the Reagan-Udall Foundation. A new vision for an “FDA Human Foods Program” is likely to be embraced by Califf.  Boxes on the FDA organization chart will likely make more sense than Gottlieb did.

Which is all well and good. We hope the FDA Commissioner experiences success in whatever is decided. But just as the great Waylon Jennings use to ask, we cannot help asking “If Hank would have done it this way?”

When you step back from the noise of the last year, the fact remains that food safety is a “hot mess” that needs to be cleaned up with a single, independent board.  There are examples of plenty around the world.

FDA and USDA’s Food Safety and Inspection Service would make up the bulk of this new independent agency.  Another 15 federal agencies that have niche responsibilities would round things out.

The Government Accountability Office (GAO) has been calling for a single food safety agency since 1990 or earlier.

“(The) Fragmented food safety system has caused inconsistent oversight, ineffective coordination, and inefficient use of sources,“ GAO says. Federal agencies administer at least 30 food-related areas. GAO finds several organizational structures that it believes would work better than the current system.  An independent agency is one of these options.

Others believe that the FDA, housed in the trillion-dollar Health and Human Services (HHS) Department, and  FSIS as a USDA unit are too far apart as cultures to ever be merged.

Still, there has long been bipartisan support for an independent food safety board. It ranged from the Obama and Trump OMB officials to Congressional leaders like Rep. Rosa DeLauro, D-CT, and Sen. Dick Durban, D-IL. The Congressional committee structure and complexities of food safety law are viewed as the major barriers.

But make no mistake. The single agency is the reorganization that will best serve food safety.

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