Sticking to the status quo? More change needed at the FDA

A year after the infant formula shortage shed light on major structural and governance issues plaguing the US Food and Drug Administration’s (FDA) Foods Program, the agency is dealing with another major crisis of its own: failure to enact long overdue, bold change. The unacceptable flaws that plague the foods program have not gone unnoticed, and the need for swift action is clear. But in the face of ongoing, resounding calls to implement key fixes for the Food Program’s problems, meaningful reform is still nowhere to be found – and this comes at the cost of public health and safety.

To address the issues exposed by the infant formula shortage, last year FDA announced that it was formulating a plan to redesign the Foods Program. The initial redesign plan was released by Commissioner Robert Califf earlier this year and received widespread criticism for lacking several profound changes the agency desperately needs to enhance the delivery of its food safety mission. Instead of heeding these concerns, the Commissioner’s most recent public update on the redesign plan showed he still intends to largely maintain the status quo.

“Specialised leader” required? 

Prior to the initial release of FDA’s Foods Program redesign plan, an external evaluation was conducted by an independent, expert panel at the commissioner’s request. The final report showed immediate functional enhancements could be realised by appointing a fully empowered, specialised leader or “Deputy Commissioner for Foods” with direct line authority over all key components of the Foods Program. The expert panel concluded that housing the research, policymaking, inspection and enforcement components under one food leader will boost functional efficiency and provide much-needed accountability for the Foods Program’s budget: a revolutionary structural change that will enable drastic improvements. 

But Califf’s redesign plan still doesn’t reflect the true substance of the report’s recommendations despite including some positive reforms that we appreciate. While his plan includes efforts to modernise IT (information technology) business processes, inspection workflows, compliance and other regulatory activities as a step in the right direction, these reforms are no substitute for bolder changes the Foods Program still needs.

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Instead, the Commissioner’s current plan doubles down, allocating watered-down managerial authority to the agency’s next foods leader. Rather than providing direct line authority over all foods program components, his plan leaves major foods program components under separate leaders who report directly to the commissioner himself. This means the next foods leader would forgo immediate oversight of a staggering 60 percent of the Food Program’s budget.

As a distinctive part of the agency, the Foods Program deserves a structure and leadership model tailored to its mission – not one improved in name only. We’ve already seen a splintered structure like this fail and allowing fragmentation to continue won’t deliver the full transformation the foods program needs. The FDA has attempted to assure us that the next Deputy Commissioner for foods will call the shots for the entirety of the foods program budget despite lacking formal control of all its components.

Even if this is the case, refusing to designate full direct line authority leaves the door open for an abrupt return to business as usual as soon as the current commissioner departs his role. More immediately, this structure will inhibit the FDA’s next foods leader from delivering complete budgetary transparency to funding authorisers in Congress. This may ultimately deter qualified candidates from applying to fill the role.

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Head-scratching reforms

FDA’s dismissal of warnings about the risks posed by its splintered foods program structure leaves us scratching our heads. It is unacceptable that a year after the infant formula shortage, the Commissioner isn’t aggressively pursuing larger reforms that reflect the seriousness of the situation at hand. Consumers deserve an FDA that takes every step possible to prevent known structural flaws from impeding its focus on preventing public health risks, but the current foods program redesign plan puts much-needed agency modernisation well out of reach.  

We urge the Commissioner to implement a truly revolutionary foods program redesign plan that will have a real and lasting impact instead of rejecting key recommendations from industry leaders, independent experts, members of Congress and his own employees without explanation. We need additional clarification on how the Foods Program’s redesign will be carried through and details on the remaining timeline in the search for a new deputy commissioner for foods. Failure to capitalise on this opportunity to enact bold change does a disservice to consumers and the many FDA employees who have and continue to dedicate their careers to supporting American health and safety.