The head of the Food and Drug Administration says his evolving plan to restructure the food side of the agency is moving forward with changes planned for regulatory affairs, but two key observers say the movement falls short of necessary steps to ensure the effectiveness of the reorganization.

FDA Commissioner Robert Califf this afternoon announced part of his plan to revise the agency’s organizational flow, focusing on the Office of Regulatory Affairs (ORA). Earlier this year, Califf announced he would reorganize the FDA and reinstate the position of deputy commissioner of foods.

“We know that in front of us is a once-in-a-generation opportunity to unify our fieldwork with the priorities of program offices and centers,” Califf said in his announcement.

“This is why I’m proposing a number of additional changes to ORA, including moving several of the office’s laboratories and merging its current compliance functions into those of the new HFP (Human Foods Program) and other agency product centers. These proposed changes are designed to help ensure the most strategic use of resources to meet the demands of our increasingly complex public health mission.” 

Some of Califf’s plan specifically refers to the agency’s post of deputy commissioner of foods, which will oversee all food operations and report directly to the commissioner. The food operations are currently handled by two agency administrators, with neither having responsibility for the entire food program.

As announced earlier this year, the deputy commissioner’s authority will include the Office of Regulatory Affairs, which is the focus of today’s announcement. The ORA’s core mission will be “conducting investigations, inspections, and imports for all FDA-regulated products, with assignments planned in partnership with the HFP and other product programs or centers,” according to Califf’s plan.

Two former key FDA administrators have reservations about the ORA changes.

Mike Taylor

Mike Taylor is a retired FDA deputy commissioner for foods and is now co-chairman of the board of STOP Foodborne Illness. When he was with the FDA, he led the efforts behind the Food Safety Modernization Act (FSMA), which was signed into law in 2011. Taylor says Califf’s plan falls short.

“Moving the food labs out of ORA is a positive step toward a unified foods program, but I remain concerned that FDA continues to portray ORA’s core mission in terms of the traditional reactive functions of investigations, inspections, and import screening,” Taylor told Food Safety News.  

“The food field mission certainly includes these functions but, under FSMA’s prevention model, must be so much broader. It still remains to be seen whether the deputy commissioner will have both the formal and practical authority over ORA’s leadership team and resources to shift the field focus from reaction to a holistic prevention strategy.”

As it currently stands, the FDA does not have a clear chain of command as it did when Taylor was deputy commissioner. Instead, two administrators with authority over different aspects of a food safety report to Commissioner Califf. That leaves the regulation and enforcement of food safety measures fragmented and without a clear chain of command.

Frank Yiannas

Currently, the FDA’s post of deputy commissioner for food policy and response — which was vacated earlier this year when Frank Yiannas resigned — is left to face off with the director of the Center for Food Safety and Applied Nutrition (CFSAN) when it comes to the nation’s food safety programs and the enforcement of them. 

Yiannas says that division helped slow the FDA’s response to an outbreak of illnesses among babies linked to infant formula and the subsequent infant formula shortage crisis. He was not notified of key whistleblower information as soon as the CFSAN director, even though a key part of his job description was to respond to food safety problems.

Some of the changes planned by Califf regarding the FDA’s Office of Regulatory Affairs will take the agency in the wrong direction according to Yiannas.

“While I believe today’s announcement is well-intentioned, it is not sufficiently strategic, creative, nor bold enough for the once-in-a-generation opportunity the FDA acknowledges it has at hand to modernize itself for the 21st century,” Yiannas told Food Safety News. “And it still falls short of the direction recently provided by a House Oversight committee for FDA to establish a fully empowered deputy commissioner for food with direct line authority — not only for resources — but also for the people who work on food. Therefore, I hope FDA’s thinking on this issue continues to evolve and eventually aligns with the broad stakeholder consensus on this matter. 

“Lastly, while this might get missed by many stakeholders, the transitioning of certain functions under the Office of Security and Emergency Management, currently in the Office of Operations, to ORA is deeply concerning. 

“If this group is transitioned to ORA, I hope there is no loss in the amazing functionality that exists in this group. If there’s any time that the agency cannot skip a beat, it’s in a crisis, and this group has proven itself over and over again as best-in-class at what they do.”

Nuts and bolts

Commissioner Calif is proposing the following changes: 

  • Establishing ORA’s core mission as conducting investigations, inspections and imports for all FDA-regulated products, with assignments planned in partnership with the HFP and other product programs or Centers. The new Deputy Commissioner for Human Foods will have oversight of all budget and resource allocations for the entire HFP, including ORA resources. 
  • Merging compliance functions currently managed within ORA into the HFP and the product centers’ existing compliance functions to streamline operations and expedite decision-making. 
  • Realigning the eight Human and Animal Food laboratories that are currently managed by ORA into the HFP. These eight labs will team up with the four labs in the FDA’s current Center for Food Safety and Applied Nutrition to form a unified food laboratory enterprise under the HFP. The labs will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods, who will work closely with the Chief Scientist and the Center for Veterinary Medicine (CVM) director to coordinate on research priorities. These labs will remain open and in the same geographic location under the proposal. 
  • Transitioning certain functions under the Office of Security and Emergency Management, currently in the Office of Operations, to ORA. This includes the Office of Emergency Management, which activates Incident Management Groups with augmented staffing from relevant Centers and Offices to monitor and manage coordinated responses to emergency situations, such as emergencies involving regulated products like recalls, hurricanes, fires, floods, etc. 
  • As previously shared, unifying state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP. This office will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods who will closely collaborate with the CVM director to advance a truly integrated food safety system. 
  • Reviewing support functions across ORA and proposing realignment of certain resources and personnel to support these changes. This includes staff and resources in ORA’s Office of Regulatory Management Operations, Office of Information Systems Management, Office of Training, and Office of Communications and Project Management. 
  • Prioritizing recruitment, retention and training opportunities for field-based employees with the availability of Title 21 hiring authority to support the agency’s ongoing efforts to increase its inspectional activities domestically and internationally. 

Califf says the changes are partly based on a review of the infant formula crisis this past year. He contends they would empower the deputy commissioner for human foods. 

A search for the person to be named deputy commissioner is underway. The FDA is also seeking someone to fill the new post of associate commissioner for regulatory affairs who will lead the Office of Regulatory Affairs.

“The FDA is in the final stages of the recruitment process for the Deputy Commissioner for Human Foods and will be providing an update in the near future. The FDA remains on target to finalize its reorganization proposal, for both ORA and the unified HFP, this fall,” according to Califf’s announcement this afternoon.

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