The FDA Commissioner says the reorganization of the agency’s food side is still a work in progress, but promises it will be ready to ship to licensing entities by fall. He says he will have an “empowered” deputy food commissioner.

Commissioner Robert Califf has been under fire for almost a year to do something about the overall organization chart of the food program that has created silos of bureaucracy with no one person in charge. In addition to having a deputy food commissioner, the plan calls for the creation of another office that will report to that person, the Office of Integrated Food Safety Systems Associations.

In a follow-up report today, which came after a similarly vague report on January 31, the commissioner said definitively that there will be an “empowered” deputy food commissioner at the Food and Drug Administration. However, today’s report does not specify what exactly “empowered” means.

“For the proposed Human Food Program, a key to success will be an authorized Deputy Human Food Commissioner reporting directly to the FDA Commissioner. The agency is focused on identifying a candidate who has the experience to lead FDA’s food safety and nutrition programs (including programs aimed at preventing and responding to chemical, microbial, and other hazards),” Califf said. “The ideal candidate will have enough executive-level and real-world experience to lead the newly envisioned Human Food Program and its vast tenure. This person will also have a clear line of authority over the proposed Human Food Program, which would include existing components of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain components related to food from ORA (Office of Regulatory Affairs). . .

“To ensure that the new Human Food Program and all other FDA regulatory programs are successful, an agency-wide transformation effort is underway in how programs and field functions are organized and operated. The FDA proposal will create a new model that better integrates ORA’s company-wide expertise in field operations with product subject matter experts who are part of all of the agency’s programs. The Deputy Commissioner of Human Food and other program leaders will be charged with setting the strategic direction for food inspections and will have authority over the allocation of program resources.”

Having a deputy commissioner for food is not a new idea. It was in effect under the Obama administration, but was removed by FDA Commissioner Scott Gottlieb during the Trump administration. That change and others within the agency fragmented the operations of the FDA’s food side.

In his statement today, Commissioner Califf said the new Human Food Program and all other FDA regulatory programs will undergo a transformation. His plan calls for the Depotu Commissioner for Human Food to set strategic directions for food inspections and have authority for program resource allocations.

The plan also calls for a larger executive team to be established for the Human Food Program “to ensure decisive leadership over the vast responsibilities of the program.” This includes a Senior Associate Commissioner for Human Food position, reporting to the Deputy Commissioner, to provide strong and effective operational management of the day-to-day operations of the program. In addition, a team of executives will be created for the main areas of responsibility of the program to provide the necessary management infrastructure.

In a series of vignettes, the commissioner lays out some broad outlines of what the agency will do to achieve these goals. None of the cartoons say how or what the “empowered” deputy commissioner will be able to do.

Among the vignettes are:

• Evaluate the specific roles of ORA, CFSAN, and OFPR to unify into a new Office of Integrated Food Safety Systems Partnerships that will engage with state, local, tribal, and territorial food safety regulatory partners. The assessment will also include how best to improve connectivity with international food safety partnership programmes.
• Analyze inspection and compliance functions found in both the ORA and program offices across the agency to determine opportunities to streamline operations and clarify decision-making authority at each step of the inspection process, as well as to integrate new automation and information technology (IT) support. The new processes will allow the ORA and program staff to function as a multi-disciplinary team, eliminating sequential steps, immediately providing the best experience to resolve the issue at hand, and expediting decisions.
• Determine how best to empower the Assistant Commissioner for Human Food and other program leaders, along with the Associate Commissioner for Regulatory Affairs, to oversee program and field resource allocation, including publicly allocating budget to functional activities for provide clarity on resource allocation.

“Our proposal specifically addresses problems identified in two independent evaluations of our feeding programs, one conducted by the Reagan-Udall Foundation and an internal evaluation of the agency’s infant formula response. We have heard loud and clear that the current resource allocation and operating model between FDA regulatory programs and field operations is siled and there is too much duplication. We intend to fix this and strengthen both the regulatory programs and the field force,” Commissioner Califf said. “Both the subject matter experts in the programs and our researchers’ expertise in the field will see more interaction as part of multidisciplinary teams that have clarity about who is in charge of making decisions.”

Commissioner Califf did not specifically say when the final proposal for the reorganization of the FDA’s food side will be submitted to the Administration and go through the congressional notification process.

He said the agency is “looking to finalize its proposal this fall,” which according to the calendar technically comes in Sept. 23 and runs through Dec. 1. 23

“This process includes the development of a reorganization package that contains the newly designed structure, an established budget, and detailed mapping and cross-staffing from the current to the new organization,” according to Califf. “The package then undergoes extensive review and approval by the leadership of the FDA, the Department of Health and Human Services, and the Office of Management and Budget, before advancing to Congress for a 30-day notice period in where members can raise any concerns that FDA may need to address FDA will subsequently issue a Federal Registration Notice, notify and engage, as necessary, in negotiations with unions for affected staff, prior to the start of the new proposal. FDA will continue to engage with stakeholders throughout this process.”

Bill Marler, a Seattle food safety lawyer and advocate for 30 years, is not impressed with the so-called plan laid out by Commissioner Califf.

“The Commissioner and current FDA leadership have essentially ignored the work of the Reagan-Udall Foundation. I’m not even sure why they asked for the panel’s opinion if they were just going to ignore the call for a stronger head of food safety and human nutrition,” Marler said.

“The current FDA commissioner and leadership are also ignoring the call for a change in culture that enables disasters like the infant formula fiasco, continued outbreaks of foodborne illness, and complete ignorance of the rise in obesity, diabetes and heart disease caused by food.

“The last paragraph of the statement says it all: the proposal must go through the leadership of the FDA, HHS, OMB, the White House, and then Congress; this is designed to never be done. That’s why it’s time to separate food from the FDA.

“Take the F out of the FDA.”

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