The FDA just dropped a press release: “FDA Provides Update on Proposal for Unified Human Foods Program, including New Model for the Office of Regulatory Affairs.”  See full release below.

Well, it seems like Commissioner Califf has taken at least one of the recommendations of the Reagan-Udal Foundationand the House Appropriations Committee direction on the restructuring of the FDA.

Here is the directive from the Appropriations Committee:

Human Foods Program Restructuring.—The Committee directs FDA to unify the foods program under an expert, empowered Deputy Commissioner for Foods with full line authority over CFSAN, the food and feed-related activities of the Center for Veterinary Medicine (CVM), and all the food-related components of the Office of Regulatory Affairs, including inspection and compliance, food-related laboratories, import oversight, State partnerships, training, and information technology.

Here is the recommendation of the Foundation:

Option B: Separate Medical Products and Foods within FDA Key Changes from Current Structure: 

  • Creates both a Deputy Commissioner of Foods and a Deputy Commissioner for Medical Products and Tobacco, each with line authority over respective Centers 
  • Establishes a Chief Foods Officer within the Office of the Commissioner 

Considerations: This structure elevates the visibility of the FDA Human Foods Program within FDA and re-establishes the Deputy Commissioner structure within FDA. It reduces the direct reports to the FDA Commissioner, and includes a designated leader for Foods (and, separately, Medical Products and Tobacco) efforts. (Notably, this structure deviates from the prior Deputy Commissioner structure by including relevant food portions of ORA within the line authority of the position.) The parallel Deputy Commissioner structure is intended to indicate the equal importance of the foods and medical products mandates within FDA, although it addresses components of the Agency outside of the Panel’s charge and the Panel did not evaluate the need for a second Deputy Commissioner. The proposed Chief Foods Officer would serve, similar to the Chief Medical Officer and Chief Scientist, as an agency-wide advocate and spokesperson for the Human Foods Program, but without an operational role. 

This approach would take time to implement but may not require explicit Congressional approval; it will likely require Congressional notification. To the extent that long-term leadership can provide program stability, the structure may be limited by the relatively short tenures of Commissioners and Deputy Commissioners, when compared with the typically-longer tenure of Center Directors. Adding a Deputy Commissioner between the Commissioner and Center Directors may create challenges in retaining (and recruiting) Center Directors across the Agency due to a perceived lower stature. 

Or, perhaps I do not understand FDA speak and the changes are not a transformative as I think?

Here is the full FDA press release:

Today, the U.S. Food and Drug Administration is providing an update on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). These additions to the FDA Commissioner’s proposal announced earlier this year will further enhance coordination, prevention and response activities across the FDA, enabling the agency to better support its public health mission. 

A cross-cutting working group of agency officials with expertise in different functional and operational areas has been working over the past several months to identify additional opportunities to bolster operations within the new HFP and ORA. 

“With a human food landscape that is rapidly evolving as consumer preferences, products, and manufacturing processes grow increasingly complex and public health needs increase, the FDA must build a stronger Human Foods Program and Office of Regulatory Affairs. Earlier this year the FDA announced steps to modernize and streamline our food program, including field operations, to address these mounting challenges,” said FDA Commissioner Robert M. Califf, M.D. “Listening closely to feedback provided by employees and stakeholders, our thinking has significantly broadened. We know that in front of us is a once-in-a-generation opportunity to unify our field work with the priorities of program offices and Centers. 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 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.” 

Based on recommendations from the working group and from an external evaluation conducted by an expert panel of the Reagan-Udall Foundation, the FDA is proposing the following additional 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 (CFSAN) 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. 

These proposed changes align with many of the recommendations from the Reagan-Udall Foundation evaluation as well as a separate internal review of the agency’s infant formula response completed last year. They also empower the Deputy Commissioner for Human Foods to have full authority over, and set the strategic direction of, all foods-related resources. 

The agency is also today providing high-level organization charts to reflect the changes that are being proposed as part of the unified HFP and new ORA model. To enhance clarity around the proposed core mission of ORA, the FDA is now considering a renaming effort for this office to more appropriately align its title to the structure and functional duties of the agency’s field operations. 

“I am deeply grateful to our employees from across the agency who provided candid feedback on our proposal to date through submitted comments and more than 40 internal listening sessions. The changes proposed for Office of Regulatory Affairs today have taken this feedback into careful consideration alongside the recommendations provided through the Regan-Udall Foundation report,” said FDA Commissioner Califf. “I believe these proposed changes will result in a new structure that is more nimble, better equipped to prevent and respond to emergencies, like recalls, and enhance the agency’s ability to align inspection resources with our Center and program priorities while also supporting our employees and the public we serve. We will continue to evaluate and make adjustments as we work closely with experts throughout the agency to revamp and enhance our field operations.” 

The FDA recently began a recruitment effort to fill the position of Associate Commissioner for Regulatory Affairs who will lead ORA through the proposed changes and assist the organizational evolution as envisioned in this proposal if approved. 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. 

Well, I suppose time will tell if I am being overly optimistic.