FDA Overhaul Starts With a New Model for the Office of Regulatory Affairs
The FDA today (June 27) provided another update on its evolving plan to reorganize the food side of the agency, today focusing on a new model for the Office of Regulatory Affairs (ORA). At least two industry associations like what they see, especially references to a singular and empowered Deputy Commissioner for Human Foods.
The key changes are moving several of ORA’s laboratories and merging its current compliance functions into those of the new Human Foods Program (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,” an agency announcement said.
The long list of bullet points in the announcement (and these are verbatim):
- 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.
- 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.
The bullets also included reviewing and possibly realigning support functions and personnel across ORA and prioritizing recruitment, retention and training for field-based employees.
The FDA is in the final stages of hiring a Deputy Commissioner for Human Foods and 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.”
Several statements from Commissioner Robert Califf said the Deputy Commissioner for Human Foods will “have full authority over, and set the strategic direction of, all foods-related resources.” Most critics thought that power was diluted in the past by having two deputy commissioners with different, sometimes conflicting, responsibilities.
Two food trade associations quickly announced their support.
“Consumer Brands [Assn.] supports a Human Foods Program overhaul that will allow the FDA to move at the speed of the consumer. We are pleased the FDA is taking bolder action to make meaningful and lasting change … and fully authorize the deputy commissioner with control over its strategic direction. This includes complete authority over the budget, as well as the responsibility to execute a common mission throughout all components, including the animal foods program.”
The International Dairy Foods Assn. added, “IDFA agrees with the agency’s continued focus on breaking down silos, unifying its food program, and emphasizing that the deputy commissioner for the human foods program will be responsible for coordinating closely with the FDA lead for the animal foods program and the office of regulatory affairs.”
The agency has been providing occasional updates since Califf bowed to pressures and promised an overhaul last year. This January was his first use of the term Human Foods Program. Califf today said he will be providing an update in the near future and “The FDA remains on target to finalize its reorganization proposal, for both ORA and the unified HFP, this fall.”
