The Food and Drug Administration (FDA) this week proposed a reorganization of its Human Foods Program (HFP), including a new model for the Office of Regulatory Affairs (ORA) as well as other additions that the FDA says “will further enhance coordination, prevent, and response activities across the FDA.”
“Listening closely to feedback provided by employees and stakeholders, our thinking has significantly broadened,” FDA Commissioner Robert Califf, M.D., said. “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 working groups and the Reagan-Udall Foundation, the FDA is proposing these following changes:
- Making ORA’s core mission to conduct investigations, inspections, and imports of all FDA-regulated products in partnership with the HFP
- Merging compliance functions from ORA into the HFP for streamlining purposes
- Realigning the eight Human and Animal Food laboratories that are currently managed by ORA into the HFP
- Transitioning some functions under the Office of Security and Emergency Management into ORA
- Unifying state and local food safety partnership functions into an Office of Integrated Food Safety System Partnerships in the HFP
- Reviewing support functions across ORA and proposing realignment of resources and personnel
- Prioritizing recruitment, retention, and training
The full FDA announcement can be found here.
