FDA updates on proposed foods reorganization, shifting some of ORA’s functions
The US Food and Drug Administration (FDA) on Wednesday offered updates on a major proposed reorganization that would establish a new unified Human Foods Program (HFP) and a shift in the mission of the Office of Regulatory Affairs (ORA), which will soon solely focus on three core functions: overseeing investigations, inspections and imports for all FDA-regulated products.Speaking on a call with stakeholders in March, FDA Principal Deputy Commissioner Janet Woodcock said the agency plans to submit a package for the proposed reorganization to the Department of Health and Human Services (HHS) in the fall, and the agency hopes to implement the reorganization some time in 2024. (RELATED: Woodcock: Pending ORA reorg will modify things significantly for all FDA regulated products, Regulatory Focus 23 August 2023)
As part of the food program overhaul, FDA announced the hiring of James “Jim” Jones as the first deputy commissioner for human foods to oversee the effort. The agency is currently recruiting candidates to serve as Associate Commissioner for Regulatory Affairs (ACRA) to lead ORA.
FDA announced that Jones “will lead the charge in setting and advancing priorities for a proposed unified Human Foods Program (HFP).” The office will oversee food safety, chemical safety and innovative food products, including those from new agricultural technologies.
“I’m delighted to welcome Jim to the FDA. His impressive career, extensive leadership experience, and passionate vision for the future of the Human Foods Program make him an ideal selection for this pivotal position,” said FDA Commissioner Robert Califf, noting that the proposed reorganization “is the largest undertaking of its kind in recent history for our agency.”
Jones has held various positions at the US Environmental Protection Agency (EPA) and has also been employed in private industry where he has worked on chemical safety issues and sustainability in the environment. He is scheduled to begin at the FDA on 24 September.
Califf also spoke of the reorganization at a 22 August webinar sponsored by the Alliance for a Stronger FDA. He reiterated that “I'm told this is the biggest reorganization in the history of the FDA. We're not doing it to win the Guinness [World Record] of reorganization size. We're just really trying to equip the FDA to be ready for the next decade, which is predictably going to be a decade of tremendous change in the external environment.”
The HFP will oversee the Office of Food Policy and Response, and the eight human and animal food laboratories currently housed in ORA will shift over to the unified HFP.
Other ORA compliance functions will be transitioning to the Center for Veterinary Medicines (CVM), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), according to an infographic video released alongside the announcement.
New model for ORA
Besides a refocusing of ORA's mission, another element of the reorganization will shift the supervision of medical products and specialty labs from ORA to the Office of Chief Scientists (OCS).
FDA announced that “repositioning ORA's medical product and specialty labs with other labs currently under OCS, such as those run by the agency's National Center for Toxicological Research, will form an expansive network that provides cutting-edge scientific and analytical support to the entire FDA portfolio.”
Califf told the Alliance webinar that FDA has a “good slate of applicants” for the ACRA position. He added that “we're in final interviews, but under the new authority we have, we can recruit right up until the time we make a decision.”
Califf also described how ORA’s role has evolved over the years. “In the beginning, essentially the FDA was ORA because it was inspectors out there, 100 years ago all across the US, with no central organization to really report to and a lot of responsibility. And so, systems developed on a regional basis.”
He added that “over time, ORA accrued a lot of other responsibilities, which are not primary responsibilities of ORA.”
He said that Woodcock and other FDA leaders are “going through every step and looking at the workflow, making decisions about where things belong. But the three I’s [investigations, inspections and imports] are going to be the focus of ORA.”
When asked to address what the agency will do with the $372M increase in its budget request for FY 2024, Califf responded that “The big structural and organizational issue is the foods program. A big chunk of change would go to things like nutrition where we feel like it's been very much chronically underfunded. Within the Nutritional Center of Excellence would be the area that deals with infant formula and medical foods, which is a special area that Congress has designated. But we’re also really shoring up things like chemical food safety.”
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