A proposed FDA reorganization might have food safety in mind first and foremost, but stakeholders across industries will feel the effects of what associate commissioner for regulatory affairs Michael Rogers called “the largest reorganization in FDA’s history.”
The wide-ranging reorganization would replace the Office of Regulatory Affairs (ORA) with the FDA Office of Inspections and Investigations (OII). It would also touch “directly or indirectly, about 8,000” FDA employees, Rogers said last week on a webinar hosted by the Alliance for a Stronger FDA.
After its response to the 2022 infant formula crisis, which the agency’s food safety director admitted was too slow, the FDA asked the Reagan-Udall Foundation, an independent industry watchdog, to conduct an operational review of its Human Foods Program.
The reorganization, which the FDA announced in December and is undergoing federal review and approval, not only incorporated the review’s findings as they related to the Human Foods Program but also included structural changes that would affect many FDA functions, said Principal Deputy Commissioner Dr. Janet Woodcock.
“Much of this was catalyzed by the Human Foods Program, but … this is a broader effort,” Woodcock said. “We’re trying to move toward [a] more enterprise-system, holistic look at how the FDA functions.”
“This proposed organizational structure really makes FDA more efficient. It eliminates duplication of effort. It’s a way to streamline decision making."
Michael Rogers
Associate commissioner, regulatory affairs, FDA
The proposed OII would oversee “the agency’s field operations who carry out inspections, investigations, and import operations,” according to the FDA. Ultimately, the goal is to put industries in more direct contact with inspectors to make communication more efficient, STAT reported.
Underneath the new office would be several specialized offices, including the Human and Animal Drug Inspectorate, Bioresearch Monitoring Inspectorate, Biologics Inspectorate and Medical Devices and Radiological Health Inspectorate.
“We think this will help ORA function better because they’ll have more uniformity in how they’re dealing with the various programs that they work with,” Woodcock said.
In addition, the panelists said the new structure would be more streamlined and have greater budget transparency.
“This proposed organizational structure really makes FDA more efficient. It eliminates duplication of effort. It’s a way to streamline decision making,” Rogers said.
It will also change how regulated industries navigate the FDA.
“This will create new contacts for the regulated industry,” Rogers said. “We know that you all engage in regulatory meetings and discussions about responses to 483s and timelines associated with corrective actions.”
Woodcock also mentioned that the FDA is trying to build a single, product-agnostic inspection platform. Although she didn’t go into detail, she said the hope is that one day, “everybody will be online to the same platform.”
“Eventually, as we get the platform running, I think there'll be even more efficiencies in bringing those programs together,” she said.
Although the FDA reorganization is pending review, the agency hopes it will go into effect this year, the panelists said.
