FDA pulls the trigger on major agency reorganization
The long-anticipated reorganization of two of the US Food and Drug Administration’s (FDA) core programs is finally here. FDA Commissioner Robert Califf on Tuesday announced that agency has implemented its plan to create a unified Human Foods Program and a new field operations office in place of the former Office of Regulatory Affairs (ORA).Since taking the helm at FDA for a second time, Califf has been working to make major organizational changes to how it regulates food products and conducts investigations and inspections more broadly after the agency was criticized for its handling of the 2022 infant formula crisis. In response to those criticisms, the agency has sought to overhaul its food program into a new unified Human Foods Program. The agency also said it would reorganize ORA into a new office, dubbed the Office of Inspections and Investigations (OII). (RELATED: Califf uses budget hearing to advocate for resources, authority to monitor supply chains, Regulatory Focus 19 May 2022)
With the start of the new fiscal year on 1 October, FDA has finally pulled the trigger on the reorganization in what Califf; Jim Jones, the agency’s recently announced deputy commissioner for Human Foods; and Michael Rogers, associate commissioner for Inspections and Investigations, describe as a new chapter in the agency’s history. (Related: FDA leaders detail reorg plans, say 1,500 ORA staff will be reassigned, Regulatory Focus 19 January 2024)
“We are pleased to announce that today, the unified Human Foods Program, a new model for field operations and other modernization efforts is now in effect,” said Califf. “This is the single largest reorganization in the agency’s modern history, as it impacts more than 8,000 employees and touches almost every facet of the FDA.”
According to FDA, a key part of the reorganization includes restructuring and renaming ORA to OII to focus on inspections, investigations, and imports to highlight its core mission.
“Restructuring the Office of Inspections and Investigations, formerly known as the Office of Regulatory Affairs, extends beyond foods and has an impact on how the FDA oversees all FDA-regulated products,” said Califf. “We have created an enterprise-wide structure that will enhance collaboration between our field investigators and other subject matter experts throughout the agency and modernize and strengthen the entire agency to work more cohesively and collaboratively in accomplishing our collective public health mission.”
In addition, FDA announced it’s launching a pilot program to get consumer complaints through an online form. It said the form will allow the agency to address complaints more efficiently and effectively internally and better respond to public health risks.
“The work has really only begun,” said Califf. “We are hopeful this modernization and reorganization will enhance transparency and trust in the agency as we work together both inside and outside the FDA to better meet our country’s shared public health goals.”
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