FDA Reorganizing Regulatory Compliance Staff by Commodity Specialty
The Food and Drug Administration is in the process of realigning its Office of Regulatory Affairs (ORA) staff to focus on specific commodities instead of geographic regions, said Howard Sklamberg, FDA deputy commissioner-Global Regulatory Operations and Policy, in a blog post May 9. In a change that appears to echo CBP’s move to the commodity-focused Centers of Excellence of Expertise (CEEs), Sklamberg says FDA’s current geographic model of regional field offices “will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco.”
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Specialization in a commodity means that FDA investigators, compliance officers, import reviewers, and laboratory personnel will have more knowledge in a given product, and will be able to collaborate better with subject matter experts at FDA’s commodity-focused centers, said Sklamberg. “They will work as part of a team with the staff from other centers, collaborating, for example, with the Center for Drug Evaluation and Research on pharmaceutical oversight or with the Center for Food Safety and Applied Nutrition on food safety issues,” he said. By working with FDA centers on the development of compliance policies and priorities, the reorganization will put investigators and compliance officers “in a better position to implement the preventive approaches contained in new statutes and work together more seamlessly with the centers,” said Sklamberg..
The reorganization is still in its early stages, and there is still a lot of work to do before it comes to fruition, said Sklamberg. “There is a lot of planning still to be done, and we will work to ensure a transparent and inclusive process. Nevertheless, change is coming and I am excited and proud to be part of a transformation that can only strengthen our efforts to safeguard the foods and medical products that are so important in the lives of people all over the world,” he said. The agency is still looking into how the new commodity-based model will interact with the CEEs, said an FDA spokesman. "FDA is working with CBP on coordination and collaboration of their CEE’s, and how their CEE’s will work with FDA’s responsibilities," he said.