REORG DAY — The largest reorganization of the FDA kicks into effect today — impacting about 8,000 employees. The changes — which include renaming the Office of Regulatory Affairs to the Office of Inspections and Investigations — assign the agency’s oversight operations into four buckets: inspections, investigations, imports and emergencies. David sat down with Michael Rogers, associate commissioner for regulatory affairs in the FDA’s new Office of Inspections and Investigations, to discuss the reorganization. The interview has been edited for length and clarity. What is the goal of renaming the oversight office, and what tangible effects will it have? Our compliance functions will be carried out by the centers, and so those activities and the associated resources are being transferred to the centers. If you think about the life cycle of an inspection, assignments are issued to the inspectorate by the centers that reflect their policies, either surveillance or for-cause inspections. The compliance function will now be carried out by the centers. This new OII allows us to focus on our core activities: inspections, investigations, import operations and emergencies, with the managerial infrastructure to support those options. The agency has lost staff to private-sector jobs the past few years. Will the reorganization provide incentives for top talent to work at the FDA? It is one of my top priorities to invest in our most important asset: our workforce. As a former investigator, one of the things that I’m trying to emphasize is to tell the story of the value of being on the front lines of FDA. To address attrition, we’re looking at strategies to retain our highly qualified investigators in those areas where it’s difficult to attract people. One of those tools is the broader utilization of hiring authority. Domestic and foreign inspections fell during the pandemic, and a backlog developed. Will the reorganization help the agency increase the number of routine inspections it conducts? I do, and I do believe that this will, this reorganization will make us more efficient. It certainly eliminates a lot of duplication of effort between the inspectorate and our centers. The expectation is when we’re able to retain people, we’re able to accomplish inspections efficiently in both the domestic and international arena. There were a number of firms that were scheduled that have been impacted by the pandemic, and we are increasing in many areas. One of the things I’d like to do is broaden the narrative around inspections to include regulatory coverage … our efforts to collaborate with foreign regulators, our efforts to collect samples at the border, our foreign supplier verification program, leveraging information from our state partners in the domestic arena, that all adds to what I would call the regulatory picture. CALIFF, BUMPUS WEIGH IN ON ADCOMMS — The FDA continues to evaluate next steps for one of Commissioner Robert Califf’s priorities: overhauling how its 31 advisory committees operate. Top FDA officials took to Nature Medicine on Monday, outlining six areas they are focused on: reducing paperwork burden, improving the utility of advice received from advisory committees, strengthening recruitment of committee members, standardizing ad comm practices across the agency, increasing public understanding of the role of advisory committees and ongoing collection of input on how advisory committees should work. “Even when the final regulatory decision does not align with the predominant [advisory committee] viewpoint, that decision still has been deeply informed by [its] input,” Califf, FDA’s Emily Helms Williams, and Namandjé Bumpus, the FDA’s principal deputy commissioner, wrote.
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