Woodcock: Pending ORA reorg will 'modify things significantly' for all FDA regulated products

Regulatory NewsRegulatory News | 03 March 2023 |  By 

FDA's Janet Woodcock

A proposed reorganization of the Food and Drug Administration Office of Regulatory Affairs (ORA) will “modify things significantly” for foods as well as medical products and is expected to be finalized this fall, said Janet Woodcock, the agency’s principal deputy commissioner at a 2 March webinar sponsored by the Alliance for a Stronger FDA.
Woodcock offered an update, yet few specifics, on the proposed restructuring of ORA, first floated on 31 January. Key among the restructuring is the creation of a new deputy commissioner for human foods and the reorganization of ORA to bring certain functions under one roof (RELATED: FDA proposes streamlining inspections office along with new human foods center, Regulatory Focus, 31 January 2023).
Woodcock was asked at the Alliance event whether the new deputy commissioner for human foods would have enough accountability and authority “if they do not have line management responsibility” to do their job.
“Modern organizations are not like monarchies; they have matrices and accountability built in,” she said. “People have not seen the reorganization proposal. They have only seen the top levels of it. Certainly, for ORA, we are going to modify things significantly and it will be for medical products as well as for foods and the goal there is to have foods be a part of the team.” She added that foods inspectors would work closely with pharmaceutical inspectors. A national search for the deputy commissioner was announced on 28 February.
Woodcock acknowledged that implementing this reorganization package will be challenging as it involves the buy in of many different stakeholders. But “that’s our job; we have to figure out how to keep the program on a steady course,” she said.
FDA plan to finalize the plan this fall, then the plan will advance to Congress where members will have 30 days to comment. Afterward, FDA will issue a notice in the Federal Register on the reorganization plan for public comment.
Woodcock said there are multiple groups involved in the reorganization. One is examining ORA’s inspections program and the procedures for inputting data onto a centralized workflow management platform.
“For almost two years now, FDA has been working on getting the inspection process across the agency onto a workflow management platform so that we are no longer transferring information and data and requests for inspections and inspection results though e-mails and excel spreadsheets,” she said. “We are seeing if we can do this in workflow management platforms with structured data elements.”
Another group is delving into the ORA budget, looking at how much money is spent on inspections, as well as the resources allocated to state contract agencies and cooperative agreements for inspections. “As many of you in industry know, it is very difficult to manage your program unless you know how to you are implementing your resources,” she said. The group aims to set up dashboards to “figure out where our resources are going.”
Woodcock said, “we’re not going to fix all the problems in this process. We have to pick our battles and do them well.”
FDA proposed reorganization


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