It is well to be noted that a proposed FDA reorganization might as well have food safety first and foremost; however, stakeholders throughout industries will go on to feel the effects of what Michael Rogers, associate commissioner for regulatory affairs, called the largest reorganization in the history of the FDA.
The wide-ranging reorganization would go on to replace the Office of Regulatory Affairs- ORA with the FDA Office of Inspections and Investigations- OII. It will in a way reach directly or indirectly, almost 8,000 FDA employees remarked Roger.
Post the response to the 2022 infant formula crisis, which the food safety director of the agency admitted happened to be too slow, the FDA went on to ask the Reagan-Udall Foundation, which is an independent industry watchdog, to do an operational review of its Human Foods Program.
Apparently, the reorganization, which the FDA went on to announce in December and is undergoing federal review as well as approval, not only incorporated the review’s findings as they related to the Human Foods Program but at the same time also included structural changes that would go on to have an effect on many FDA functions, said Dr. Janet Woodcock, Principal Deputy Commissioner.
Much of this happened to be catalyzed by the Human Foods Program; however, this is a broader effort, said Woodcock. They are trying to move towards a more enterprise-system, take a look at how the FDA goes on to operate.
The proposed OII would go on to oversee the agency’s field functions, which carry out audits and investigations as well as import operations, as per the FDA. The goal, ultimately, is to put sectors in more direct contact with inspectors so as to make communication more effective, STAT reported.
It is well to be noted that underneath the new office would be numerous specialized offices, such as the Human and Animal Drug Inspectorate, the Biologics Inspectorate and Medical Devices, the Bioresearch Monitoring Inspectorate, and the Radiological Health Inspectorate.
As per Woodcock, this will help ORA go on to operate better as they will have more uniformity in how they happen to be dealing with the numerous programs that they happen to work with.
Besides, the panelists said that the new structure would be more seamless and streamlined and have better transparency in the budget.
The proposed organizational structure goes on to make the FDA more efficient. It eradicates duplication of effort and happens to be a way to streamline decision-making, as Rogers remarked.
It is also going to change how regulated sectors go on to navigate the FDA.
According to Rogers, this will create fresh contacts for the regulated industry. They know that they all go on to engage in regulatory meetings as well as discussions on responses to 483s as well as timelines associated with corrective actions.
Woodcock also went on to mention that the FDA is trying to create a single, product-agnostic inspection platform. Although she has not gone into the details, she said the hope is that one day everybody will come online on the same platform.
At the end of the day, as one gets the platform running, she thinks that there are going to be even more efficiencies when bringing the programs together, she added.
Although FDA reorganization is pending a review, the agency is hoping that it will go into effect in 2024, the panelists remarked.
