A vast array of suggestions and proposals have arisen over the years for changes to the U.S. food regulatory system – from both within and outside the federal government. But the FDA’s latest Proposal for a Unified Human Foods Program and New Model for the Office of Regulatory Affairs, which FDA officials discussed on a January 19 webinar, may finally be one that moves the agency into the future. While it does not create a single food agency (combining FDA and USDA), as many have suggested, it does seem that, if enacted as proposed, it will at least begin the process toward “transforming the FDA to be more efficient, nimble and ready for the future,” as FDA Deputy Commissioner Janet Woodcock stated on the webinar.
The reorganization proposal, which stems from the agency’s review of the findings and recommendations of a Reagan-Udall Foundation evaluation, an internal review of the agency’s infant formula response, and feedback from external and internal stakeholders, is currently undergoing the formal external review process required for all federal reorganizations. However, FDA is hopeful that implementation can occur in 2024.
As the “largest reorganization in FDA history,” it involves numerous budget, structural and personnel changes – impacting 8,000 personnel “directly or indirectly” and nearly all offices and centers in FDA. However, it is stated to be “budget neutral” overall. Once implemented, there will be some early short-term efficiencies, but it will take time to realize the real benefit of the reorganization, as duplication of efforts are eliminated, decision-making is streamlined, and the culture changes.
One of the key industry areas to be impacted by the proposed reorganization are inspections. No longer will field activities be separate, rather all compliance programs are to be combined in the centers to streamline actions and decision-making and provide for more clarity and promptness in enforcement actions. This will create new contacts for industry, as primary contacts will shift from the field to the centers; there will no longer be two separate contacts. Field staff will have direct access to relevant experts in the centers, with all online on the same platform and involved in the decision-making. So, for example, an inspector could upload a photo from an inspection which experts in the centers could view in real-time, and assist in compliance and enforcement decisions.
FDA Deputy Commissioner for Human Food Jim Jones attributed the reason for and ability to make some of these changes as being a direct result of the instantaneous communication available through the internet and cell phones. Before the Internet, it made sense for a person in the plant to make the decision. But “now that we have instantaneous communication, you don’t have to be in the plant.” It made sense before the internet, but now decisions can be made anywhere, and field inspectors can connect with center experts immediately.
Such collaboration, along with the plan to realign most compliance functions and staff, as well as complain responsibilities, to human foods, will also allow for metrics around the lifecycle of complaints, and help to ensure follow up is conducted in a timely manner and serious complaints are prioritized.
The lack of unification within FDA is nothing of which the agency was unaware. In fact, Woodcock said this is a primary focus of the reorganization with a goal to “stop hemorrhaging money on separate systems.” Thus, the proposal includes a number of areas of restructuring and consolidation, with one of the most obvious efficiencies to be developed being the combining of compliance programs in the center, enabling the streamlining of action, and added clarity and promptness in enforcement actions. While the industry may not initially see quicker enforcement as a positive, it is better for all to have enforcement action, such as 483s, dealt with quickly and effectively, to get the firm out of the situation.
Another area highlighted by Jones is the increased focus on nutrition and the addition of a Center of Excellence for Nutrition. Noting that the risks related to nutrition are larger than anything else FDA is managing, the agency is seeking to raise the profile and bring more attention to nutrition, including labeling.
Although FDA does need to await approval before it can move full-steam ahead, the agency began to work on aspects of the proposal that did not involve reorganization as soon as the proposal was submitted. For further detail on the proposed reorganization, visit the related FDA webpage.
From TAG’s perspective, we see these changes as both overdue and welcome. As the FDA has noted, these changes encompass a desire to change culture. As we know, changing culture does not happen simply by reorganizing reporting structures, but rather requires the commitment of management who need to lead by example. We also urge FDA to continue to work closely with industry as the changes are made and both regulators and industry strive to provide safe affordable food to consumers with a minimum of waste.
TAG will continue to stay on top of FDA’s activities and reorganization to help keep you informed, prepared, and to assist you with any issues the may arise. Give us a call 24/7/365.
