FDA Serves Up More Food for Thought: 2024 Will Be a Pivotal Year for the Agency’s Reorganization Efforts

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of their proposal over the course of this year. As discussed in our prior alert, the agency’s announcement in January set in motion a very iterative process, and stakeholders were hungry for additional details. On December 13, FDA announced that the agency had advanced its reorganization proposal, and it is now under review by the Department of Health and Human Services (HHS). In reaching this important internal milestone, FDA took the opportunity to share new details regarding both the substance of, and process related to, the planned reorganization and path forward. While FDA’s proposal continues to be heavily focused on restructuring the agency’s HFP, the latest details released by the agency underscore the far-reaching and agency-wide impacts of the proposal. These details also provide additional insight into both the timeline and process for consideration of FDA’s proposal and why 2024 will be a pivotal year for the agency’s efforts on this front. This alert outlines key takeaways from FDA’s latest reorganization update.

Key Takeaways

Under the agency’s proposal, the Office of Regulatory Affairs (ORA) is renamed the Office of Inspections and Investigations (OII)—the frontline of FDA’s field-based inspection, investigation and import operations. Additionally, FDA’s HFP and product centers would be solely responsible for receipt, triage and closing of consumer and whistleblower complaints.

The proposal establishes an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner that is charged with coordination of cross-agency medical issues, including those related to special populations such as children and rare diseases—policy areas that are perennial areas of interest by Congress and other stakeholders alike. It also includes a new Office of Public Health Preparedness and Response to support medical countermeasure policy, emergency preparedness work and medical product shortage coordination across the agency, additional policy areas in which there is no shortage of interest.

The Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) are currently housed within FDA’s Office of the Chief Scientist (OCS). Under FDA’s proposal, OCET and ORSI would be merged into a new Office of Regulatory and Emerging Science with the stated goal of strengthening support of regulatory science and preparedness research efforts.

As part of the reorganization, FDA further proposes creating an Office of Enterprise Transformation within the Office of the Commissioner to work across FDA to drive high-priority, cross-cutting business process improvement efforts. As outlined in the agency’s announcement, FDA sees this shift as an opportunity to achieve a more strategic and efficient use of the agency’s resources.

What’s Next?

In its latest reorganization update, the agency expressed its hope that implementation will occur sometime in 2024. The reorganization road can be long as agencies must navigate an iterative, multistep process, which includes multiple internal layers of review by the executive branch as well as congressional engagement. While FDA advancing its reorganization proposal to HHS for review constitutes a major milestone, it will not be the last step required to achieve the reforms the agency is seeking. In its most recent announcement, the agency laid out the additional steps in the reorganization process, the exact timing of which remains to be seen. These additional process steps include review by both HHS and the Office of Management and Budget, as well as a 30-day notification period to Congress, issuance of a Federal Register notice and the agency’s engagement with unions representing impacted staff. FDA will also need to plan for a smooth transition that minimizes disruption in pre-approval inspections, post-market inspections, compliance actions and imports.

Given the significant, agency-wide impacts of FDA’s proposal, including the resource implications, Congress may look to engage with the agency on this front. This engagement may be part of the upcoming Fiscal Year 2025 budget process, as the FDA Commissioner often testifies before both the House and Senate Appropriations Subcommittees that oversee FDA as part of the annual budget and appropriations process. Regardless of the outstanding uncertainties surrounding FDA’s proposed reorganization, given the agency’s progress to date, 2024 is shaping up to be a pivotal year for FDA on this front, and stakeholders will continue to closely watch to see how these efforts unfold going forward.