It’s been 18 months since the FDA began studying problems in its Human Foods Program and an update from the agency says it will take more time to implement changes.
The head of the Food and Drug Administration said on Dec. 13 that he is “hopeful” that changes will come sometime in 2024.
Problems in the structure of the foods programs at the Food and Drug Administration came to a head during an outbreak of cronobacter among infants in 2021 and 2022 and the subsequent the infant formula crisis of 2022. That crisis saw the recall of much of the infant formula in the United States. The factory that makes the formula was closed for months, causing more shortages.
During a May 2022 congressional hearing, FDA Commissioner Robert Califf was grilled by members of the U.S. House of Representatives and told to make changes so that internal communication problems brought to light by the infant formula crisis would be resolved.
Those communication problems showed that the lack of a clear chain of command for the food side of the Food and Drug Administration had resulted in delays in identifying the cronobacter outbreak and action to contain it.
Following internal review by the FDA and an external review by the Reagan-Udall Foundation, Califf appointed Jim Jones, a 30-year veteran from the Environmental Protection Agency’s administration, to the new post of FDA Deputy Commissioner for Human Foods. Jones has been working with a team at the FDA to reorganize the agency.
The proposed reorganization includes the creation of new offices, shifting of responsibilities from one office to another, and the consolidation of other programs within the FDA superstructure.
“The FDA’s proposed reorganization package includes new updates that not only shift how the agency’s food and field work is conducted, but also impacts a number of additional FDA offices outside of these programs,” Califf said in a statement on Dec. 13.
Some of the proposed changes, as described by Califf, are:
- Making the FDA’s human Foods Program and product Centers solely responsible for receipt, triage and closing consumer and whistleblower complaints, rather than this role being split between Centers and field Offices.
- Renaming the Office of Regulatory Affairs (ORA) as the Office of Inspections and Investigations (OII) and solidifying its role as the frontline of the FDA’s field-based inspection, investigation and import operations.
- Establishing an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of cross-agency medical issues, including special populations such as people with rare diseases and children. This 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.
- Merging the Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) to form a new office; both offices are currently housed within the FDA’s Office of the Chief Scientist (OCS). This new merged office in OCS, proposed as the Office of Regulatory and Emerging Science, will strengthen support of regulatory science and preparedness research efforts.
- Creating an Office of Enterprise Transformation. This proposed new office in the Office of the Commissioner will work across the FDA to drive high-priority cross-cutting business process improvement efforts. The proposed shift will result in more strategic and efficient use of agency resources.
The FDA is continuing to review the reorganization plan and will submit it to its parent entity — the Department of Health and Human Services (HHS) — for further review. Once HHS signs off on the plan, it will go to the U.S. Office of Management and Budget, providing Congress with a 30-day notification period. Then the plan will be posted in the Federal Register for further review.
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