Thursday, July 18, 2024
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FDA advances HFP – ORA model and additional modernization efforts

WASHINGTON, USA – The US Food and Drug Administration is providing an update on its efforts to create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model, including additional details about the proposed structure, status of activities and timeline for next steps. These proposed changes will strengthen the agency’s ability to oversee and protect the human food supply and other products it regulates.

The FDA’s proposed reorganization package is now under review at the US Department of Health and Human Services (HHS), which begins the formal external review process. After more than a year of work following the findings and recommendations of a Reagan-Udall Foundation evaluationExternal Link Disclaimer and other feedback, this is a significant step in the process. Following several remaining critical steps, the agency is hopeful implementation will occur sometime in calendar year 2024.

“Moving our proposal forward is an exciting milestone in our ongoing modernization initiative,” said FDA Commissioner Robert M. Califf, M.D. “This is a unique moment in the history of the FDA. We began this journey knowing we had a real opportunity in front of us to make meaningful and lasting change. By working to build a unified Human Foods Program and a more resilient model for our field operations, we also found ways to improve the way we work together as a whole – inside and outside the agency-to better meet our public health mission.” 

In addition to previous announcements, the FDA’s proposed reorganization package includes the following new updates that not only shifts how the agency’s foods and fieldwork is conducted, but also impacts a number of additional FDA offices outside of these programs.

The proposed changes highlight the agency-wide nature of the proposed reorganization package, including:

  • Making the FDA’s HFP 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. This will refine the processing of complaints, ultimately improving our ability to detect problems faster.
  • Renaming 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.

In addition to HHS’ review, there are several critical steps remaining before the agency can implement the proposed reorganization. These steps include review by the Office of Management and Budget, providing Congress with a 30-day notification period, issuing a Federal Register notice and engaging in all necessary negotiations with Unions representing impacted staff.

The FDA’s reorganization proposal has closely tracked with the agency’s efforts to enhance its infant formula response processes following the Abbott infant formula recall in February 2022. Last year, the agency conducted an Internal Evaluation of the FDA’s Infant Formula Response to identify areas for improvement.

The FDA is now releasing a progress update on the important actions the agency has taken to address these recommendations as part of the proposed HFP and ORA new model. Although work is ongoing, there has been significant progress.

For example, the FDA has:  

  • Reevaluated the agency’s infant formula staffing needs and provided substantive input for the development of the Food and Drug Omnibus Reform Act of 2022, which authorized the creation of an Office of Critical Foods (OCF) (including infant formula products). The FDA has now begun to announce, interview, and staff many positions related to the OCF as well as other positions, which will help to support infant formula oversight and regulation. This has included the hiring of a chief critical foods officer, a senior advisor for critical foods enforcement and compliance, and a senior regulatory counsel for critical foods.
  • Began establishing a critical foods investigator cadre, which will solely focus on the inspection and oversight of the infant formula (and other critical foods) industry. Hiring for the cadre is currently underway, and specialized training programs are continuously being developed, piloted and deployed as a part of that effort.

The FDA remains committed to keeping the public up to date as the proposal continues to be developed.



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