FDA’s human foods, regulatory affairs office reorg edges forward

The US Food and Drug Administration (FDA) has submitted a plan to reorganize its human foods program and Office of Regulatory Affairs to the Department of Health and Human Services (HHS). The proposal includes creating a more consolidated process for handling consumer and whistleblower complaints and creating a new chief medical officer position to coordinate medical issues across product centers.

FDA has been working on what it calls its unified Human Foods Program (HFP) a new model for ORA after it was criticized for mismanaging the 2022 infant formula crisis. FDA Commissioner Robert Califf vowed to prioritize the issue after taking the reins at the agency during his Senate hearings, and on 13 December, he unveiled a plan to make significant reforms that are intended to prevent a similar crisis in the future. (Related: Interview: FDA’s Califf talks with Focus about 2023 priorities, Regulatory Focus 21 December 2022)

“This is a unique moment in the history of the FDA,” he said in an agency announcement. “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.”

The plan is based on recommendations developed with the help of the Reagan-Udall Foundation and includes centralizing consumer and whistleblower complaint handling to the HFP and other FDA product centers. The agency says the move will streamline the process and help it detect issues sooner. (Related: Califf: FDA will be a ‘more activist’ agency, Regulatory Focus 24 August 2023)

FDA is also proposing to rename ORA to the Office of Inspections and Investigations (OII) and use it as its main office to handle field-based inspections, investigations and import operations. The agency also wants to create an Office of the Chief Medical Officer (OCMO) within the commissioner’s office that would centralize its coordination of medical issues across product centers as well as address special populations such as children and patients with rare diseases. It would also include the creation of a new Office of Public Health Preparedness and Response (OPHPR) to develop policies in areas such as medical countermeasures, emergency preparedness and product shortages.

Furthermore, FDA is proposing to merge its Office of Counterterrorism and Emerging Threats (OCET) and Office of Regulatory Science and Innovation (ORSI) to form a new office called the Office of Regulatory and Emerging Science (ORES) that would centralize research in regulatory science and preparedness. Finally, the plan calls for developing an Office of Transformation (OT) to work across product centers on high-priority business process improvement issues.

Alongside news that it had submitted its plan to reform its HFP and ORA, FDA also provided an update on its efforts to address the infant formula crisis, which includes creating an Office of Critical Foods (OCF) and hiring a cadre of critical foods investigators who will focus on infant formula inspections and oversight.

If HHS approves the plan, it would still need to clear several hurdles, including review by the Office of Management and Budget (OMB), a 30-day Congressional notification period and publishing a notice in the Federal Register. The agency would also need to conduct negotiations with the unions representing its staff at the affected offices.

FDA

FDA’s human foods, regulatory affairs office reorg edges forward

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