US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections
Executive Summary
A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.
The US Food and Drug Administration’s plan to address concerns about its food safety operations will mean changes for the allocation of resources in the Office of Regulatory Affairs that will have implications for drug inspections.
FDA announced a “new vision” for its human foods work on 31 January, proposing the creation a new unified Human Foods Program which will combine the Center for Food Safety and Applied Nutrition, Office of Food Policy and Response, and certain functions of the Office of Regulatory Affairs under one leader.
Changes to ORA, the agency said, will be applied across the agency creating an “enterprise-wide organization.”
In December, an assessment of the agency’s food programs conducted by a group of independent experts and facilitated by the Reagan-Udall Foundation in response to the infant formula shortage called for structural changes as a key part of the response.
The report urges elevating the agency’s food activities and offered options ranging from splitting FDA into two separate agencies, to restoring the deputy commissioner for food post as a separate reporting line to the Commissioner, to elevating the role of the food center within the existing structure. (Also see "Food For Thought On US FDA Reforms" - Pink Sheet, 8 Dec, 2022.)
FDA is following up by proposing a single deputy model – and in doing so, planning changes to how ORA works across the agency.
“As part of this proposed new vision, ORA’s operating structure will be transformed into an enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs (e.g., agency centers) by focusing on its critical activities,” FDA said.
“This realignment will allow ORA to be singularly focused on excellence in its core mission – inspections, laboratory testing, import, and investigative operations. This will optimize ORA’s operations in line with the FDA’s public health and prevention-oriented goals. Certain other functions of ORA will be aligned in other parts of the FDA to create an overall stronger agency.”
The details are still clearly very much in flux, and FDA is well aware of the history of challenges of balancing centralized management of ORA with the specific needs and priorities of the different centers.
The new model for ORA, FDA explains, will focus on core activities as they relate to each Center, “setting the global gold standard in inspections, investigations, laboratory analysis, and import operations.”
During a media call, FDA Principal Deputy Commissioner Janet Woodcock indicated the agency has already stood up an “implementation and change management group” focused on “developing detailed plans to ensure the successful execution” of the proposed overhaul. (See box for a related story on how IT changes at the agency can drive some of the reorganization.)
“We look forward to sharing further details next month and in the future on our progress as we initiate this agency proposal in close coordination with internal and external stakeholders while also ensuring we meet labor obligations,” she added.
Strengthening the agency’s enterprise-wide information technology, analytical capability, and workflow management will be important components of the changes, Woodcock continued. Changes will include development of unified, agency-wide systems for ordering and carrying out inspections, as well as managing inspection follow-up actions.
That focus fits with Woodcock’s emphasis on “Enterprise Modernization” as a key priority since she was named principal deputy commissioner. (Also see "Woodcock Focusing On Food Issues, Rather Than Drugs, As US FDA’s Principal Deputy Commissioner" - Pink Sheet, 19 May, 2022.)
The changes to ORA will allow the separate Center leaderships to set priorities and budgets for ORA activities that fall under their regulatory authorities, Woodcock and FDA Commissioner Robert Califf confirmed during the call.
“The inspectors – or investigators as they’re now called – who do the inspections will remain in ORA, but the priorities and budget-setting will be in the purview of” product center leadership, Califf said.
The vision is intended to allow ORA to focus on logistical details of actually conducting inspections and other activities, Califf explained. “The inspectors who are out in the field have a lot of activities in common across ORA. Like, How do they get from one place to another, Where do they stay?” Califf said.
When it comes to monitoring imports, “it doesn’t matter whether it’s a food or a drug or a device coming in, it all comes in through the same system where our folks have to be there.”
“We currently have a work group to work through the specific operations,” Califf added. “I think we all agree we want to bring these groups together, that is the subject matter experts … and the inspectors who are out in the field.”
The reshaping of ORA’s role in the broader center structure of FDA comes as the agency faces an important operational and political challenge to “catch up” on overdue inspections after three years of COVID impacts on travel. (Also see "US FDA’s Biggest Post-COVID Challenge May Be Helped By Small Inspections Tweak In FDORA" - Pink Sheet, 31 Jan, 2023.)