A proposal for reorganizing the US Food and Drug Administration into five offices and consolidating all product review functions is “a mindless approach to centralization and standardization” and would not adequately support the agency’s functions, former agency officials said.
The proposal for a reorganized FDA that is being circulated by the Trump Administration “is a really, really bad idea,” former Acting Commissioner and Principal Deputy Commissioner Janet Woodcock said at the recent Biopharma Congress, presented by Prevision Policy and Friends of Cancer Research.
Woodcock suggested the reorganization proposal was devised by someone who does not understand how the agency operates.
Former Principal Deputy Commissioner Joshua Sharfstein said the plan would eliminate vital expertise in highly specialized areas in favor of making all agency staff “generalists” who could work across the FDA’s many regulatory areas.
Reorganizing The FDA
Health and Human Services Secretary Robert F. Kennedy Jr. is pursuing a major restructuring of the department that includes elimination of some agencies, streamlining of administrative functions and staff downsizing.
HHS saw the recent reduction-in-force of approximately 10,000 employees, 3,500 of whom were at the FDA.
Although the FDA layoffs largely spared reviewers and inspectors, they encompassed administrative staff and experts who support reviews, inspections and advisory committees, and who develop policy governing the FDA’s activities and guidance for industry.
The FDA RIFs came on top of the departure of hundreds of staffers due to voluntary resignations and retirement programs and the firing of probationary employees.
Woodcock, the long-time Center for Drug Evaluation and Research director, said the staff reductions, as well as the loss of key agency leaders, have undermined the apparatus for a getting a drug on the market.
HHS also is proposing to reorganize the FDA “to remove unnecessary management layers and offices and streamline them into five shared services offices,” according to an HHS memo.
A more detailed reorganization plan proposed consolidating the FDA’s product review and regulatory decision-making across drugs, biologics, devices, tobacco and foods into a single office known as the Office of Product Evaluation and Regulation.
The remaining four cross-functional offices in the proposal are:
Office of Inspections, Compliance and Enforcement
Office of Scientific and Regulatory Policy
Office of Administrative and Shared Services
Office of Strategic Programs and Innovation
The reorganization proposal suggests a “mindless approach” and “somebody is pursuing centralization and standardization without actually knowing what’s going on,” Woodcock said.
She theorized that someone is looking at office names and seeing “seven policy offices across the agency, so pick one, we’ll keep that one as a central one and get rid of all the others because clearly that’s redundant, having no idea what was actually done.”
Although there are potential benefits of both matrix approaches and vertical integration approaches for managing large organizations, “you have to think about it,” Woodcock said. “You have to have people who understand what the program is, whatever it is … or whatever the people do, and understand … the benefits and harms of each type of thing.”
She noted the agency recently completed its largest reorganization with the creation of the Human Foods Program and restructuring of the Office of Regulatory Affairs into the Office of Inspections and Investigations. The latter move shifted all compliance functions into the product centers. However, the reorganization proposal circulating would lump all the compliance staff back with the inspections and import functions.
“Structure should always support function,” former Center for Devices and Radiological Health Director Jeff Shuren said.
From Specialists To Generalists
Sharfstein, who is now vice dean for public health practice and community engagement at Johns Hopkins University, noted the reorganization proposal would group together various types of FDA-reviewed products that involve different science and different laws.
“It’s almost like you have this idea someone could do a food additive review in the morning, over lunch come up with a new inspection standard, and then in the afternoon do a cell-based therapy.”
Johns Hopkins University’s Joshua Sharfstein
“What could possibly go wrong?” he asked, facetiously.
“It’s almost like you have this idea someone could do a food additive review in the morning, over lunch come up with a new inspection standard, and then in the afternoon do a cell-based therapy,” Sharfstein said.
The varied products that the agency regulates demand specialized expertise.
At the agency, “you run into people who really, really understand one specific thing, and believe me, we all need” that, he said. However, the reorganization plan seems to call for “a big team of generalists.”
“I’m sure there’s some synergies here and there,” Sharfstein said. However, “that’s something that you have to be able to work out within a structure that really respects the law and policy and science.”
