The FDA Is Officially Codifying DOGE-Era Changes

The agency will stop specializing its field inspectors starting in October.

FDA

The Food and Drug Administration shed thousands of staff during DOGE-era cuts. Aaron M. Sprecher/AP

The Food and Drug Administration will officially consolidate administrative staff across the agency’s nine centers and stop specializing its field inspectors starting in October.

The Trump administration approved the agency’s reorganization proposal, according to an internal agency announcement reviewed by NOTUS. In the announcement, Melanie Keller, the FDA’s deputy commissioner for operations and chief operating officer, said the reorganization proposal known as “Simple Reform” will go into effect on Oct. 1.

Under the revised structure, individual centers like the Center for Drug Evaluation and Research will no longer conduct their own administrative affairs like human resources, finance and information technology services. Instead, the agency will operate under a “shared service” model in which the FDA Office of Operations controls those functions across the agency.

The agency will also stop assigning its specialized field inspectors, who oversee the safety of medical products and clinical trials, to specific subject areas. Instead, they’ll operate as generalists and conduct inspections and investigations across multiple industries.

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“Shared Services seeks to maximize efficiency and consistency,” the internal FDA website detailing the plan states.

Some former agency staff criticized the changes as not understanding how specialized different aspects of the agency are. One former acting commissioner, Janet Woodcock, called the changes a “mindless approach” and a “really, really bad idea” when the proposal was first announced in 2025, according to the regulatory news publication Pink Sheet.

The reorganization will not drastically change the roles and responsibilities of the agency’s nine centers. Nor will it result in any current FDA employees losing their jobs, according to the internal agency web page.

The changes formalize shifts to the agency’s operations and administrative structure that were put in place by the Trump administration over the past 18 months. Like other agencies across the Health Department, many of the FDA’s administrative staff were let go in the reductions-in-force led by DOGE in 2025. The agency let go a total of 3,500 employees in the DOGE cuts and is now hiring about 2,200 new employees.

The FDA did not immediately respond to a request for comment on the reorganization.

Steven Grossman, a regulatory consultant who writes the blog FDA Matters, said that while he wasn’t familiar with the specific changes proposed, he was concerned that they could oversimplify an agency that’s complicated for a reason.

“Centralization is not always good and efficient,” Grossman said, adding that it “often leaves functions understaffed. It often misses the contours of how work is actually done.”

Some experts also pointed out that the changes will generalize the duties of inspectors who oversee medical products and clinical research. The agency moved in 2017 to place inspectors within specific programs of expertise, rather than requiring them to work across multiple programs. The approved plan would reverse that change.

“Proper assessment requires FDA investigators with matching skills and knowledge, and it’s absurd to expect ‘generalists’ to develop those traits,” Steven Silverman, a former director of the FDA Office of Compliance, Center for Devices and Radiological Health, wrote in a blog post when the proposal was announced. “How and why would a generalist build these strengths while going from a drug inspection one week to a biologics site the next with a device inspection the week after?”