Staff Cuts At CDRH Focus On Administrative Workers, Spare Reviewers

About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.

Scissors cutting line of blocks with human icons; staff cuts concept.
(Cagkan Sayin/Shutterstock)

Employees throughout the US Food and Drug Administration’s Center for Devices and Radiological Health were among the 3,500 FDA staff who fell victim to agency-wide reductions in force on 1 April, with office dealing with industry and consumer education, meeting logistics, communications and employee management particularly hard-hit.

Most if not all employees within the Office of Communication, Information Disclosure, Training and Education have been let go. This office’s responsibilities include developing device safety alerts, as well as working to educate the public about the benefits and risks of different devices and diagnostics.

Another hard-hit administrative division is the Office of Management, which organizes functions such as acquisitions, meeting and travel logistics, and employee management.

“Due to my commute, I checked my e-mail at 5:00 am before departing for work. I had received no communication,” one acquisitions team project manager posted to LinkedIn. “I drove to campus, made it through security, and opened an e-mail sent at 5:13 am informing me that, effective immediately, I was placed on administrative leave. The RIF affects my entire division. All members of my team have been dismissed.”

Reviewers and inspectors appear to have been spared, as the FDA has repeatedly promised. But many observers believe the cuts to administrative staff will still have devastating effects on timely product review, as well as staff morale.

“In the near term, these cuts will have detrimental impacts on CDRH because even if certain job series, like reviewers or investigators, aren’t specifically targeted, FDA relies on team-based activities and if you gut the necessary infrastructure for those activities, they can’t occur effectively,” said Steve Silverman, president of The Silverman Group and a former director of the CDRH Office of Compliance. “Second, there are grave long-term risks regarding departure from the FDA of capable staff who are so demoralized by the current events that they find opportunities outside the agency, which dilutes FDA’s strong, crucial work force.”

Employees Fear Deeper Cuts To Come

Two CDRH employees reached by Medtech Insight had been spared so far, but expressed concerns about their colleagues in other divisions that were not and said they feared the device center could be next.

One described a recent meeting with senior leadership in which there was no clarity about the future, just concern.

“They were sad and some even choked up,” the staffer said, “but other than that we were not provided with any information about what was going on.”

“Everyone’s morale is down. With most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed, I think a dark future is ahead.”

CDRH Employee

The staffer referred to the DOGE cuts at the FDA as a “Manhattan Project” rather than a reorg.

“Everyone’s morale is down. With most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed, I think a dark future is ahead. History will judge this,” the staffer said. “With no clarity and anxiety among our colleagues at all time high, everyone is saying that they can’t focus on the review submissions.”

The other staffer said those who were fired were treated without dignity or recognition for their public service and sometimes were not allowed access to their offices.

“I believe most Americans wouldn’t stand for this kind of treatment if they knew the full story,” the staffer said. “They simply aren’t aware. People here genuinely care about protecting public health, working hard to make sure our food, drugs, and medical devices are safe.”

But even if further cuts are not in the offing, though both suspected they were, the damage, in the view of both, has been done.

I honestly don’t think anyone wants to be part of this anymore, even those who are not impacted yet,” the staffer said. “There is no trust anymore.”

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