FDA Reverses Course on Layoffs, Moves to Rehire Hundreds of Employees

The U.S. Food and Drug Administration (FDA) has initiated a rapid reversal of its recent layoffs, aiming to rehire approximately 300 employees across its device, drug, and food regulation divisions. This development comes just days after more than 1,000 probationary workers were suddenly let go, causing significant disruption within the agency.

Device Center Disproportionately Affected

The Center for Devices and Radiological Health (CDRH) appears to have been hit particularly hard by the initial layoffs. Scott Whitaker, CEO of the medical device trade association AdvaMed, estimated that at least 180 workers were cut from CDRH's staff of about 2,000. Many of these positions were funded by user fees collected from the medtech industry, rather than federal budget appropriations.

Whitaker suggested that CDRH may have been disproportionately affected due to recent efforts to expand its workforce. These expansions were aimed at reducing product review times, as outlined in user fee agreements negotiated with industry and passed by Congress.

Rehiring Efforts Underway

According to reports, FDA employees began receiving phone calls late Friday and into Saturday morning, informing them of their reinstatement. The agency is moving quickly to reverse the cuts, with a particular focus on retaining expertise in cutting-edge technologies.

STAT reports that two of the three people let go from the FDA's digital health office have been rehired, along with employees tasked with reviewing AI-powered imaging software. Additionally, all twelve product reviewers focusing on surgical and infection-control devices have been reinstated.

Impact on Emerging Technologies

The initial layoffs had raised concerns about the FDA's ability to keep pace with rapidly advancing technologies. Many of the affected staff were working on programs related to artificial intelligence, brain-computer interfaces, and other emerging fields. These employees had been recently brought on to help the agency address technologies that have seen significant advancements in recent years.

The swift reversal of these cuts suggests a recognition of the critical role these specialists play in the FDA's ability to evaluate and regulate innovative medical technologies.