ARTICLE SUMMARY:
In this week’s Pathways Picks: HHS moved ahead with cutting about 18% of FDA’s workforce; a federal judge resoundingly rejected FDA’s authority to regulate laboratory-developed tests; guidance on “sex-specific” device study data resurfaces; IMDRF issues draft playbook on global regulatory reliance; Australia enacts its UDI requirements; South Africa institutes quality management mandates; and more.
HHS Firings
Ongoing mass layoffs at FDA and beyond:
Firings unleashed at FDA. HHS moved forward April 1 with cutting about 3,500 FDA employees, or about 18% of the agency’s total workforce, as part of massive department-wide layoffs. Policy, communications, and administrative staff were hardest hit at the device center, though industry groups tried to convey a constructive tone in the hope that the premarket review process wouldn’t be derailed. “Reduction in force” (RIF) notices, putting staff on administrative leave, are being sent to approximately 10,000 employees HHS-wide. The department estimates another 10,000 have left or are on their way out as a result of prior actions by the administration, including buyout and early retirement offers, reducing the health department’s overall workforce from 82,000 to 62,000. The action comes more than a month after the Trump administration terminated hundreds of probationary FDA staffers only to call an unspecified number of them back to work. While those prior layoffs disproportionately impacted CDRH, early reports and information suggest the drug, biologic, and tobacco centers, among other parts of the agency, might be experiencing an equal or larger relative impact compared to CDRH, though the device center experienced significant cuts nonetheless. The health department said product reviewers and inspectors will be exempted from the cuts.
Who’s impacted? Sources who are in touch with FDA employees confirm to Market Pathways that CDRH staffers are among those receiving RIF notices April 1, but there are no clear numbers on proportion compared to other parts of the agency. Initial conversations suggest the cuts are not targeting reviewers. Officials at the Office of Strategic Partnerships and Technology Innovation (where the Digital Health Center of Excellence and cybersecurity divisions, among other cross-center functions, are housed), the Office of Regulatory Programs, and the Office of Management were among the hardest hit. In addition, the entire FDA and center-specific media and communications staffs have been cut. Media seeking information on the ongoing actions were directed to a centralized HHS public affairs office. AdvaMed tried to convey a constructive tone. “If it’s true that medical device reviewers and inspectors haven’t been affected, then that is good news,” Scott Whitaker, president and CEO of the trade group, said. “Looking forward, our view is that any reduction in force should be accompanied by policy and regulatory improvements that encourage innovation in medtech.”
