ARTICLE SUMMARY:
More than 200 CDRH staffers, including experts in AI, imaging, cybersecurity, cardiac devices, and the director of the center's evaluation and quality office, among others, were fired as part of the Trump administration’s mass layoffs of "probationary" government workers. Industry groups and outside experts are warning of risks to patients and reminding FDA of its MDUFA V user fee commitments.
Editor’s note: This article was updated February 19 to incorporate more details about the number of employees impacted at CDRH and comments from AdvaMed.
Some device companies are already getting word from FDA that their pending submissions might be delayed or suspended days after the Trump administration sent out termination notices to upwards of 230 CDRH employees, or about 10% of the device center’s workforce, according to industry insiders. Medtech advocates say they are pressing the administration to reverse the actions, particularly for more than half of the laid-off workers who they believe have salaries funded by industry user fees rather than congressional appropriations.
“I’m still hopeful they just didn't understand the full impact of what they were proposing,” AdvaMed President and CEO Scott Whitaker said of the administration on a call with media February 19.
The actions came as part of the Trump administration’s mass firing of employees throughout the federal government over the President’s Day weekend. Public reports suggest a significant proportion of the 5,000-plus Department of Health and Human Services (HHS) employees who are designated as probationary were terminated (including at FDA, as well as the Centers for Disease Control and Prevention, the National Institutes of Health, and CMS, among others). Impacted employees were either hired by the agency in the past one-to-two years, or in some cases relevant to FDA, they may have been with the agency for a longer period of time but were originally hired under a fellowship. Reviewers and scientists across CDRH offices and divisions were impacted, raising questions throughout industry about the current capacity to perform premarket reviews, meet user fee performance commitments, and carry out other activities.
On February 18, Whitaker sent a letter to the new HHS Secretary Robert F. Kennedy Jr. imploring him to reverse the cuts, arguing the reductions will hurt patient care and negate the gains of the successful MDUFA V user fee agreement. Review activities receive significant funding from industry user-fee payments, which are linked to an array of FDA commitments to meet certain hiring targets and various communication and review timeline thresholds. AdvaMed and other trade associations negotiate those fees and commitments with FDA every five years. The user fee deal, Whitaker explained, triggered a hiring spree by CDRH of experts in areas like artificial intelligence, cybersecurity, and other high-tech areas over the past few years. Many of those recently hired scientists were impacted by the cuts.
