The FDA has lost several senior employees in recent weeks, including some who have been at the agency for more than two decades.
The FDA has been hit with a new wave of staff departures, raising concerns that the agency’s crucial functions—including the approval of new drugs—have been compromised.
Over the past few weeks, the regulator has lost several high-ranking employees, according to reporting by Endpoints News, many of whom had decades’ worth of experience and knowledge about the FDA’s operations. Some, according to social media posts, seem to feel that their exit came prematurely. Sally Seymour, former senior physician at the regulator’s Office of New Drug Policy and director at the FDA’s Division of Pulmonology, Allergy, and Critical Care, wrote in a LinkedIn post that her “time at the FDA ended sooner than expected.”
Before her retirement, Seymour had been with the FDA for more than 20 years, working “to serve the American public by supporting the FDA’s public health focused mission.”
Ladan Jafari had also served the FDA for more than 20 years, most recently as the chief of project management at the agency’s Division of Pulmonology, Allergy, and Critical Care. She retired four weeks ago, writing on LinkedIn that “I leave behind friends and colleagues whose dedication is questioned and their value is undermined.”
“I know there is light at the end of the tunnel,” she added.
Seymour and Jafari are just two of the thousands of FDA employees who have left or been fired. In March, just weeks after his confirmation as Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr announced that he would eliminate some 10,000 posts at HHS —including 3,500 posts at the FDA.
By some estimates, and assuming that all of these proposed layoffs have been pushed through, the FDA would have suffered a 20% to 25% reduction in headcount, as per an accounting of the departures at the agency by Steven Grossman, policy expert and author of the FDA Matters Blog.
Aside from the staff cuts, Kennedy is also eyeing a drastic reorganization of the FDA, with plans to consolidate the regulator into just five offices, according to reporting from Endpoints News earlier this month.
In an interview with Harvard physician Jeremy Faust published on Tuesday, FDA Commissioner Marty Makary clarified that “there will not be a reorganization,” but added that “yes, we are consolidating travel offices, IT, and some other things that make sense for efficiency.” Makary said he “rejected” proposals to consolidate FDA units involved in product review.
Amid these disruptions and staffing exodus, the FDA earlier this week missed its deadline to release a decision for Stealth BioTherapeutics’ drug candidate, elamipretide, for Barth Syndrome. In a statement, the biotech announced that the regulator would not meet the PDUFA, with CEO Reenie McCarthy saying the company “hope[s] to gain more information on the revised action date in the coming days.”
