The US Food and Drug Administration (FDA) is experiencing a significant staff exodus, with several senior employees leaving or being fired over the past few weeks. Some of these departing officials have decades-long experience at the agency.
The departures come as part of efforts by Secretary of Health and Human Services Robert F. Kennedy Jr to reform the FDA. In March, he announced plans to eliminate around 10,000 jobs across HHS, including 3,500 positions at the FDA. This would result in a 20-25% reduction in headcount.
Kennedy’s proposed reforms also include consolidating the FDA into just five offices. However, FDA Commissioner Marty Makary has stated that there will not be a reorganization of product review units.
The staffing disruptions have had an impact on the agency’s performance, with the FDA missing its deadline to release a decision on Stealth BioTherapeutics’ drug candidate elamipretide for Barth Syndrome. The regulator did not meet the PDUFA deadline, and CEO Reenie McCarthy hopes to gain more information on a revised action date in the coming days.
The FDA has faced concerns about its ability to function effectively with such significant staff changes. Many of the departing officials have expressed frustration at their departure, citing the value they brought to the agency.
Source: https://www.biospace.com/fda/fda-misses-another-deadline-amid-staff-exodus-structural-disruptions