Because of my history of close association with various FDA Centers and Offices over my time at the FDA, as well as thirty years consulting for the industry and interacting with the FDA, I can’t help but think about our colleagues at the Agency. It has been reported that there has been a significant brain drain recently, with many talented people walking out the door. But while the rank and file may be worried about their jobs, the only refrain I’m hearing from inside the walls of the FDA is concern regarding the need to be able to complete the Agency’s core mission. Many worry not that they may be losing their jobs but, rather, with a significant reduction in force, how they will be able to maintain the mission of approving new drugs and biologics while continuing to approve high-quality, lower-cost generic drugs and biosimilars, and get them out to patients, in an effort to lower and contain prescription drug costs.

The FDA has always been mission driven. And I can tell you from experience that the goal is universally engrained in most (if not all) of the staff. What I am hearing is “how will we be able to meet the User Fee Goals if there is a significant reduction in force?” Not what you might expect to hear from people concerned about losing a paycheck, is it? The FDA has a very, very dedicated staff. I can tell you that when I was working there, it was not a 9to5 job. We often spent 10 to 12 hours in the office as well as a significant amount of time working at home, especially when there was a backlog of applications.

I also want to note that the great majority of the people at the FDA who have the ability to work from home actually spend much more than eight hours per day working. First of all, there is no commute time and there are fewer interruptions than in the office. Even as a consultant, I was much more efficient when working from home. The other big issue that the FDA faces is that there may not be enough physical working space at the FDA’s Bethesda campus if everyone is recalled to the office on a daily basis. Remaining flexible about the home/work schedule with appropriate monitoring of employee output should be a viable solution.

Another issue that has me worried is how any reduction in force will impact the FDA in all of its Centers, with a workload that includes review of drug applications, 510ks, and Premarket Approvals (PMAs) as well as (of course) onsite inspections of manufacturing facilities and laboratories. This concern extends to other organizational units within the FDA. In my opinion, any reduction in force should be mindful of the FDA’s mission and, perhaps, driven more by employee performance than just trying to universally meet a pre-defined number of employee reductions, which could impact the ability of the Agency to perform its many functions. One idea that is being floated relates to reviewing employee performance more keenly. I read a recent memo from the Office of Personnel Management (OPM) (here) that asks for information on employees who have less than satisfactory performance evaluations and requests information on whether these employees have been placed on employee improvement plans. While it is not clear how this information will be used, it appears that force reductions may be linked to low performance levels. I can tell you that, while I was at the FDA, it was extremely hard to remove staff who performed poorly from their positions. I agree with giving employees a chance to improve their performance by giving them tools for success, like placing them on improvement plans, but failure to improve typically leads down a rather long road before it is possible to be able take action on removal.

While I have no concrete ideas about how staff reductions will be carried out ultimately, the memo states, “To assist OPM in developing those metrics [relating to employee performance], no later than Friday, March 7, 2025, all agencies should submit data regarding their performance management plans and policies—including those contained in collective bargaining agreements— and identify any barriers to ensuring that 1) agency performance plans make meaningful distinctions based on relative employee performance and 2) the agency has the ability to swiftly terminate poor performing employees who cannot or will not improve.” Of course, many federal government employees are covered under collective bargaining agreements that offer significant protections against termination, but the idea of being able to more easily remove chronically underperforming employees likely will have some appeal to supervisors who must struggle within the process outlined in the current system.

No matter what happens with any reduction in force, many are confident that the administration will be cognizant of any potential downstream impact on government programs and the importance of agencies, like the FDA, that drive approval of products that save lives and can dramatically impact cost containment.