How Many People Still Work for FDA & Other FDA Thoughts
FDA’s responsibilities have not changed since January 20th. However, its capacity to carry out its duties has been meaningfully reduced by the Administration’s downsizing. We should all be able to agree on that.
It has not been clear how many people still work for FDA after the RIF and voluntary departures. How many employees are left to get the work done? That seems especially important to know[1].
Yet, in the absence of an announcement or the release of budget documents, we have been left in the dark.
I have been working with the assumption that there are 19,500 full-time equivalent employees[2], which is based on extrapolating from older budget documents and reflects the flat taxpayer funding and modest user fee increases in FY 24 and FY 25. My number should be reduced by the RIF announced by Secretary Kennedy (3,500) and the lay-offs and voluntary separations (reported to be 900-1000 but I have no confirmation).
That projects to roughly 15,000 remaining employees and is a 20% to 25% downsizing of the FDA workforce. Also, we can reasonably assume there are unfilled vacancies that occurred between July 1 and December 31, 2024. It is unclear if they are included in the 4,500 or are additional to it.
In contrast to my rough calculation of a 20% to 25% downsizing, one news organization is calling it a 15% downsizing of FDA. They did not include voluntary separations because that number has never been announced. Anecdotally, we know there are a lot of voluntary separations, but excluding them makes sense if we do not know whether it is 100 or 1000.
Further, that news organization was working from the Office of Personnel Management’s official FedScope database, which shows the FDA workforce in September 2024 as just under 21,000 (here). That is an official source, presumptively more accurate than mine. However, I cannot reconcile the OPM numbers with any data I have in my files[3]. Using their methodology, FDA might have as many as 17,500 FTE employees remaining.
How many employees are left to do the work is profoundly important. Yet, we have a discrepancy of 2,500 FTE employees between two good-faith estimates!
I am not sure my numbers are right. In fact, I hope that they are way too low.
I am not critical of the other analysis. It is a less speculative than mine and based on better documentation of January 1 staffing levels. However, it probably does not account for other sources of departures and may overstate the baseline headcount.
If somebody has better numbers, please let me know.
False Choices: Priorities Do Not Need to Compete
Based on his recent interview, Dr. Makary believes that the microbiome[4] is the key to many chronic conditions. Coming from a family with a long history of gastrointestinal diseases, this seems plausible, even intriguing.
However, “plausible and intriguing” is a reason to put more resources into a particular area of research……not a reason to put less into other areas that have already proven their value (e.g., cell and gene therapy).
Why would we choose one or the other, rather than pursue both?
The same could be said about two of Secretary Kennedy’s priorities. Why does an autism focus need to be framed in a way that diminishes other areas of research on childhood diseases? Why emphasize chronic disease as if infectious diseases no longer have the power to rapidly reshape human destiny.
To be clear, I favor more attention and investment in the microbiome, autism, and chronic diseases. In the process we should not lessen our efforts on cell and gene therapy, other childhood illnesses, and infectious diseases. We need to be able to find the resources to give proper attention to all of these priorities.
Applying Chesterton’s Fence to Industry Representatives on FDA Advisory Committees
I was quoted in BioSpace, this week, observing that:
Industry representatives on advisory panels do not vote; do not have a professional or monetary interest in the outcome; and have little ability to sway the outcome. Yet, they do provide a useful perspective that other panelists often value. Nonetheless, the appearance is jarring, and it is understandable that questions are being raised.
Missing from my quote and most of the public discussion has been a description of the benefits of including industry reps. Once companies deliver their presentations and answer questions, they must remain silent.
If the committee discussion misstates the company’s data or position, often the industry representative is the one who clarifies the company’s point and gets the advisory committee’s discussion back on track.
I do not see the tide turning in favor of keeping the industry representatives. However, I wish that someone had applied Chesterton’s Fence[5] first: do not take down a fence until you understand why someone put it up.
I have written several times about the other part of the problem: since RIF’s were random and arbitrary, is there any reason to think the remaining workforce has the needed distribution of expertise to match the agency’s responsibilities. https://www.fdamatters.com/fdamatters/rx-for-fda-an-agenda-for-the-commissioner
Full-time equivalent (FTE) is a way to standardize headcounts within a workforce. Two half-time employees equals one FTE.
I wonder if the dramatically higher OPM number counts total employees rather than FTE’s. Or maybe there are one thousand never-to-be-filled slots in the total that are now permanent vacancies.