As government reform efforts converge, significant FDA staff cuts are likely

Life Sciences | By Alexander Gaffney, MS, RAC

Feb. 10, 2025

President DONALD TRUMP’s administration is advancing a wide array of reforms intended to shrink the federal bureaucracy and otherwise reduce the power and influence of regulatory agencies. In the wake of these actions, significant FDA staff cuts are likely, making it harder for the agency to maintain its current operations – potentially reducing FDA staff capacity for regulatory reviews of new medical products.

  • As of FY2024, the FDA employed approximately 19,700 employees across its many centers, divisions and offices. Of those, 7,580 were employed by its drug review division, the Center for Drug Evaluation and Research (CDER), 1,643 were employed by its biologics division, the Center for Biologics Evaluation and Research (CBER), and 2,555 were employed by its medical device division, the Center for Devices and Radiological Health.
  • But in the coming weeks, a once-in-a-generation convergence of government reform efforts could substantially shrink the size of FDA’s workforce. Cuts to FDA’s appropriated budget, the use of budgetary impoundments, reforms to the U.S. civil service, White House-led reforms to working arrangements, and new leadership at key federal agencies – including the FDA – are all likely to leave the FDA with thousands fewer staff by the end of the year than when it started.

A catalogue of likely cuts

  • Over the next few weeks, the U.S. Department of Government Efficiency (DOGE) Service is likely to prompt many of the cuts. DOGE, created by President DONALD TRUMP by executive order on his first day in office, is an effort led by technology billionaire ELON MUSK through a renaming of the United Stated Digital Service. DOGE has already begun an attempt to dismantle whole agencies and their budgets, in at least one case by placing many to most employees of a targeted federal agency on paid administrative leave. These were the actions DOGE took this past week to wipe the staff roster at the U.S. Agency for International Development.
  • DOGE is also thought to be behind several communications to federal employees offering deferred resignation, an offer first tendered in the January 28 “ Fork in the Road” notice issued by the Office of Personnel Management (OPM). In short, it offered employees the chance to resign from government service by February 6 (the deadline has since been extended to February 10 under court order), and be paid through Sept. 30, 2025, the end of the fiscal year, with no expectation of meeting return-to-work requirements. Employees electing deferred resignation “should promptly have their duties re-assigned or eliminated and be placed on paid administrative leave,” according to guidance issued by OPM. However, thus far the offer has resulted in the voluntary resignation of fewer than 3 percent of federal employees, or less than half the number who quit or retire annually. Voluntary resignation figures for the FDA are not currently available. DOGE has also been cancelling some contracts between federal agencies and contractors, according to its posts on X (including funding to POLITICO and AgencyIQ), which could potentially decrease the number of contracted staff working at or with the FDA.
  • OPM is also telegraphing other likely cuts and changes, with some taking place soon. As a division of the Office of Management and Budget (OMB), OPM directs human resources and personnel policy for the federal government and its employees. Since the start of the Trump administration, a series of OPM memos have provided detailed roadmaps for implementing Trump’s executive orders, advancing immediate changes or announcing imminent significant change.
  • For example, all agencies were directed to terminate employees and offices focused on diversity, equity, inclusion and accessibility by late March 2025. OPM has also ordered employees back to in-office work, which for the FDA means that all leaders within 50 miles of FDA’s headquarters in Silver Spring, Maryland will need to return by February 24, and all other employees aligned to headquarters by March 17. Employees outside that range will have until April 28 to report to their nearest FDA duty station, POLITICO has reported. The order could prompt some FDA staff to leave federal employment rather than return to in-office work.
  • Other OPM orders hint at the possibility of future actions. For example, OPM issued a memo to federal agencies asking them to identify all employees on “probationary periods,” or those personnel who have only been in the competitive service for less than a year of service, or in the general service of government less than two years. Such employees are far easier to terminate, indicating that they might be targeted for widespread reductions in force. OPM also has implemented an Executive Order that will allow agencies to reclassify federal agency staff in policymaking roles (including FDA staff), thereby making them easier to terminate, as well as another order asking agencies to develop performance metrics for evaluating the federal workforce that might also be used as a pretext to terminate employees.
  • Congress is likely soon to take actions of its own that could accelerate FDA’s fiscal challenges, which would in turn lead to likely reductions in force. Republicans, who control both the House and Senate, are currently working on a new budget to take effect once the current continuing resolution expires at the end of the day on March 14, 2025. Right now, the Senate and House are figuring out the scope of their budget blueprint and the extent to which they expect to cut federal expenditures. With a razor-thin majority in the House of Representatives, Republicans don’t have much room for error in strategy. More details on the budget bill are expected to be published by the first week in March, although early reports indicate that some committees are targeting massive cuts to federal spending. If the FDA’s funding is slashed, it will likely cut spending and hence, staff.
  • More changes could soon be coming following the confirmation of RUSSEL VOUGHT as OMB director. Vought served as OMB director during the first Trump administration and is expected to take a hardline approach toward federal rulemaking and rule-makers alike. He quickly moved to shutter the Consumer Financial Protection Bureau by cutting off all funding for the agency through the impoundment process, where OMB directs that no funding go toward a specific program or agency. Impoundment is expected to be used widely by the Trump administration to put a halt to any programs it doesn’t agree with or to gain leverage over any uncooperative government employees. Vought has been quoted as saying he wants federal employees to feel like they’re “ in trauma,” and is otherwise intent on dismantling the administrative state.
  • New leaders could also facilitate or accelerate some cuts. ROBERT F. KENNEDY JR., who is expected to be confirmed as the next Secretary of the Department of Health and Human Services this week, has previously written on X that he feels the FDA has waged a “war on public health,” and has encouraged staff to “pack your bags.” In an MSNBC interview after the election, Kennedy also said he intends to clear out entire departments within the FDA. “In some categories of workers, there are entire departments like the nutrition departments at FDA, that have to go – that are not doing their job, that are not protecting our kids,” he said. While FDA Commissioner-nominee MARTY MAKARY has not publicly weighed in on FDA staffing, he has frequently taken a dim view of the agency’s expertise and in 2021 in an op-ed published in Fox News publicly called for changeover in FDA leadership. “For too long, FDA leaders have acted like a crusty librarian who gets annoyed when someone wants to borrow a book,” Makary said. He argued that FDA “needs a change in culture,” and said, “It’s time for our old guard medical leaders to step aside into advisory roles and let new scientists, ones who are not afraid to speak up, take charge.”
  • It’s possible that some cuts to the FDA could be coming shortly. Last week, the Wall Street Journal and BioCentury reported that the White House was drafting an order that could cut thousands of federal health workers who work for HHS. While White House officials have denied that such an order is in the works, BioCentury reported that – if published – the order could call for as many as half of all FDA staff to be terminated. The order also comes just days after federal managers were ordered on short notice to rank their staff based on whether they were mission critical (10% of staff), important (50%) or not mission critical (40%), according to reporting by the Washington Post. Reports indicate that some managers had less than an hour to complete the rankings, which were reportedly sparse in detail.

Analysis

  • Any cuts to the FDA could have significant impacts on its ability to carry out certain tasks. The FDA hires specialized staff with deep experience in highly technical scientific fields, to carry out specific roles within the agency. Employees are thus not fungible, easily replaced units. Depending on which staff leave and under which conditions, the FDA may find itself losing disproportionate numbers of staff in certain hard-to-replace fields. For example, CBER leadership have previously spoken about how remote hiring authority was useful for hiring reviewers for its gene therapy division. Staff departures could therefore create review bottlenecks for some products, even as processes might remain stable for others.
  • FDA’s unique funding structure has the potential to confuse fly-by reformers. Something apparent in the aftermath of the overhauling of USAID and the CFPB is the speed at which changes happened and the lack of regard for staffing and programmatic consequences. The FDA’s user fee funding accounts for significant portions of its budget, meaning that cuts to user fee-funded personnel wouldn’t actually save taxpayers any money. For example, according to FDA’s FY2025 budget request, out of 7,580 CDER staff budgeted in FY2024, 5,297 of those staff were paid for through user fees (69.9%). For CBER, 812 out of 1,643 employees are funded by user fees (49.4%); for CDRH, 1,020 out of 2,555 are funded by user fees (39.9%). Any cuts to non-user fee-funded staff would therefore have a disproportionate impact on medical device reviews and biologics reviews as compared to drug reviews.
  • Cuts to FDA could trigger an outcry in ways that other budget cuts or reforms wouldn’t. Most Americans aren’t directly affected by USAID and may not be familiar with the work of the CFPB. Even if they know the NIH, they might not feel its effects immediately unless they work in research fields. But the FDA regulates foods, and everyone eats food. The FDA regulates medicine, and everyone knows someone who’s sick. Any impacts to FDA that negatively affect its ability to oversee food safety, product availability or the approval of a promising new drug or device may well be met with political pushback. Patient advocacy groups are among the most well-connected groups on legislative issues, and health care innovation remains one of the only political issues that consistently attracts support from both Republicans and Democrats.
  • Cuts to FDA staffing or programs could also attract unique and unwanted attention to DOGE. Elon Musk has medical products in development that are subject to FDA review and regulation. It’s not clear if that familiarity is likely to strengthen the resolve of DOGE and its leader to make changes to the FDA, or if it could shield it from the sort of indiscriminate cuts that DOGE has inflicted upon other agencies.
  • Staffing cuts would come at a time when the FDA’s reputation has fallen. In one 2025 survey conducted by the Kaiser Family Foundation, just 53% of respondents expressed either a great deal or a fair amount of trust in the FDA to “make the right recommendations when it comes to health issues.” Just 39% of Republicans expressed that same amount of trust, compared to 71% of Democrats. The FDA’s reputation has taken a series of hits in recent years, including an erosion of trust following the Covid-19 pandemic, negative attention related to shortages of infant formula and drugs, and increasing rates of skepticism in vaccine safety. Bearing in mind these shifts in public perception, it’s not clear if the FDA can count on an outpouring of public support to staunch the impact of any future staffing cuts.
  • Incoming leaders also seem unlikely to be advocates for FDA staff. Kennedy has a notoriously dim view of the FDA and its staff, and is likely to push for cuts to the agency. Makary doesn’t have much first-hand or in-depth experience with the FDA, and his public comments about the agency have generally been negative. While a leader with FDA experience and deep political connections – such as a leader in the mold of former FDA Commissioner SCOTT GOTTLIEB – might be able to argue against some cuts or position FDA to be a booster of the Trump agenda, Makary seems unlikely to pursue that course of action. And given Trump’s posture toward the agency during his first term – when he once blamed the agency for losing him the election – it would take some exceptionally strong advocacy to defend the FDA from impending cuts.
  • Defending FDA’s staff from cuts may be especially difficult given how specific and esoteric some of their tasks are. An example: “Regulatory science” is the application of scientific methods to regulatory decision-making to assess a product’s quality, safety and efficacy in specific populations. Applying regulatory science principles allows the FDA to accelerate its assessment and review of products, reduce the use of animal testing, and improve product safety – all noble and popular goals. But the term “regulatory science” is a foreign one to most laypersons, who are more likely to fixate on the term “regulatory,” which conjurs notions of unnecessary bureaucracy. And with anti-regulatory landing teams from DOGE expected soon to arrive at the FDA, “regulatory” science could quickly be in their crosshairs. It’s not a farfetched idea that the FDA’s National Center for Toxicological Research (NCTR), which conducts much of the agency’s regulatory science work, could be hard-hit, as could the agency’s contracts in support of its Centers for Excellence in Regulatory Science and Innovation (CERSI).
  • The bottom line: The next few weeks and months are likely to be exceptionally turbulent for FDA staff. That turbulence is likely to result in significant numbers of FDA staff, likely numbering in the thousands, departing the agency. Those departures will likely have negative, and uneven, impacts on medical product reviews, with greater impact on specific product types, depending on which staff are dismissed or resign. While the agency is likely to be spared from some of the draconian cuts now decimating some other federal agencies, it is unlikely to escape unscathed.

To contact the author of this analysis, please contact Alexander Gaffney ( agaffney@agencyiq.com)
To contact the editor of this analysis, please contact Kari Oakes (koakes@agencyiq.com)

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