Under new executive order, FDA to prep for DOGE-directed reductions in force
Life Sciences
| By Laura DiAngelo, MPH
A Feb. 11 executive order from President DONALD TRUMP calls for federal agencies to coordinate and consult with the Department of Government Efficiency (DOGE) to “shrink the size of the federal workforce and limit hiring to essential positions,” among other workforce reforms. This could place pressure on FDA hiring and retention, longtime challenges for the regulator.
Trump’s new executive order on “workforce optimization”
- The Department of Government Efficiency (DOGE), headed by ELON MUSK, has been working on several projects related to the federal workforce and staffing, as directed by various executive orders (EOs) issued in the first days of President DONALD TRUMP’s second term. One EO established DOGE by reorganizing and renaming the U.S. Digital Service (USDS, now U.S. DOGE Service). Another EO from January directs that “each Agency Head shall establish within their respective Agencies a DOGE Team of at least four employees,” with these in-agency DOGE teams directed to “coordinate their work with USDS and advise their respective Agency Heads on implementing the President’s DOGE Agenda.”
- A new EO expands the role of DOGE in the federal workforce. Issued Feb. 11, 2025, this EO seeks to implement a DOGE-led “workforce optimization initiative.” The order directs the DOGE team leads to take a bigger role in hiring plans and processes. The Director of the Office of Management and Budget (OMB) – recently confirmed RUSSEL VOUGHT – will develop a plan to reduce the overall size of the federal government, including a requirement that “each agency hire no more than one employee for every four employees that depart.” Agency heads are to collaborate with their DOGE team leads to develop a hiring plan “to ensure new career appointment hires are in highest-need areas.” DOGE team leads will also consult on hiring decisions, to include determining which vacancies should be filled.
- The EO also directs agencies to prepare for a reduction in force. “Agency Heads shall promptly undertake preparations to initiate large-scale reductions in force (RIFs), consistent with applicable law, and to separate from Federal service temporary employees and reemployed annuitants working in areas that will likely be subject to the RIFs.” The order prioritizes reducing staff working in areas related to diversity, equity and inclusion (DEI) and “employees performing functions not mandated by statute or other law who are not typically designated as essential during a lapse in appropriations as provided in the Agency Contingency Plans on the Office of Management and Budget website.”
- Agency heads are also directed to submit “reorganization plans” to OMB within 30 days – by mid-March 2025. The plans should outline the “statutorily required entities” within an agency and whether “the agency or any of its subcomponents should be eliminated or consolidated.”
- The EO allows for some exclusions via the proviso that “Agency Heads may exempt from this order any position they deem necessary to meet national security, homeland security, or public safety responsibilities,” while the OMB Director (Vought) can also “grant exemptions from this order.”
What does this mean?
- Regulatory agency workforce reductions have been expected under the new administration, as the new Trump administration has advanced a wide array of reforms intended to shrink the federal bureaucracy. One such measure was the Jan. 28 “ Fork in the Road” notice issued by the Office of Personnel Management (OPM). This measure offered employees the chance to resign from government service by Feb. 6 and be paid through Sept. 30, 2025, the end of the fiscal year, with no expectation of meeting return-to-work requirements. The deadline was then extended to Feb. 10 under a temporary restraining order that was dissolved on Feb. 12. The program is now closed, according to the OPM.
- DOGE has also been cancelling some contracts between federal agencies and contractors, according to its posts on X. [Note: Federal agencies also terminated subscriptions to POLITICO Pro and AgencyIQ.] These cancellations could potentially decrease the number of contracted staff working at or with the FDA, while OPM has ordered staff back to in-office work – a move that is expected to prompt some regulatory staff to leave federal employment. Further, agencies have already been directed under previous EOs to terminate DEI-focused employees and offices.
- This EO is not quite an across-the-board cut, instead deferring to both agency heads and their new DOGE team leads, a different circumstance from the potential for FDA-specific cuts that were reported in the Wall Street Journal and BioCentury last week. The Washington Post also reported that 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%).
- What could this mean for the FDA? That depends. Much of the FDA’s work is statutorily directed or would theoretically fall into the category of “public safety” – although the EO does defer to the perspective of the FDA Commissioner and the FDA DOGE team lead. Currently, diagnostics regulator and Principal Deputy Commissioner SARA BRENNER is leading the agency as acting commissioner, but she has not made any public statements about the agency’s direction under the new workforce paradigm. It’s also unclear who serves as FDA’s DOGE team lead, as names haven’t been added to any public-facing resources on agency leadership. It seems unlikely that Trump’s nominee for FDA Commissioner, MARTY MAKARY, would be confirmed and in seat by the time the reorganization plan is due in mid-March, so presumably Brenner will be leading this charge.
- There are some numbers we do know. Essential personnel – those who would stay at work even in case of a shutdown – may be spared from reductions in force under the EO. According to FDA’s 2025 contingency plan, “In the event of a lapse of appropriation, 15,223 (77%) of FDA staff will be retained including 12,878 (65%) who are exempt (their activities or position are already funded or otherwise exempted) and 2,345 (12%) who are excepted” from shutdown since their activities are “deemed necessary.” This means that, theoretically, 77% of FDA’s staff would not be prioritized for a RIF – but this doesn’t mean that the cuts wouldn’t reach the agency.
- The user fee funding system is likely to be a stumbling block for how the provisions of the EO would apply to the FDA. As AgencyIQ previously discussed, 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. Further, there are legal commitments to increase staffing in parts of the FDA’s workforce under its user fee agreements. For example, the current prescription drug user fee agreement (PDUFA VII) includes specific hiring targets by year, calling for 44 new full-time employees (FTEs) in 2025 alone. It’s not yet clear how this would work with the four-out-one-in staffing directives in the EO, or where user fee-committed and funded positions will fit on the FDA’s DOGE staffing plan.
- PDUFA VII also calls for the agency to publish a report about “FDA’s hiring and retention outcomes and which challenges remain” by June 30, 2025 – and to host a meeting on the subject in September 2025. While the FDA has its own legal obligations to increase hiring, improve retention and mitigate challenges with federal hiring for regulatory positions, all these issues will be directly influenced by the federal workforce reforms in coming months. And it’s not yet clear what the agency will do when faced with competing priorities from its user fee funding commitments and White House directives. However, this report and meeting are likely to provide a unique forum for FDA’s regulated industry to provide feedback on how agency staffing has been impacted.
- For now, non-user fee-funded work seems the most likely to face cuts. These include positions and workstreams funded through federal appropriations – which are also likely facing steep cuts in 2025 under the newly proposed budget package, per POLITICO reporting. The appropriations-funded activities at the FDA include regulatory science efforts, the Human Foods Program, operational activities like enterprise transformation and information technology (IT) upgrades, and supply chain efforts (see an explainer from the FDA here). However, the 2025 budget request has been taken down from the FDA website. Human foods and the supply chain efforts could, theoretically, be included in both “national security” and “public safety” categories of RIF-exempted staff, but the actual implementation of the EO will inform what that looks like. While the case could be made that FDA’s functions are largely outside of the directives in the EO since nearly 80% of staff continue working during a government shut down, user fee-funded work reduces the agency’s budgetary blueprint, and many of its oversight responsibilities serve both “national security” and “public safety.” It will depend on the agency – and HHS – leadership to make that case, which will depend on their own priorities and perspectives for the agency.
To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com).
To contact the editors of this item, please email Karen Early ( kearly@agencyiq.com) or Kari Oakes ( koakes@agencyiq.com).