The DOGE Workforce Optimization EO: Implications for FDA

The Trump administration has yet to issue anticipated U.S. Food and Drug Administration (FDA)-specific executive orders, but as we have previewed in other Advisories,¹ the executive orders that have been issued may have far reaching effects on the Life Sciences Industry and drug and device manufacturers in particular.

On February 11, 2025, President Trump issued the executive order (EO) titled, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative”² (the Workforce Optimization EO) which formally implements rumors that have been circulating concerning one of the administration’s stated goals of drastically reducing the size of the federal workforce. The executive order appears to apply to nearly all employees of federal agencies, including FDA as an establishment in the executive branch.³ Building upon previous Trump administration executive orders, it seeks to reduce the size of the federal workforce in two ways. The first will reduce the overall size of the workforce by requiring agency heads to prepare for large-scale reductions in force (RIFs). Second, the Workforce Optimization EO mandates that only one new employee can be hired to replace every four employees who leave.

As part of the Workforce Optimization EO, the Director of the U.S. Office of Management and Budget (OMB) is also required to submit a plan to reduce the size of the federal workforce. And the executive order requires each agency head to consult a “Team Lead” at the Department of Government Efficiency (DOGE) about whether career positions should be filled.

Recent executive orders supporting (and foreshadowing) this action include those challenging collective bargaining agreements executed in the 30 days prior to the inauguration,⁴ ending diversity, equity, and inclusion (DEI) and diversity, equity, inclusion, and accessibility (DEIA) policies,⁵ requiring development of a Federal Hiring Plan that emphasizes skill and dedication to the furtherance of American ideals, values, and interests,⁶ and establishing the DOGE.⁷ This executive order also follows the widely publicized deferred resignation offer and return to work requirements.

This latest Workforce Optimization EO instructs that certain federal employees be specifically targeted for RIFs, including those working on DEI initiatives and other initiatives or operations that have been suspended or closed by the administration. Employees not “typically” designated as essential and that otherwise do not perform legally-mandated functions should also be prioritized for RIFs. And employees engaged in public safety, immigration enforcement, and law enforcement functions are excluded, as are military personnel, though the executive order only defines “immigration enforcement” and “law enforcement” for purposes of the executive order.

What Does This Executive Order Mean for FDA and Industry?

The two major programs included in the EO, the hiring ratio and the large-scale RIFs, are both potentially far-reaching. FDA, with its more than 18,000 employees in the U.S. and internationally,⁸ was already grappling with hiring and retaining the number of highly qualified personnel necessary to conduct, among other things, timely reviews of medical products. Even before the Workforce Optimization EO, it was going to be difficult for FDA to maintain this workforce. The return-to-work order put strain on remote employees, to be sure, but also local employees who have been teleworking and office sharing due to space constraints on FDA’s campus since well before the pandemic. The new EO adds additional questions specific to whether and the extent to which positions funded by industry-paid user fees and funds appropriated in conjunction with those user fee programs are susceptible to RIFs and the 4:1 rule.

On its face, the Workforce Optimization EO says that it shall be implemented consistent with applicable law and subject to the availability of appropriations. There are good arguments that this should mean that positions funded by user fees are “safe” — and so, too, positions funded through user-fee-required appropriations. These positions are granted by law explicitly. The user fee authorities of the Food, Drug, and Cosmetic Act (FDCA) require that fees authorized by the relevant sections must be available to defray costs incurred in processing the respective applications, including costs of full-time equivalent positions.⁹ In other words, the statute says that the agency is authorized to hire a certain number or “enough” employees to carry-out the congressional intent of user fee legislation.

In addition, “essential” personnel for purposes of the Workforce Optimization EO can be reasonably interpreted to roughly parallel “excepted” employees with respect to government shutdowns. Under U.S. Office of Personnel Management’s (OPM) “Guidance for Shutdown Furloughs,” excepted employees include employees whose work is funded through user fees (not appropriations) and those whose work involves “the safety of human life or the protection of property or the performance of certain other types of ‘excepted work activities’ as defined in DOJ and OMB guidance.”¹⁰ The term “essential worker” has been used inconsistently across federal agencies in recent years, applying, for example, to grocery store employees and other non-federal employees during the COVID-19 lockdowns, and healthcare personnel that were unable to socially distance by the Centers for Disease Control and Prevention (CDC) for purposes of prioritizing vaccine access during the pandemic.¹¹ For these purposes, however, it seems that most — if not all — user-fee-funded positions can be characterized as “essential.”

Finally, there are good arguments that much of the work done by FDA employees should fall within the “public safety” exception to the Workforce Optimization EO. Stripping FDA’s food safety and blood-related operations of critical employees would certainly raise “public safety” problems — as would reducing inspections for food and medical products. So, too, undermining medical product reviews necessary to ensure that medicines and medical devices are safe and effective.

If the Workforce Optimization EO is interpreted aggressively vis-à-vis FDA, it will be impossible to maintain the volume and speed of the agency’s medical product review and other public safety work. This is particularly true if the current hiring freeze morphs into the EO’s 4:1 hiring ratio, which would effectively keep FDA understaffed and has the potential to undermine user fee goals and commitments. An understaffed FDA, particularly in the centers for drugs, biologics, and devices, may lead to greater review times and less ability for FDA to work interactively with sponsors — a stark reminder of the pre-Prescription Drug User Fee Act (PDUFA) state of affairs.

Recall that the era before the modern user fees programs at FDA was plagued by long review timelines and a paucity of engagement. As explained by former acting Commissioner Woodcock: “it could take years, for example, for a review division to address an application and then, just as inexplicably, it could be set aside for an unspecified amount of time before being picked up again as one group waited for another to complete its piece of the work.”¹² Industry had little or no access to reviewing officials; meetings were considered a privilege given limited resources and were rarely available.¹³ It was to solve those problems that, since the first PDUFA in 1992, Congress has authorized FDA to collect user fees for certain work related to drugs and devices under the FDCA.

For now, FDA remains open for new submissions and has thus far not curtailed any of its interactive review programs in response to staffing concerns.

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Arnold & Porter is closely monitoring the Trump administration’s executive orders as they are issued with a keen eye towards potential impacts on our Life Sciences clients. If you have any questions about the content discussed in this Advisory or would like more information, please reach out to one of the authors or your existing Arnold & Porter contact.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.