The regulatory affairs community is facing a new wave of uncertainty following recent layoffs at key federal agencies, including the FDA, NIH, HHS, and CDC. Last week, we surveyed regulatory affairs professionals across the pharmaceutical and biotech industries to assess the impact of these recent layoffs. Our goal was to understand how these changes are affecting professionals today, what challenges they anticipate, and how they’re preparing to respond.
Disruption on the Horizon
While only 6.41% of respondents reported a significant direct impact on their work, a much larger segment—34.62%, acknowledged somewhat of an effect. Notably, 42.31% said that although they have not yet been impacted, they expect disruptions in the near future. This highlights a growing sense of anticipation and concern across the industry.
The Real Cost: Expertise and Oversight
When asked about the most pressing challenges stemming from the layoffs, nearly half of respondents (46.15%) pointed to the loss of institutional knowledge and expertise. This finding underscores the depth of concern about long-term impacts on the quality and continuity of regulatory oversight. Perhaps the strongest sentiment voiced in the open comments was concern over the departure of key figures like Dr. Peter Marks from the FDA, and the broader exodus of experienced division heads. As one respondent noted, “Peter Marks’ departure is a disaster for the FDA… these agencies will have difficulty staffing to adequate levels now.“
Other top challenges include:
- Increased workload for remaining staff (14.10%)
- Reduced oversight and public safety risks (10.26%)
- Delays in regulatory approvals (10.26%)
Only a small portion (6.41%) believed that these changes pose no major challenges, signaling a consensus that the layoffs will likely impair agency function. Respondents emphasized that this knowledge gap not only threatens operational efficiency but also poses long-term risks to the regulatory integrity of the U.S. system
Few See Upside
Despite efforts in some circles to frame downsizing as a means to increase efficiency, a strong 67.61% of respondents reported seeing no benefits from the layoffs. Just over 21% acknowledged a potential for reduced bureaucratic inefficiencies, and under 10% saw value in streamlining regulatory processes. Several comments reflected this cautious optimism:
- “Reduced operational costs could allow the agency to redirect funds to high-priority areas or modernize systems.“
- “In the disruption and reduced staffing, there may be a greater opportunity to influence.“
- “If the ultimate goal is to shift burden to private firms, there may be advantages to industry… though it comes at a cost to taxpayers.“
However, these views were tempered by skepticism: “This could have been done so much better and still achieved the goal of reducing the FDA.” Others were more direct, calling the effort “truly unacceptable without any rationale.“
This data paints a clear picture: While there may be marginal administrative gains, most professionals feel the losses far outweigh any potential benefits.
A Call to Action
In the face of these shifts, what should regulatory professionals do? Survey participants offered a resounding answer: Push for policy changes to improve funding and stability (67.61%).
Additionally, many emphasized the importance of:
- Strengthening public-private partnerships (35.21%)
- Leveraging automation and AI for greater efficiency (16.90%)
Only 7.04% felt no action was needed, indicating that the majority view these layoffs as a call to mobilize, innovate, and advocate.
With fewer regulators and less available guidance, many believe the onus will now fall more heavily on industry professionals. One respondent bluntly advised: “Get used to having less regulatory guidance; figure it out on your own.“
Several professionals shared actionable suggestions:
- “Bolster in-house regulatory affairs teams. Include clear summaries and well-supported data to make reviewers’ jobs easier.“
- “Consider hiring former FDA employees—they bring valuable insights.“
- “Prioritize public health and scientific talent. Knowing the regs isn’t enough—you must understand the science.“
- “Industry professionals must have strong science and quality backgrounds—regulatory knowledge alone is no longer enough.“
One common thread: proactivity is essential. As one respondent advised, “Maintain close communication with FDA project managers and monitor real-time agency decisions rather than relying on the press.“
The Bigger Picture: Public Trust and Policy Reform
Beyond operational challenges, several professionals raised concerns about the broader consequences of these layoffs: diminishing public trust, decreased confidence in regulatory bodies, and the erosion of U.S. leadership in global health policy.
“The layoffs have not been coupled with legislative changes to reduce regulatory burden,” one respondent wrote. “Massive deregulation would harm credibility, and I’m not in favor of that approach.“
Others suggested it’s time for the industry to not only adapt—but advocate: “Work to improve public perception of the value provided by NIH, FDA, and CDC.“
A Sector in Flux, A Community Responding
While it’s still “early days,” as multiple respondents noted, the outlook is already clear: the regulatory community is bracing for more turbulence, less support, and greater responsibility. But it’s also mobilizing—through stronger internal systems, closer industry-government collaboration, and persistent calls for smarter, more sustainable policy.
The message from the field is sharp and sobering: if federal agencies cannot be stabilized, the responsibility for safeguarding public health and regulatory integrity will fall increasingly on the shoulders of industry professionals. Preparedness, vigilance, and collective action will be critical in navigating this new era.
Now is the time to double down on collaboration, innovation, and advocacy to ensure regulatory integrity remains strong—even amid institutional upheaval.
At Dennis Partners, we understand the shifting regulatory landscape and the evolving demands on professionals across the industry. Whether you’re navigating new policy changes, strengthening internal capabilities, or building resilience into your compliance strategy, we’re here to help.
Want to talk more about what these changes mean for your team or your career? Contact us today.
