What the HHS Layoffs Mean for Biotech and What Companies Should Do Now

What the HHS Layoffs Mean for Biotech and What Companies Should Do Now

The U.S. Department of Health and Human Services (HHS) has undergone a dramatic reorganization in 2025, with sweeping layoffs that have affected thousands of professionals across the FDA, NIH, CDC, and other critical agencies. Nearly 3,500 positions at the FDA alone have been eliminated, including key roles in drug review, clinical guidance, and CMC oversight. The effect across the biotech and pharmaceutical industries is already being felt—and the consequences may be long-lasting.

As the regulatory system reels from workforce losses and program disruptions, small to mid-sized biotech companies are especially vulnerable. Delays in clinical guidance, extended review timelines, and a lack of institutional continuity at regulatory agencies pose serious risks to development pipelines. However, proactive planning and strategic regulatory consulting support can help mitigate the impact.

The Potential Impact on Biotech

From postponed IND and BLA submissions to missed funding milestones, the layoffs are introducing a new level of uncertainty. Companies are already facing slower FDA turnaround times for feedback, increased Complete Response Letters (CRLs) due to inconsistent or delayed CMC and data reviews, and difficulty reaching subject matter experts for regulatory clarification or pre-submission advice. As some agencies attempt to restructure internally, the regulatory environment is now fluid and difficult to predict. But there are steps companies can take now to adapt and maintain momentum.

What Biotech Companies Should Do Now

For resource-limited small to mid-size companies, adjusting to the impact of regulatory restructuring will require strategic action and external support. Companies should consider the following steps:

1. Reassess submission timelines.

Building in a six-to-nine-month buffer for regulatory submissions allows teams to accommodate delayed meeting feedback, prolonged review cycles, and the impact of agency staffing shortages. Development plans, investor communications, and operational budgets should all reflect this new reality.

2. Bolster CMC documentation and regulatory readiness.

A significant number of recent FDA rejections have been tied to CMC deficiencies, making it crucial to have comprehensive and defensible documentation in place. This includes process development summaries, analytical validation reports, and risk-based control strategies. For early-stage companies, it is especially important to ensure their CMC content aligns with evolving expectations. With deep expertise in CMC strategy, Pharmefex can help author and review critical modules to ensure readiness and reduce the risk of delays.

3. Explore alternative global regulatory pathways.

Relying solely on U.S. approvals in the current environment carries significant risk. Sponsors should consider submission strategies through the EMA, MHRA, Health Canada, or collaborative programs like Project Orbis. These may offer more predictable timelines or fast-track opportunities, especially for high-priority indications.

4. Engage experienced regulatory consultants.

With FDA reviewers and leadership in flux, continuity must come from partners who understand both the science and the process. Pharmefex provides expert support across submission planning, CMC risk assessment, briefing package development, and agency communication—ensuring your program stays on track even amid external disruption.

5. Monitor the legal and policy landscape.

As litigation and regulatory reversals continue, biotech firms must stay agile. Pharmefex can assist with tailored regulatory intelligence updates and scenario planning to help companies pivot strategies quickly and effectively.

How Pharmefex Supports Regulatory Continuity

As a leading regulatory and CMC consulting firm, Pharmefex offers the continuity and expertise biotech companies need in times of uncertainty. Our team provides comprehensive regulatory strategy development, submission planning and authoring, CMC documentation support, FDA meeting coordination, and global market alignment. Whether you're preparing an IND, CTA, or BLA, we work with you to anticipate challenges, reduce regulatory friction, and accelerate progress. Check our services on our site.

Conclusion

The HHS and FDA layoffs have reshaped the regulatory landscape for the life sciences industry. But with strategic foresight, flexible planning, and the right consulting support, biotech innovators can continue to advance. Whether you’re preparing for a first-in-human trial or a pivotal BLA submission, Pharmefex is here to help you navigate these challenges with clarity and confidence.

Reach out to us to discuss how we can support your next regulatory milestone.