U.S. Federal Health Agency Layoffs Pose Strategic Risk and Disruption to Life Sciences

Across recent client conversations, one theme is clear: the ripple effects of U.S. federal health agency layoffs are compounding with pressures like the IRA, tariffs, defunding, and budget constraints—making it harder to determine what to prioritize next.

Companies are asking: “Am I behind? What are others doing?” From launch delays at the FDA to supply chain strain and evolving patient access challenges, leaders are assessing what scenarios will impact them most—and how to respond with agility. Whether it’s a small transformation or sweeping change, now is the time to plan decisively and navigate with resilience.

Our executive summary below explores the regulatory disruption underway and the strategic considerations for life sciences companies to remain proactive, patient-centric, and resilient.

Executive Summary

Impact of U.S. Federal Health Agency Restructuring on Pharma and Biotech

Recent sweeping layoffs across U.S. health agencies—FDA, CDC, NIH, CMS, and HHS—represent a major disruption to the regulatory and scientific ecosystem that life sciences companies operate. With an estimated 10,000 job cuts, including experienced reviewers, researchers, and policy leaders, companies should prepare for regulatory delays, decreased collaboration opportunities, and increased market access challenges.

Key Impacts by Agency:

• FDA: Slower drug and biologic approvals, delayed sponsor meetings, and potential inconsistencies in regulatory guidance.
• CDC: Disruptions to disease surveillance, vaccine implementation partnerships, and health equity initiatives.
• NIH: Reduced research funding and public-private collaboration, especially affecting early-stage and rare disease innovation.
• CMS: Delays in reimbursement policies and coding determinations, impacting patient access and commercial uptake.

Opportunities For U.S Pharma and Biotech Amid Changing Landscape

• Greater industry leadership in setting standards and shaping policy
• Expanded role for private capital and consortia in driving early innovation
• New models for public-private collaboration in areas like decentralized trials and digital health
• Incentive to modernize internal capabilities for regulatory and evidence generation

Recommended Actions to Mitigate Disruptions

• Scenario-plan for launch delays and regulatory bottlenecks
• Strengthen internal regulatory and policy functions
• Expand real-world evidence and HEOR infrastructure
• Increase proactive external engagement with policymakers and stakeholders
• Redesign operating models for resilience and agility

Conclusion

This marks a pivotal shift from government-guided progress to private-sector leadership in life sciences innovation. Companies must act decisively to safeguard development pipelines, adapt commercial strategies, and maintain momentum in delivering patient value amid a more unpredictable U.S. regulatory environment.

Download a copy of the summary here.