FDA Staffing Constraints And Operational Risk In Clinical Supply

By Kevin Coker, JD, MPH, MS, innovation strategist, MD Anderson Cancer Center

Delays and reduced capacity at the FDA are changing how clinical trials are executed. Staffing shortages create tangible risks for timelines, manufacturing, and regulatory interactions and they interact with other external pressures in ways that magnify operational fragility. In my previous article, we explored how tariffs threaten the stability of clinical trial supply chains, increasing cost uncertainty and forcing earlier decision-making in sourcing, inventory, and logistics.

This second installment examines how FDA staffing constraints intersect with those supply pressures to create compounded risk for manufacturing decisions, regulatory timelines, and trial execution. The combined effect is that operational leaders must now navigate an environment where supply chain, regulatory, and trial execution considerations are inseparable. Understanding how these forces interact is critical for sponsors, clinical operations teams, and contract research organizations that aim to maintain continuity, manage risk, and ensure patient access under increasing uncertainty.

CDMOs, Manufacturing Capacity, And Hidden Risk

CDMOs are indispensable partners in modern clinical development, particularly for emerging biotech sponsors and advanced therapy programs. Tariffs affect CDMOs in several ways, most visibly through increased costs for imported raw materials, consumables, and single-use systems. These costs are often passed through to sponsors, either directly or through revised pricing models.

Less visible, but equally important, is the effect of tariff uncertainty on capacity planning. When input costs fluctuate and demand signals become less predictable, long-term investments in expansion or new technologies may be delayed. For clinical programs dependent on narrow manufacturing windows or limited-slot platforms, this hesitation introduces scheduling risk that is difficult to mitigate downstream.

Some sponsors are exploring relocating manufacturing to reduce tariff exposure. Indeed Eli Lilly as an example has committed billions of dollars to build multiple manufacturing plants across the United States. In practice, technology transfers introduce validation requirements, process comparability studies, and extensive documentation. Under constrained FDA review conditions, these transfers often extend timelines rather than shorten them, offsetting anticipated savings. The decision to move manufacturing is therefore not purely economic; it is regulatory and operational at its core.

FDA Staffing Constraints In Practice

While clinical supply chains are absorbing greater external risk, the FDA is operating with fewer personnel and reduced institutional capacity. Recent workforce reductions eliminated approximately 3,500 positions across the agency.¹ Even before those reductions, inspection and review capacity was under sustained pressure, with clinical inspection staffing declining by roughly 20 percent between fiscal years 2018 and 2022.²

For sponsors and clinical sites, these constraints show up in practical, day-to-day ways. Timelines for pre-submission and pre-IND meetings have lengthened. Feedback on protocol amendments and manufacturing changes often requires additional review cycles. Inspection scheduling for clinical sites and manufacturing facilities has become less predictable. Industry reporting has documented delayed or denied meeting requests as review staff absorb broader workloads.³

Individually, these delays are manageable. Collectively, they introduce cumulative schedule risk that is difficult to model. Oncology development magnifies this effect. Adaptive trial designs, dose-expansion cohorts, and biomarker-driven stratification are now standard practice rather than exceptions. Each adaptation depends on timely regulatory interaction. When review capacity is constrained, teams may delay improvements not because the science is unclear but because the regulatory path is uncertain. Over time, this dynamic can discourage innovation and slow adoption of more efficient trial designs.

Manufacturing oversight is similarly affected. Facility inspections that support clinical supply release, scale-up, or technology transfer may be delayed or rescheduled. For cell and gene therapy programs, where manufacturing slots are scarce and tightly sequenced, even modest inspection delays can ripple across multiple trials and sponsors.

Global Trials And Regional Divergence

Tariffs and regulatory constraints also complicate multinational trial execution. Import pathways, customs enforcement, and regulatory expectations vary by region, creating uneven risk profiles within a single study. In some cases, it may be easier to move investigational product into certain regions than into the United States, influencing site sequencing and enrollment strategy.

These regional differences complicate supply planning. Depot placement, labeling configurations, and shipping lanes must be balanced against local requirements and transit risk. When supplies arrive asynchronously, enrollment patterns may skew geographically, affecting data consistency and operational assumptions.

What Sponsors And Trial Leaders Should Consider Now

FDA staffing constraints are no longer abstract; the effect is actually shaping real execution risk. Sponsors and sites can adapt by recalibrating expectations and planning more intentionally, such as:

• Engaging regulatory strategy earlier in the process, particularly for manufacturing changes, technology transfers, and adaptive trial designs.
• Strengthening submission quality and documentation to reduce iterative review cycles that consume limited agency bandwidth.
• Building regulatory review variability into development timelines, especially for programs reliant on inspections, scale-up approvals, or protocol adaptations.
• Coordinating manufacturing and regulatory plans more tightly, recognizing that operational decisions are increasingly leading to regulatory consequences.

Looking Ahead

Tariffs and FDA staffing constraints are often discussed as external or temporary challenges. In practice, they are now shaping how clinical trials are designed, supplied, governed, and executed. The combined effect is not simply delay but a redistribution of risk away from predictable regulatory milestones and toward operational decision points that must be made earlier and with less certainty.

For clinical supply leaders, this shift raises important questions. How much optionality is enough? Where should inventory risk sit? Which decisions require earlier executive visibility, and which can still be managed tactically? These are no longer abstract considerations. They influence enrollment continuity, manufacturing strategy, and patient access in real time.

In the final article of this series, I will bring these forces together, including tariffs, regulatory capacity, and operational execution, and focus on how sponsors and trial leaders can build resilience across clinical supply and trial operations. I will examine practical approaches to risk management, governance, and planning that support continuity in an increasingly constrained environment. Watch for it and share your thoughts or reach out with questions.

References:

1. Bloomberg Law. FDA drug, device reviewers struggle after critical staff fired.
2. Government Executive. FDA clinical inspections are plummeting due to staffing issues.
3. Pharma’s Almanac. Silence at the FDA: Biotechs report delays, denied meeting requests amid staff cuts.

About The Author:

Kevin Coker, JD, MPH, MS, is an innovation Strategist and leads MedTech development at MD Anderson Cancer Center, the world’s top-ranked cancer center, and advisor to First Bight Investments, a venture fund/accelerator for synthetic biology and industrial biomanufacturing. Coker cofounded and was CEO of Proxima Clinical Research, a CRO ranked by Inc. Magazine as one of the fastest-growing companies in 2021 and 2022, earning more than 30 awards in its first seven years. He also founded M1MedTech, a virtual venture studio for medical devices, and co-hosted Inventing Tomorrow podcast. Coker has held senior leadership roles across biotech, MedTech, and clinical research, including board director at Volumetric Biotechnologies (acquired by 3D Systems), CEO of MolecularMatch, VP at Worldwide Clinical Trials, and VP, US Oncology Research at McKesson Corp. He holds degrees in biology, pathology, law, and public health and is certified in clinical molecular biology and U.S. regulatory affairs.