ACT Brief: Policy Shifts, FDA Inspections, and Tariffs Pose New Challenges for Clinical Trials

Welcome to the ACT Brief, your quick update on the top conversations shaping clinical trials and operations.

In this episode, we’re sharing highlights from a video interview with Ron Lanton, partner at Lanton Law, who spoke with Applied Clinical Trials about some of the policy and market forces that could reshape the research landscape.

First, Lanton discussed the potential impact of rising drug costs. He noted that while industry-sponsored trials are unlikely to be directly affected, government-sponsored trials may face further cuts. Drawing parallels to the Sovaldi pricing debate in 2013, he explained that manufacturers typically pass higher costs on to market prices. But he warned that federal agencies could use this moment to justify reducing research funding even further.

Next, we turned to FDA inspections. Lanton highlighted that last year’s staffing cuts have already created bottlenecks in scheduling and logistics. With fewer support staff and inspectors carrying additional workloads, fewer inspections are being completed. He warned this could lead to longer approval timelines, stalled trial stages, and increased risk of private funding being put on hold—slowing down the broader clinical trial supply chain at a time when demand for site partnerships is higher than ever.

Finally, Lanton addressed the impact of potential tariffs on active pharmaceutical ingredients. Because pharma relies heavily on global sourcing, tariffs would raise expenses across the board. He cautioned that companies may need to reallocate resources from R&D pipelines to cover these costs, ultimately raising the overall expense of running trials and creating further pressure on development timelines.

That’s all for this edition of the ACT Brief. Thanks for listening. For more insights and full coverage, visit appliedclinicaltrialsonline.com.