How FDA Cuts Are Creating New Bottlenecks in Clinical Operations

In a recent video interview with Applied Clinical Trials, Ron Lanton, partner, Lanton Law, discussed the impact of drug cost increases on clinical research, predicting a reduction in government-sponsored trials due to higher R&D costs and potential funding cuts. Lanton also touched on FDA inspection cuts and how they are expected to slow down the clinical trial supply chain, leading to longer approval times and reduced site readiness.

ACT: How could cuts to spending devoted to FDA inspections impact the clinical trial space?

Lanton: I think, despite assurances that inspectors would not be affected, the FDA layoffs that occurred last April eliminated a lot of support staff who handled a lot of visas and travel arrangements and other logistical operations of the inspections, and in doing so, that effectively made the availability of inspections go down, because inspectors are now responsible for an additional workload, so you can kind of see like a supply demand issue here. Fewer inspections will mean longer wait times for approvals, longer periods between clinical trial stages are going to happen. I think the longer the wait between that stuff, the bigger possibility that a site's private funding will also be cut or put on hold. I think that while demand for site partnerships from pharma sponsors that's at an all-time high of what we've been seeing, I think a reduction in site readiness will significantly slow down the entire clinical trial supply chain, which it's unfortunate.