In this video interview, Ron Lanton, partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry.
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 would a potential increase in drug costs affect the clinical research industry?
Lanton: I think most likely it would reduce government sponsored clinical trials and not the industry sponsored clinical trials. You go back to the Sovaldi incident in 2013 where there was this huge drug price increase on that one drug, and everybody's like, “Oh my god.” And they were like, “Oh, well, the reason we did is because of better science,” and it's kind of the same reason here. Pharma has always said that increased drug prices are the result of higher R&D cost and better outcomes, so it's the same argument just presented here. I think if a drug increases for any other reason, the manufacturer would just simply pass that on and just add that cost into its market price, but I don't think this is the case for any government sponsored clinical trials. We've already seen cuts in research from the administration, and I think it's likely that HHS could use the issue of drug price increases as a way to further cut the funding for this. That's what I foresee.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
2 Commerce Drive
Cranbury, NJ 08512