Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The Government Accountability Office or GAO, the investigative arm of US Congress plans to investigate the FDA drug approvals and FDA-ordered post-marketing studies, according to FiercePharma.
Subscribe to our email newsletter
The office intends to investigate the practice of using biomarkers such as blood sugar in diabetics and cholesterol levels among those at risk of heart disease, in evaluating efficacy. Following the request from the US senator Charles Grassley, the GAO may enquire into the effectiveness of the FDA’s follow-up policies for drugs that were approved by it.
The recent debacle of GlaxoSmithKline’s Avandia and of Merck and Schering-Plough’s cholesterol drug Vytorin has raised several concerns about the efficacy of biomarkers in drug trials to that of actual study outcomes. Healthcare experts contended that the FDA shouldn’t approve products without real outcomes studies.