GAO to Enquire into FDA's Drug Approval Policies
Posted on: Thursday, 6 March 2008, 09:01 CST
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.
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.
Source: Datamonitor
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