To Ease Or Not To Ease: FDA Panel Votes To Loosen Avandia Restrictions

After an intense two-day meeting that illustrated the challenges in determining drug safety, a divided FDA advisory panel voted to ease restrictions on the use of the controversial Avandia diabetes pill, which has been under the equivalent of regulatory lock and key for nearly three years. Of the 26 panelists, 20 voted to either remove or somehow modify the existing REMS, or Risk Evaluation and Mitigation Strategy, which was established in 2010 following a protracted controversy over the extent to which the GlaxoSmithKline drug causes serious cardiovascular events. That debate emerged after a 2007 meta-analysis found a 43 percent greater risk of causing heart attacks and strokes (see this and this). Despite the vote, uncertainty remains. The panelists were not in agreement on how to ease the REMS, one of many the FDA established in response to drug safety scandals. The Avandia program contains a medication guide and another component known as ETASU, or elements to assure safe use, which spells out terms for physician participation, patient enrollment and distribution requirements for pharmacies (here is the Avandia REMS). “I do feel we should continue with the medication guide and communication strategy, and maybe it’s possible to eliminate the ETASU or soften it,” said Marvin Konstam, a panelist and director of the cardiovascular center at Tufts University School of Medicine. “This shifts the burden to physicians and allows him or her to use their judgment.” He was...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs