What Patient Harm? FDA Slams Shionogi, Inc. for Not Preparing Studies

Published: May 28, 2013

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File this under ‘what chutzpah!” Last September, the FDA informed Shionogi that two clinical trials would be required after a serious risk of an irregular heartbeat was associated with its Rybix painkiller. The agency informed the drugmaker that a draft protocol was due this past February and a final report was expected by September 2014. But last November, Shionogi told the FDA to forget about it. Why? The drugmaker wrote the agecncy that “the costs of participating in the PMR (post-marketing requirement… were not commercially justified based on the sales potential for Rybix.” Never mind that patients may have been harmed, Shionogi did not want to invest the resources to determine the cause of the problem.

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