What Patient Harm? FDA Slams Shionogi For Not Preparing Studies

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 agency 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. But there is more. Instead of agreeing to withdraw the product immediately, Shionogi actually asked the FDA if shipments of existing stock could continue through September 2013, “or when unexpired inventory is depleted, whichever occurs first.”  In other words, the drugmaker wanted it both ways – forget about the study and sell down inventory, all at the expense of patients. Such an approach would seem to contradict the Shionogi mission, which is “working to deliver a better life.” In this case, the drugmaker would appear to have been working to deliver a bigger profit. This is not the first time that the FDA has slammed a drugmaker over post-marketing requirements, an issue that generated substantial criticism over concerns that drugmakers will fail t...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs