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Drugmakers with Triangle ties wait for FDA to rule

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#1 Jeffrey Roberts

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Posted 06 March 2011 - 12:48 PM

Drugmakers with Triangle ties wait for FDA to ruleMarch 6, 2011BY ALAN M. WOLF - Staff WriterThe News & ObserverFederal regulators approved 21 drugs last year, the smallest total since 2007, and the tougher stance could have a dampening effect on the Triangle's economy.The Food and Drug Administration is under pressure to protect patients, especially in the wake of high-profile health problems caused by controversial medicines such as the painkiller Vioxx and the diabetes treatment Avandia.But increased scrutiny by the FDA is creating more uncertainty among drug developers and investors. Those worries could weaken interest in research and lead to less investment and fewer jobs at local companies....Patients accept riskHealth advocates and other critics say the FDA's tougher policies toward new drugs are long overdue and are saving lives. But many patients and physicians say it's causing hardship.Some diseases, including lupus and irritable bowel syndrome, or IBS, have limited treatment options. And people who suffer from such ailments say they're willing to accept risks that come with almost every drug.Salix's Xifaxan is already approved to treat travelers' diarrhea and hepatic encephalopathy, a rare liver condition. The results of a major clinical trial, which the New England Journal of Medicine published in January, showed success in treating IBS.Since Salix announced that the FDA would likely delay approval of Xifaxan for IBS and require further testing, doctors, patients and patient advocacy groups have been lobbying the agency and Congress.Several other promising medicines for IBS have been blocked or delayed by the FDA, Jeffrey Roberts, president of the IBS Self Help and Support Group, wrote in a letter to the agency. The group has 41,000 members."I believe (again) there is a lack of understanding about the quality of life issues facing an IBS patient each and every day and the risk(s) that IBS patients are willing to accept for access to a medication," Roberts wrote.Full story >>© Copyright 2011, The News & Observer Publishing Company


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