FDA: Going on defense..Is it hurting or helping patients?

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The pharma industry is suffering a dearth of new drug approvals thanks to an increasingly stringent FDA, according to a report released Wednesday. The Food and Drug Administration approved 38 new drugs through July of this year, down 31 percent from 55 approvals during the same period in 2006, according to a report from James Kumpel, analyst for Friedman, Billings, Ramsey. One has to ask if the delays in new drug approvals is providing a service or hurting patients? Read More...
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Do drug labels now need to be localized?

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In a way Shakespeare was right...shoot all the lawyers ! Let's face it, lawyers should be thanking the pharma industry for all the business they getting. The latest comes from a woman in Vermont who is suing Wyeth because the FDA approved label "didn't go far enough". She won a $6.8 million judgement but now it maybe up to the Supreme Court to determine if in fact there is any liability here. Read More...
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A new tactic for the FDA - Are they overstepping their authority?

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The Food and Drug Administration said proposed prescription painkillers should fill an unmet medical need for patients who have no other "relatively safer" alternatives, suggesting Merck & Co.'s bid to have a Vioxx-like successor drug approved in the U.S. faces a tough road. But who is to say that a new drug fills an unmet medical need for patients who have no other "relatively safer" alternatives ? This author feels that this action by the FDA is a dangerous precedent that could quickly lead to major issues for consumers, insurers and pharma companies. Read More...
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