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Posted By
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July 3, 2008, 1:46 pm
Flag as Inappropriate gbyrd
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Subject
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When it comes to the approval of new drugs, is there such a thing as too careful?
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I read on Forbes.com today that the FDA voted 14-2 to re-evaluate a new diabetes drug. The panel insisted that the manufacturers test the drug for several more years in 2,000 diabetics without heart disease before the drug would gain approval.
I think this is great, and will set a precedent of a more strenuous approval process. The FDA's lax standards have hurt a lot of people in the past. Even if the extra safety steps ad what the experts are saying will be around six months onto the approval process, and costs the drug companies a little more money (which I am sure they can spare), I think it is worth it when all is said and done. Better safe than sorry.
Here’s the story
http://www.forbes.com/home/2008/07/03/fda-nissan-diabetes-biz-healthcare_mh_0703diabetes.html
What do you think?
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Comments
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July 3, 2008, 6:36 pm
Flag as Inappropriate Philbo says...
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I applaud when a regulatory body follows up on genuine concerns. Too often potential problems have been ignored in favor of getting something on the market just to get something there that might work or the money involved.
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July 3, 2008, 7:32 pm
Flag as Inappropriate BabeRuth says...
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It's about time that they actually tested something properly. I have been quite horrified at how poorly testing and evaluation has been in the past, and the trend was towards becoming increasingly lax as time went on.
It's time this happened.
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July 4, 2008, 8:46 am
Flag as Inappropriate John says...
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The stakes are too high to do anything less. There have been far too many recalls and lawsuits after the fact because somebody dropped the ball in their rush to market.
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July 4, 2008, 9:41 am
Flag as Inappropriate ewills says...
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Its nice when someone does the job they are getting paid to do. I would much rather see drugs get approved a few months slower than have a unsafe drug on the market harming people. This is a baby step in the right direction for the FDA.
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July 5, 2008, 4:31 pm
Flag as Inappropriate Upstairs_Mommy says...
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I think meds should be tested and tested and tested again! However, if it appears that is the only thing that will save the life of people who will be long in the grave before it ever gets approved, then it should be allowed for them even while still testing. I mean really...if you had a terrible terminal illness of some sort (such as full-blown AIDS for example) and they found a miracle cure drug, but they would have to spend 10 years or so testing it would you want to wait? Chances are you couldn't. And even if it creates another problem...isn't it better than being dead?
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