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Old 11-22-2013, 12:49 AM   #7
sarah
Senior Member
 
Join Date: Sep 2005
Location: france
Posts: 1,648
Re: From the NEJM: The FDA's New “Breakthrough Therapy” Designation

Phil, that would be great. It's not always the FDA that slows down approval, sometimes it's their medical advisory board, in fact there was a case recently where the FDA approved a drug - pain drug I believe - over their medical advisory board's wish not to approve. I wonder how many drugs they have to check on each year? That's why I feel more bodies might work but as you say, they'd have to be the right kind.
I totally agree that seriously ill patients should be allowed to get drugs more easily - if the patient is willing to risk their life to try and save it, the wish should be honored. The lottery of getting into a trial is too difficult and stressful. I understand the FDA's responsibility but there could be an out of trial or some such method in place to allow patients the freedom to get early drugs that show promise. The 3 stage trial is very slow and expensive. There are so many completely new type drugs being worked on (immunology) that will complicate this process but show promise. Thank goodness the US government had the intelligence to pay for the Genome Project which has helped scientists all over the world work on more presicely targeted drugs. I wonder if today that funding would have been approved. Let's hope the next "Herceptin" and "TDM1" is coming soon.
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