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http://www.newsobserver.com/thursday/busin...7p-418561c.html (I don't know how long this story will be up so I'm putting up a few exerpts, and the archives may no longer be free)
quote:Ramona DuBose, a spokeswoman for GSK, said that both the company and the U.S. Food and Drug Administration have been deluged with pleas from doctors and people who had used Lotronex to make it available again."We were surprised with the numbers and the intensity of the patients' concerns over not having access to their drug," DuBose said.
Sounds like the campaign did get heard at GSK.
quote:DuBose would not describe in detail the nature of the talks between GSK and the FDA, which she said have been going on since January. She also declined to comment about the likelihood that Lotronex will be returned to the market.But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said that the discussion has accelerated in recent weeks.He said there is "a war going on" within the FDA over whether to allow Lotronex back on the market and, if so, under what conditions.
This may explain the latest PC thing, they think they are losing the battle to keep Lotronex off the market.
quote:DuBose of GSK said that appropriate safety precautions will be taken if Lotronex is brought back."If it comes back out," she said, "it will be in a way that both the company and the FDA believe will minimize risk and maximize benefit for patients." When GSK pulled Lotronex off the market, company officials said the FDA was seeking restrictions that GSK considered too severe. At the time, an FDA official said that the agency was open to restricting the use of the drug to the most severe cases of the syndrome.
Here is the author's info. he is a staff writer for the N&O.Staff writer Bill Krueger can be reached at 829-4522 or bkrueger###nando.com------------------I have no financial, academic, or any other stake in any commercial product mentioned by me.My story and what worked for me in greatly easing my IBS: http://www.ibsgroup.org/ubb/Forum17/HTML/000015.html
 

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I think I talked with Bill Kreuger when the drug was removed from the market. Interesting article...especially interesting are Dr. Wolfe's comments...my instinct is that things must be getting closer to resolution, and PC wanted to make a pre-emptive strike.Here's hoping things get worked out...Colleen
 

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K,I just wanted to commend you on all of the excellent information you regularly provide us. Whenever I need some solid info, I know I can look to you for accurate answers. Thanks so much for all of your hard work.Maria
 
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