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"Dear Ms. Lewis:We at GlaxoSmithKline appreciate and share your frustration with a process and statements that may be confusing. It is important to understand that Glaxo Wellcome proposed a range of elements to FDA that we believed would adequately and effectively address potential risks with Lotronex (aloesetron HCl). The FDA disagreed as to the adequacy of these programs and proposed more restrictions that would limit the availability of the drug to a very small patient population, and would require us to oversee physicians' prescribing of Lotronex. But we strongly believe that the relationship between a physician and patient should be individualized, private and confidential, and not subject to interference from any pharmaceutical company.We are disappointed that there is confusion concerning the possibility of a compassionate use program.If you have any qustions concerning our company or products, you may call our Customer Response Center at 1-888-825-4249 during our normal business hours, Monday through Friday, 8:00 AM to 8:00 PM EST."At least the response wasn't canned and I can somewhat understand their position.
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