Many people have written us asking for our advice on how to get in touch with the United States Food and Drug Administration regarding the availability of Tysabri.
If you would like to share your opinion with the regulatory body on whether this therapy should be made available again, please send a message to the FDA Center for Drug Evaluation and Research on their feedback site:
http://www.fda.gov/cder/comment.htm
It is not unheard for the FDA to listen to patient demand when considering the availability of a drug deemed potentially dangerous. A very interesting article in Business Week has this to say:
"The classic case [of successful patient lobbying] is GlaxoSmithKline PLC's (GSK ) Lotronex, for irritable bowel syndrome (IBS), a painful but non-life-threatening condition. The drug was suspended in 2000 when it was linked to a gastrointestinal illness that killed five people. After receiving thousands of letters from patients demanding Lotronex' return, the FDA allowed it in 2002, albeit with many restrictions. "It was clear from the letters we got that Lotronex was life-altering for these patients," says Theresa A. Toigo, director of the FDA's Office of Special Health Issues."
If you do/did happen to send a message, please take a moment to attach a comment on this post saying as much. It will be an interesting experiment to see if this is an avenue our community finds worthwhile...
Advertisement
Links
Link to FDA site for comments re: Tysabri:
Link to FDA status page on Tysabri
Link to Business Week article entitled: "Don't Ban my Drug!"
