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In a reponse I received from Janet Woodcock concerning the continuingdistribution of accutane under a patient waiver, or what she she callsrestricted drug distribution, she said that this is possible with lotronex.I cannot read into what she wrote; I can only assume that it is apossibility.The following is the offer that the FDA made to GlaxoSmithKline for arestricted drug distribution:This is a quote from the FDA TALK PAPER of January 22, 2001, concerning whatthe FDA offered to GlaxoSmithKline for continued marketing of lotronex:"FDA's view of the options included marketing withdrawal or or a restricteddrug distribution program. The restricted drug distribution program wouldprovide: (1) save use of Lotronex in appropriately informed patients, (2)continued access to Lotronex by severely delibitated IBS patients underclosely monitored conditions, and (3) continued clinical research into thebenefits, risks, and safe and appropriate use of Lotronex. The FDArecognized that the other available treatments for IBS may offer inadequaterelief from a condition that can be severely incapacitating for somepatients."Personally, I think that this is a better alternative for us to persue thanthe compassionate use program because the FDA offered it to GlaxoSmithKlinein January; because Janet Woodcock said it is possible; because it is usedwith accutane at the present time; and because it is much less cumbersomethan than the compassionate use program. However, I don't want to geteveryone confusedand going off in different directions. ANY THOUGHTS ON THIS? I just read WBrown's message that Glaxo will not do a compassionate use program.In light of that, I think that the restricted drug distribution program is a much betteralternative to begin lobbying for.Judy Graves[This message has been edited by Jeffrey Roberts (edited 02-20-2001).]