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> Could Upjohn's "problem" with "Labeling" be a characteristic(s) of > pramipexole that the FDA would require be disclosed on the label or on > the > data sheet that seemingly accompanies all perscription drugs? Could > these > characteristics not affect pramipexole's , in the strictest sense, > medication > effectiveness, but rather threaten its competitiveness/profitabilty in > a > market that seems to be very active with new, and purportedly > promising PD > meds? Could it be that the "delay" (timing) of the commercialization > of > pramipexole is not a result of FDA lethargy? > > Any knowlege, insights, or speculations are appreciated. > Don Hoesterey <[log in to unmask]> Don, That is my assumption as well. See my last post. Regarding the issue of labeling not only are they referring to the package insert but more importantly from a commercial standpoint they are referring to what the company can legally advertise that the drug does and what it doesn't do. So for instance if Upjohn wants to say that Pramipexole slows the progression of PD in addition to being a good treatment they must be able to prove it to the FDA's satisfaction. If the FDA would approve such a statement (and I am not saying that this is the issue at question) then obviously it would give the drug a significant advantage in the market place. Or if they were allowed to state that it does not cause a side effect like e.g. dyskinesia, that would also be to their advantage. If they advertise something that the FDA does not approve they can be in serious trouble. In the meantime while they are haggling we go without the medication. Charlie -- ********************************************************** CHARLES T. MEYER, M.D. MADISON, WISCONSIN **********************************************************