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Ivan M Suzman wrote: > > ^^^^^^GREETINGS FROM^^^^^^^^^^ > Ivan Suzman 47/10 [log in to unmask] > Portland, Maine land of lighthouses 51 deg. F still not warm > ****************** > Dear listfriends, > > I am writing to share information which was passed to me by Sara > Holmbom, Portland aide to Republican Senator Susan Collins, about the > drug, pramipexole. > > Sara called to tell me that the FDA "has issues" concerning > pramipexole, the Upjohn Company's new dopamine agonist.. I am > personally trying to decide between pallidotomy, pramipexole, or > pallidal > stimulation, so I have, like many of us ,great interest in these FDA > "issues." > > Although Upjohn expects release of pramipexole to the general > public > by July 10, Sara said to me that "release might have to wait until the > issues are resolved." > > The specific issues are kept confidential under the Privacy Act of > 1974. This law protects Upjohn's privacy. > > The money Upjohn paid the FDA in August, 1996, is a fee that is > art > of a 1993 law to speed up the processing of an application to release > a > new drug, and is a normal fee, not "hush money," according to Ms. > Holmbom. > > As for people like Jacob Drollinger and myself and many others, > Sara > said that if there is either a "terminal illness" or a "very > debilitating condition," your DOCTOR has to contact both the FDA and > Upjohn, and request Upjohn to release pramipexole on a single > individual > basis. > > Ann Goodrich from Democratic Congressman Tom Allen's office called > this > an "IND" application for release of a drug to a single individual. > > SO, I don't think we'll be able to get pramipexole (Mirapex) at the > local > pharmacy until the FDA is satisfied about the "issues" still delaying > the > release of pramipexole I guess we'll have to get our doctors involved > in > phoning Upjohn and the Federal Drug Administration. > > Ivan Suzman > Portland, Maine IVAN, Thanks for the info re the pramipexole. That confirms what I had been told. The FDA is not necessarily the bad guy here. As much as I dislike the government bureaucracy and inefficiency sometimes they- the FDA- are our only protection from the snake oil salesmen. While what I have heard about the drug is good I wouldn't put it past Upjohn to be attempting to claim more about the drug than has been proven- or less if the labeling problem is regarding a side effect or risk. Regarding the money that has been paid by according to the FDA this refers to a program where the drug company pays the FDA for the cost of processing the application and in return the FDA promises to expedite the application. Hopefully that is not buying approval only expedited processing. We don't know all the facts here but I applaud your efforts pushing at the system until it works for us. I am sitting here in a wheelchair waiting for the release. Charlie -- ********************************************************** CHARLES T. MEYER, M.D. MADISON, WISCONSIN **********************************************************