^^^^^^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
