In response to Jacob's question: pramipexole (brand-name: "Mirapex") is still
under review by the FDA. We believe that copy for the package insert
(normally, the final hurdle prior to FDA action) was submitted as early as
last December and resubmitted with changes (following FDA comments) in early
January. That was more than three months ago.
Although technically the FDA is entitled to hold a new drug for up to six
months before acting (meaning action can legally be delayed until late June
1997), it is unclear why such a long time should be necessary in this case.
This is the kind of query ("my constituents are asking why a promising
medication is being held for so long") that your member of Congress could
handle very well. And FDA responds well to members of Congress.
- Robin Elliott, Executive Director, Parkinson's Disease Foundation
