Posted by JohnL on February 12, 2000, at 4:40:27
In reply to amisulpride and general FDA question, posted by Abby on February 11, 2000, at 18:45:32
FDA approval is a long and expensive process, involving millions of dollars. In the end, if the drug for some reason isn't approved, the company has lost millions of dollars on a failed mission. For example if Reboxetine is not approved, imagine how much time and money was lost in the effort. And in that case of Reboxetine, the failed approval would be based on certain wording on the insert? Ouch. That's a huge expense and a risk not all are willing to take. I suspect the pharmaceutical company that makes Solian (Amisulpride) is too small a player to afford the expense or the risk. They have their drug approved in other parts of the world where there aren't so many expensive roadblocks. In addition, my pdoc told me that the USA is hindered by excessive litigation. Too many greedy victims (some legit, some not) hiring greedy lawyers. Too much litigation. This is yet another roadblock that causes pharmaceutical companies to hesitate. It's too bad, because Solian is a wonderful drug with few side effects.
But for anyone interested, it is available legally even in the absence of FDA approval. A Swiss pharmacy can mailorder it with a valid prescription. I know of several neighboring European pharmacies that can mailorder it to your door in ten days with a valid (or even not so valid) faxed prescription. On the green customs label on the shipping box it will say 'prescriptin medicine for personal use, prescription included'. Sure enough, a copy of the faxed prescription is inside the box for customs to see if they so desire. No prob.
poster:JohnL
thread:21185
URL: http://www.dr-bob.org/babble/20000209/msgs/21245.html