Posted by naughtypuppy on April 16, 2007, at 8:36:02
In reply to Re: Stablon (tianeptine)?, posted by notfred on April 16, 2007, at 0:18:46
> > It's not just the pharma companies. My pdoc applied to the government to get tianapine imported was refused.
>
> Stablon has not been tested at all in the US, Foreign studies are not accepted by the FDA, to approve a new med. While this seems a PITA, there were no flipper babies in the US, due to the FDA's strict requirements.
>
> The rounds of testing are very expensive. Even if a patentable analogue was tested and approved, as
> Stablon is now off patent generic tianeptine could then be offered, using the existing studies on the analogue. So the pharma that pays for the testing
> does not stand to get any ROI. This is the way a business operates.
>
> As I said, the reasons are often complex.
>
> I think the gov needs to step in and do the testing on tianeptine, then we would have generics, as there would be ROI in offering them.
>
>
Well put. The government should at least fast track a med that has already been approved elsewhere.
poster:naughtypuppy
thread:749517
URL: http://www.dr-bob.org/babble/20070413/msgs/750223.html