Posted by bleauberry on April 17, 2010, at 10:58:21
In reply to Amisulpride - Why isn't it FDA approved?, posted by evenintherain on April 16, 2010, at 13:28:05
Others have already answered your question. It is too expensive a process to pass the FDA hurdles, and the drug is old enough that it can be made generic. Nobody is going to spend those millions of dollars to market a generic.
I wish new laws would be written to allow foreign drugs to become available in the USA pharmacies without going through the customary FDA process of newly developed drugs that do not have a track record. Some of the qualifying factors could be:
1. A track record of at least 10 years.
2. Widely prescribed.
3. As safe or safer than its USA counterparts.
4. A good body of scientific evidence.
5. Proven efficacy equal to or greater than its USA counterparts.The FDA serves a good purpose. But I believe their immense size, politics, and inner ego would prevent any thought of even acknowledging that other drugs around the world would benefit Americans in a big way.
poster:bleauberry
thread:943575
URL: http://www.dr-bob.org/babble/20100416/msgs/943689.html