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Subject:  Re: Bayer & Cipro Date:  1/29/2002  9:38 PM
Author:  ghost102 Number:  147 of 898

I must say as a former FDAer and current regulatory affairs specialist in the Biz, I am dismayed with your portrayal of an FDA and Company collusion to keep other foreign drugs off the market. The FDA has approved a lot of drugs that are manufactured in whole or in part outside of the united states, these manufacturing facilities are inspected by FDA inspectors to ensure that the product is manufactured as it is supposed to be with appropriate components. There are a lot of good manufacturers outside of the states, there are also a lot of generic manufactures outside the states that would not pass an FDA inspection with respect to quality of the product or control over their process.

With respect to the european market, the reason prices are so low there, is that the governments set the prices through the mechanism of socialized medicine. Companies do sell outside of the states because some money is better than no money, but the cash cow is and will continue to be the united states where without socialized medicine companies are free to charge what the market will bare. We are a rich country and have been willing to shell out a lot of money for new and brand name drugs. I am not saying that private companies do not collude with generic manufacture's, this has been shown to be true, often times big pharma companies will pay a generic company to stay off of the market.

Hope this perspective helps, let me know if you have questions, am new to TMF but have read a lot of posts in other places that indicate that a lot of people do not understand the drug discovery, review and approval process and would like to provide some insight if that is wanted.
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