http://blog.pharmtech.com/2011/04/04/how-accountable-are-makers-of-generic-drugs/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2011/04/04/how-accountable-are-makers-of-generic-drugs/comment-page-1/#comment-36290 malcolm ross Fri, 08 Apr 2011 08:37:51 +0000 http://blog.pharmtech.com/?p=4012#comment-36290 I have never seen or heard such muddled thinking over this issue in my life. The whole concept of generics is that they are legal copies of branded products. The branded products are many times more expensive than the generic because, quite rightly, they take the risk of the product failure. The generic industry has an absolute responsibility to make sure that the product they manufacture is safe, cGMP, and identical to the brand in its quality and safety attributes. The whole significance here is identical. If you expect relabelling, then this must be done from a professional appraoch based on the generic companies data...which of course is probably less than 1% of the data available to the brand. So all in all, there is no value in the argument that the generic should relabel...i.e. be better than the brand. It would of course mean that the generic companies would have to add insurance cover which will mean that they will have to put up their prices to cover this. All in all a no win situation for the patient, the generics company, and federal funds. WHo wins, the branded companies..why am I not suprised? I have never seen or heard such muddled thinking over this issue in my life. The whole concept of generics is that they are legal copies of branded products. The branded products are many times more expensive than the generic because, quite rightly, they take the risk of the product failure. The generic industry has an absolute responsibility to make sure that the product they manufacture is safe, cGMP, and identical to the brand in its quality and safety attributes. The whole significance here is identical. If you expect relabelling, then this must be done from a professional appraoch based on the generic companies data…which of course is probably less than 1% of the data available to the brand. So all in all, there is no value in the argument that the generic should relabel…i.e. be better than the brand. It would of course mean that the generic companies would have to add insurance cover which will mean that they will have to put up their prices to cover this. All in all a no win situation for the patient, the generics company, and federal funds. WHo wins, the branded companies..why am I not suprised?

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