Comments on: Novartis Slapped By FDA Over Exelon http://www.pharmalot.com/2007/08/novartis-slapped-by-fda-over-exelon/ News, Comment and Conversation Fri, 10 Feb 2012 20:00:35 +0000 http://wordpress.org/?v=2.6.2 By: Ed Silverman http://www.pharmalot.com/2007/08/novartis-slapped-by-fda-over-exelon/#comment-16982 Ed Silverman Wed, 15 Aug 2007 15:16:43 +0000 http://www.pharmalot.com/2007/08/novartis-slapped-by-fda-over-exelon/#comment-16982 Hi Bruce, Understood. I used the word 'unsubstantiated' only because that's how the FDA chose to characterize its take on the file card. Thanks for stopping by. ed Hi Bruce,

Understood. I used the word ‘unsubstantiated’ only because that’s how the FDA chose to characterize its take on the file card.

Thanks for stopping by.

ed

]]> By: Bruce Grant http://www.pharmalot.com/2007/08/novartis-slapped-by-fda-over-exelon/#comment-16980 Bruce Grant Wed, 15 Aug 2007 15:04:54 +0000 http://www.pharmalot.com/2007/08/novartis-slapped-by-fda-over-exelon/#comment-16980 Just for the record, Ed, having reviewed the file card, this is not a case of "unsubstantiated" claims but rather a quibble between FDA and Novartis as to how substantial the evidence supporting the claims is. All of the claims in the file card are referenced to study data...it's just that the FDA thinks the data isn't strong enough (or corroborated enough) to support the claims. In my 20 years of experience, FDA is on shaky grounds in these disputes about as often as they're on solid ground. In any event, this is a difference of opinion (which, as Mark Twain pointed out, makes a horse race) not a case of unambiguous wrongdoing. Just for the record, Ed, having reviewed the file card, this is not a case of “unsubstantiated” claims but rather a quibble between FDA and Novartis as to how substantial the evidence supporting the claims is. All of the claims in the file card are referenced to study data…it’s just that the FDA thinks the data isn’t strong enough (or corroborated enough) to support the claims. In my 20 years of experience, FDA is on shaky grounds in these disputes about as often as they’re on solid ground. In any event, this is a difference of opinion (which, as Mark Twain pointed out, makes a horse race) not a case of unambiguous wrongdoing.

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