Comments on: Abbott Pays $22.5M To States Over TriCor http://www.pharmalot.com/2010/01/abbott-pays-225m-to-states-over-tri-cor/ News, Comment and Conversation Fri, 10 Feb 2012 21:55:30 +0000 http://wordpress.org/?v=2.6.2 By: pharmavet http://www.pharmalot.com/2010/01/abbott-pays-225m-to-states-over-tri-cor/#comment-456684 pharmavet Fri, 08 Jan 2010 02:29:54 +0000 http://www.pharmalot.com/?p=20787#comment-456684 Even an NDA for a brand-name albeit "me-too" drug doesn't have to prove itself better than the original. It just has to beat placebo to be approved. This is consistent with the FDA's core philosophy that it is not in the business of regulating the practice of medicine. Even with drugs such as ACE inhibitors, they all do about the same thing, but individual doctors prefer ceratin ones, and patients may tolerate one better than another. If NDA's or sNDA's were held to a comparative efficacy standard, we would not have the wide range of therapeutic options open to both doctors and patients. Even an NDA for a brand-name albeit “me-too” drug doesn’t have to prove itself better than the original. It just has to beat placebo to be approved. This is consistent with the FDA’s core philosophy that it is not in the business of regulating the practice of medicine. Even with drugs such as ACE inhibitors, they all do about the same thing, but individual doctors prefer ceratin ones, and patients may tolerate one better than another. If NDA’s or sNDA’s were held to a comparative efficacy standard, we would not have the wide range of therapeutic options open to both doctors and patients.

]]> By: shytown http://www.pharmalot.com/2010/01/abbott-pays-225m-to-states-over-tri-cor/#comment-456641 shytown Thu, 07 Jan 2010 22:27:34 +0000 http://www.pharmalot.com/?p=20787#comment-456641 This has been going on for YEARS. ISOMeR TECHNOLOGY has extended many a patent life. It is good to see the meds with no real advantage are being investigated. I will be the 1st to acknowlege that having options open for dr.s is important. However, me-too drugs that are obviously just trying to extend their product life cycles should not get approved. IE: Clarinex(Clariton), Focalin(Ritalin). How about setting up efficacy thresh-holds that a current nda must meet to get addl pat extensions for these older drugs. If a drug can show that it can do better than it's original, than I say give it an extension. If it cannot, which I am afraid most drugs fall into this catogory, then do not grant it an extension. It seems pretty simple to me. Am I wrong? I know this much, Focalin's efficacy was the exact same as Ritalin. Yet, we were able to spin dr.s off of Ritalin to Focalin with the implied message that the drug was cleaner, yet no studies showed less side effects and even less efficacy. Let's see your pro-pharma people defend that one! This has been going on for YEARS.
ISOMeR TECHNOLOGY has extended many a patent life. It is good to see the meds with no real advantage are being investigated.
I will be the 1st to acknowlege that having options open for dr.s is important. However, me-too drugs that are obviously just trying to extend their product life cycles should not get approved. IE: Clarinex(Clariton), Focalin(Ritalin). How about setting up efficacy thresh-holds that a current nda must meet to get addl pat extensions for these older drugs.
If a drug can show that it can do better than it’s original, than I say give it an extension.
If it cannot, which I am afraid most drugs fall into this catogory, then do not grant it an extension. It seems pretty simple to me. Am I wrong?

I know this much, Focalin’s efficacy was the exact same as Ritalin. Yet, we were able to spin dr.s off of Ritalin to Focalin with the implied message that the drug was cleaner, yet no studies showed less side effects and even less efficacy. Let’s see your pro-pharma people defend that one!

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