Comments on: FDA Avandia Reviewer: Change The Process http://www.pharmalot.com/2007/11/fda-avandia-reviewer-change-the-process/ News, Comment and Conversation Fri, 10 Feb 2012 18:16:30 +0000 http://wordpress.org/?v=2.6.2 By: Nathan http://www.pharmalot.com/2007/11/fda-avandia-reviewer-change-the-process/#comment-28982 Nathan Tue, 27 Nov 2007 14:41:39 +0000 http://www.pharmalot.com/2007/11/fda-avandia-reviewer-change-the-process/#comment-28982 He wants to add another safety trial before approval? It would be a lot easier to set the bar higher for one of the existing trials -- which already look at safety, just in a smaller population. He thinks that the FDA should “set a high standard for drugs that offer no advantage over existing therapy.” This sounds great at first glance -- but think about it. So you have a single drug on the market for a particular indication. The bar is set much higher for any competitors to come in. Two problems: 1) There is no competition, so the drugmaker who gets the first product to market can charge whatever they want 2) If the first drug gets pulled from the market due to some unforeseen safety/toxicity issue (as frequently happens these days), there is NOTHING left for patients to turn to! This could potentially be a disaster waiting to happen. In my opinion, the FDA should look at just two factors: safety and efficacy. Politics and personal opinion factor in greatly when the FDA tries to say something like “The product in question works a bit less effectively than product X, but is a little more safe. Now what?” He wants to add another safety trial before approval? It would be a lot easier to set the bar higher for one of the existing trials — which already look at safety, just in a smaller population.

He thinks that the FDA should “set a high standard for drugs that offer no advantage over existing therapy.”

This sounds great at first glance — but think about it. So you have a single drug on the market for a particular indication. The bar is set much higher for any competitors to come in. Two problems:
1) There is no competition, so the drugmaker who gets the first product to market can charge whatever they want
2) If the first drug gets pulled from the market due to some unforeseen safety/toxicity issue (as frequently happens these days), there is NOTHING left for patients to turn to! This could potentially be a disaster waiting to happen.

In my opinion, the FDA should look at just two factors: safety and efficacy. Politics and personal opinion factor in greatly when the FDA tries to say something like “The product in question works a bit less effectively than product X, but is a little more safe. Now what?”

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