Comments on: The high price of FDA approval http://mylocalhealthguide.com/2009/12/29/the-high-price-of-fda-approval/ Your source for Seattle health news and information Wed, 16 May 2012 23:56:45 +0200 hourly 1 http://wordpress.org/?v=3.3.2 By: Ed http://mylocalhealthguide.com/2009/12/29/the-high-price-of-fda-approval/comment-page-1/#comment-628 Ed Fri, 01 Jan 2010 03:37:12 +0000 http://localhealthguideonline.com/?p=10468#comment-628 This is nothing more than a legalized scam, which the FDA is complicit in. Dr. Hazlet-- this is not a "new drug". The company took an old drug that many companies make and did a few drug interaction studies and a study in acute gout comparing two dosing regimens. For this they get to increase the price by 50-fold? They didn't even do any studies in actual FMF patients or for gout prophylaxis, two common uses of colchicine they got FDA approval and exclusivity for. Their package insert cites previous efficacy studies in the literature-- ironically, studies done with the "unapproved" colchicine they are forcing off the market. This is nothing more than a legalized scam, which the FDA is complicit in. Dr. Hazlet– this is not a “new drug”. The company took an old drug that many companies make and did a few drug interaction studies and a study in acute gout comparing two dosing regimens. For this they get to increase the price by 50-fold?

They didn’t even do any studies in actual FMF patients or for gout prophylaxis, two common uses of colchicine they got FDA approval and exclusivity for. Their package insert cites previous efficacy studies in the literature– ironically, studies done with the “unapproved” colchicine they are forcing off the market.

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