http://www.pharmalot.com/2008/10/fda-reviewers-fret-over-genzyme-drug/ News, Comment and Conversation Fri, 19 Mar 2010 21:45:25 +0000 http://wordpress.org/?v=2.6.2 http://www.pharmalot.com/2008/10/fda-reviewers-fret-over-genzyme-drug/#comment-378395 laura Fri, 17 Oct 2008 20:41:27 +0000 http://www.pharmalot.com/?p=16676#comment-378395 I don't know anything about Eli Lilly, but I do know a bit about Genzyme and, from what I can tell with regard to one particular medical device manufactured by Genzyme, the FDA has allowed them to quite literally get away with murder for a number of years. If the FDA appears to be cracking down on Genzyme, it may be because Genzyme has given them reason to. I don’t know anything about Eli Lilly, but I do know a bit about Genzyme and, from what I can tell with regard to one particular medical device manufactured by Genzyme, the FDA has allowed them to quite literally get away with murder for a number of years. If the FDA appears to be cracking down on Genzyme, it may be because Genzyme has given them reason to.

]]> http://www.pharmalot.com/2008/10/fda-reviewers-fret-over-genzyme-drug/#comment-378387 Scott Fri, 17 Oct 2008 19:26:09 +0000 http://www.pharmalot.com/?p=16676#comment-378387 The irony here is that other protein-based medicines are already being outsourced to third-party manufacturers without having to undergo clinical trials. Two cases-in-point: since 2003 at least, Eli Lilly & Co. has had FDA approval to sell Humulin® R and Humalog® vials which are actually manufactured by Hospira, Inc.'s "One 2 One Contract Manufacturing Services" (known previously as Abbott Laboratories' One2One Global Pharmaceutical Services which was spun-off as an independent company in 2004) at a facility in McPherson, KS. Aside from having the same master cell bank, nothing else has been required by the FDA other than an initial approval. I realize that Myozyme is a glycosated protein, whereas biosynthetic insulin is non-glycosated (and that insulin is governed by the by the Federal Food Drugs and Cosmetics Act, whereas Myozyme is governed by the Public Health Services Act), but the reality is that the FDA is making Genzyme jump through hoops for approval in this case, while Lilly got a rubber-stamp approval. The FDA is clearly inconsistent in its demands of biotech and pharma, which calls for Congressional investigation. The irony here is that other protein-based medicines are already being outsourced to third-party manufacturers without having to undergo clinical trials. Two cases-in-point: since 2003 at least, Eli Lilly & Co. has had FDA approval to sell Humulin® R and Humalog® vials which are actually manufactured by Hospira, Inc.’s “One 2 One Contract Manufacturing Services” (known previously as Abbott Laboratories’ One2One Global Pharmaceutical Services which was spun-off as an independent company in 2004) at a facility in McPherson, KS. Aside from having the same master cell bank, nothing else has been required by the FDA other than an initial approval. I realize that Myozyme is a glycosated protein, whereas biosynthetic insulin is non-glycosated (and that insulin is governed by the by the Federal Food Drugs and Cosmetics Act, whereas Myozyme is governed by the Public Health Services Act), but the reality is that the FDA is making Genzyme jump through hoops for approval in this case, while Lilly got a rubber-stamp approval. The FDA is clearly inconsistent in its demands of biotech and pharma, which calls for Congressional investigation.

]]> http://www.pharmalot.com/2008/10/fda-reviewers-fret-over-genzyme-drug/#comment-378372 Jaynesday Fri, 17 Oct 2008 16:46:10 +0000 http://www.pharmalot.com/?p=16676#comment-378372 Sounds similar to what Genzyme did with Seprafilm. They recieved fast track approval then proceeded to change their manufacturing process and testing procedures, with FDA approval. Seprafilm has been known (according to doctors evaluation) to cause deadly reactions in some patients and has over 250 listed adverse events on the FDA's MAUDE database. Sounds similar to what Genzyme did with Seprafilm. They recieved fast track approval then proceeded to change their manufacturing process and testing procedures, with FDA approval. Seprafilm has been known (according to doctors evaluation) to cause deadly reactions in some patients and has over 250 listed adverse events on the FDA’s MAUDE database.

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