Comments on: Andy: FDA Responded To Heparin With ‘Alacrity’ http://www.pharmalot.com/2008/02/andy-fda-responded-to-heparin-with-alacrity/ News, Comment and Conversation Fri, 10 Feb 2012 22:11:24 +0000 http://wordpress.org/?v=2.6.2 By: B. Martin, MD http://www.pharmalot.com/2008/02/andy-fda-responded-to-heparin-with-alacrity/#comment-168255 B. Martin, MD Tue, 19 Feb 2008 18:17:30 +0000 http://www.pharmalot.com/2008/02/andy-fda-responded-to-heparin-with-alacrity/#comment-168255 Ed, You are probably already aware, but some interesting information is buried deep in today's WSJ article on the continuing investigation re Baxter's heparin (graf 6): "But the agency [FDA] said it doesn't know the cause of the heparin reactions potentially tied to Baxter's drug. Baxter said earlier it was focused on differences among batches of the heparin. It offered few details, but yesterday Baxter disclosed that the variations from standard product occurred in the Chinese-made batches." Ed,

You are probably already aware, but some interesting information is buried deep in today’s WSJ article on the continuing investigation re Baxter’s heparin (graf 6):

“But the agency [FDA] said it doesn’t know the cause of the heparin reactions potentially tied to Baxter’s drug. Baxter said earlier it was focused on differences among batches of the heparin. It offered few details, but yesterday Baxter disclosed that the variations from standard product occurred in the Chinese-made batches.”

]]> By: Ed Silverman http://www.pharmalot.com/2008/02/andy-fda-responded-to-heparin-with-alacrity/#comment-162219 Ed Silverman Sat, 16 Feb 2008 22:13:59 +0000 http://www.pharmalot.com/2008/02/andy-fda-responded-to-heparin-with-alacrity/#comment-162219 Hi B. Martin, Thanks for the note. If you read the post above the von Eschenbach e-mail to FDA staffers, you'll see that, yes, it's not clear what if any link there is between the Chinese plant and the medication. I've tried to reiterate that in the few posts I've run on this subject. Meanwhile, you may be interested to read the interview with the Rutgers Business School professor about this subject. You can access that post by glancing to the right on the main Pharmalot page and looking for featured posts. It's entitled 'Message to Pharma - Get Out of China, Now.' Thanks for stopping by, ed Hi B. Martin,

Thanks for the note. If you read the post above the von Eschenbach e-mail to FDA staffers, you’ll see that, yes, it’s not clear what if any link there is between the Chinese plant and the medication. I’ve tried to reiterate that in the few posts I’ve run on this subject.

Meanwhile, you may be interested to read the interview with the Rutgers Business School professor about this subject. You can access that post by glancing to the right on the main Pharmalot page and looking for featured posts. It’s entitled ‘Message to Pharma - Get Out of China, Now.’

Thanks for stopping by,

ed

]]> By: B. Martin, MD http://www.pharmalot.com/2008/02/andy-fda-responded-to-heparin-with-alacrity/#comment-161915 B. Martin, MD Sat, 16 Feb 2008 18:25:58 +0000 http://www.pharmalot.com/2008/02/andy-fda-responded-to-heparin-with-alacrity/#comment-161915 The current implication by the media is that the severe reactions to Baxter's bolused heparin are related to the fact that the company's heparin supplier, Scientific Protein, receives some of its raw material from its Chinese plant. However, we simply don't know the link to be causal yet. Scientific Protein Labs also processes some of its heparin in its Wisconsin facility. Further, the contention that policing the global manufacture and world trade of pharmaceuticals and their raw materials is somehow "easy" (especially for an already overextended agency like the FDA) defies the experience of anyone whose held a position of responsibility. The current implication by the media is that the severe reactions to Baxter’s bolused heparin are related to the fact that the company’s heparin supplier, Scientific Protein, receives some of its raw material from its Chinese plant. However, we simply don’t know the link to be causal yet. Scientific Protein Labs also processes some of its heparin in its Wisconsin facility.

Further, the contention that policing the global manufacture and world trade of pharmaceuticals and their raw materials is somehow “easy” (especially for an already overextended agency like the FDA) defies the experience of anyone whose held a position of responsibility.

]]> By: Matt http://www.pharmalot.com/2008/02/andy-fda-responded-to-heparin-with-alacrity/#comment-160949 Matt Sat, 16 Feb 2008 08:35:16 +0000 http://www.pharmalot.com/2008/02/andy-fda-responded-to-heparin-with-alacrity/#comment-160949 I am not too sure how complex, challenging, or stessful it is for the FDA to inspect the manufacturing plant in China or their products at the border when they enter the United States; seems like an easy process, but one that the FDA didn't bother to implement. I am not too sure how complex, challenging, or stessful it is for the FDA to inspect the manufacturing plant in China or their products at the border when they enter the United States; seems like an easy process, but one that the FDA didn’t bother to implement.

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