For those of you who haven’t read about the Wyeth v Levine case, here are two links.
Wyeth Loses Preemption Battle and The Facts—Wyeth Vs. Levine
There are a lot of issues to be addressed in this case, I do realize that. My main issue is with the fact that Wyeth wanted to change the labeling on Phenergan regarding intra-arterial administration of the drug, but the FDA specifically asked them to retain the language on the label. In the end, Wyeth was sued by Diana Levine for not including appropriate information on intra-arterial administration of Phenergan. For once, I believe that the drug company isn’t at fault. The FDA, the body that regulates drugs in the United States, asked Wyeth not to make changes in their label. And they get sued for not making changes!
Not being a lawyer, I’m sure I don’t understand the case as well as a lawyer would, but I am truly bewildered by the thought that the FDA would ask a drug company to not include a warning when that drug could be potentially harmful.
Tuesday, October 20, 2009
Wyeth Vs. Levine
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I have less and less trust in the FDA as time goes on. I wonder if their shortcomings are a matter of ethics, or if the problem is that they are so short-staffed and overworked that they cannot make competent decisions.
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