Americans benefit from the safest drugs and the safest drug supply chain in the world. That’s a good thing, because we also consume more drugs for more conditions than anyone else in the world. And that is precisely why everyone in the United States should read Fortune Online’s new article covering the backstory that lead to the shocking May 13, 2013 guilty plea by Ranbaxy USA, the US subsidiary of the India-based generic drug maker, to seven U.S. federal criminal counts of selling substandard and adulterated drugs with intent to defraud. Once you start reading the article, you won’t be able to stop, thanks to the skillful writing of Katherine Eban, author of “Dangerous Doses”.
The company admitted to falsifying drug test data for years and for hundreds of products sold worldwide. I was stunned by how callous company employees—from the lowest levels to the CEOs themselves—could be over the quality of their drug products. They seemed to believe that Continue reading Ranbaxy, FDA, FDASIA and Indian Pharma Credibility
I’ve been reading the Institute of Medicine (IOM) report called “Countering the Problem of Falsified and Substandard Drugs” that was published last week. At 360 pages, it is quite literally a book, and you can buy it that way. But they also allow you to download the “Pre-publication Copy: Uncorrected Proofs” version in a 300 page PDF for free. I’m not sure why they would post uncorrected proofs rather than the final document on their site but I assume the text is in its final edited form and only the formatting might be different between the book and the PDF. I hope so anyway.
I have not yet read the whole thing so this isn’t intended to be a proper review (see the Regulatory Focus article about it). The document offers Continue reading Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals
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