Dirty Medicine
Posted: Tue Jul 30, 2013 11:54 pm
The People's Pharmacy recently interviewed Katherine Eban author of the book "Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America's Drug Supply" which discusses the problem of criminal fraud by generic pharmaceutical companies such as Ranbaxy in India. The interview can be found at http://www.peoplespharmacy.com/2013/07/ ... -medicine/ and will be freely available for the next 4 weeks. Some parts of the book can be read at Google books. http://books.google.com/books/about/Dan ... OEKcUSyVoC
Katherine Eban also published an article in Fortune magazine.
http://features.blogs.fortune.cnn.com/2 ... d-lipitor/
Katherine Eban's interview, book and article illustrate the difficulty with regulating foreign generic drug manufacturers as it revolves around an honor system such that the FDA takes it on face value that the data being submitted for drug approval is legitimate. However, in the case of several drugs manufactured by Ranbaxy, it was completely fraudulent. Moreover, there was a global recall on Ranbaxy's generic atorvastatin as it was found to contain particles of glass. Ranbaxy was fined $500 million, but no one was prosecuted since they are outside of the FDA's legal reach.
The author suggests mitigating problems such as these by insisting on the "authorized generic version" of a drug. This is the generic that was approved by the original branded pharmaceutical manufacturer made under their guidelines. However, such authorized generics do not exist for every name brand drug. Moreover, there are cases where patients may not have a choice due to their insurance company's guidelines.
Katherine Eban also published an article in Fortune magazine.
http://features.blogs.fortune.cnn.com/2 ... d-lipitor/
Katherine Eban's interview, book and article illustrate the difficulty with regulating foreign generic drug manufacturers as it revolves around an honor system such that the FDA takes it on face value that the data being submitted for drug approval is legitimate. However, in the case of several drugs manufactured by Ranbaxy, it was completely fraudulent. Moreover, there was a global recall on Ranbaxy's generic atorvastatin as it was found to contain particles of glass. Ranbaxy was fined $500 million, but no one was prosecuted since they are outside of the FDA's legal reach.
The author suggests mitigating problems such as these by insisting on the "authorized generic version" of a drug. This is the generic that was approved by the original branded pharmaceutical manufacturer made under their guidelines. However, such authorized generics do not exist for every name brand drug. Moreover, there are cases where patients may not have a choice due to their insurance company's guidelines.