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Last year, millions of Americans wondered whether their cholesterol-lowering drug was safe. The giant Indian drug maker Ranbaxy had recalled its atorvastatin, the generic equivalent of Lipitor, because it was contaminated with ground glass.
Earlier this year, Ranbaxy pleaded guilty to “seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government,” as our guest reported in her expose. The company was fined $500 million, but Ranbaxy drugs are still on pharmacy shelves. Do Ranbaxy’s misdeeds suggest weaknesses in FDA’s oversight of the generic drug industry?
A few days ago we learned that another Indian generic drug company, Wockhardt, also got into trouble. In addition to problems with record keeping and manufacturing, FDA investigators found problems with a bathroom close to sterile facilities:
“For example, our investigators found that the washing and toilet facility located approximately twenty (20) feet (approximately 6 meters) from the entrance/gowning area to the Sterile Formulation (b)(4) manufacturing facility was found to have urinals that lacked drainage piping. The urine was found to fall directly onto the floor, where it was collected in an open drain. Stagnant urine was observed near the open drain. In addition, the investigators also observed what appeared to be mildew or other mold(s) in this toilet facility. The facilities used in the manufacture of drugs should be appropriately maintained and repaired, and remain in a clean condition.”
Learn about foreign drug manufacturing and oversight on this week’s show with:
Guest: Katherine Eban is an investigative reporter who writes for Fortune and other national magazines. Her book is titled Dangerous Doses: How Counterfeiters are Contaminating America’s Drug Supply. Her article on Ranbaxy, “Dirty Medicine,” was published in the May 15, 2013, issue of Fortune.
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