A story that was virtually ignored by the mainstream press and disappeared almost without a trace has to do with serious allegations against Ranbaxy Laboratories, an Indian drug company. Ranbaxy is not just any drug company. It is the largest pharmaceutical company in India, by sales. The company has huge sales around the world, thanks in large measure to its dominance in the generic drug arena. Not surprisingly, Ranbaxy sells a LOT of meds in the U.S.
According to reports, Justice Department investigators are concerned that Ranbaxy may have submitted false claims, fabricated documents and committed fraud in drug submissions to the FDA.
Congress is getting into the act. Leaders of the House Committee on Energy and Commerce have put the FDA on the hot seat, raising questions about what FDA staffers knew about this and when they knew it. There are court documents suggesting that FDA has been aware of trouble at Ranbaxy for at least 18 months. FDA apparently did nothing to warn physicians, patients or pharmacists of the suspected problems.
If Ranbaxy fabricated evidence for its generic drug applications to the FDA and concealed violations of manufacturing practices, this is a big deal. We have been questioning the ability of the FDA to monitor the quality of generic drugs for several years. (Read some of the reports on this site for frightening examples of apparent generic shortcomings.) We suspected that some companies in China and India may have taken short cuts. If the Ranbaxy mess proves true, we will know that our fears were justified. We wonder how many other problems may not have been detected by the FDA.
