Foreign drug manufacturing plants target of FDA and Dept. of Justice Inspections

Following the revelations concerning the massive fraudulent data submissions by India’s generic drug manufacturer Ranbaxy which agreed to pay $500 million to settle a False Claims Act case, the Department of Justice has publicly said that it will be taking an especially hard look at drug manufacturers abroad. The DOJ wants to make sure that the pharma companies are following good manufacturing processes (GMP’s) to assure the safety, quality and ┬ápurety requirements for prescription drugs. In one case against GlaxoSmithKline, it was found that a manufacturing plant in Puerto Rico was grossly deficient and that the drugs were coming out impure, adulterated and contaminated. That case only came out because of a quality assurance employee who became a whistleblower. That was also true of Ranbaxy. Ranbaxy was introducing generic Lipitor into the United States stream of commerce with glass particles. The dangers weren’t revealed in an FDA inspection of plants but rather a senior level manager who filed a whistleblower case. Whistleblowers have more recently also reported “off-label” sales practices which relate to how some pharma companies market their drugs for unapproved uses which are frequently dangerous. Ranbaxy knew that its drugs were tainted and admitted in the settlement that it was aware that batches of the drug gabapentin, used to treat epilepsy and nerve pain, tested positive for unknown impurities and had unreliable shelf lives. Yet these drugs were sold for patient use. No company employees or management were prosecuted criminally. Just the $500 million fine. Ranbaxy earns over $1 billion per year in U.S. sales and that number is skyrocketing. Jeffrey Newman represents whistleblowers. His email is jeffrey.newman1@gmail.com