On the front of its Business Day section, the New York Times reports that “the generic drug maker Ranbaxy pleaded guilty…to federal drug safety violations and will pay $500 million in fines to resolve claims that it sold subpar drugs and made false statements to the Food and Drug Administration about its manufacturing practices at two factories in India, the company and federal prosecutors announced.” According to the Times, “the settlement is the largest in history involving a generic manufacturer and drug safety, the Justice Department said” in a news release.
Bloomberg News reports, “Ranbaxy, in papers filed in federal court in Baltimore today, admitted it had sold batches of drugs that were improperly manufactured, stored and tested.” In a statement, Maryland US Attorney Rod Rosenstein said, “‘This is the largest false claims case ever prosecuted in the District of Maryland, and the nation’s largest financial penalty paid by a generic pharmaceutical company’ for violation of the Food, Drug and Cosmetic Act [FDCA].”
The AP reports that Ranbaxy “agreed to a fine and forfeiture of $150 million as well as an additional $350 million penalty to settle civil claims that it submitted false statements to Medicaid, Medicare and other government health care programs.” In addition, the company “admitted making false statements to the Food and Drug Administration about dates of stability testing, which detect impurities of a drug and determine appropriate storage conditions for it.” Also covering the story are the Wall Street Journal, Modern Healthcare, Buffalo (NY) Business First, AFP, and Reuters.
From the American Association for Justice news release.
