According to a January 2014 FDA Inspection report, workers at a Ranbaxy pharmaceutical manufacturing plant repeatedly faked test results to make it appear that raw materials and active pharmaceutical ingredients met required standards when they didn’t. Ranbaxy was retesting products “until acceptable results are obtained” and deleting evidence of failed tests, according to the reports. The FDA’s discovery occurred when inspectors recently visited Ranbaxy’s Toansa factory, and, as a result, the FDA banned the use of ingredients from Ranbaxy’s Toansa factory, which supplies many of the critical ingredients used in Ranbaxy’s generic drugs.
Ranbaxy was under increased FDA scrutiny, after the company reached a consent decree with the Justice Department, in January 2012, which required the company to take steps to ensure the integrity of its pharmaceutical production. The 2012 consent decree stemmed from a global settlement with the United States, in which Ranbaxy agreed to pay the United States $500 million to resolve criminal and civil liability resulting from its manufacture and distribution of allegedly adulterated drugs.
The False Claims Act has implications for current Good Manufacturing Practice Violations (cGMP violations) because the United States (funding as it does the Medicare program, the majority of state Medicaid programs, the Veterans Administration, the TRICARE program, and others) is the world’s largest purchaser of prescription medications. The False Claims Act encourages and incentives employees to pursue qui tam actions against pharmaceutical manufacturers who engage in pharmaceutical fraud such as the violation of cGMP regulations.
More information for whistleblowers is located at the Nolan Auerbach & White website.