Indian drug maker to plead guilty in Nevada case, pay $50M
A drug manufacturer from India has agreed to plead guilty in Nevada and pay $50 million for concealing and destroying records ahead of a Food and Drug Administration plant inspection, the Department of Justice announced Tuesday.
According to a criminal complaint unsealed in Las Vegas, Fresenius Kabi Oncology Limited was charged with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators.
The company would plead guilty to a misdemeanor and pay a $30 million fine, and forfeit another $20 million, according to a DOJ news release.
It also agreed to implement a compliance and ethics program designed to prevent, detect and correct violations of U.S. law in relation to its production of cancer drugs, the release stated.
“Pharmaceutical companies that obstruct FDA inspections jeopardize patient safety,” Nevada U.S. Attorney Nicholas Trutanich said in the release. “Maintaining the integrity of records and data is a critical part of drug manufacturing, and our office will continue prosecuting those that obstruct FDA inspections by destroying records or other means.”
According to court documents, the company owned and operated a manufacturing plant in Kalyani, West Bengal, India, that manufactured active pharmaceutical ingredients used in various cancer drug products distributed to the United States.
The allegations stem from a 2013 inspection of the plant, where the company’s managers directed employees to remove certain records from the premises and delete other records from computers that would have revealed that the company was manufacturing drug ingredients in violation of FDA requirements.
“By hiding and deleting manufacturing records, FKOL sought to obstruct the FDA’s regulatory authority and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for U.S. consumers,” Acting Assistant Attorney General Brian Boynton said in the news release. “FKOL’s conduct put vulnerable patients at risk.”
Contact David Ferrara at dferrara@reviewjournal.com or 702-380-1039. Follow @randompoker on Twitter.