Washington, DC - Indian drug manufacturer Fresenius Kabi Oncology Limited (FKOL) has agreed to plead guilty to concealing and destroying records prior to a 2013 U.S. Food and Drug Administration (FDA) plant inspection and pay $50 million in fines and forfeiture, the Department of Justice announced Tuesday.
In a criminal information filed in federal court in the District of Nevada and unsealed today, the United States charged FKOL with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators. As part of a criminal resolution, FKOL agreed to plead guilty to the misdemeanor offense, pay a criminal fine of $30 million, and forfeit an additional $20 million. FKOL also agreed to implement a compliance and ethics program designed to prevent, detect, and correct violations of U.S. law relating to FKOL’s manufacture of cancer drugs intended for terminally ill patients.
“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,” said Acting Assistant Attorney General Brian Boynton of the Justice Department’s Civil Division. “FKOL’s conduct put vulnerable patients at risk. The Department of Justice will continue to work with FDA to prosecute drug manufacturers who obstruct these inspections.”
“Pharmaceutical companies that obstruct FDA inspections jeopardize patient safety,” said U.S. Attorney Nicholas A. Trutanich for the District of Nevada. “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.”
“FDA inspections of pharmaceutical manufacturing facilities help ensure the strength, quality and purity of our medicines. Any attempt to obstruct or interfere with these inspections threatens the public health,” said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs of the FDA. “We will continue to aggressively investigate and present any such obstruction for prosecution.”
According to court documents, FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, India, that manufactured active pharmaceutical ingredients (APIs) used in various cancer drug products distributed to the United States. The government alleges that prior to a January 2013 FDA inspection of the Kalyani facility, FKOL plant management directed employees to remove certain records from the premises and delete other records from computers that would have revealed FKOL was manufacturing drug ingredients in contravention of FDA requirements. Kalyani plant employees removed computers, hardcopy documents, and other materials from the premises and deleted spreadsheets that contained evidence of the plant’s violative practices.
This case is being prosecuted by Assistant Director Clint Narver and Trial Attorney Natalie Sanders of the Department of Justice’s Consumer Protection Branch, with assistance from Assistant U.S. Attorney Nicholas D. Dickinson of the U.S. Attorney’s Office for the District of Nevada. The FDA’s Office of Criminal Investigations, Los Angeles Field Office, investigated the case. The Central Bureau of Investigation in India provided invaluable assistance to U.S. authorities in the investigation of this matter.