Indian cancer drug manufacturer agrees to plead guilty, pay $50 million for concealing, destroying records

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 Feb. 9, 2021.

In a criminal information filed in federal court in the District of Nevada and unsealed Feb. 9, 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, the press release from the Justice Department said.

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.

Referring to court documents, the press release said FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, that manufactured active pharmaceutical ingredients (APIs) used in various cancer drug products distributed to the United States.

The U.S. 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, the Justice Department press release said.