Indian Cancer Drug Maker Agrees to Plead Guilty and Pay $ 50 Million for Covering Up and Destroying Records Before FDA Inspection | Takeover bid

Indian drug maker Fresenius Kabi Oncology Limited (FKOL) has agreed to plead guilty to concealing and destroying records ahead of a 2013 U.S. Food and Drug Administration (FDA) plant inspection and paying $ 50 million. dollars in fines and forfeiture, the Justice Department said today.

In criminal information filed in federal court in the Nevada district and unsealed today, the United States accused FKOL of violating federal food, drug and cosmetic law by failing to provide certain documents to investigators from the FDA. As part of a criminal resolution, FKOL agreed to plead guilty to the misdemeanor offense, pay a criminal fine of $ 30 million, and waive an additional $ 20 million. FKOL has also agreed to implement a compliance and ethics program designed to prevent, detect and correct violations of US law relating to the manufacture by FKOL of anticancer drugs for use in terminally ill patients.

“By hiding and removing manufacturing records, FKOL has sought to obstruct the regulatory authority of the FDA and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for American consumers,” he said. said Acting Deputy Attorney General Brian Boynton of the Department of Justice. Division. “FKOL’s conduct puts vulnerable patients at risk. The Department of Justice will continue to work with the FDA to prosecute drugmakers who obstruct these inspections. ”

“Drug companies obstructing FDA inspections are putting patient safety at risk,” said US Attorney Nicholas A. Trutanich for the Nevada District. “Maintaining the integrity of records and data is a critical part of drug manufacturing, and our office will continue to prosecute those who obstruct FDA inspections by destroying records or by other means. “

“FDA inspections of pharmaceutical manufacturing facilities help ensure the strength, quality and purity of our drugs. Any attempt to obstruct or interfere with these inspections threatens public health, ”said Judy McMeekin, Pharm.D., Associate Commissioner of Regulatory Affairs, FDA. “We will continue to aggressively investigate and present any such obstruction to prosecution. “

According to court documents, FKOL owned and operated a manufacturing facility in Kalyani, West Bengal, India, which manufactured active pharmaceutical ingredients (APIs) used in various anti-cancer products distributed in the United States. The government alleges that prior to an FDA inspection of the Kalyani plant in January 2013, the management of the FKOL plant ordered employees to remove some records from the premises and remove other records from computers that allegedly had revealed that FKOL was manufacturing drug ingredients in violation of FDA requirements. Employees at the Kalyani plant removed computers, paper and other documents from the premises and deleted spreadsheets containing evidence of the plant’s abusive practices.

This case is being pursued by Assistant Director Clint Narver and Attorney Natalie Sanders of the Consumer Protection Branch of the Department of Justice, with the assistance of Assistant United States Attorney Nicholas D. Dickinson of the Nevada District Attorney’s Office. . The FDA’s Bureau of Criminal Investigations, Los Angeles field office, investigated the case. The Central Bureau of Investigation in India provided invaluable assistance to US authorities in the investigation of this case.