The Fight Against Counterfeit Drugs, Interview with Lisa McClennon

Lisa McClennon specializes in risk management in the international arena and is a trusted authority on investigations and government enforcement. She is a seasoned global executive with 25 years of experience in federal law enforcement, compliance, and ethics. Lisa loves leading teams to prevent and detect fraud, sophisticated financial crimes, and public corruption.

On the podcast, Lisa and I discuss her work on the U.S. federal government’s investigation of Ranbaxy USA Inc. (“Ranbaxy”), a subsidiary of Indian generic pharmaceutical manufacturer, Ranbaxy Laboratories Limited.  Ranbaxy pleaded guilty to felony charges related to the manufacturer and distribution of adulterated drugs made at facilities in India.

The investigation and prosecution of Ranbaxy lead to the largest federal drug safety settlement (as of May 13, 2013) of a criminal fine and forfeiture totaling $150 million plus and additional $350 million to settle civil claims under the False Claims Act and related State laws. 

LINKS
DOJ Press Release: Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations, and False Statements to the FDA 

U.S. Office of Inspector General 

Fighting a culture of fraud, Fraud Magazine (interview with the whistleblower in Ranbaxy)