Statement by the whistleblower in the Ranbaxy case

Statement By Dinesh Thakur Regarding US Government's Case Against Ranbaxy


WASHINGTON, May 13, 2013 /PRNewswire-USNewswire/ -- Today, the United States government brought to a conclusion an eight-year criminal and civil investigation of Ranbaxy Laboratories Limited, India's largest generic drug company, and Ranbaxy, Inc., Ranbaxy Pharmaceuticals, Inc., Ranbaxy Laboratories, Inc., Ranbaxy USA, Inc., and Ohm Laboratories, Inc. ("Ranbaxy"). Ranbaxy has agreed to pay $500 million to resolve allegations of falsifying drug data and systemic manufacturing violations. Ranbaxy USA Inc. has pleaded guilty to multiple criminal violations. Dinesh Thakur served as the whistleblower in this case and is the former Ranbaxy Director and Global Head, Research Information & Portfolio Management.

Statement by Dinesh Thakur:

"I am relieved that the government's investigation has concluded. I am thankful for the remarkable effort of United States Food and Drug Administration, Department of Justice, United States Attorney's Office for the District of Maryland, USAID, and State Medicaid Fraud Control Units. Their work has been tireless and dedicated.

"Eight years ago, as the Director of Project & Information Management at Ranbaxy, I discovered that the company falsified drug data and systemically violated current good manufacturing practices and good laboratory practices. Ranbaxy's management was notified of these widespread problems. When they failed to correct the problems, it left me with no choice but to alert healthcare authorities.

"I worked with U.S. regulatory authorities for two years to expose the fraud. In furtherance of this effort, I filed a lawsuit to hold Ranbaxy accountable. It took us eight years to help government authorities unravel a complicated trail of falsified records and dangerous manufacturing practices that threatened to compromise the quality and safety of Ranbaxy drugs. Along the way, the government barred the importation of Ranbaxy drugs, held the company accountable for its data fraud under FDA's Application Integrity Policy, and required it to implement corrective measures to prevent the problems from recurring.

"As a senior pharmaceutical executive, I understand the importance of regulatory oversight in ensuring drug quality and safety. There are unique challenges in a global drug market, which is highly dependent on international manufacturing and distribution. In fact, approximately 78 percent of prescription drugs dispensed in the United States are generic, and a growing percentage of drugs – both generic and name brand – is manufactured overseas. This case highlights the need for effective regulation that applies to drugs sold in the United States, regardless where they are manufactured.

I would like to thank FDA's Office of Criminal Investigation, United States Attorney's Office for the District of Maryland, Department of Justice, USAID, and Andrew M. Beato, Bob Muse, and Rory Kelly of Stein Mitchell Muse & Cipollone LLP. I hope that our actions and this case have helped to improve the quality and safety of drugs in the United States and abroad."

FOR MORE INFORMATION
Please visit www.dineshthakur.com

MEDIA INQUIRIES
For media inquiries, please contact media@gloverparkgroup.com or 202-337-0808.; for inquiries from India media, please contact Indianmedia@gloverparkgroup.com.

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News from Attorney General Eric T. Schneiderman

May 13, 2013

New York City Press Office / 212-416-8060

Albany Press Office / 518-473-5525

nyag.pressoffice@ag.ny.gov

Twitter: @AGSchneiderman

A.G. SCHNEIDERMAN ANNOUNCES PHARMACEUTICAL GIANT TO PAY $500 MILLION PENALTY FOR SELLING DRUGS THAT FELL BELOW FDA STANDARDS

New York State To Receive $44 Million From Settlement Of Whistleblower Case With India-Based Ranbaxy

A.G. Schneiderman: We Will Continue To Hold Big Pharma Accountable And Recoup Dollars Stolen From New York’s Medicaid Program

NEW YORK - Attorney General Eric T. Schneiderman announced today that New York helped lead the negotiation of a national, $500 million settlement with a giant generic pharmaceutical manufacturer based in India. The settlement with Ranbaxy resolved civil and criminal allegations that introduced generic drugs that lacked necessary active ingredients due to poor quality control standards into interstate commerce. As part of the settlement, Ranbaxy will return $44 million to New York’s Medicaid programs.

“Pharmaceutical companies that manufacture and distribute worthless pills harm patients and abuse our Medicaid programs,” said Attorney General Schneiderman. “Under this national settlement, Ranbaxy’s flagrant violation of America’s drug standards will stop, they will pay civil and criminal penalties, and their US subsidiary has pled guilty to numerous felony charges in federal court.”

The investigation stemmed from a whistleblower lawsuit filed in federal court in Maryland under the federal False Claims Act and various state false claims statutes. The whistleblower’s complaint alleged that Ranbaxy knowingly manufactured, distributed and sold generic pharmaceutical products in the United States and that the strength, purity and quality of those drugs fell below standards required by the FDA. The products at issue consisted of 26 generic pharmaceutical drugs manufactured at Ranbaxy’s facilities in India at various times between April 1, 2003 and September 16, 2010. The drugs included Amoxicillin, a common antibiotic, and Fenofibrate, used to reduce high cholesterol.

The whistleblower suit was filed 2007 in the United States District Court for the District of Maryland.

Ranbaxy has agreed to pay the states and the federal government $350 million dollars in civil damages and penalties to resolve civil allegations of poor manufacturing practices in two Indian manufacturing plants, in Paonta Sahib and Dewas. Of this amount, $266,729,715.10 will be returned to the state Medicaid programs, which are funded jointly by the states and the federal government. The remaining $83,270,284.86 is designated for other federal health care programs affected by Ranbaxy’s conduct. The total portion of the settlement amount recovered by New York is $43, 882,807.70.

Additionally, Ranbaxy USA, a subsidiary, has pled guilty to seven felony counts alleging violations of the U.S. Food, Drug, and Cosmetic Act and has agreed to pay $150 million dollars in criminal fines and forfeitures in the United States District Court for the District of Maryland. Ranbaxy entered into a consent decree in January 2012 with the federal government to address outstanding current good manufacturing practice (cGMP) and data integrity issues in the two Indian manufacturing plants at issue. These provisions include a wide range of actions to correct its violations and to ensure that the violations do not occur again.

A team from the National Association of Medicaid Fraud Control Units (NAMFCU) conducted the settlement negotiations with Ranbaxy on behalf of the states and included representatives from the Offices of the Attorneys General for the states of New York, California, South Carolina, Maryland and Oregon.

The New York team consisted of Jay Speers, Counsel to MFCU and Meghan Collins, Associate Special Auditor Investigator. It was supervised by Deputy Attorney General Monica Hickey-Martin, Director of the Medicaid Fraud Control Unit, and Executive Deputy Attorney General for Criminal Justice Kelly Donovan.