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India's Largest Generic Drugmaker Ranbaxy Pays $500 Million to Settle Systemic Generic Drug Manufacturing Fraud
Date:5/13/2013

"Nearly 80 percent of the generic drugs taken by American consumers trace to overseas manufacturing facilities. These drugs must comply with FDA quality and manufacturing requirements. The settlement today is a significant step toward achieving that outcome. The message is clear that there are severe consequences if a company breaks the rules and takes shortcuts that sacrifice drug quality in pursuit of profit."

The settlement resolves a sweeping, multi-year investigation by numerous government agencies including the DOJ and FDA to uncover and document deficient current good manufacturing and laboratory practices affecting the quality of Ranbaxy's generic drugs. It is the capstone to numerous legal actions against Ranbaxy growing out of the eight-year investigation started by Mr. Thakur's disclosure of the problems to the government in 2005. These legal actions include (1) a 2007 FDA raid on Ranbaxy's United States offices, (2) FDA's imposition of its Application Integrity Policy on Ranbaxy plants in India due to pervasive data falsification in 2009, (3) FDA's banning of more than 30 Ranbaxy drugs from entering the United States, (4) numerous FDA warning letters for manufacturing violations, and (5) the entry of a Consent Decree and permanent injunction prohibiting Ranbaxy from introducing into interstate commerce drugs made at various facilities in India and the United States.

Bob Muse , a partner at Stein Mitchell Muse & Cipollone, commented that "This high-profile case is a strong reminder of the power of the FCA and exemplifies the important role whistleblowers play in the public-private partnership to prevent government fraud. It is another confirmation that people who report fraud even beyond our borders can expect to be treated fairly and in a manner that encourages them to come forw
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SOURCE Stein Mitchell Muse & Cipollone LLP
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