Ranbaxy Laboratories wants the world to know it is not the same company it was when it lied to the FDA and tried to hide serious manufacturing and drug quality problems that led to last week's felony convictions for the Indian drugmaker. Today it laid out many of the of the improvements it has made since the fraud, such as adding independent members to its board of directors.
But while it acknowledges the consent decree it signed last year with U.S. authorities, it does not fully point out that many of the improvements the company has undertaken were dictated to it in the 55-page, 5-year agreement that imposed perhaps the most rigorous quality control program in the industry.
"Ranbaxy is a different company today," Arun Sawhney, CEO and managing director, said in Wednesday's statement. "The steps we have taken over the recent years reflect the wide-ranging efforts of the current board and management to address certain conduct of the past and ensure that Ranbaxy moves forward with integrity and professionalism in everything we do."
The announcement points to the fact that Ranbaxy has invested more than $300 million in its manufacturing facilities. It also mentions its "rigorous new Code of Conduct for all Ranbaxy employees" and the chief data reliability officer, both stipulations of the consent decree. In fact, the decree required Ranbaxy to hire a raft of experts in data integrity and manufacturing who will watch over its shoulder, make recommendations, and, if they don't like the responses they get, take the issues up directly with the FDA. For its plants in Paonta Sahib and Dewas in India, it had to hire an independent current good manufacturing practices expert who can report to the FDA independently if there are any disagreements with Ranbaxy over recommended improvements. On top of all of that, Ranbaxy was ordered by authorities to establish and publicize an anonymous whistleblower program so employees can report any "suspected violations" to the data reliability office.
The 7 felony charges the company pleaded guilty to last week and the $500 million in fines and penalties it paid settle the litigation that has been hanging over the company for several years. The consent decree, however, lives on through 2016 to make sure Ranbaxy does not again become the bad actor it once was.
- here's the release