Ranbaxy Hires Rudy Giuliani To Fend Off Feds
5 CommentsBy Ed Silverman // September 17th, 2008 // 7:59 pm
The Indian generic drugmaker, which is under investigation for allegedly falsifying records that resulted in the production and sale of generic meds that didn’t meet FDA standards, has hired Rudy Giuliani “to provide advice and review compliance issues,” according to a statement this evening.
This is the second time the former New York City mayor has acted as a paid consultant to a troubled drugmaker. He also worked for Purdue Pharma, which was fined for its Oxycontin marketing, and he helped negotiate a deal with federal prosecutors that kept company execs out of jail. Ironically, when he was a US Attorney in Manhattan, Rudy didn’t hesitate to send junk bond dealers to jail because they preyed on the system. Of course, Rudy is a private consultant now and paid to serve his clients.
Rudy will certainly have fun negotiating the morass that Ranbaxy has created. Yesterday, the FDA issued an import alert for 30 generic meds made by the Indian drugmaker, which means federal authorities have the right to stop the drugs from entering the US. The agency also issued warning letters to Ranbaxy for failing to meet acceptable manufacturing standards at two plants in India.
The feds alleged officials at Ranbaxy’s plant in northern India used raw chemicals from unapproved sources, fabricated in-house test data to meet FDA standards and attempted to conceal the ruse from FDA inspectors. The Parexel consulting firm is also named in connection with its audits of Ranbaxy facilities, some of which Ranbaxy refused for months to produce, claiming attorney-client privilege.
Among the drugs that didn’t meet FDA standards, by the way, are AIDS meds that are distributed as part of the Bush administration’s PEPFAR program (although a key Bush administration official seemed oblivious recently to the problems).
Mike Reimringer
In 1989, the FIRST generics scandal shook the FDA and generic drug companies alike. FDA fired employees for accepting bribes, revoked product approvals, debarred people from working in the industry, + companies and investors lost money.
Is Ranbaxy the only classical drug company in India and China ignoring the CGMP regs in 2008 and betting FDA will not inspect them? How many others are out there? Do you feel safe taking your medicines and not knowing where it was produced? Or where their raw materials were made? Do you feel safe about your family taking these medicines? Is Ranbaxy the tip of the iceberg? When will FDA inspect the plant that makes your medicine? When will companies act ethically on behalf of the patients that use their products?
ultrasound gel
^_^
Marianne Skolek
Rudy just likes to be associated with convicted criminals. Speaks volumes for the meaning of the word integrity doesn’t it Rudy?
Insider
I prefer my picture!
http://pharmagossip.blogspot.com/2008/09/daiichi-ranbaxy-corporate-culture-clash.html
SanD
How Daiichi will react now?