Feds Drop Legal Action Against Ranbaxy
3 CommentsBy Ed Silverman // October 10th, 2008 // 6:55 am
The US Department of Justice has dropped legal action against Ranbaxy after the Indian generic drugmaker agreed to provide long-sought audits, which may shed light on allegations that falsified records resulted in the production and sale of generic meds that failed to meet FDA standards (back story and latest court filing).
The move appears to end a stalemate that last July prompted the US Attorney in Maryland to force Ranbaxy to release the audits, which were conducted by Parexel and that Ranbaxy claimed were privileged information. In the interim, the FDA banned nearly 30 Ranbaxy meds from entering the US after the FDA cited two Indian plants for inadequate controls and procedures.
The hoopla recently prompted the President’s Emergency Plan for AIDS Relief, or PEPFAR, which buys meds for African countries and other developing countries, to ends its purchases. The program doled out nearly $9 million to Ranbaxy for its generics last year (read here).
Whether Rudy Giuliani will take credit for the breakthrough remains to be seen. You may recall last month, Ranbaxy hired the former New York City mayor and US Attorney “to provide advice and review compliance issues,” a job he performed for Purdue Pharma, which was fined for its Oxycontin marketing. He helped negotiate a deal with federal prosecutors that kept company execs out of jail.
PBurns
I think that the title should perhaps say that they dropped a *contempt* action for not supplying the audits. The main legal action, as you suggest, is still very much in motion and I expect very serious fall out. Rudy’s job, I think is to do for Ranbaxy what he did for Purdue — keep people from going to jail after people were killed by drug company action and inaction.
P
Anne PME
In addition to the civil inquiry, published reports indicate that there is an ongoing criminal inquiry. That being said, I don’t recall seeing any published reports of deaths associated with the use of Ranbaxy drugs.
Mark
Ed:
Greetings. Hope things are well with you.
I have a question on the Federal investigation now being dropped. I understand that is the case. However, I think that is mutually exclusive of the FDA’s current impot alert on the 30 products coming out of the two plants (Dewas and Paonta Sahib). That alert and non-approval for any future ANDAs coming from these two plants or any NDA approvals with API coming from these two plants is still being enforced. Is that your understanding?
Mark