Thursday, November 20, 2014
The biter bit?
Once again, Ranbaxy and its fraught relationship with the FDA are in the news, but for a very different reason this time - Ranbaxy is suing the US drug regulator. At issue are the approvals that the FDA granted to Ranbaxy in 2008 to manufacture generic versions of two drugs, Valcyte and Nexium. The FDA claims that these approvals were granted 'in error'; Ranbaxy claims that the FDA is acting in a manner 'arbitrary, capricious, and otherwise contrary to law' and has no authority to reverse a decision taken six years ago.
Here is a more detailed explanation of the entire situation. As it turns out, Ranbaxy was never able to manufacture the two generics due to ongoing regulatory problems with the FDA, problems that they say the FDA knew about when the approvals were granted. Legally, the matter is a point of dispute about the laws which govern the FDA when it comes to granting generic drug approvals. But Ranbaxy's run-ins with the FDA are both numerous and well-known; see here, here and here for more. It's awfully tempting to speculate that this latest lawsuit is not just a wrangling over points of law, but an attempt by the beleaguered drugmaker to get a bit of its own back at the agency that has (in parts justifiably) given it such a hard time over the last few years. How is this going to affect the generics industry in India, considering that the FDA seems to have stepped up its quality control and oversight processes in a big way? Well, considering that Ranbaxy's loss is now Dr. Reddy's gain - the latter has received final approval to produce a generic form of Valcyte - let's hope it's a positive signal for companies to tighten their quality control standards and build a professional relationship with the FDA rather than the bitter recriminations that Ranbaxy is now resorting to.