FDA has kicked Ranbaxy Laboratories out of the frying pan and into the fire. The agency accused the Indian generics maker of falsifying data and test results in its applications for drug approvals. The faked data supported apps for medications that have already been approved and for pending applications, too. The latter came to a quick halt at FDA until the agency can wrap up an investigation.
The ersatz data was generated at Ranbaxy's Paonta Sahib plant in India, FDA said. That's one of the two facilities named in an agency ban on Ranbaxy imports last September. At the time, FDA barred more than 30 generic drugs because of manufacturing violations uncovered at those plants. Meanwhile, the Justice Department has been investigating charges that Ranbaxy faked data to get FDA approval for some products.
There's no evidence that the drugs approved based on the false data are actually dangerous, the FDA says, so patients should keep taking them unless or until they talk to their doctors. Examples of the fakery: the company said some drugs were stored at room temperature when they were actually refrigerated, and it claimed to have tested the shelf life of certain products when those test were never made.
What does this mean for Daiichi Sankyo, the Japanese company that bought control of Ranbaxy last year in a much-ballyhooed deal? The Wall Street Journal Health Blog tried to find out, but Daiichi types weren't forthcoming.
- see the FDA press release and letter to Ranbaxy (.pdf)
- read the AP story
- get more from the Wall Street Journal
- see the Health Blog's coverage