Wednesday, July 29, 2009
Miscommunication with a regulator can be painful. That is apparently what happened to Mylan, a generic drug maker. In defense of Mylan, it is hard to believe that the company would have declared an "all clear" without someone in the FDA nodding assent. It appears that there might well have been miscommunication within the FDA too. The lesson here is to doublecheck everything with a regulator before going public. One never knows when a press release might boomerang.