FDA Takes Issue With Boston Scientific

Boston Scientific (NYSE: BSX) has until later this month to respond to an FDA letter, prompted by the company's failure to disclose two of five deaths in a stent trial that the medical-device maker abandoned in 2006.

The letter is another PR black eye for the company, but it should not have a substantial impact on the stock, since the trial has long since been discontinued.

With Boston Scientific's stock price down more than 20% since the beginning of the year, this has not been the year investors had hoped for. And the company faces an even bigger dilemma: the corporate warning letter that the company received from the FDA in January 2006, relating to compliance issues at various facilities. Boston Scientific noted yesterday that it's headed in the right direction to close out this issue, but does not expect to resolve the matter until 2008.

The problem with this timing -- for the company and its shareholders -- is that competitor Medtronic (NYSE: MDT) is projecting that it will win approval for its Endeavor cardiac drug-coated stent in the U.S. as early as the end of this year. That could beat out FDA approval of Boston Scientific's promising drug-coated Taxus Liberte stent, which could be stalled pending the resolution of these warning letters. Aside from Boston Scientific, Johnson & Johnson (NYSE: JNJ) is the only other company presently offering a drug-coated stent approved for use in the U.S.

Boston Scientific now trades not far above its 52-week low. I'm not convinced that it's a bargain, though. At this point, I'm inclined to wait until its sales trends improve, and to see whether it will be able to bounce back from these FDA rebukes and push Taxus Liberte to market before Medtronic wins approval for Endeavor.