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New Boston Scientific CEO committed to having FDA warning letter lifted

This article was originally published in The Silver Sheet

Executive Summary

Ray Elliott took the reins as CEO of cardiovascular device maker Boston Scientific July 13 following the retirement of Jim Tobin. The most specific short-term priority identified by Elliott is clearing the company completely from its 2006 FDA corporate warning letter, which identified pervasive quality system and adverse event reporting deficits throughout Boston Scientific's operations ("The Silver Sheet" March 2009). The agency agreed to lift restrictions associated with the warning letter on new product approvals last October due to a finding of "substantial compliance," the company says. However, Elliott acknowledges that "we still have some work to do" to get the letter lifted, primarily in the area of adverse event reporting. Elliott - who spent a decade as chief executive at orthopedic firm Zimmer - committed himself to at least five years in the CEO post, according to Boston Scientific's June 25 filing with the Securities & Exchange Commission. Tobin, who served as CEO for a decade, will stay on as a senior adviser through Nov. 30
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