Taxus expedited review change-of-heart
This article was originally published in The Gray Sheet
Executive Summary
FDA grants "fast-track" review status to Boston Scientific's paclitaxel-eluting stent PMA - a reversal from earlier agency indications. During a January CRT meeting, FDAers claimed expedited review would not be given to a second drug-eluting stent because the device would not address an unmet clinical need (1"The Gray Sheet" Feb. 3, 2003, p. 6). FDA now says it granted Boston Scientific's request because there currently is no approved drug-eluting stent available in the U.S. Johnson & Johnson's Cypher sirolimus stent, the first PMA to be filed with the agency, is widely expected to gain FDA approval the week of March 17. The Taxus reversal also reflects Commissioner Mark McClellan's emphasis on efficient review and prompt designation of innovative technologies...