FDAnews
www.fdanews.com/articles/84672-device-won-approval-though-fda-staff-objected

DEVICE WON APPROVAL THOUGH FDA STAFF OBJECTED

February 17, 2006

A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported Thursday. The device, the surgically implanted vagus nerve stimulator, had not proved effective against depression in its only clinical trial for treatment of that illness. As a result, scientists at the Food and Drug Administration repeatedly and unanimously recommended rejecting the application of its maker, Cyberonics Inc., to sell it as such a treatment, said the report, written by the staff of the Senate Finance Committee.

New York Times (http://www.nytimes.com/2006/02/17/politics/17fda.html?ex=1140843600&en=6c4814ddf4166f88&ei=5070&emc=eta1)