Dr. von Eschenbach's unfortunate past reference to "the locker room" has again come back to haunt FDA as another conscientious and talented player on the Agency's drug review team has opted to leave FDA. The mainstream media (read here to access a particularly good report from the New York Times) and major blogs (e.g. Pharmalot) have reported on the fact that Dr. Rosemary Johann-Liang, the FDA drug reviewer who had recommended a black box label for GSK's Avandia, one year before the Agency required such a label, has resigned from the Agency.
Her staff is reportedly "demoralized," and a former colleague describes a "feeling of fear" among some drug reviewers at the Agency.
Dr. Johann-Liang would appear to be just the type of employee that FDA should want to keep. FDA's Chief Medical Officer Dr. Janet Woodcock has stated that one of her top priorities is to establish a more open culture, and encourage more open debate on safety and science, at the Agency---couldn't this latest defection have been prevented? The Times report describes Dr. Johann-Liang as feeling increasingly isolated, and being excluded from key activities, since she voiced her opinion.
BIOCOM's and PwC's recent survey on FDA and industry relations showed that FDA has had to "reverse positions" and make staff changes during reviews of drugs, all of which has hurt drug review time and overall efficiency. Poor staff morale also has a negative impact, and former Commissioners have all pointed to the urgent need to reward and incent FDA staffers and retain the good ones.
News like this will not help FDA leadership convince the public, Washington and the media that they really mean what they say.
