How does the FDA treat employees who blow the whistle? US Senator Chuck Grassley, a long-standing agency nemesis, wants to know. And so he has written FDA commish Margaret Hamburg to explain the circumstances surrounding a controversial episode in which several current and former agency employees say they were harassed and dismissed after complaining about device reviews to Congress.
Their charges were contained in a sensational lawsuit filed last month, in which they accused the agency of secretly reading their personal email accounts, while the agency maintained they illegally disclosed confidential business information after writing to Congress to complain they were being coerced to approve devices that posed unacceptable risks (back story).
For instance, the employees, who are all scientists and doctors and worked in the Center for Devices and Radiological Health, charged three devices could have missed signs of detecting breast cancer; one device risked falsely diagnosing osteoporosis, and an ultrasound device could malfunction while monitoring pregnant women in labor.
Their lawsuit charges the FDA repeatedly attempted to initiate formal criminal investigations and harmed their reputations, which has angered Grassley. "It is troubling me to see your agency actively pursue the dismissal of an employee against the advice of the OSC (US Department of Health & Human Services Office of Special Counsel) - not because they violated procedure and leaked genuinely confidential classified information - but simply because you "cannot trust him," he writes Hamburg.
Moreover, he charges that the actions taken by the FDA contradict testimony from Hamburg before Congress in which she maintained that whistleblowers "serve a very important role in government in surfacing critical issues and concerns and making sure they're addressed. As leader of FDA, I would very much want to create a culture that all enables all voices to be heard."
Grassley goes on to note that interfering with a Congressional inquiry - the letter from the employees sparked Congressional interest in the review process - is a federal crime, as is preventing employees from providing information to Congress. And so, he wants Hamburg to explain not only how this episode occurred, but any steps the agency has taken to avoid a repeat (here is his letter).
pic thx to katerha on flickr