And now, the House Committee on Government Oversight and Reform is investigating the FDA surrounding a sensational episode in which several current and former agency employees have charged in a lawsuit that they were harassed and dismissed after complaining about device reviews to Congress.
In a letter yesterday to FDA commish Margaret Hamburg, committee chair Darrell Issa raises the same concerns that Chuck Grassley, the ranking member of the Senate Judiciary, outlined in his own missive to the agency two weeks ago (read here). Like Grassley, Issa wants Hamburg to turn over documents and spell out agency policy on handling employees who have a right to disclose info.
For the record, the employees accused the FDA 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). And their lawsuit charges the FDA repeatedly attempted to initiate formal criminal investigations and harmed their reputations.
They were motivated by alleged problems. The employees, who are all scientists and doctors, charged three devices could have missed signs of detecting breast cancer, according to the paper. Other examples: one device risked falsely diagnosing osteoporosis and an ultrasound device could malfunction while monitoring pregnant women in labor.
In his letter, Issa points out that federal law prohibits managers from initiating personnel actions against employees in response to protected whisteblowing. And he accuses the FDA of engaging in unlawful activity by retaliating against the employees (here is his letter).
pic thx to katerha on flickr