The probe into the sensational charges that the FDA secretly monitored several former and current employees, and then harassed and dismissed some of them, has now widened. The Office of Special Counsel, which is an independent federal investigative and prosecutorial agency, is also investigating. This follows a probe opened by the House Committee on Government Oversight and Reform (see here).
The back story: 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). The recently filed a lawsuit charging 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 a statement, the OSC notes the FDA acknowledged monitored emails that were sent by employees at the Center for Devices and Radiological Health to congressional investigators and also OSC staff. And the OSC says it has received "new and troubling allegations of retaliatory surveillance of OSC communications and other acts of retaliation against the whistleblowers, including FDA attempts to initiate criminal prosecution of the whistleblowers. We are reviewing these additional allegations and information from Congress and will take appropriate action."
“Monitoring employee emails with OSC or Congress could dissuade employees from making important disclosures,” Special Counsel Carolyn Lerner says in a statement. “Monitoring communications with OSC is unacceptable. We encourage other agencies to review their policies to ensure that they are not monitoring or otherwise impeding employee disclosures to OSC or Congress."
In a letter to FDA commish Margaret Hamburg last week, House committee chair Darrell Issa noted that federal law prohibits managers from initiating personnel actions against employees in response to protected whisteblowing.
pic thx to katerha on flickr
7 Comments
When the managers of the FDA are from big pharma and hope to go back to big pharma, I think you already have an obvious comflict of interest. GO OSC AND CONGRESS- finally unto something important. THE FDA is imitating what the big pharma companies like Pfizer do to their employees who whistle blow internally.
CI - Agreed! I realize that there is no expectation of privacy in emails but I also know that in the Code of Conduct of my corp. there can be no retaliation against associates who are whistle blowers. I also realize that there is often a fine line between reality and idealism. But I do hope that the OSC and Congress can root out those who retaliated against those who disagreed with the findings. It's a sorry shame that open disagreement isn't a built-in part of the review instead of becoming a public mess...although that is the only way it seems that the sun can shine on the FDA procedings. Too bad transparency isn't part of their process.
The managers at the FDA are mostly entrenched government bureaucrats who seem to believe they work for pharma (perhaps some of them secretly do...).as witnessed here, employees who try to do the actual mission of the agency - to protect the public health - are harrassed, intimidated, censured, overruled, and worse.
It would behoove the Obama Admnistration to do a thorough housecleaning of the agency. And CDER would be a good place to start.
May I observe an inconveninet fact - the group in question worked at Center for Devices & Radiological Health (CDRH( rather than CDER. Perhpas you should rail against their customers at "Big Device" although that would be both novel .. and odd.
While the group in question were device reviewers. The same situation exists within the 'Center for Drugs' (CDER). From personal experience I can attest that many of the other comments are spot on accurate for drugs.
Its not just CDRH.....CDER is also the problem. Re: merck's SEARCH study: why on earth would the FDA leave simvastatin 80 mg on the market when it has a 25-fold increase in myopathy/rahbdomyolysis as compared to all other statins?
Maybe they're protecting merck inc? Maybe they're protecting insurance companies???
The FDA is a generally corrupt organization, run by the obviously corrupt Big Pharma, need I say more!