As expected, there's a lot more to the story about the FDA and its monitoring of whistleblowing employees. Steve Usdin at BioCentury has details (PDF, free access), and good grief, what a mess. Read the whole thing; you'll be amazed.
It looks like the agency's Center for Devices and Radiologic Health has devolved into a cross between "Dilbert" and some ministry in Pyongyang. The employees that the agency has been monitoring have been accusing their superiors of approving screening devices based on flawed (even fraudulent) data, while the agency seems to think that they're out of line and off on their own crusade. At issue is whether the reviewers or their bosses really have the expertise to make regulatory decisions, and there seems to be a real, uh, divided opinion on that question. To put it lightly.
As it turns out, any time an employee at the FDA logs on to a computer, the following warning pops up: "You have no reasonable expectation of privacy regarding any communica- tions or data transiting or stored on this information system. At any time, and for any lawful government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this information system." This case shows that they're not kidding about any of that, since the employees in question found everything they did being keylogged, screen-captured, etc., without (of course) their knowledge.
The CDRH higher-ups were treating this primarily as a criminal case by this point. But legitimate whistleblowing is a tricky grey area in this regard - with varying values of "legitimate" often decided years later - and the Office of Special Counsel is now investigating the FDA's own steps for their legality. No one is going to come out of this looking good, is my guess.
There's even more reason to think that, because (as it turns out), several of the CDRH employees were simultaneously filing suit (!) against the manufacturers of the devices that they were arguing about inside the agency:
While FDA reviewers were publicly working to persuade the agency to with- draw approval of computer-aided detection (CAD) mammography and CT colonoscopy devices, they also were secretly pursuing a lawsuit against the products’ manufactur- ers. The suit included a request that a substantial share of any financial awards go directly to the plaintiffs. . .
The suit was filed “under seal,” so the defendants were not aware that the FDA staff reviewing their products were also asking a court to levy potentially billions of dollars in civil penalties against them.
Under the False Claims Act, private individuals can file a suit under seal and invite the U.S. Department of Justice to join the case. If the federal government joins the case, it takes responsibility and foots the bill for prosecution, and the individual plain- tiffs can be awarded a portion of the civil penalties.
The FDA employees requested in the suit that they be awarded “at least 15% but not more than 25% of the proceeds of any award or settlement” if the government joined the suit, and more if the government did not join.
No, this whole business is a stink bomb. I really don't see how the CDRH can be operating effectively at all with all this sort of stuff going on. Is the rest of the FDA this hosed up, or is this just a particularly dysfunctional branch? Who knows?