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FDA sued over email privacy

Scandal at the FDA!

We haven’t heard much in the way of any FDA shenanigans since the end of last year, when news broke that they were allowing contaminated foods to stay on the shelves.

But after a month or so of relative quiet, they’re starting off 2012 with a bang–a nice big scandal to ring in the new year.

The FDA has been sued by current and former employees for monitoring personal emails after those employees warned Congress that they were being forced to approve medical devices that carried unacceptable risks.

Over the course of two years, those emails were monitored when accessed from government computers. The employees also claim they were harassed and forced out of their positions.

Now, having your personal emails monitored by your employer is pretty worrisome. But the FDA is pretty upfront about this. They, like many other employers, let employees know that they shouldn’t have any “reasonable expectation of privacy” when it comes to any information accessed or created on government computers. So, when it comes to writing personal emails, it’s a sort of “play at your own risk” scenario.

Of course, that doesn’t excuse any harassment or unsavory dismissal. But that’s still not what’s really scary to me in this whole scenario. While other news outlets are focusing on the privacy issues at hand, they seem to be downplaying the big news here–that the FDA was possibly pushing employees to approve unsafe medical devices.

The employees, who are all scientists and doctors, warned that three devices in question could miss signs necessary for detecting breast cancer. Another could falsely diagnose osteoporosis; yet another, an ultrasound device, could malfunction when monitoring women in labor.

And yet these devices were all approved. In 2009, the employees sent a letter to Congress stating that they were under investigation by the FDA Office of Criminal Investigation after sending a 2008 letter to the House Energy and Commerce Committee alleging that the FDA process for approving medical devices was coercive and intimidating.

That didn’t sit well with the FDA, so they started intercepting emails sent to Congress and reviewing documents prepared by the employees. The FDA says this is because they feared these employees had been illegally releasing confidential business information in their correspondence with Congress. The Department of Health and Human Services called shenanigans on that claim, saying the employees were within their rights to share the information they did.

Now the FDA is saying the emails “undermine the mission of the FDA” and are therefore possibly illegal. They’re worried that the release of the information “will compromise the integrity of the ongoing premarket review of the subject device applications,” according to the director of the arm of the FDA for which these employees worked.

I’m sorry–integrity? I think you lose your rights to talk about integrity when your program intimidates employees into approving devices that could put people’s health at risk.

Okay, so it’s kind of stupid to send high-risk emails from your work computer after you’ve poked the lion that is the FDA. But the important thing is that these employees were doing the right thing–they took a stand against a dangerous practice, and are facing a tough fight because they dared to speak up.

Whether or not they chose the right pathway for their messages, though, is secondary. What we really need to focus on here is why the FDA would intimidate employees into approving medical devices that do no good–and could potentially do harm.

P.S. Already switched deodorants but looking for other ways to avoid aluminum? Keep reading.

“FDA Sued By Employees Over Email Privacy,” Pharmalot (