According to an article in today’s edition of the New York Times, “Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints.”
The complete New York Times story can be found here.
If the FDA has undertaken such an investigation (and the agency will not confirm or deny), the reason is that these nefarious nine leaked confidential agency documents to the media. That’s a felony.
The Nefarious Nine are unhappy that their complaints about device approvals aren’t being addressed with greater alacrity. So, in their righteous indignation, they decided that their purity placed them above the law.
Unfortunately, not only will their behavior not speed up the agency’s investigation of their brief – it may very well slow it down.
Breaking the law is the wrong path to better regulatory oversight of medical devices. The ends doesn’t justify the means.
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