Earlier this year, the Washington Post reported on a horrific scandal: the FDA was… spying on employees. Spying!
The story stirred Congress into action with several committees sending letters to the FDA demanding answers. The person at the center of attention is an expert in the medical device section who was convinced that the agency was approving dangerous products. Apparently to protect themselves, the FDA had hired an outside firm to monitor the e-mails of the employee who is now suing the agency. And then, the rest of the story.
In July, the Wall Street Journal and New York Times both broke stories about the FDA whistleblower. He had a history of similar confrontations with past employers that include raising an alarm about potential unethical actions and suing them. One story included comments from the whistleblower’s former agency colleagues calling him difficult and a problem.
The other fact is that the agency has a duty to protect trade secret information. Companies who submit proprietary data to the agency have a right to ensure it is not disclosed to competitors. The issue is incredibly complex.
How do we balance the right of agency employees to contact Congress when unethical practices happen against the legal need to protect companies’ proprietary information? It’s not easy.
In this case, the evidence is leaning against the whistleblower who seems to have a history of crying foul and then suing his employers for sizeable settlements. Whatever the final outcome, the complexity of this issue is not going away.
Paul Thacker, a former investigator for Sen. Charles Grassley, is an investigative reporter based in Washington, DC.
From the September 01, 2012 Issue of MM+M - Medical Marketing and Media
