Regulatory Focus™ > News Articles > Senator Calls on Agencies to Investigate FDA Surveillance Activities

Senator Calls on Agencies to Investigate FDA Surveillance Activities

Posted 31 July 2012 | By Alexander Gaffney, RAC 

Senator Charles Grassley (R-IA) has called on two federal agencies open independent investigations into the US Food and Drug Administration (FDA) regarding its surveillance of several employees involved in whistleblowing against the agency and potential violations of both whistleblowing and data protection laws.

Both the Department of Health and Human Services (DHHS), FDA's parent organization within the federal bureaucracy, and the Office of Special Counsel, an agency tasked with protecting the rights of federal whistleblowers, were sent letters by Grassley.

Agency 'Might Have Broken the Law'

In the letters, sent 30 July 2012, the senator notes, "The agency's conduct might have broken the law. Independent investigations are necessary to determine whether that's the case." (For background, please see Regulatory Focus' 16 July story, "Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices).

"Besides the legal questions, we need independent investigations to determine what the agency did and why," Grassley continued. "Accountability requires getting these kinds of answers."

Grassley said he had sent along copies to both agencies of 80,000 files accidentally released by FDA last month. The files contained a massive cache of information to the agency's surveillance activities, and were accidentally released to the public before being found by one of the whistleblowers. A subsequent article by the New York Times called significant attention to the files, and has been the source of mounting pressure on the agency.

The files were taken down soon after The Times brought them to FDA's attention, and it was unknown whether any outside parties had a chance to review or download them before their removal.

Potential Problems Mounting

Grassley's letter to the agencies also brings to light several other potential problems for FDA. "The Stored Communications Act makes it a crime to use [obtained] passwords to login to the employees personal email accounts without legal process and go fishing for emails that were not sent or received from a government computer," wrote Grassley. "While the FDA denied in a letter to me on 13 July 2012, that the passwords were used, it cited only one unnamed engineer in support of its claim."

Some of the whistleblowers told Grassley they were unsure how certain documents came to be known to FDA staff short of using such passwords, and the senator said he was concerned the act may have been violated.

"[An] investigation should include, at a minimum, interviewing each employee who had access to the captured personal passwords of the whistleblower employees," concluded Grassley.

Read more:

Grassley letter to OSC/DHHS

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