Last week, Sen. Chuck Grassley (R-Iowa) sent a letter to the U.S. Office of Special Counsel and another letter to HHS' Office of Inspector General asking the two offices to investigate allegations that FDA conducted surveillance on employees who raised concerns about the agency's medical device review processes, MassDevice reports (MassDevice, 7/31).
In January, six current and former FDA scientists and physicians filed a lawsuit alleging that FDA monitored their personal email after they warned congressional staffers that the agency approved medical devices that might pose risks to patients.
According to government documents gathered by the plaintiffs, FDA started intercepting personal emails between several of its employees and congressional staffers in January 2009 and continued the surveillance for two years, generating 80,000 pages of documents. FDA also took screenshots of the employees' computer desktops and reviewed documents that they had saved on their hard drives.
FDA officials acknowledged the secret computer-monitoring effort but added that it was limited to communications from five scientists whom they suspected of leaking confidential information about the safety and design of medical devices (iHealthBeat, 7/17).
Details of the Letters
Along with the letters, Grassley sent the two offices copies of the 80,000 pages of FDA employees' emails and other documents that previously were available on a public website (Grassley release, 7/30).
Grassley's letters called for both offices to investigate FDA's methods for collecting such information. Grassley said that although FDA has a right to monitor employees' computers, the Stored Communications Act prohibits employers from using passwords and other login data gathered via surveillance to access employees' accounts.
Grassley said, "There appears to be a need for a more thorough investigation to determine whether there may have been a violation of the Stored Communications Act to gather emails from purely personal email accounts using the captured passwords to access them."
Grassley noted that he has contacted FDA for information on the matter but has "been met with stonewalling and incomplete answers" (MassDevice, 7/31).