FDA Commissioner Margaret Hamburg and other top officials knew that the agency was monitoring the emails of employees who warned congressional staffers that FDA-approved medical devices might pose risks to patients, according to FDA officials, the Wall Street Journal reports (Burton, Wall Street Journal, 8/6).
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, 8/1).
In recent weeks, the agency opened an internal investigation to determine how the monitoring program was authorized in 2010.
FDA officials said Jeffrey Shuren, director of the agency's medical device center, asked another official, Ruth McKee, to see if she could stop information about the safety complaints being leaked to the media. McKee met with then-Chief Information Officer Lori Davis, who requested the monitoring of the scientists.
FDA said that former FDA General Counsel Ralph Tyler, other agency officials and lawyers at HHS also were informed of the monitoring program
According to the Journal, neither Tyler nor Hamburg objected to the monitoring program (Wall Street Journal, 8/6).