Senior officials at the Food and Drug Administration knew the agency was monitoring emails of scientists who had leaked concerns about faulty medical devices being greenlit, The Wall Street Journalreported, citing officials and a document sent to Senate investigators.
The monitoring of emails began in the spring of 2010, after media leaks on supposedly proprietary information about companies' medical devices. The agency used spy software that logged keystrokes, intercepted personal emails, and tracked messages as they were drafted in real time, according to a New York Times investigative report.
Jeffrey Shuren, director of the FDA's medical-device center, had asked his No. 2 official in the device center, Ruth McKee, to look into what could be done to stop the leaks, according to the Journal report. Lori Davis, then-chief information officer of the agency, requested the surveillance of five scientists who ultimately were monitored. The scientists were among a group of nine whistleblowers who complained to then-President-elect Barack Obama's transition team in early 2009 that safety issues were being neglected at the agency.
The scientists filed lawsuits against the FDA. In recent weeks, an FDA team led by John M. Taylor III, counselor to Commissioner Margaret Hamburg, has opened an internal investigation to find out how the monitoring program was allowed, according to the Journal. Hamburg knew about the monitoring of emails of scientists, the report said.