US Food and Drug Administration officials, including Commissioner Margaret Hamburg, knew about the agency's email surveillance efforts, reports The Wall Street Journal. After reports of email monitoring came to light, Reuters reported that Senator Chuck Grassley (R-Iowa) asked FDA to detail who at the agency ordered the surveillance.
In a letter to Congress, FDA officials say the surveillance came about as a way to prevent leaks. After information about a medical device was leaked to the media, Jeffrey Shuren, who directs the medical device center at FDA, asked Ruth McKee, an associate director of that center, to look into how to prevent such leaks. McKee turned to the chief information officer of the agency, Lori Davis, who then requested the email monitoring, the Journal says. Hamburg and other officials were informed of the monitoring after it began. The surveillance focused on researchers who raised safety issues.