Top FDA officials were aware of the surveillance and monitoring programs targeting agency employees who raised questions about certain medial device review practices, according to a letter obtained by the Wall Street Journal.
Agency leadership, including Commissioner Dr. Margaret Hamburg and medical devices chief Dr. Jeffrey Shuren, were apprised of surveillance efforts against a group of medical device reviewers accused of leaking proprietary information to the media, according to the letter.
Neither Shuren nor Hamburg called for secret computer and email monitoring, according to the letter sent to Sen. Charles Grassley (R-Iowa), who has been a vocal critic of the federal watchdog agency’s employee surveillance tactics.
Shuren asked his 2nd in command, Ruth McKee, to take action after a group of medical device companies complained that information that they had sent the FDA had been leaked.
McKee enlisted then-chief information officer Lori Davis, who then requested monitoring for 5 FDA scientists, according to the Journal.
FDA leadership, including Hamburg, were brought up to speed "after the initiation of the monitoring," according to the letter.
The former FDA employees have filed a lawsuit against the federal watchdog agency, alleging that the government violated their constitutional rights with surveillance of their private email accounts.
The staffers allege that the FDA spied on the private email accounts they accessed using their government-issued computers, after they warned Congress and the president that unsafe medical devices were being allowed onto the U.S. market.
