We have been keeping you up to date and informed on the situation that is headlining many news reports within the US Food & Drug Administration over claims that the FDA was spying on their employee emails; emails that were apparently planning to out the FDA for approving unsafe medical devices.
The latest on this investigation now points to top Food and Drug Administration officials, including Commissioner Margaret Hamburg, knew about the monitoring of emails of scientists who had raised safety issues. This information was revealed in a letter the agency sent to Senate investigators. The FDA letter gives us insight into FDA’s digital surveillance of staffers who were complaining to legislators and journalists that the agency approved allegedly unsafe medical devices.
The monitoring of emails evidently began in the spring of 2010, FDA officials said, after proprietary information about a companies’ medical device was leaked to some media outlets. Several companies that had applications for FDA approval pending complained about the disclosures to the director of the FDA’s medical-device center, Jeffrey Sharon.
The Wall Street Journal reported on August 6, 2012 that FDA Commissioner Margaret Hamburg and Jeffrey Shuren knew of the effort to monitor the email accounts of 5 FDA scientists starting in the spring of 2010, though they claim not to have directly ordered the digital snooping.
To set the record straight, the FDA has detailed a chain of command that led to the decision to spy on its own staffers, after information about the approval of radiological devices was leaked to the media. According to the WSJ, Shuren asked associate director of the CDRH Ruth McKee to explore how the agency might prevent some leaks. Then McKee went to Lori Davis, FDA’s chief information officer, who subsequently requested the email monitoring. Hamburg, officials at the Department of Health and Human Services, and government lawyers were apprised of the monitoring program soon after it began.
Neither McKee, Shuren, nor Hamburg responded to the WSJ‘s requests for comment and Davis couldn’t be reached, but the FDA maintains that the monitoring was conducted in order to stem leaks of proprietary information.