A clearer picture of the US Food and Drug Administration's digital surveillance of staffers who complained to legislators and journalists that the agency had approved potentially unsafe medical devices is emerging. The Wall Street Journal reported on Monday (August 6) that Commissioner Margaret Hamburg and Jeffrey Shuren, head of the FDA's Center for Devices and Radiological Health (CDRH), 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.