Report: Top FDA officials knew of whistleblower email monitoring

The FDA's email monitoring of employees after they testified to Congress about questionable medical device approval practices appears to have been sanctioned all the way to the top, according to The Wall Street Journal.

Commissioner Margaret Hamburg and the FDA's Center for Devices and Radiological Health Director Jeffrey Shuren are among the high-level regulatory officials briefed on the practice, according to FDA officials and an agency letter sent to Senate investigators cited by the newspaper. Shuren may not have ordered the monitoring of the 5 scientists himself, but the story notes that he appears to have set the action in motion by asking the official directly under him to explore how to stop the leak of corporate medical device proprietary information to the media.

The spied-upon group, who all handled FDA medical device approval evaluations, are suing the regulatory agency for spying on their personal Gmail accounts for two years. The action, they claim, comes after they testified before Congress about medical devices that had gained approval despite serious safety risks. FDA officials, however, say the monitoring was perfectly legal and began after device companies complained that the disclosures breached confidentially. Regulators say they can intercept any data transmitted from an FDA computer "for any lawful government purposes."

That hasn't stopped Congressional scrutiny. Long-time FDA critic Sen. Charles Grassley (R-IA) has called for the Department of Justice to investigate the matter and told The Wall Street Journal that "the FDA's treatment of these whistleblowers deserves full scrutiny and answers."

- read the WSJ story (sub. req.)

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