Employee surveillance at the FDA wasn't confined to the device division. Top agency brass knew that device officials were monitoring scientists who raised red flags about their approvals, The Wall Street Journal reports. HHS officials had been briefed about the surveillance, too, FDA sources told the newspaper.
Congress has called the agency on the carpet for spying on 5 scientists who complained to then President-elect Obama in 2009. The 5 scientists, along with four colleagues in the Center for Devices and Radiological Health, said the agency was overlooking safety problems for political reasons.
The FDA has defended the email monitoring by saying that it's bound to protect proprietary information submitted by companies seeking device approvals. The 5 scientists were suspected of leaking proprietary information to the press.
Commissioner Margaret Hamburg and CDRH chief Jeffrey Shuren both knew about the surveillance. Neither of them ordered it, WSJ's sources said, though Shuren may have triggered it. He asked another CDRH official to find out how the leaks could be stopped, and that ultimately resulted in the email monitoring.
FDA's chief information officer, Lori Davis, originally asked that one of the five scientists be monitored for improper disclosures, the WSJ says. But higher-ups were briefed about the surveillance, including Hamburg, Shuren and Ralph Tyler, then general counsel. Officials at HHS, including government lawyers, were also briefed, the WSJ's sources said.
- read the WSJ story
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