FDA investigating how device-approval files leaked

The FDA is already facing a lawsuit from 5 current and former investigators after the agency monitored their email communications. Now the regulator has another problem: About 75,000 pages of related confidential documents ended up posted online for all to see.

As The Wall Street Journal reports, the FDA contracted a firm called Quality Associates to print the documents and make them available to parties involved in the lawsuit, but somehow the confidential information--detailing the design and approval processes of some medical devices--ended up on the Internet for a few days. The documents have since been taken down, and the agency is investigating how they got posted in the first place.

The flap started in 2008, when the 5 scientists began complaining about how often devices with "unacceptable risks" sailed through the FDA. Specifically, the regulators were concerned about 12 radiological devices of questionable effectiveness that were poised to get FDA approval, and they sent email to other agencies and members of Congress. In 2009, after devicemakers complained that the disclosures constituted a breach of confidentiality, the FDA began spying on those scientists, monitoring their personal email accounts.

The agency says that its monitoring is within the law, as any data transmitted from an FDA computer can be intercepted "for any lawful government purposes." The scientists, in their suit, argue that because their email messages were legal communications with Congress and other federal agencies, they should have been off-limits.

- read the WSJ story
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