Article preview from "The Gray Sheet"- July 23, 2012
Multiple investigations and lawsuits have opened in response to the matter, with more potentially to come. Some worry the intensifying issue has serious implications for the quality of the device center’s output.
Article preview from "The Gray Sheet"- July 23, 2012
FDA and CDRH officials are facing escalating pressure following the accidental public release of thousands of emails and documents captured by agency surveillance of CDRH scientists who complained to Congress and others about the device review process.
Multiple investigations and lawsuits have opened in response to the matter, with more potentially to come. Some FDA watchers, both from industry and consumer advocacy groups, worry the intensifying issue has serious implications for the quality of the device center’s output.
FDA maintains that the monitoring of the staffers’ email and computer activity was legal and limited in scope to five current and former CDRH employees who were being investigated for leaking proprietary commercial information related to pre-market submissions for imaging devices to the press and others.
However, a recent accidental and unauthorized release of thousands of pages of computer documents generated by the two-year surveillance effort have bolstered the scientists’ claims that the effort was more expansive than FDA says it was and that it captured legally protected information, such as attorney-client communications.
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