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Regulatory News
30 August 2012
by RAPS

FDA Limits Research Misconduct Information Release

The U.S. Food and Drug Administration (FDA) wants exemptions for releasing information tied to misconduct investigations, according to a report by Pharmalot.

FDA wrote in a Federal Register notice it is concerned premature release of names of sources could affect evidence gathering, influence witnesses, or otherwise jeopardize the investigation. The new approach would be modeled after a system used by the U.S. Department of Health and Human Services Office of Research Integrity, according to Pharmalot.

The Privacy Act allows people who are under investigation to request information about the proceedings. FDA is concerned about revealing sources who were expressly promised confidentiality, according to the report. FDA is not expecting any challenges to the changes, but comments are open until 13 November.

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