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Sidney Wolfe v. FDA

Close Date: 07/13/2006
Topic(s): Foods, Drugs, Medical Devices, and Dietary Supplements
Government Transparency – non – FOIA
Status: closed
Date Of Involvement: 07/12/2006

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Description:

Public Citizen filed a complaint and a motion for a temporary restraining order to prevent the Food and Drug Administration from closing a July 14, 2006 meeting of its Blood Products Advisory Committee. The Federal Advisory Committee Act requires advisory committee meetings to be open to the public except in the case of a few narrow exceptions. If the President or head of the agency determines one of those exceptions applies to a portion of the meeting, he must state in writing the reasons for that determination. In announcing that the July 14 meeting would be closed, the FDA did not even report the topic of the meeting, let alone give specific reasons for its closure. The agency just stated that the meeting would be closed to permit discussion of trade secrets and/or confidential commercial information. Subsequent to the announcement of the meeting, Sidney Wolfe, director of Public Citizen Health Research Group, learned that the topic of the meeting was the Navy’s proposal to test a blood substitute called Hemopure on civilian trauma patients. Biopure Corp., the manufacturer of Hemopure, has told Dr. Wolfe that little, if any, of the presentations and discussions at the July 14 meeting are likely to disclose information it considers a trade secret or confidential commercial information.

In response to the Public Citizen lawsuit, the meeting was cancelled on July 13.