July 13, 2006

Public Citizen Sues FDA Over Secrecy on Blood Substitute Meeting

Move to Hold Closed Advisory Meeting on Proposal to Test Blood Substitute Product on Civilian Trauma Patients Is Unlawful

    WASHINGTON, D.C. – Public Citizen filed an emergency suit last night against the U.S. Food and Drug Administration (FDA) to force the agency to open a closed meeting scheduled for Friday, July 14, on an experimental blood substitute product.

    The lawsuit, filed in the U.S. District Court for the District of Columbia by Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, asserts that the plan to close to the public the meeting of the FDA’s Blood Products Advisory Committee violates the Federal Advisory Committee Act (FACA) and the Administrative Procedure Act. Public Citizen has a longstanding interest in the safety of prescription drugs, medical devices and blood products.

   The meeting is scheduled to discuss the safety and efficacy of Hemopure, a blood substitute product derived from cow’s blood and produced by Biopure Corp., and the U.S. Navy’s proposal to test the producton civilian trauma patients. The FDA kept secret the topic of the July 14 meeting and announced its intent to close the entire meeting to the public in the June 28 Federal Register “to permit discussion of review of trade secret/and or confidential information.” Public Citizen has learned from Biopure Corp. that little, if any, of the information that likely will be discussed at the meeting will be confidential commercial information or a trade secret.

    Public Citizen’s lawsuit states that the FDA’s determination violates FACA’s mandate that every meeting of an advisory committee shall be open to the public unless the head of the agency to which the advisory committee reports determines that a portion of the meeting may properly be closed. The law requires that the determination be in writing, explain the topics to be discussed at the closed portion of the meeting and contain the reasons for such determination. The FDA’s Federal Register determination did not provide any description of the topics to be discussed.

    “The FDA has purportedly turned down the Navy’s request three times to test Hemopure in trauma patients,” said Wolfe. “The public has a right to know what happens at this meeting, and I should have a right to attend and to participate in the discussion concerning the testing of this product.”

To view the lawsuit, click here. To view an accompanying memorandum of law in support of a temporary restraining order on the FDA, click here.

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