July 15, 2006

FDA on Artificial Blood: Um, This Time, We're Going to Think First

From the "FDA Statement on Blood Product Advisory Committee Meeting on Proposed Clinical Trial for Blood Substitute Product":
In view of significant public interest in the proposed study and the benefit of public discussion, FDA has cancelled tomorrow's meeting of the Blood Products Advisory Committee. We will work toward a future meeting where information can be shared with the public.

FDA had planned to devote the July 14th portion of the Blood Products Advisory Committee meeting to consider a proposed clinical trial by the U.S. Naval Medical Research Center of an investigational blood substitute product manufactured by Biopure.

The complexities involved in the development and evaluation of the safety and effectiveness of such products can raise many unique scientific issues. This meeting was scheduled to provide the Advisory Committee an opportunity to discuss development plans for this product, and to provide the FDA with additional independent expert input. Advisory committee meetings that involve early development issues are frequently closed to public participation because confidential commercial information is central to the discussions.

The development of safe and effective treatments that could substitute for blood holds significant public health promise and could potentially save many lives. Given the level of public interest in this matter, the parties will work toward greater public involvement at this early stage.

thanks Al Yarinsky

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