July 13, 2006

FDA Avoids Law Violation by Canceling Secret Meeting on Experimental Blood Substitute

Statement of Sidney M. Wolfe, M.D., Director, Public Citizen’s Health Research Group

The Food and Drug Administration (FDA) has avoided a major violation of the law today by canceling its scheduled closed July 14 meeting to consider the safety of the blood substitute product known as Hemopure for use in trials involving trauma patients. The FDA’s decision is a de facto admission that the meeting, had it been held in its closed format, would have violated the Federal Advisory Committee Act.

The FDA’s claim that opening the meeting to the public would have revealed confidential commercial information was belied by the 92 articles, including 12 involving clinical trials, already published about this product. Even Biopure Corp., which produces Hemopure, indicated in today’s court scheduling conference that it wanted to go ahead with an open meeting tomorrow.

It is clear that the FDA was trying to hide something when it planned a closed meeting on this product. It has held up the beginning of this experimental blood substitute trial because of concerns over safety. Allowing the public to be informed and participate in discussions about this product is the best way to determine whether it is safe enough to begin the trials in patients.

For more information about this case, click here.