FDA "avoids violation" by cancelling meeting, says Public Citizen

The US Food and Drug Administration has avoided a major violation of the law by cancelling 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, says consumer group Public Citizen.

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 the court scheduling conference that it wanted to go ahead with an open meeting, said Public Citizen, alleging that "it is clear that the FDA was trying to hide something when it planned to close a meeting on this product."