FDA'S BLOOD PRODUCTS ADVISORY COMMITTEE CLOSED HEARING CANCELED
The FDA canceled a closed meeting of its Blood Products Advisory Committee one day after a government watchdog group filed a lawsuit to force the agency to hold the hearing in the open.
The meeting had been scheduled for July 14 to hear a request by the U.S. Navy to hold a clinical trial of Biopure's blood substitute, Hemopure. On July 12, Public Citizen filed a lawsuit in U.S. District Court for the District of Columbia, claiming the closed meeting violated federal law.
The cancellation is "a de facto admission that the meeting, had it been held in its closed format, would have violated the Federal Advisory Committee Act," Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. "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."
The FDA, however, said the decision to cancel the meeting was in the interest of good policy. "In view of what has been substantial public interest in the proposed study and the benefit of public discussion, the FDA has canceled tomorrow's meeting of the Blood Products Advisory Committee," Lorrie McNeill, director of the Division of Communication and Consumer Affairs for the FDA's Center for Biologics Evaluation and Research, said. "We will work toward a future meeting where information can be shared with the public."
While Public Citizen said Biopure had told it that little, if any, of the information in the meeting would be confidential or relate to trade secrets, the company's public stance favors the FDA's original position of closing the meeting. "There was concern that the prerequisites for an open meeting could have significantly delayed the meeting," the company said in a statement on July 12. "Therefore, in order to focus on substantive preparations, Biopure and the Navy agreed that the meeting would be held in closed session."
Controversy has arisen over the safety of the blood substitute, which would be administered to hospital trauma patients in the proposed study, and over the fact that the patients' informed consent would not be required due to their medical condition. (http://www.fdanews.com/did/5_137/)