The lawsuit was filed by Ohio-based nonprofit organization Care to Live on July 30. The FDA made its decision not to approve the vaccine in May this year on the back of insufficient clinical trial data. The company’s shares plummeted 60% a day after the decision was announced.
However, the suit alleges that Dendreon’s application was sabotaged by Dr Richard Pazdur, head of the FDA’s office of oncology drug products, in a conflict of interest. He allegedly put two advisers on the review board, one of which was a lead investigator in a rival Novacea’s cancer drug trial.
While the FDA failed to approve Provenge, it was recommended by an outside advisory panel, which unanimously agreed that the vaccine was safe. The FDA usually goes along with panel opinions, but said it did not in this case because the vaccine failed to meet its primary goal of shrinking prostate tumors. Instead, the agency requested more information from Dendreon, potentially delaying approval of Provenge for years.
The federal circuit court in Washington is in the process of considering Care to Live’s lawsuit, which if won, could bring about a constitutional right to experimental drugs.