At the last TEDMED in April, Dr. Margaret A. Hamburg, Commissioner of the FDA, was interviewed on stage by Larry Brilliant, MD MPH, President and CEO of the Skoll Global Threats Fund about how the agency regulates medicine and its current attempts at transformation. Dr. Hamburg is certainly confident of the FDA, claiming the agency approves drugs faster than anywhere in the world and that majority of the devices are approved “as fast or faster” than Europe. If anything, these claims are subject to great debate, and complaints about FDA’s regulatory bottleneck are never lacking. It is enlightening to see what the head of the agency that regulates 20 cents of every dollar in the U.S. economy thinks about these and other issues:
