Most can agree that regulating the safety and effectiveness of drugs and medical devices is for the protection of public health. The FDA is appointed this responsibility, but is it failing? The time-consuming and costly approval process could be preventing life-changing treatments from reaching the market; however, more lives could be at risk if safety were sacrificed for speed. The topic of the most recent Intelligence Squared U.S. debate, “The FDA’s Caution is Hazardous to Our Health,” had panelists vehemently arguing for or against this motion.
On the team defending the motion was Scott Gottlieb, M.D., currently a resident fellow at the American Enterprise Institute and formerly FDA deputy commissioner, with his partner Peter Huber, senior fellow at the Manhattan Institute. The pair debating against the motion was Jerry Avorn, M.D., professor of medicine at Harvard Medical School, and his teammate David R. Challoner, M.D., vp of Emeritus for Health Affairs of the University of Florida.