How the FDA Could Cost You Your Life (written by Dr. Scott Gottlieb for The Wall Street Journal. Dr. Gottlieb was the deputy commissioner of the FDA from 2005-2007, and is now a practicing physician)
When people age, the main valve carrying blood out of the heart becomes brittle. As this aortic valve narrows, it can cause debilitating heart failure, and even death.
Fixing the problem in the United States requires open-heart surgery. In Europe, the problem can be repaired using a tiny catheter that introduces a replacement valve through an artery in the leg. In July, a Food and Drug Administration advisory panel said this device should also be approved for sale in the U.S. It is expected to reach patients by year end—more than four years after it first hit the market in Europe.
This is an all too familiar story, the FDA is impeding useful innovations in the U.S. Entrepreneurs here are forced to test promising medical devices in costly animal studies for years before they can advance their products into clinical trials. When clinical studies get started, the FDA is asking for longer and larger trials that increasingly mirror hurdles proposed for new drugs.
In response, Ameri...
