Dan Coats: “this is the first reform in 30 years at FDA. Obviously, a lot has changed in the industry. New drugs and new devices…”

“this is the first reform in 30 years at FDA. Obviously, a lot has changed in the industry. New drugs and new devices, new methods of bringing life-saving and health-improving benefits to the American people, and the people of the world. I think it is remarkable, particularly given the fact that it has been nearly 2 rac{1}{2}, 3 years now that we have been specifically working on this legislation in the committee, through a number of hearings, through a considerable, lengthy, and complex committee consideration, extensive floor debate. There were very difficult procedural hurdles to overcome and a difficult conference. We now arrive at this point with a bill that, very shortly, will be passed. This has only been done with a bipartisan effort.”