Political Quotes

“I would like to start by commending Chairman Upton, Ranking Member Pallone, Ms. DeGette, Mr. Green, and so many others. I am proud to join as a cosponsor for the 21st Century Cures Act, which is really a first step to updating our approval process to help countless Americans gain access to lifesaving drugs and devices. This bill will save lives. I am proud to support it and send a strong message that we need to move forward with reform. But at the same time we are passing this bill, we should start thinking about what the next step is. Passage of this bill should not foreclose additional opportunities in the future to improve access to lifesaving medical device products and lifesaving drugs. Most importantly, this body can move forward with the next generation and start the process to help people get access to medical technology that can help keep people healthy, independent, save lives, and save money. It is in that spirit that I put forward my amendment, which would look at a two-tiered approval process for medical devices, that would allow devices to come to market once they have demonstrated safety while the FDA is still reviewing them for efficacy. This solves a real problem in the world. In the U.S., the cost of bringing a medical device to market through the approval process is $30 million to $100 million. Those are costs that are then added to consumers of the medical device.…”