Dan Coats: “Although these improvements are certainly laudable, they are not worth the human costs of the FDA's approval system.…”

“Although these improvements are certainly laudable, they are not worth the human costs of the FDA's approval system. Rather than protecting public safety, in some cases the FDA's system for approving medical devices actually endangers lives. Let me cite some examples: Coronary stents. Coronary stents are simply a wire mesh tube that holds the artery open to facilitate the flow of blood to the heart muscle. During angioplasty, which nearly 400,000 Americans a year undergo, before the coronary stent was developed 15 percent of patients undergoing that operation had a blood vessel collapse and had to go into emergency bypass surgery, which placed them at greater risk, and a lot of lives were lost. The coronary stent, however, became an alternative method of treatment for most of these patients and reduced dramatically the amount of collapsed blood vessels and dramatically the lives that were lost. You would think that, given the importance of this technological breakthrough, the FDA would have given expeditious handling to the application for approval of the stent. Sadly, for thousands of Americans who died when they could have benefited from this stent, this was not the case. It took 9 months for the device's developers to obtain permission from the FDA to even begin preliminary phase I clinical trials. These trials took another year.”