I stand to strongly support this legislation. This bipartisan agreement represents over 18 months of work from the Energy and Commerce Health Subcommittee, and I'm especially proud and appreciative of the hard work of Ryan Long and Clay Alspach for their diligent and tireless efforts in helping to make this bill possible. The FDA Safety and Innovation Act is critical to saving lives, improving regulatory operations, and sustaining a vital and dynamic American industry. {time} 1440 American companies are the leading developers of new medical devices and drugs to save and sustain life. To ensure that products are both safe and effective, we've tasked the Food and Drug Administration with reviewing products before they make their way into the market, and this is a critical responsibility. The device and drug industries are dynamic and innovative. Companies spend hundreds of millions of dollars and years of research and work to develop products. The review stage is a critical time for any company. Inconsistent reviews mean that the true cost of developing new products is hidden, making it difficult to properly prepare. When our Health Subcommittee began considering this legislation last year, we heard from a number of individuals about the increasing difficulty of working through the review process. American patients were waiting almost 4 years longer for new devices that had already been approved in Europe. And despite the slower U.S.…
On the recordJune 20, 2012
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