Mr. Speaker, today, the House considers a bill that represents a significant bipartisan achievement. Our work to find a common approach to legislation to support and strengthen the FDA is truly remarkable. It has been a pleasure to work with Mr. Upton, Mr. Pitts, Mr. Pallone, Mr. Dingell, and other members of the Committee to achieve this result. When we began this process, there were wildly divergent views on the various issues contained in this bill. But we worked together and found ways to address those issues in a way that protects both innovation and patients. This legislation contains several provisions that are critical to the functioning of major parts of FDA. Our reauthorization of FDA's drug and medical device user fee programs will provide resources to enable the efficient review of applications and give patients access to therapies at the earliest possible time. We are also reauthorizing two pediatric programs which foster the development and safe use of prescription drugs in children. This year we will be establishing two new programs to help speed FDA's review of new generics and biosimilars. These provisions illustrate our bipartisan commitment to ensuring a vibrant generic marketplace. All of us will see the benefits when more low-cost generics are on the market as a result of this legislation. The bill also includes provisions to modernize FDA's authorities with respect to the drug supply chain.…
On the recordMay 30, 2012
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