Frank Pallone: “Today marks a very exceptional day in this body, one that deserves great praise. The bill before us, H.R. 5651, the FDA…”

“Today marks a very exceptional day in this body, one that deserves great praise. The bill before us, H.R. 5651, the FDA Reform Act of 2012, is the product of bipartisanship, collaboration, and compromise that I'm very proud of. The bill is a result of more than a year of negotiations between industry, FDA, and Congress. In the Energy and Commerce Committee, we held a number of hearings on the critical issues within the bill, and earlier this month it passed unanimously in both subcommittee and full committee. The bill is slightly modified from the bill reported by committee, as it now includes a bipartisan provision which results in the bill reducing the deficit by $370 million over the next 10 years. The FDA Reform Act will ensure that Americans have access to safe and effective new medicines and medical devices by reauthorizing the user- fee programs for prescription drugs and medical devices. It will reduce drug costs for consumers by speeding the approval of lower-cost generic drugs with the establishment of new user-fee programs for generic drugs and for lower-cost versions of biotech drugs. The bill will also reform and revitalize many FDA programs to improve its regulatory scheme to facilitate a more efficient and predictable review process. Mr.…”