Congressman Pallone's Statement on Vote for FDA Reform Act of 2012

FOR IMMEDIATE RELEASE:
Thursday, May 24, 2012

Washington, D.C.—Congressman Frank Pallone, Jr. (NJ-06), the senior Democrat on the House Energy and Commerce Committee’s Health Subcommittee, issued the follow statement on the floor of the U.S. House of Representatives in advance of a vote to pass the FDA Reform Act of 2012. The FDA Reform Act of 2012 passed the House with overwhelmingly bipartisan support by a vote of 387-5. Congressman Pallone was an original co-sponsor of the bill which will help bring new drugs and medical devices to the market faster and at lower costs to consumers.

The following is his statement:

“Thank you, M. Speaker. 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 am proud to be a part of.

“This bill is the 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 the 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.

“The bill also makes permanent two complementary programs - the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act - which both help to foster the development and safe use of prescription drugs for children.

In addition, a significant improvement was made to the FDA’s ability to police an ever-growing global drug supply chain to improve patient safety. These provisions will give the FDA critical tools it needs to keep our medicine safer.

“It also includes important provisions to help prevent and mitigate drug shortages, by requiring that drug makers notify the FDA in advance of any expected disruptions in the supply of certain critical drugs, and for the FDA to inform health care providers of the potential drug shortage.

“Thank you to Chairmen Upton and Pitts, Ranking Member Waxman, Mr. Dingell and my other colleagues on the Committee for their leadership and dedication to this important piece of legislation. A special thanks to the staffs on both sides of the aisle for their hard work – you all should be very proud of what you’ve accomplished.

“Reauthorizing and revitalizing the FDA user fee system is a critical investment to our nation’s public health. M. Speaker, I urge all Members of the House to vote aye.”