User Fee Bill Co-Authored by Dingell Passes House

May 31, 2012 (Congressional Documents and Publications/ContentWorks via COMTEX) -- Wednesday, May 30, 2012 Contact: Betsy Barrett 202-225-4071 / betsy.barrett@mail.house.gov User Fee Bill Co-Authored by Dingell Passes House H.R. 5651, the Food and Drug Administration Reform Act will encourage drug and medical device innovation, modernize FDA's drug supply chain authorities, and support and create jobs in the United States Washington, D.C. - Tonight, U.S. Representative John D. Dingell (D-MI15) issued the following remarks on the floor of the House of Representatives to voice his support of H.R. 5651, the Food and Drug Administration Reform Act. The bill passed by a vote of 387 to 5.

"Mr. Speaker, today the House is considering H.R. 5651, to reauthorize the prescription drug and medical device user fee programs and establish new user fee programs for generic drugs and biosimilars. H.R. 5651 is an example of what good can be done when both parties come together in the spirit of bipartisanship, cooperation and compromise.

"The legislation will help ensure timely access to safe and effective drugs and medical devices, encourage the development of innovative drug treatments for our children, and improve FDA's current authority related to drug shortages. More importantly, this legislation will provide FDA with much needed new authorities to secure the safety of our drug supply chain and help prevent another Heparin incident.

"H.R. 5651's drug supply chain provisions will improve information FDA has about domestic and foreign drug manufacturers and for the first time provide FDA with information about importers. It will also allow FDA to detain or destruct counterfeit or adulterated drugs, prohibit entry of imported drugs that have delayed or denied inspection by FDA, and encourage parity in the inspections of domestic and foreign drug establishments. These provisions mirror those in my drug safety legislation and the new authorities provided to FDA for our food supply, will level the playing field for our domestic drug manufacturers, and give American families peace of mind that FDA can quickly respond to counterfeit or contaminated drugs.

"I want to thank Energy and Commerce Committee Chairman Upton and Ranking Member Waxman, Subcommittee on Health Chairman Pitts and Ranking Member Pallone, and their staff: Clay Alspach, Ryan Long, Rachel Sher, Eric Flamm, Arun Patel and Tiffany Guarascio, as well as Kimberlee Trzeciak, for their hard work and their commitment through this process to producing a bipartisan bill.

"Mr. Speaker, I am pleased to be a co-author of this important legislation. We have built upon the good work that FDA is already doing, as well as the strong agreements negotiated by industry and FDA, and I urge the House to pass this bill. I look forward to working with my colleagues in the Senate to swiftly pass legislation this summer that can be signed into law by the President." Congressman Dingell has long been concerned with the quality and safety of our nation's drug supply. He is the original author of H.R. 759, the Food and Drug Administration Globalization Act of 2009, H.R. 6543, the Drug Safety Enhancement Act of 2011, and H.R. 1483, the Drug Safety Enhancement Act of 2011, that would provide FDA with the authorities it needs to regulate an increasingly globalized drug supply chain. The provisions included in H.R. 5651 model Congressman Dingell's H.R. 1483.

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