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Washington, DC -- The House Energy and Commerce Committee today unanimously approved legislation authored by Rep. Tim Murphy (R-PA) to bring life-saving generic medications to market faster and make the global drug supply chain safer for consumers.
Murphy's legislation, the Generic Drug and Biosimilar User Fee Act of 2012 (H.R. 3988), authorizes the Food and Drug Administration to expedite approvals of generic pharmaceuticals and eliminate a backlog within the agency. The program is funded with $1.5 billion in user fees from generic drug makers. The legislation also makes critical reforms to drug safety by requiring the FDA move toward inspecting overseas facilities with the same frequency and vigilance that it does with domestic plants.
"When we set out on creating a generic drug program, we had one goal: to make cost effective, life-saving medications more available and accessible. Today's legislation accomplishes that goal and levels the playing field for US manufacturers by establishing one quality standard for all drugs sold in the United States," said Rep. Murphy who serves on the Committee's Health panel and co-chairs the GOP Doctors Caucus.
Murphy's bill was part of the Food and Drug Administration Reform Act (H.R. 5651), which reauthorized various FDA programs related to medical devices and brand-name pharmaceuticals. H.R. 5651 passed by a vote of 46 to 0 and now moves to the House floor for further consideration.
Congressman Murphy worked with Michigan lawmaker John Dingell on the bill's facility inspection requirements. Many of the ingredients used in U.S. manufacturing facilities for both new and generic medicines come from foreign nations. However, the Government Accountability Office has found the FDA visits foreign facilities only once every nine years. The Murphy bill will move toward inspection parity between foreign and domestic facilities, which are currently reviewed once every other year.
Murphy's legislation is based on a historic user fee program agreement crafted by the FDA and generic drug stakeholders led by Mylan, which is headquartered at the business park Southpointe in Murphy's district. Murphy will be visiting Mylan tomorrow for an employee town hall about the legislation and healthcare reform.
Read this original document at: http://murphy.house.gov/index.cfm?sectionid=135&parentid=24§iontree=23,24,135&itemid=2011