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S 1413 FDA User Fee Protection Act /HR 2725 FDA Safety Over Sequestration Act of 2013 Position Paper The Leukemia & Lymphoma Society (LLS) is the world’s largest voluntary health agency dedicated to curing leukemia, lymphoma, Hodgkin’s disease and myeloma, while improving the quality of life of patients and their families. Treating cancer involves accessing a complex and extensive set of health care services including chemotherapy and prescription drugs, among others. LLS is committed to ensuring sustainable access for patients to affordable, coordinated, quality healthcare. U.S. Food & Drug Administration User Fees The Food and Drug Administration (FDA) relies on two sources of revenue: Congressional appropriations and user fees. User fees account for 35% of the FDA’s total budget, are 100% industry paid, and intended specifically for purposes such as review and approval of a new medical therapy or device. These funds are critical to furthering one of FDA’s core missions: to ensure patient access to safe, effective medical products. Industry-paid user fees negotiated through the Prescription Drug User Fee Act ensure that FDA has adequate resources to accomplish this mission in an efficient manner. Due to sequestration, in FY 2013 alone, nearly $85 million in private, industry-paid user fees have been made inaccessible to the FDA. By law, these fees cannot be used for any other purpose. This threatens to delay patient access by inhibiting faster approval times for promising, innovative new therapies. LLS supports S. 1413, the FDA User Fee Protection Act /H.R. 2725, the FDA Safety Over Sequestration Act of 2013, legislation which will ensure that industry user fees paid to the U.S. Food & Drug Administration are protected against further across-the-board cuts due to sequestration. We urge Members to co-sponsor this legislation. For more information on LLS’ position, please contact Emily Shetty, Senior Director of Federal Legislative Affairs at To cosponsor S. 1413, the FDA User Fee Protection Act, please contact Tate Heuer in Senator Pryors’ office at To cosponsor HR 2725, the FDA Safety Over Sequestration Act of 2013, please contact Helen Dwight (Lance) at, Erin Katzelnick-Wise (Eschoo) at, Louis Agnello (Matsui) at; or Meghan Drenan (Rogers) at

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