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Proposed User Fee Legislation to Include Stronger Patient Voice During Drug and Device Approval Process
Statement of Christopher W. Hansen, President of the American Cancer Society Cancer Action Network (ACS CAN)
May 16, 2012
WASHINGTON May 16, 2012 The U.S. Senate is considering legislation that would strengthen the patient voice as part of an effort to reauthorize and expand the industry-supported user fee program that pays for the expeditious review of new pharmaceutical drugs and medical devices by the Food and Drug Administration (FDA). A statement from American Cancer Society Cancer Action Network (ACS CAN) President Christopher W. Hansen follows: Families affected by cancer are applauding efforts by lawmakers to strengthen patient participation in the drug and device approval process at the Food and Drug Administration (FDA) a process that more broadly has the potential to make a significant difference in the lives of patients, providing them with timely access to the latest and most innovative lifesaving treatment. The FDA recognizes the value that patients bring to the drug review process.æ Having experienced treatment personally, patients bring a unique perspective on the benefit and risks of new drug therapies.æ For that reason, it is in everyone 's best interest to facilitate and enhance patient involvement in FDA drug development, and ACS CAN has worked very hard to make that happen. If enacted, the Senate bill would require the Secretary of Health and Human Services to implement strategies that will allow the FDA staff to better identify patients eligible to participate in appropriate agency meetings with medical product sponsors and investigators and provide the patient perspective. ACS CAN commends lawmakers for their bipartisan efforts to renew and further expand patient participation that has the potential to make a significant difference in the lives of cancer patients, providing them with timely access to cutting edge therapies. The user fee legislation also takes important steps to address the critical drug shortage issue that has directly impacted cancer patients and survivors. ACS CAN, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, supports evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem. ACS CAN works to encourage elected officials and candidates to make cancer a top national priority. ACS CAN gives ordinary people extraordinary power to fight cancer with the training and tools they need to make their voices heard. For more information, visit www.fightcancer.org. For More Information, Contact: Alissa Crispino or Steven Weiss American Cancer Society Cancer Action Network Phone: 202-661-5772 or 202-661-5711 Email: [email protected] or [email protected] #acscan #cancer #userfee #FDA
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