http://www.washingtonwatch.com/bills info@washingtonwatch.com http://www.pjdoland.com/chai/?v=0.1 http://www.washingtonwatch.com/bills/history/110_SN_1024.html?rev=3647 <p>S. 1024 would improve the underlying science of drug safety decisionmaking and strengthen the ability of the Food and Drug Administration to assess, manage, and communicate drug safety information to patients and providers.</p> <h2 id="toc0"> Detailed Summary </h2> <p>(Log in to edit the wiki and be the first to provide a detailed summary of the bill!)</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc1"> Status of the Legislation </h2> <p>Latest Major Action: 3/29/2007: Referred to Senate committee. Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc2"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc3"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 3647@http://www.washingtonwatch.com Tue, 03 Jul 2007 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_SN_1024.html?rev=3648 <p>S. 1024 would improve the underlying science of drug safety decisionmaking and strengthen the ability of the Food and Drug Administration to assess, manage, and communicate drug safety information to patients and providers.</p> <h2 id="toc4"> Detailed Summary </h2> <p>Safer Drug Assessment Technology Advancement Act or the Safer DATA Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to establish: (1) minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; and (2) a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources.</p> <p>Directs the Secretary to establish and maintain an active surveillance infrastructure to collect and report data for pharmaceutical postmarket risk identification and analysis.</p> <p>Requires the Secretary to establish and implement procedures under which the Secretary may routinely collaborate with a qualified entity to: (1) clean, classify, or aggregate data collected and data that is publicly available or that is provided by the Secretary; (2) perform advanced research on identified drug safety risks; (3) identify safety questions that require further clinical study; and (4) convene an expert advisory committee to oversee the establishment of standards for the ethical and scientific uses for, and communication of, postmarketing data collected.</p> <p>Requires the Secretary to improve the transparency of pharmaceutical data and allow patients and health care providers better access to pharmaceutical data by developing and maintaining an Internet site that: (1) provides comprehensive drug safety information for prescription drugs; and (2) improves communication of drug safety information to patients and providers.</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc5"> Status of the Legislation </h2> <p>Latest Major Action: 3/29/2007: Referred to Senate committee. Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc6"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc7"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 3648@http://www.washingtonwatch.com Tue, 03 Jul 2007 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_SN_1024.html 3/29/2007: Referred to Senate committee. Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 21234@http://www.washingtonwatch.com Thu, 29 Mar 2007 00:00:00 EDT