http://www.washingtonwatch.com/bills info@washingtonwatch.com http://www.pjdoland.com/chai/?v=0.1 http://www.washingtonwatch.com/bills/history/110_HR_6047.html?rev=27456 <p>H.R. 6047 would amend the Federal Food, Drug, and Cosmetic Act to mandate early access by desperately ill patients to treatment use of new drugs under clinical investigation for a serious or immediately life-threatening disease condition for whom no comparable or satisfactory drug or other therapy is available.</p> <h2 id="toc0"> Detailed Summary </h2> <p>Early Access to Treatment Act - Amends the Federal Food, Drug, and Cosmetic Act to require a drug that is not approved for marketing, but that is under clinical investigation for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available, to be made available for treatment use by an individual patient if: (1) the drug is intended to treat such condition; (2) there is no comparable or satisfactory alternative available to treat that stage of the disease; (3) the drug is under investigation in a controlled clinical trial as an investigational new drug in effect for the trial or all clinical trials have been completed; and (4) an application for treatment use has been filed with the Food and Drug Administration (FDA) by a licensed practitioner which sets forth the intended use of the drug, an explanation of the rationale for its use, the treatment protocol, statements of the practitioner's qualifications to use the drug and familiarity with its safety and effectiveness, and a notarized statement of the patient's informed consent.</p> <p>Requires the Secretary of Health and Human Services, within 30 days after an application is filed, to grant permission to the sponsor to furnish such drug to the practitioner under such terms as the sponsor, practitioner, and patient determine to be appropriate, including any agreement to waive liability. Provides for application transmission by telephone or other means of rapid communication and for rapid action on it in an emergency situation.</p> <p>Requires (current law authorizes) the Secretary to approve an application under the Public Health Service Act for a fast track product determined to have an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit.</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: 5/15/2008: Referred to House subcommittee. Status: Referred to the Subcommittee on Health.</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> 27456@http://www.washingtonwatch.com Wed, 16 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_6047.html?rev=27163 <p>H.R. 6047 would amend the Federal Food, Drug, and Cosmetic Act to mandate early access by desperately ill patients to treatment use of new drugs under clinical investigation for a serious or immediately life-threatening disease condition for whom no comparable or satisfactory drug or other therapy is available.</p> <h2 id="toc4"> 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="toc5"> Status of the Legislation </h2> <p>Latest Major Action: 5/15/2008: Referred to House subcommittee. Status: Referred to the Subcommittee on Health.</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> 27163@http://www.washingtonwatch.com Fri, 11 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_6047.html?rev=23990 <p>H.R. 6047 would amend the Federal Food, Drug, and Cosmetic Act to mandate early access by desperately ill patients to treatment use of new drugs under clinical investigation for a serious or immediately life-threatening disease condition for whom no comparable or satisfactory drug or other therapy is available.</p> <h2 id="toc8"> 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="toc9"> Status of the Legislation </h2> <p>(Log in to edit the wiki and be the first to update the status of the bill!)</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="toc10"> 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="toc11"> 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> 23990@http://www.washingtonwatch.com Thu, 15 May 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_6047.html?rev=23991 <p>H.R. 6047 would amend the Federal Food, Drug, and Cosmetic Act to mandate early access by desperately ill patients to treatment use of new drugs under clinical investigation for a serious or immediately life-threatening disease condition for whom no comparable or satisfactory drug or other therapy is available.</p> <h2 id="toc12"> 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="toc13"> Status of the Legislation </h2> <p>Latest Major Action: 5/14/2008: Referred to House committee. Status: Referred to the House Committee on Energy and Commerce.</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="toc14"> 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="toc15"> 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> 23991@http://www.washingtonwatch.com Thu, 15 May 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_HR_6047.html 5/15/2008: Referred to House subcommittee. Status: Referred to the Subcommittee on Health. 37516@http://www.washingtonwatch.com Thu, 15 May 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_HR_6047.html 5/14/2008: Referred to House committee. Status: Referred to the House Committee on Energy and Commerce. 35744@http://www.washingtonwatch.com Wed, 14 May 2008 00:00:00 EDT