http://www.washingtonwatch.com/bills info@washingtonwatch.com http://www.pjdoland.com/chai/?v=0.1 http://www.washingtonwatch.com/bills/history/110_SN_1156.html?rev=4674 <p>S. 1156 would amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Best Pharmaceuticals for Children program.</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: 4/18/2007: 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> 4674@http://www.washingtonwatch.com Wed, 18 Jul 2007 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_SN_1156.html?rev=4675 <p>S. 1156 would amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Best Pharmaceuticals for Children program.</p> <h2 id="toc4"> Detailed Summary </h2> <p>Best Pharmaceuticals for Children Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make changes to provisions in regard to market exclusivity for pediatric drug studies on new drugs or already approved drugs, including to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than nine months prior to the expiration of such period.</p> <p>Requires an applicant or holder who does not agree with a request to conduct pediatric studies to submit to the Secretary the reasons such pediatric formulation cannot be developed.</p> <p>Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective that is not introduced onto the market within one year; and (2) create an internal review committee to review all written requests issued and all reports submitted.</p> <p>Reduces market exclusivity for pediatric studies from six months to three months for drugs for which combined annual gross sales exceed billion.</p> <p>Requires the Secretary to order the labeling of a drug to include information about the result of a pediatric study whether such study does or does not demonstrate that the drug is safe and effective.</p> <p>Requires the Comptroller General to submit a report to Congress that addresses the effectiveness of providing market exclusivity for pediatric studies in ensuring that medicines used by children are tested and properly labeled.</p> <p>Includes pediatric pharmacological research within the pediatric research loan repayment program.</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: 4/18/2007: 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> 4675@http://www.washingtonwatch.com Wed, 18 Jul 2007 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_SN_1156.html 6/5/2007: Referred to House subcommittee. Status: Referred to the Subcommittee on Higher Education, Lifelong Learning, and Competitiveness. 26849@http://www.washingtonwatch.com Tue, 05 Jun 2007 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_SN_1156.html 4/18/2007: Referred to Senate committee. Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 21367@http://www.washingtonwatch.com Wed, 18 Apr 2007 00:00:00 EDT