http://www.washingtonwatch.com/bills info@washingtonwatch.com http://www.pjdoland.com/chai/?v=0.1 http://www.washingtonwatch.com/bills/history/110_HR_2589.html?rev=9094 <p>H.R. 2589 would amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize and amend the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.</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: 6/6/2007: 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="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> 9094@http://www.washingtonwatch.com Tue, 28 Aug 2007 17:14:23 EDT http://www.washingtonwatch.com/bills/history/110_HR_2589.html?rev=9095 <p>H.R. 2589 would amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize and amend the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.</p> <h2 id="toc4"> Detailed Summary </h2> <p>Improving Pharmaceuticals for Children Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions relating to market exclusivity for pediatric drug studies on new or already approved drugs 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 one year prior to the expiration of such period.</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 in the pediatric population if such formulation is not introduced onto the market within one year; and (2) order the labeling of a drug to include information about the results of a pediatric study.</p> <p>Requires the Secretary, acting through the Director of the National Institutes of Heath (NIH), to develop, publish, and revise a priority list of needs in pediatric therapeutics.</p> <p>Revises requirements for the submission of pediatric assessments of the safety and effectiveness of a drug or biological product with a new drug or supplemental application to require an applicant seeking: (1) a deferral of such requirements to submit a timeline for the completion of such studies; and (2) a waiver of such requirements to submit documentation detailing why a pediatric formulation cannot be developed.</p> <p>Considers a supplement to any new drug or biological license application proposing a labeling change as a result of any pediatric assessment to be a priority application or supplement.</p> <p>Requires the Comptroller General to study the effectiveness of federal law in ensuring that medicines used by children are tested and properly labeled.&lt;br&gt;</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: 6/6/2007: 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="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> 9095@http://www.washingtonwatch.com Tue, 28 Aug 2007 17:14:23 EDT