Orphan drugs Legislation - Federal Government

An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. 5/9/2007--Passed Senate amended.    (There are 2 other summaries) Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety. Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user [...]

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To accelerate efforts to develop vaccines for diseases primarily affecting developing countries, and for other purposes. 3/7/2007--Introduced. Vaccines for the Future Act of 2007- Directs the President to establish a strategy to accelerate efforts to develop vaccines and microbicides for neglected diseases such as HIV/AIDS, malaria, and tuberculosis, which shall: (1) expand public-private partnerships; (2) create economic incentives for such vaccines' research, development, and manufacturing; (3) include the negotiation of advanced market commitments; (4) address related intellectual property and regulatory approval issues; (5) maximize U.S. capabilities to support clinical trials in developing countries; (6) expand the purchase and delivery of existing vaccines; and (7) address the challenges of advance delivery of vaccines in developing countries. Directs the Secretary of the Treasury to enter into negotiations with the World Bank, the International Development Association,[...]

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A bill to authorize the Secretary of Health and Human Services to conduct activities to rapidly advance treatments for spinal muscular atrophy, neuromuscular disease, and other pediatric diseases, and for other purposes. 9/12/2007--Introduced. SMA Treatment Acceleration Act - Requires the Director of the National Institutes of Health (NIH) to upgrade and unify existing spinal muscular atrophy (SMA) clinical trial sites to establish a national clinical trials network for SMA. Requires the Director of NIH to ensure that such network: (1) conducts coordinated, multisite, clinical trials of pharmacological approaches to the treatment of SMA; and (2) rapidly and effectively disseminates scientific findings to the field.Requires the Director of NIH to: (1) establish an SMA data coordinating center; and (2) expand and intensify NIH programs with respect to preclinical translation research and medicinal chemistry related to SMA.Requires the Secretary of Health and Human [...]

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To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 7/11/2007--Passed House amended.    (There is 1 other summary) Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems; (2) implementing and enforcing provisions relating to postapproval studies, clinical trials, labeling changes, and risk [...]

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To authorize the Secretary of Health and Human Services to conduct activities to rapidly advance treatments for spinal muscular atrophy, neuromuscular disease, and other pediatric diseases, and for other purposes. 8/2/2007--Introduced. SMA Treatment Acceleration Act - Requires the Director of the National Institutes of Health (NIH) to upgrade and unify existing spinal muscular atrophy (SMA) clinical trial sites to establish a national clinical trials network for SMA. Requires the Director of NIH to ensure that such network: (1) conducts coordinated, multisite, clinical trials of pharmacological approaches to the treatment of SMA; and (2) rapidly and effectively disseminates scientific findings to the field.Requires the Director of NIH to: (1) establish an SMA data coordinating center; and (2) expand and intensify NIH programs with respect to preclinical translation research and medicinal chemistry related to SMA.Requires the Secretary of Health and Human Services,[...]

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A bill to accelerate efforts to develop vaccines for diseases primarily affecting developing countries and for other purposes. 2/13/2007--Introduced. Vaccines for the Future Act of 2007 - Directs the President to establish a comprehensive strategy to accelerate efforts to develop vaccines and microbicides for neglected diseases such as HIV/AIDS, malaria, and tuberculosis. States that such strategy shall: (1) expand public-private partnerships and seek to leverage foreign country and private sector resources; (2) include the negotiation of advance market commitments and other economic incentives for the research, development, and manufacturing of vaccines and microbicides for HIV/AIDS, tuberculosis, malaria, and other neglected diseases; (3) address related intellectual property and regulatory issues; (4) maximize U.S. capabilities to support clinical trials of vaccines and microbicides in developing countries; and (5) expand the purchase and delivery of existing vaccines.[...]

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A bill to provide incentives for investment in research and development for new medicines, to enhance access to new medicines, and for other purposes. 10/19/2007--Introduced. Medical Innovation Prize Act of 2007 - Prohibits any person from having the right to exclusively manufacture, distribute, sell, or use in interstate commerce a drug, a biological product, or a drug or biological product manufacturing process, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents under the Federal Food, Drug, and Cosmetic Act, notwithstanding provisions of that Act and other specified laws. Establishes the Fund for Medical Innovation Prizes. Requires the Board of Trustees for the Fund to award prize payments for medical innovations relating to a drug, biological product, or manufacturing process. Requires an eligible award recipient to be either the first person to receive market clearance or the holder [...]

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To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 9/27/2007--Public Law.    (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential [...]

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To amend the Internal Revenue Code of 1986 to modernize the tax treatment of biomedical research corporations. 7/31/2007--Introduced. American Life Sciences Competitiveness Act of 2007 - Amends the Internal Revenue Code to allow biomedical research corporations to: (1) engage in investment activity involving shifts in ownership without incurring limitations on net operating loss carryforwards; (2) claim a full research and development tax credit for contract research expenses (currently, limited to 65%); (3) claim a business tax credit for 20% of eligible countermeasures research expenses (for biomedical threats); and (4) claim a tax-free rollover of gain from stock sales reinvested in another biomedical research corporation.Expands the tax credit for clinical testing expenses for drugs to treat rare diseases (orphan drugs) to include expenses incurred after an application is made to the Food and Drug Administration (FDA) but before receipt of an orphan drug designation.[...]

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A bill to provide incentives for investment in research and development for new medicines, to enhance access to new medicines, and for other purposes. 10/19/2007--Introduced. Medical Innovation Prize Act of 2007 - Prohibits any person from having the right to exclusively manufacture, distribute, sell, or use in interstate commerce a drug, a biological product, or a drug or biological product manufacturing process, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents under the Federal Food, Drug, and Cosmetic Act, notwithstanding provisions of that Act and other specified laws. Establishes the Fund for Medical Innovation Prizes. Requires the Board of Trustees for the Fund to award prize payments for medical innovations relating to a drug, biological product, or manufacturing process. Requires an eligible award recipient to be either the first person to receive market clearance or the holder [...]

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To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 9/27/2007--Public Law.    (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential [...]

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A bill to authorize the Secretary of Health and Human Services to conduct activities to rapidly advance treatments for spinal muscular atrophy, neuromuscular disease, and other pediatric diseases, and for other purposes. 9/12/2007--Introduced. SMA Treatment Acceleration Act - Requires the Director of the National Institutes of Health (NIH) to upgrade and unify existing spinal muscular atrophy (SMA) clinical trial sites to establish a national clinical trials network for SMA. Requires the Director of NIH to ensure that such network: (1) conducts coordinated, multisite, clinical trials of pharmacological approaches to the treatment of SMA; and (2) rapidly and effectively disseminates scientific findings to the field.Requires the Director of NIH to: (1) establish an SMA data coordinating center; and (2) expand and intensify NIH programs with respect to preclinical translation research and medicinal chemistry related to SMA.Requires the Secretary of Health and Human [...]

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To authorize the Secretary of Health and Human Services to conduct activities to rapidly advance treatments for spinal muscular atrophy, neuromuscular disease, and other pediatric diseases, and for other purposes. 8/2/2007--Introduced. SMA Treatment Acceleration Act - Requires the Director of the National Institutes of Health (NIH) to upgrade and unify existing spinal muscular atrophy (SMA) clinical trial sites to establish a national clinical trials network for SMA. Requires the Director of NIH to ensure that such network: (1) conducts coordinated, multisite, clinical trials of pharmacological approaches to the treatment of SMA; and (2) rapidly and effectively disseminates scientific findings to the field.Requires the Director of NIH to: (1) establish an SMA data coordinating center; and (2) expand and intensify NIH programs with respect to preclinical translation research and medicinal chemistry related to SMA.Requires the Secretary of Health and Human Services,[...]

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To amend the Internal Revenue Code of 1986 to modernize the tax treatment of biomedical research corporations. 7/31/2007--Introduced. American Life Sciences Competitiveness Act of 2007 - Amends the Internal Revenue Code to allow biomedical research corporations to: (1) engage in investment activity involving shifts in ownership without incurring limitations on net operating loss carryforwards; (2) claim a full research and development tax credit for contract research expenses (currently, limited to 65%); (3) claim a business tax credit for 20% of eligible countermeasures research expenses (for biomedical threats); and (4) claim a tax-free rollover of gain from stock sales reinvested in another biomedical research corporation.Expands the tax credit for clinical testing expenses for drugs to treat rare diseases (orphan drugs) to include expenses incurred after an application is made to the Food and Drug Administration (FDA) but before receipt of an orphan drug designation.[...]

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To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 7/11/2007--Passed House amended.    (There is 1 other summary) Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems; (2) implementing and enforcing provisions relating to postapproval studies, clinical trials, labeling changes, and risk [...]

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An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. 5/9/2007--Passed Senate amended.    (There are 2 other summaries) Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety. Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user [...]

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To accelerate efforts to develop vaccines for diseases primarily affecting developing countries, and for other purposes. 3/7/2007--Introduced. Vaccines for the Future Act of 2007- Directs the President to establish a strategy to accelerate efforts to develop vaccines and microbicides for neglected diseases such as HIV/AIDS, malaria, and tuberculosis, which shall: (1) expand public-private partnerships; (2) create economic incentives for such vaccines' research, development, and manufacturing; (3) include the negotiation of advanced market commitments; (4) address related intellectual property and regulatory approval issues; (5) maximize U.S. capabilities to support clinical trials in developing countries; (6) expand the purchase and delivery of existing vaccines; and (7) address the challenges of advance delivery of vaccines in developing countries. Directs the Secretary of the Treasury to enter into negotiations with the World Bank, the International Development Association,[...]

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