Drug approvals Legislation - Federal Government

A bill to amend title XIX of the Social Security Act to provide additional funds for the qualifying individual (QI) program, and for other purposes. 9/23/2008--Introduced. QI Program Supplemental Funding Act of 2008 - Amends title XIX (Medicaid) of the Social Security Act, as amended by the Medicare Improvements for Patients and Providers Act of 2008, to provide supplemental funding for the qualifying individual (QI) program. Requires a state to have in operation, in mechanized Medicaid claims processing and information retrieval systems, an eligibility determination system which provides for data matching through the Public Assistance Reporting Information System (PARIS) facilitated by the Secretary of Health and Human Services, including matching with medical assistance programs operated by other states. Amends the Federal Food, Drug, and Cosmetic Act to make sponsors of certain antibiotic drugs eligible for a three-year or a five-year market exclusivity if [...]

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To amend title XIX of the Social Security System to provide additional funds for the qualifying individual (QI) program, and for other purposes. 9/25/2008--Introduced. QI Program Supplemental Funding Act of 2008 - Amends title XIX (Medicaid) of the Social Security Act, as amended by the Medicare Improvements for Patients and Providers Act of 2008, to provide supplemental funding for the qualifying individual (QI) program. Requires a state to have in operation, in mechanized Medicaid claims processing and information retrieval systems, an eligibility determination system which provides for data matching through the Public Assistance Reporting Information System (PARIS) facilitated by the Secretary of Health and Human Services, including matching with medical assistance programs operated by other states. Amends the Federal Food, Drug, and Cosmetic Act to make sponsors of certain antibiotic drugs eligible for a three-year or a five-year market exclusivity if a marketing [...]

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A bill to amend title XIX of the Social Security Act to provide additional funds for the qualifying individual (QI) program, and for other purposes. 10/8/2008--Public Law.    (There are 3 other summaries) (This measure has not been amended since it was introduced. The summary of that version is repeated here.) QI Program Supplemental Funding Act of 2008 - Amends title XIX (Medicaid) of the Social Security Act, as amended by the Medicare Improvements for Patients and Providers Act of 2008, to provide supplemental funding for the qualifying individual (QI) program. Requires a state to have in operation, in mechanized Medicaid claims processing and information retrieval systems, an eligibility determination system which provides for data matching through the Public Assistance Reporting Information System (PARIS) facilitated by the Secretary of Health and Human Services, including matching with medical assistance programs operated by other [...]

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A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes. 7/31/2008--Introduced. Drug and Device Accountability Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a drug or device to be misbranded unless certain conditions related to registration of establishments, identification of prior transactions, labeling for country of manufacture, and provision of required information on importation are met.Includes in the definition of "drug" a precursor ingredient.Repeals the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.Expands the information required to be included for registration of establishments.Deems a drug to be adulterated if certain conditions related to verification of identity and purity, identification of [...]

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A bill to amend the Public Health Service Act to provide grants or contracts for prescription drug education and outreach for healthcare providers and their parents. 7/31/2008--Introduced. Independent Drug Education and Outreach Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality, to award grants or contracts for: (1) the development and production of educational materials concerning the evidence available on the relative safety, effectiveness, and cost of prescription drugs, nonprescription drugs, and nondrug interventions for treating selected conditions, to be distributed and presented to health care providers who prescribe such drugs and their patients; and (2) the development and implementation of a program to appropriately train and deploy health professionals to distribute such materials to, and otherwise educate, physicians and other drug [...]

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To amend the Public Health Service Act to provide grants or contracts for prescription drug education and outreach for healthcare providers and their patients. 7/31/2008--Introduced. Independent Drug Education and Outreach Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality, to award grants or contracts for: (1) the development and production of educational materials concerning the evidence available on the relative safety, effectiveness, and cost of prescription drugs, nonprescription drugs, and nondrug interventions for treating selected conditions, to be distributed and presented to health care providers who prescribe such drugs and their patients; and (2) the development and implementation of a program to appropriately train and deploy health professionals to distribute such materials to, and otherwise educate, physicians and other drug prescribers [...]

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To provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away. 7/9/2008--Introduced. Healthy Americans Act - Requires each adult to have the opportunity to purchase a Healthy Americans Private Insurance Plan (HAPI plan), which includes employer-sponsored health coverage. Makes individuals who are not enrolled in another specified health plan and who are not opposed to coverage for religious reasons responsible for enrolling themselves and their dependent children in a HAPI plan. Sets forth penalties for failure to enroll. Establishes standardized coverage and state options for HAPI plans. Requires the Secretary of Health and Human Services to promulgate guidelines concerning the benefits, items, and services to be covered. Sets forth requirements for setting premiums. Requires the Secretary to establish the Healthy America Advisory Committee to provide annual recommendations concerning modifications to the benefits,[...]

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To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs. 7/30/2008--Reported to House amended.    (There is 1 other summary) Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.Authorizes appropriations for FY2009-FY2013.Requires the Secretary to report to Congress and make publicly available information [...]

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To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes. 8/14/2008--Public Law.    (There are 3 other summaries) (This measure has not been amended since it was passed by the House on July 30, 2008. The summary of that version is repeated here.) Title I: Animal Drug User Fee Amendments - Animal Drug User Fee Amendments of 2008 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act to revise definitions, including defining the "process for the review of animal drug applications" to include the review of advertising and labeling prior to an approval of an animal drug application or supplemental animal application after the animal drug has been approved.(Sec. 103) Requires the [...]

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To expand the authority of the Secretary of Health and Human Services to impose debarments in order to ensure the integrity of drug, biological product, and device regulation, and for other purposes. 6/26/2008--Introduced. Strengthening of FDA Integrity Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product. Requires the Secretary of Health and Human Services to initiate debarment not later than one year after a person or individual is convicted of a felony. Requires the Secretary, in determining the appropriateness and the period [...]

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