Drug advertising Legislation - Federal Government

A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away. 1/18/2007--Introduced. Healthy Americans Act - Requires each adult individual to have the opportunity to purchase a Healthy Americans Private Insurance Plan (HAPI). 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 offered through their state of residence. 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 [...]

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A bill to amend the Public Health Service Act to expand the clinical trials drug data bank. 1/31/2007--Introduced. Fair Access to Clinical Trials Act of 2007 or the FACT Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to establish and operate a data bank of information on clinical trials, to include: (1) a clinical trials registry of health-related interventions conducted to test the safety or effectiveness of any drug, biological product, or device intended to treat serious or life-threatening diseases and conditions; and (2) a clinical trial results database of health-related interventions to test the safety or effectiveness of any drug, biological product, or device. Requires the Commissioner of Food and Drugs to make available to the public: (1) the full reviews conducted by the Food and Drug Administration (FDA) of new or supplemental new drug [...]

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A bill to reduce the Federal budget deficit, and for other purposes. 2/12/2007--Introduced. Act for Our Kids - Repeals the Television Broadcasting to Cuba Act. Amends the Cuban Liberty and Democratic Solidarity (LIBERTAD) Act of 1996 to prohibit federal funding of television broadcasting to Cuba. Terminates the U.S. Court of Federal Claims. Requires federal agencies to reduce administrative expenses. Eliminates the Medicare Advantage Regional Plan Stabilization (SLUSH) Fund. Amends the federal criminal code to prohibit profiteering and fraud involving a contract or the provision of goods or services in connection with a war or military action. Requires: (1) suspension and debarment of unethical contractors; (2) disclosure by federal agencies, upon request, to the appropriate committee chairman or ranking member of audit reports regarding federal contractors; and (3) public access to information on federal contractor penalties and [...]

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To amend the Federal Food, Drug, and Cosmetic Act concerning foods and dietary supplements, to amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases, and for other purposes. 5/2/2007--Introduced. Health Freedom Protection Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide that a food or dietary supplement is not a drug solely because the label or labeling contains a claim to cure, mitigate, treat, or prevent disease. Prohibits the Secretary of Health and Human Services from: (1) restricting the reprinting and distribution or sale of any U.S. government publication or any accurate quotations of such a publication, including content concerning nutrients and disease treatment or prevention; or (2) construing the distribution or sale of, or accurate quotation from, such a publication in connection with the sale of a food or dietary supplement as evidence of an intent to sell that food or dietary supplement [...]

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To amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes. 5/10/2007--Introduced. Food and Drug Administration Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons [...]

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To direct the Secretary of Health and Human Services to require the incorporation of counterfeit-resistant technologies into the packaging of prescription drugs, and for other purposes. 6/14/2007--Introduced. Reducing Fraudulent and Imitation Drugs Act of 2007 - Directs the Secretary of Health and Human Services to require prescription drug packaging to incorporate: (1) radio frequency tagging technology or similar trace and track technologies; (2) tamper-indicating technologies; and (3) blister security packaging when possible. Directs the Secretary to: (1) require that such technologies be used exclusively to authenticate the pedigree of prescription drugs; and (2) prohibit such technologies from containing or transmitting any identifying information of a health care practitioner or consumer, or any advertisement or information about indications or off-label uses. Requires the Secretary to encourage prescription drug manufacturers and distributors to incorporate: [...]

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To amend the Internal Revenue Code of 1986 to deny any deduction for direct-to-consumer advertisements of prescription drugs that fail to provide certain information or to present information in a balanced manner, to amend the Federal Food, Drug, and Cosmetic Act to require reports regarding such advertisements, and to amend such Code to deny any deduction for direct-to-consumer advertisements of qualified prescription drugs for a two-year period. 6/21/2007--Introduced. Fair Balance Prescription Drug Advertisement Act of 2007 - Amends the Internal Revenue Code to disallow a tax deduction for: (1) expenses for direct-to-consumer prescription drug advertising that fails to provide adequate information on drug side effects, contraindications, or lack of effectiveness; and (2) expenses for direct-to-consumer prescription drug advertising of a new drug, a new combination of active substances, or a new delivery system for an existing drug for a two-year period after the introduction [...]

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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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A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes. 1/10/2007--Introduced. Pharmaceutical Market Access and Drug Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences.[...]

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To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes. 1/10/2007--Introduced. Pharmaceutical Market Access and Drug Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences.[...]

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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 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 amend the Internal Revenue Code of 1986 to deny any deduction for direct-to-consumer advertisements of prescription drugs that fail to provide certain information or to present information in a balanced manner, to amend the Federal Food, Drug, and Cosmetic Act to require reports regarding such advertisements, and to amend such Code to deny any deduction for direct-to-consumer advertisements of qualified prescription drugs for a two-year period. 6/21/2007--Introduced. Fair Balance Prescription Drug Advertisement Act of 2007 - Amends the Internal Revenue Code to disallow a tax deduction for: (1) expenses for direct-to-consumer prescription drug advertising that fails to provide adequate information on drug side effects, contraindications, or lack of effectiveness; and (2) expenses for direct-to-consumer prescription drug advertising of a new drug, a new combination of active substances, or a new delivery system for an existing drug for a two-year period after the introduction [...]

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To direct the Secretary of Health and Human Services to require the incorporation of counterfeit-resistant technologies into the packaging of prescription drugs, and for other purposes. 6/14/2007--Introduced. Reducing Fraudulent and Imitation Drugs Act of 2007 - Directs the Secretary of Health and Human Services to require prescription drug packaging to incorporate: (1) radio frequency tagging technology or similar trace and track technologies; (2) tamper-indicating technologies; and (3) blister security packaging when possible. Directs the Secretary to: (1) require that such technologies be used exclusively to authenticate the pedigree of prescription drugs; and (2) prohibit such technologies from containing or transmitting any identifying information of a health care practitioner or consumer, or any advertisement or information about indications or off-label uses. Requires the Secretary to encourage prescription drug manufacturers and distributors to incorporate: [...]

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To amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes. 5/10/2007--Introduced. Food and Drug Administration Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons [...]

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