Product safety Legislation - Federal Government

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 amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients [...]

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A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 2/1/2007--Introduced. Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product [...]

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A bill to amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. 2/15/2007--Introduced. Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the [...]

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A bill to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products. 2/15/2007--Introduced. Family Smoking Prevention and Tobacco Control Act - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration, including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. Sets forth criteria by which tobacco products are deemed adulterated or misbranded. Allows the Secretary to require prior approval of all label statements. Allows the Secretary to restrict the sale or distribution of tobacco products, including advertising and promotion, if the Secretary determines that such regulation would be appropriate for the protection of the public health. Prohibits such regulations from: (1) limiting product sales or distribution to authorization [...]

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A bill to require the Food and Drug Administration to conduct consumer testing to determine the appropriateness of the current labeling requirements for indoor tanning devices and determine whether such requirements provide sufficient information to consumers regarding the risks that the use of such devices pose for the development of irreversible damage to the skin, including skin cancer, and for other purposes. 2/16/2007--Introduced. Tanning Accountability and Notification Act of 2007 - Requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to determine whether: (1) the labeling requirements for indoor tanning devices provide sufficient information to consumers regarding the risks that the use of such devices pose for the development of irreversible damage to the eyes and skin, including skin cancer; (2) adding the warning suggested by the American Academy of Dermatology or any other additional warning to the current warning [...]

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To amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients or the [...]

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An act to amend the Toxic Substances Control Act to reduce the health risks posed by asbestos-containing materials and products having asbestos-containing material, and for other purposes. 10/4/2007--Passed Senate amended.    (There is 1 other summary) Ban Asbestos in America Act of 2007 - (Sec. 3) Amends the Toxic Substances Control Act to include within the meaning of the term "asbestos" asbestiform varieties of: (1) any material formerly classified as tremolite, including winchite asbestos and richterite asbestos; and (2) any asbestiform amphibole mineral. Requires the Director of the National Institute for Occupational Safety and Health to conduct a study that: (1) describes the science concerning the disease mechanisms and health effects of exposure to non-asbestiform minerals and elongated mineral particles and methods for measuring and analyzing such minerals; and (2) recommends future research relating to diseases caused by exposure [...]

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To require the Consumer Product Safety Commission to issue regulations mandating child-resistant closures on all portable gasoline containers. 7/17/2008--Public Law.    (There are 3 other summaries) (This measure has not been amended since it was passed by the House on October 9, 2007. The summary of that version is repeated here.) Children's Gasoline Burn Prevention Act - Requires each portable gasoline container manufactured for sale in the United States and intended for use by consumers to conform to a specified child-resistance standard issued by ASTM International. Considers that requirement to be a consumer product safety rule issued by the Consumer Product Safety Commission (CPSC) under the Consumer Product Safety Act. Requires the CPSC to report to specified congressional committees on the degree of industry compliance, related enforcement actions, and incidents involving children interacting with portable gasoline containers [...]

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A bill to prohibit text message spam. 6/16/2008--Introduced. Do-Not-Text Act of 2008 - Amends the CAN-SPAM Act of 2003 to exclude from the definition of "mobile service commercial message" a commercial e-mail if the message's primary purpose is to: (1) facilitate, complete, or confirm a transaction between the message recipient and the sender; (2) provide warranty, recall, safety, or security information regarding the recipient's product or service; (3) provide notice of a change in terms or conditions, a change in the status of the recipient, or account statements regarding a subscription, membership, account, loan, or comparable ongoing commercial relationship; (4) provide information regarding an employment relationship or benefit plan in which the recipient is involved; or (5) deliver goods or services, including updates or upgrades, that the recipient is entitled to receive.Declares that provisions relating to the application of the Act to wireless do [...]

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To amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. 6/12/2008--Introduced. Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device [...]

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A bill to require a review of existing trade agreements and renegotiation of existing trade agreements based on the review, to set terms for future trade agreements, to express the sense of the Senate that the role of Congress in trade policymaking should be strengthened, and for other purposes. 6/4/2008--Introduced. Trade Reform, Accountability, Development, and Employment Act of 2008, or the TRADE Act of 2008 - Directs the Comptroller General of the United States to: (1) review certain free trade agreements (including Uruguay Round Agreements) between the United States and foreign countries; and (2) report to the Congressional Trade Agreement Review Committee regarding such agreements, including analyses of specified subjects and of each agreement, as well as whether the country has a democratic form of government that respects certain core labor rights and fundamental human rights, protects intellectual property rights, and enforces environmental laws.Declares that [...]

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A bill to amend the Toxic Substances Control Act to reduce the exposure of children, workers, and consumers to toxic chemical substances. 5/20/2008--Introduced. Kid-Safe Chemicals Act of 2008 - Amends the Toxic Substances Control Act to require each manufacturer of a chemical substance distributed in commerce to submit to the Administrator of the Environmental Protection Agency (EPA): (1) a statement certifying that the substance meets required safety standards or that there is insufficient data to make such determination; and (2) all reasonably available information concerning the substance not previously submitted. Requires manufacturers to update such information at least every three years or at any time new information becomes available on a substance's toxicity. Requires manufacturers to provide chemical safety information upon the Administrator's request.Prohibits the manufacture, importation, or distribution in commerce of a chemical substance if the Administrator [...]

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A bill to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. 5/21/2008--Introduced. Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or [...]

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To amend the Toxic Substances Control Act to reduce the exposure of children, workers, and consumers to toxic chemical substances. 5/20/2008--Introduced. Kid-Safe Chemicals Act of 2008 - Amends the Toxic Substances Control Act to require each manufacturer of a chemical substance distributed in commerce to submit to the Administrator of the Environmental Protection Agency (EPA): (1) a statement certifying that the substance meets required safety standards or that there is insufficient data to make such determination; and (2) all reasonably available information concerning the substance not previously submitted. Requires manufacturers to update such information at least every three years or at any time new information becomes available on a substance's toxicity. Requires manufacturers to provide chemical safety information upon the Administrator's request.Prohibits the manufacture, importation, or distribution in commerce of a chemical substance if the Administrator [...]

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A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the postmarket surveillance of devices. 5/15/2008--Introduced. Food and Drug Administration Accountability and Transparency Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to publish in the Federal Register postmarket surveillance plans for medical devices, unless such information is exempted under the Freedom of Information Act. Subjects medical device manufacturers that fail to comply with postmarket surveillance requirements to civil monetary penalties. Requires the Secretary to take into consideration whether the manufacturer is making efforts toward correcting the violation in determining the amount of the civil penalty. Authorizes the Secretary to order notification of health personnel and other relevant persons if a violation of postmarket surveillance requirements of a device presents an unreasonable risk of substantial [...]

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To establish a comprehensive process to inform American consumers about food and product recalls, and for other purposes. 3/13/2008--Introduced. Consumer Product and Food Safety Information Act of 2008 - Requires the head of each federal product safety enforcement agency to design and implement a public information plan to use agency and media resources to provide information to the public concerning: (1) the role of the agency in ensuring product safety; (2) steps consumers can take to enhance their safety while using regulated products; (3) product recalls; and (4) additional information to enhance consumer safety. Requires such plan to include procedures for developing and distributing product safety information to the public.Requires the Consumer Product Safety Commission (CPSC) to establish: (1) a clearinghouse to collect and distribute product recall and safety information to government entities and the public; (2) a toll-free number for such information; and [...]

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A bill to amend the National Manufactured Housing Construction and Safety Standards Act of 1974 to require that weather radios be installed in all manufactured homes manufactured or sold in the United States. 3/6/2008--Introduced. CJ's Home Protection Act of 2008 - Amends the National Manufactured Housing Construction and Safety Standards Act of 1974 to revise federal standards for manufactured homes (other than one affixed to a permanent foundation) to require each such home to be installed with a weather radio: (1) capable of broadcasting emergency information relating to local weather conditions; (2) equipped with a tone alarm and Specific Alert Message Encoding, or SAME technology; and (3) compliant with the Consumer Electronics Association (CEA) Standard 2009-A Performance Specification for Public Alert Receivers (or its current revision). Shields from common law civil liability: (1) manufacturers, installers, or retailers of manufactured homes for any aspect [...]

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A bill to respond to a medicare funding warning. 2/25/2008--Introduced. Medicare Funding Warning Response Act of 2008 - Directs the Secretary of Health and Human Services to: (1) develop and implement a system for encouraging nationwide adoption and use of interoperable electronic health records and to make available personal health records for Medicare beneficiaries; (2) develop and implement a plan for ensuring that, by the year 2013, quality measures are available and reported with respect to at least 50% of the care provided under the Medicare program; (3) design and implement a system under which a portion of Medicare payments that would otherwise be made to some or all classes of individuals and entities furnishing items or services to beneficiaries would be based on the quality and efficiency of their performance; (4) implement incentives for Medicare beneficiaries to use more efficient providers and preventive services known to reduce costs; and (5) use and release [...]

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