Drug Safety, Medical Device, And Laboratory Regulation
US Congress 112th Congress
Safety Of Untested and New Devices Act of 2012 [HB-3847]
[Healthcare ]
[Public Health ]
[Consumer Protection ]
[Science ]
[Technology and Innovation ]
[Pharmaceuticals ]
Safety Of Untested and New Devices Act of 2012 or the SOUND Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require a medical device company seeking approval of a new device based on a determination of substantial equivalence to a predicate device to inform the Food and Drug Administration (FDA) if any predicate lineage products have harmed device recipients and to explain how the current device avoids past flaws. Prohibits finding a new device substantially equivalent to a predicate device if the predicate has been removed
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Sponsored by: Rep. Janice Schakowsky
Referred To The House Committee On Energy And Commerce. on 01/31/2012
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Drug Shortage Prevention Act of 2012 [HB-3839]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Law Enforcement ]
[Overdose Prevention ]
[Criminal Justice ]
[Crime ]
Drug Shortage Prevention Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to: (1) define the term "critical drug" based on the medical necessity and vulnerability to shortage of a drug or biological product; (2) establish, make publicly available, and update semiannually a list identifying each critical drug and its manufacturers; (3) promptly remove from such list any drug or biological product that no longer meets such definition; and (4) establish, make publicly available,
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Sponsored by: Rep. Gerald Connolly
Referred To The Subcommittee On Crime, Terrorism, And Homeland Security. on 02/16/2012
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ULTRA [HB-3737]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Unlocking Lifesaving Treatments for Rare-Diseases Act or ULTRA - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to approve an application for a drug as a fast track product using a surrogate endpoint, based on the existence of reasonable scientific data that support and qualify the relevance of such endpoint to the disease state and treatment, if the Secretary: (1) makes an initial determination that the drug is eligible for approval as a drug designated for a rare disease or condition
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Sponsored by: Rep. Andy Harris
Referred To The Subcommittee On Health. on 12/23/2011
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Medical Controlled Substances Transportation Act of 2011 [HB-3724]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Disaster Relief ]
[Transportation and Motor Vehicles ]
[Law Enforcement ]
[Public Safety ]
[Crime ]
Medical Controlled Substances Transportation Act of 2011 - Amends the Controlled Substances Act to authorize a physician registered to dispense, or conduct research with, schedule II, III, IV, or V controlled substances to enter into an agreement with the Attorney General that authorizes the physician to transport controlled substances from a practice setting to another practice setting or to a disaster area and that requires the physician to: (1) notify the Attorney General in advance of any such transport; (2) identify the controlled substances
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Sponsored by: Rep. Pete Sessions
Referred To The Subcommittee On Crime, Terrorism, And Homeland Security. on 01/06/2012
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Patient Centered Healthcare Savings Act of 2011 [HB-3682]
[Healthcare ]
[Medicare and Medicaid ]
[Insurance ]
[Small Business ]
[Labor, Jobs, Employment ]
[Criminal Justice ]
[Public Health ]
[Workers' Compensation ]
[Senior Citizens ]
Patient Centered Healthcare Savings Act of 2011 - Repeals the Patient Protection and Affordable Care Act (PPACA) and the health care provisions of the Health Care and Education Reconciliation Act of 2010, effective as of their enactment. Restores or revives provisions amended or repealed by such Act or such health care provisions. Sets conditions for lawsuits arising from health care liability claims regarding health care goods or services or any medical product affecting interstate commerce. Establishes a statute of limitations and limits noneconomic
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Sponsored by: Rep. Sean Duffy
Referred To The Subcommittee On Health, Employment, Labor, And Pensions. on 03/29/2012
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Counterfeit Drug Penalty Enhancement Act of 2012 [HB-3668]
[Crime ]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Public Safety ]
[Criminal Justice ]
Counterfeit Drug Penalty Enhancement Act of 2012 - Amends the federal criminal code to prohibit and to establish criminal penalties for trafficking, or attempting to traffic, in counterfeit drugs. Directs: (1) the Attorney General to give increased priority to efforts to investigate and prosecute offenses that involve trafficking in counterfeit drugs; and (2) the United States Sentencing Commission to review and, if appropriate, amend its guidelines and policy statements applicable to persons convicted of such offense to reflect congressional intent
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Sponsored by: Rep. Susan Davis
Received In The Senate And Read Twice And Referred To The Committee On The Judiciary. on 06/19/2012
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Foreign Manufacturers Legal Accountability Act of 2011 [HB-3646]
[Consumer Protection ]
[Trade ]
[Manufacturing ]
[Food ]
[Agriculture ]
[Public Safety ]
[Law Enforcement ]
[International ]
Foreign Manufacturers Legal Accountability Act of 2011 - Directs the Food and Drug Administration (FDA) (with respect to drugs, devices, cosmetics, and biological products), the Consumer Product Safety Commission (CPSC) (with respect to consumer products), the Environmental Protection Agency (EPA) (with respect to chemical substances, new chemical substances, and pesticides), and the National Highway Traffic Safety Administration (NHTSA) (with respect to a motor vehicle or motor vehicle products) to require foreign manufacturers and producers of
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Nutrition And Horticulture . on 01/17/2012
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Genetically Engineered Safety Act [HB-3554]
[Agriculture ]
[Food ]
[Public Health ]
[Science ]
[Pharmaceuticals ]
[Consumer Protection ]
Genetically Engineered Safety Act - Genetically Engineered Pharmaceutical and Industrial Crop Safety Act of 2011 - Prohibits: (1) a pharmaceutical crop or industrial crop from being grown, raised, or otherwise cultivated until the final regulations and tracking system required by this Act are in effect; and (2) cultivation of a pharmaceutical crop or industrial crop in an open air environment, or in a food commonly used for human food or domestic animal feed. Directs the Department of Agriculture (USDA) to establish a tracking system to regulate
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Rural Development, Research, Biotechnology, And Foreign Agriculture. on 12/19/2011
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Heart Disease Education, Analysis, Research, and Treatment for Women Act [HB-3526]
[Healthcare ]
[Public Health ]
[Science ]
[Funding ]
[Grants ]
[Medicare and Medicaid ]
[Pharmaceuticals ]
[Race and Civil Rights ]
Heart Disease Education, Analysis, Research, and Treatment for Women Act or the HEART for Women Act - Directs the Comptroller General to report on whether the presentation of clinical study safety and effectiveness data by sex, age, and racial subgroups complies with Food and Drug Administration (FDA) requirements. Requires the Secretary of Health and Human Services (HHS) to submit a response to such report, including a corrective action plan as needed. Requires the Director of the Office of Women's Health of FDA to report on the compliance of
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Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Health. on 12/02/2011
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MODDERN Cures Act of 2011 [HB-3497]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Science ]
Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 or the MODDERN Cures Act of 2011 - Requires the Secretary of Health and Human Services (HHS) to: (1) establish the Advanced Diagnostics Education Council to recommend standard terms and definitions related to innovative diagnostics for use by patients, physicians, health care providers, payers, and policy makers.; and (2) publish a guide regarding such terms and definitions. Sets forth additional factors for the Secretary to consider in determining the payment
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Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Intellectual Property, Competition And The Internet. on 12/02/2011
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Counterfeit Drug Penalty Enhancement Act of 2011 [HB-3468]
[Pharmaceuticals ]
[Crime ]
[Public Health ]
[Public Safety ]
Counterfeit Drug Penalty Enhancement Act of 2011 - Amends the federal criminal code to establish criminal penalties of a fine, imprisonment for life or any term of years, or both, for trafficking in counterfeit drugs. States that nothing in this Act shall be construed to apply to a drug solely because the drug is manufactured in or imported from a foreign country.
Sponsored by: Rep. Patrick Meehan
Referred To The Subcommittee On Crime, Terrorism, And Homeland Security. on 12/02/2011
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Protecting Our Kids' Medicine Act [HB-338]
[Healthcare ]
[Consumer Protection ]
[Public Health ]
[Children and Youth ]
[Pharmaceuticals ]
Protecting Our Kids' Medicine Act - Amends the Federal Food, Drug, and Cosmetic Act to require a liquid formulation of an over-the-counter drug to be packaged with a dosage delivery device meeting specified requirements. Defines "dosage delivery device" as an object that is designed to measure the dosage of a drug in liquid form and deliver that drug to an individual and includes calibrated cups, droppers, syringes, and spoons. Sets forth requirements for such a dosage delivery device, which include that such device: (1) is calibrated in units of
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Sponsored by: Rep. Steve Israel
Referred To The Subcommittee On Health. on 02/01/2011
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Stop Online Piracy Act [HB-3261]
[Technology and Innovation ]
[Cybersecurity ]
[Data Privacy ]
[Law Enforcement ]
[National Security ]
[Public Health ]
[Trade ]
[Consumer Protection ]
[Criminal Justice ]
[Science ]
[Crime ]
Stop Online Piracy Act - Authorizes the Attorney General (AG) to seek a court order against a U.S.-directed foreign Internet site committing or facilitating online piracy to require the owner, operator, or domain name registrant, or the site or domain name itself if such persons are unable to be found, to cease and desist further activities constituting specified intellectual property offenses under the federal criminal code including criminal copyright infringement, unauthorized fixation and trafficking of sound recordings or videos of live musical
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Sponsored by: Rep. Theodore Deutch
Committee Consideration And Mark-up Session Held. on 12/16/2011
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Keeping America Competitive Through Harmonization Act of 2011 [HB-3230]
[Healthcare ]
[Pharmaceuticals ]
[Trade ]
[International ]
[Public Health ]
[Consumer Protection ]
Keeping America Competitive Through Harmonization Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to enter into agreements with listed countries (countries eligible for exports of drugs or biological products that have not been approved under certain circumstances) regarding methods and approaches to harmonizing regulatory requirements for premarket review, inspections, and common international labeling symbols. Requires the Secretary to report on the agreements entered under
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/18/2011
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Food and Drug Administration Mission Reform Act of 2011 [HB-3214]
[Healthcare ]
[Labor, Jobs, Employment ]
[Pharmaceuticals ]
[Public Health ]
[Food ]
[Science ]
[Technology and Innovation ]
[Consumer Protection ]
[Economic Development ]
Food and Drug Administration Mission Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the mission of the Food and Drug Administration (FDA) to include establishment of a regulatory system that: (1) advances medical innovation by incorporating modern scientific tools, standards, and approaches; (2) protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by the FFDCA; (3) is based on the best
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/18/2011
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Humanitarian Device Reform Act of 2011 [HB-3211]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Humanitarian Device Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to repeal provisions that prohibit the sale of a medical device approved under the humanitarian device exemption (available for devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States) for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. Adds provisions clarifying that the 4,000 individuals that must be affected in the United States under
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/18/2011
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Premarket Predictability Act of 2011 [HB-3209]
[Healthcare ]
[Technology and Innovation ]
[Pharmaceuticals ]
[Public Health ]
Premarket Predictability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to assign a tracking number to a medical device upon submission of: (1) an application for an exemption of a device for investigational use, (2) a request to classify a device, or (3) a premarket report or notification related to a device. Requires the Secretary to use the tracking number to record interactions between the Secretary and applicant with respect to the device. Directs the Secretary to: (1)
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/18/2011
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Patients Come First Act of 2011 [HB-3208]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS): (1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for medical devices required to remain in class III; and (2) not later than one year after the schedule is established, to issue a final regulation for each such device. Directs the Secretary to: (1) establish a program to assess information relating to device recalls
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/18/2011
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Modernizing Laboratory Test Standards for Patients Act of 2011 [HB-3207]
[Healthcare ]
[Medicare and Medicaid ]
[Public Health ]
[Science ]
[Technology and Innovation ]
[Consumer Protection ]
[Data Privacy ]
Modernizing Laboratory Test Standards for Patients Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish a single publicly accessible test registry data bank of laboratory-developed tests and direct-to-consumer DNA tests, which shall include information on the purpose of each test, the claimed use or uses of each test, and information regarding the analytical validity of each test. Requires notification to the Secretary: (1) before marketing such a test, (2) after any significant
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Sponsored by: Rep. H. Morgan Griffith
Referred To The House Committee On Energy And Commerce. on 10/14/2011
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Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 [HB-3206]
[Healthcare ]
[Pharmaceuticals ]
[Science ]
[Public Health ]
Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to financial interests of Food and Drug Administration (FDA) advisory committee members to require the Secretary of Health and Human Services (HHS) to ensure that individual appointments to advisory committees are made to promote scientific and technical expertise while at the same time minimizing any potential conflicts of interest. Requires the Secretary to consider, with respect to any financial
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/18/2011