Drug Safety, Medical Device, And Laboratory Regulation
US Congress 112th Congress
Medical Innovation Prize Fund Act [S.1137]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Funding ]
[Grants ]
[Insurance ]
Medical Innovation Prize Fund Act - 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, notwithstanding provisions of U.S. patent law and other relevant statutes. Establishes remuneration in lieu of such market exclusivity. Establishes: (1) the Fund for Medical Innovation
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Sponsored by: Sen. Bernard Sanders
Committee On Health, Education, Labor, And Pensions Subcommittee On Primary Health And Aging. Hearings Held. With Printed Hearing: S.hrg. 112-570. on 05/15/2012
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Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. [HR-98]
[Science ]
[Healthcare ]
[Public Health ]
[Food ]
[Pharmaceuticals ]
Urges the Commissioner of the Food and Drug Administration (FDA) to: (1) give the greatest weight in making critical policy decisions to readily available hard science data; and (2) avoid paternalistic policy decisions not grounded in hard science.
Sponsored by: Rep. Ted Poe
Referred To The Subcommittee On Health. on 02/28/2011
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Preservation of Antibiotics for Medical Treatment Act of 2011 [HB-965]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
[Animals ]
[Food ]
Preservation of Antibiotics for Medical Treatment Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Health. on 03/14/2011
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Provider Shield Act of 2011 [HB-816]
[Healthcare ]
[Medicare and Medicaid ]
[Consumer Protection ]
[Public Health ]
[Insurance ]
[Law Enforcement ]
Provider Shield Act of 2011 - Declares that the development, recognition, or implementation of any guideline or other standard under specified Patient Protection and Affordable Care Act (PPACA) provisions related to health care quality shall not be construed to establish the standard of care or duty of care owed by a health care provider to a patient in any medical malpractice or medical product liability case. Repeals a PPACA provision requiring the Comptroller General to study whether the development, recognition, or implementation of any such
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Sponsored by: Rep. Ted Poe
Referred To The Subcommittee On Health. on 02/28/2011
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To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs. [HB-741]
[Pharmaceuticals ]
[Consumer Protection ]
Amends the Federal Food, Drug, and Cosmetic Act to prohibit a holder of a new, approved drug application from commencing to manufacture, market, sell, or distribute a generic version of such drug from the time of the receipt of notice from the generic manufacturer that an abbreviated new drug application has been submitted for approval until the expiration or forfeiture of the exclusivity period granted to the generic manufacturer.
Sponsored by: Rep. Jo Emerson
Referred To The Subcommittee On Health. on 02/28/2011
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Mercury Use Reduction Act of 2012 [HB-6686]
[Environmental ]
[Public Health ]
Mercury Use Reduction Act of 2012
Sponsored by: Rep. Anna Eshoo
Referred To The House Committee On Energy And Commerce. on 12/19/2012
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Counterfeit Drug Enforcement Act of 2012 [HB-6679]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
[Law Enforcement ]
[Criminal Justice ]
[Public Safety ]
[Food ]
[Crime ]
Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human
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Sponsored by: Rep. Steve Israel
Referred To The Subcommittee On Health. on 12/19/2012
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Pandemic and All-Hazards Preparedness Reauthorization Act of 2012 [HB-6672]
[Healthcare ]
[Public Health ]
[National Security ]
[Science ]
[Children and Youth ]
[Defense ]
[Pharmaceuticals ]
[Veterans ]
[Funding ]
[Grants ]
[Cybersecurity ]
[Technology and Innovation ]
Pandemic and All-Hazards Preparedness Act Reauthorization of 2012 - Title I: Strengthening National Preparedness and Response for Public Health Emergencies - (Sec. 101) Amends the Public Health Service Act (PHSA) to require the Secretary of Health and Human Services (HHS) to submit the National Health Security Strategy to the relevant congressional committees in 2014. Makes one of the Strategy's preparedness goals ensuring that the periodic evaluations of federal, state, local and tribal preparedness and response capabilities include drills and
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Sponsored by: Rep. Frank Pallone
Referred To The Subcommittee On Health. on 01/02/2013
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S.A.F.E. Compounded Drugs Act of 2012 [HB-6638]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Supporting Access to Formulated and Effective Compounded Drugs Act of 2012 or S.A.F.E. Compounded Drugs Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounded drugs. Eliminates authority for compounding pharmacies to compound any drug product that is a copy of a commercially available drug. Establishes notification requirements before a patient is prescribed, dispensed, or administered a compounded drug, which must include providing the patient a document concerning the availability, safety,
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Sponsored by: Rep. Nita Lowey
Referred To The Subcommittee On Health. on 12/07/2012
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Health Care Innovation and Marketplace Technologies Act of 2012 [HB-6626]
[Healthcare ]
[Technology and Innovation ]
[Small Business ]
[Medicare and Medicaid ]
[Public Health ]
[Pharmaceuticals ]
[Science ]
[Funding ]
[Grants ]
[Cybersecurity ]
Health Care Innovation and Marketplace Technologies Act of 2012 - Amends the Internal Revenue Code to allow a medical care provider to deduct from gross income the amount paid or incurred for qualified health information technology placed in service during the taxable year. Amends the Small Business Act to authorize the Administrator of the Small Business Administration (SBA) to guarantee up to 90% of the amount of a loan, up to specified loan amounts, to a small business health professional to be used for the acquisition and installation of health
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Sponsored by: Rep. Michael Honda
Referred To The Subcommittee On Health. on 12/07/2012
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Verifying Authority and Legality In Drug Compounding Act of 2012 [HB-6584]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
Verifying Authority and Legality In Drug Compounding Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Eliminates authority for compounding pharmacies to: (1) compound drugs before the receipt of a valid prescription order, or (2) compound any drug product that is a copy of a commercially available drug. Requires the Secretary of Health and Human Services (HHS) to develop, maintain and transmit to the appropriate state agencies a list of drug products that should not be compounded,
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Sponsored by: Rep. James McGovern
Referred To The House Committee On Energy And Commerce. on 11/02/2012
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Cody Miller Initiative for Safer Prescriptions Act [HB-6514]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
[Overdose Prevention ]
Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs. Requires such regulations to require the PMI for such a drug: (1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and (2) to include plain
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Sponsored by: Rep. Barney Frank
Referred To The House Committee On Energy And Commerce. on 09/21/2012
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Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 [HB-6502]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to designate a combination of drugs as a significant drug combination if such combination: (1) includes two or more drugs or biological products that, when used in combination, offer the potential to significantly advance treatment for a serious or life-threatening disease and, in combination, meet the criteria for co-development of drug combinations in Food and
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Sponsored by: Rep. Rosa DeLauro
Referred To The Subcommittee On Health. on 09/26/2012
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FDA User Fee Corrections Act of 2012 [HB-6433]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
FDA User Fee Corrections Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food and Drug Administration Safety and Innovation Act (P.L. 112-144), to: (1) make clerical corrections to provisions of such Act; and (2) eliminate the restriction that appropriated funds shall be available only for payment of increases in the cost of reviewing medical device applications, including related personnel costs. Specifies due dates in FY2013 under FFDCA for the drug master file fee, the abbreviated new drug application
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Sponsored by: Rep. Fred Upton
Signed By President. on 10/05/2012
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Sequestration Prevention Act of 2012 [HB-6389]
[Budget and Spending ]
[Healthcare ]
[Medicare and Medicaid ]
[Food ]
[Climate Change ]
[Public Health ]
[Defense ]
[Insurance ]
[Disaster Relief ]
Sequestration Prevention Act of 2012 - Title I: Fully Repeal the Sequestration Provision of Round 2 of the Budget Control Act - Amends the Balanced Budget and Emergency Deficit Control Act of 1985 (Gramm--Rudman-Hollings Act), as amended by the Budget Control Act of 2011, to repeal its budget goal enforcement requirements (sequestration mandate). Title II: Repeal of Health Care Law - Repealing the Job-Killing Health Care Law Act - Repeals the Patient Protection and Affordable Care Act (PPACA), and restores or revives any provisions of law amended
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Sponsored by: Rep. Doug Lamborn
Referred To The Subcommittee On The Constitution. on 09/19/2012
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Compassionate Freedom of Choice Act of 2012 [HB-6342]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Compassionate Freedom of Choice Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the importation, distribution, or sale of investigational drugs or devices for terminally ill patients. Prohibits the FDA Commissioner from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 08/03/2012
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Patient Choice Act of 2012 [HB-6288]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Patient Choice Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug. Defines the term “adequately safe” to mean that: (1) for at least one population,
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 08/03/2012
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TEST Act [HB-6272]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
[Science ]
Trial and Experimental Studies Transparency Act of 2012 or TEST Act - Amends the Public Health Service Act to expand the clinical trials that must be reported to the clinical trial registry data bank to include: (1) any interventional study of a drug, device, or biological product conducted outside of the United States the results of which are submitted to the Secretary of Health and Human Services (HHS) as support for approval of an application; and (2) postmarket surveillance of a class II or class III device that involves data collection from
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Sponsored by: Rep. Janice Schakowsky
Referred To The Subcommittee On Health. on 08/03/2012
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Stop Tampering of Prescription Pills Act of 2012 [HB-6160]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Overdose Prevention ]
[Law Enforcement ]
Stop Tampering of Prescription Pills Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for tamper-resistant drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and
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Sponsored by: Rep. Colleen Hanabusa
Referred To The Subcommittee On Health. on 07/20/2012
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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013 [HB-5973]
[Agriculture ]
[Food ]
[Budget and Spending ]
[Small Business ]
[Trade ]
[Healthcare ]
[Energy ]
[Telecommunications ]
[Consumer Protection ]
[Environmental ]
[Science ]
[Technology and Innovation ]
[Funding ]
[Grants ]
[Children and Youth ]
(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013 - Title I: Agricultural Programs - Appropriates FY2013 funds for the following Department of Agriculture (USDA) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) Office of the Chief Economist; (3) Office of Budget and Program Analysis; (4) Office of the Chief Information Officer;
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Sponsored by: Rep. Jack Kingston
The House Committee On Appropriations Reported An Original Measure, H. Rept. 112-542, By Mr. Kingston. on 06/20/2012