Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Improving the American Drug Supply Chain Act of 2020 [HB-8588]
[Healthcare ]
[Pharmaceuticals ]
[Manufacturing ]
[Trade ]
[Public Health ]
Requires the Department of Health and Human Services to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to (1) study the current and historical production of drugs and key ingredients in the United States and in foreign countries, and (2) formulate recommendations for promoting increased production of drugs and key ingredients in the United States.
Sponsored by: Sen. Lisa Rochester
Introduced In House on 10/13/2020
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Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 [S.968]
[Technology and Innovation ]
[Cybersecurity ]
[Data Privacy ]
[Law Enforcement ]
[Consumer Protection ]
[Trade ]
Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 or the PROTECT IP Act of 2011 - (Sec. 3) Authorizes the Attorney General (AG) to commence: (1) an in personam action against a registrant of a nondomestic domain name (NDN) used by an Internet site dedicated to infringing activities (ISDIA) or an owner or operator of an ISDIA accessed through an NDN; or (2) if such individuals are unable to be found by the AG or have no address within a U.S. judicial district, an in rem action (against a domain name
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Sponsored by: Sen. Robert Casey
Cloture Motion On The Motion To Proceed To S. 968 Withdrawn By Unanimous Consent In Senate. (consideration: Cr S13) on 01/23/2012
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US Congress 112th Congress
Lung Cancer Mortality Reduction Act of 2011 [S.752]
[Healthcare ]
[Public Health ]
[Veterans ]
[Medicare and Medicaid ]
[Military ]
Lung Cancer Mortality Reduction Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to implement a comprehensive program to achieve a 50% reduction in the mortality rate of lung cancer by 2020. Requires the program to include initiatives throughout HHS, including: (1) a strategic review and prioritization by the National Cancer Institute of research grants; (2) the establishment by the Food and Drug Administration (FDA) of quality standards and guidelines for facilities that conduct computed
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Sponsored by: Sen. Robert Casey
Sponsor Introductory Remarks On Measure. (cr S2208-2209) on 04/06/2011
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US Congress 112th Congress
Creating Hope Act of 2011 [S.606]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Children and Youth ]
Creating Hope Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the priority review voucher program for tropical diseases to: (1) include rare pediatric diseases; (2) allow unlimited transfers of vouchers under the program; and (3) require a sponsor intending to use a voucher to notify the Secretary of Health and Human Services (HHS) at least 90 days (currently, 365 days) before submission of the application. Revises provisions regarding the priority review user fee, including to make it payable upon notification of the Secretary
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Sponsored by: Sen. Robert Casey
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/17/2011
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US Congress 112th Congress
Heart Disease Education, Analysis, Research, and Treatment for Women Act [S.438]
[Healthcare ]
[Public Health ]
[Science ]
[Medicare and Medicaid ]
[Funding ]
[Grants ]
[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: Sen. Susan Collins
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/02/2011
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Fair Prescription Drug Competition Act [S.373]
[Pharmaceuticals ]
[Healthcare ]
[Consumer Protection ]
Fair Prescription Drug Competition Act - 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 180-day exclusivity period granted to the generic manufacturer.
Sponsored by: Sen. Patrick Leahy
Sponsor Introductory Remarks On Measure. (cr S797) on 02/16/2011
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US Congress 112th Congress
A bill to amend the Toxic Substances Control Act relating to certain mercury compounds, products, and processes. [S.3697]
[Environmental ]
[Waste Management / Recycling ]
[Public Health ]
A bill to amend the Toxic Substances Control Act relating to certain mercury compounds, products, and processes.
Sponsored by: Sen. Sheldon Whitehouse
Read Twice And Referred To The Committee On Environment And Public Works. on 12/19/2012
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US Congress 112th Congress
Improving Dementia Care Treatment for Older Adults Act of 2012 [S.3604]
[Healthcare ]
[Medicare and Medicaid ]
[Senior Citizens ]
[Mental Health ]
[Pharmaceuticals ]
[Public Health ]
Improving Dementia Care Treatment for Older Adults Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to direct the Secretary of Health and Human Services (HHS), acting through the Centers for Medicare and Medicaid Services, to establish and implement prescriber education programs to promote high quality evidence-based treatment through the development and dissemination of objective, educational, and informational materials to physicians and other prescribing practitioners, including such a program developed by the Agency
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Sponsored by: Sen. Chuck Grassley
Read Twice And Referred To The Committee On Finance. on 09/20/2012
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Ethical Pathway Act of 2012 [S.3506]
[Pharmaceuticals ]
[Healthcare ]
[Science ]
[Ethics ]
[Human Rights ]
[Animals ]
[Public Health ]
Ethical Pathway Act of 2012 - Directs the Commissioner of Food and Drugs (FDA) to establish a mechanism by which an applicant to sell any new pharmaceutical drug, vaccine, biologic product, or medical device that requires regulatory approval by the Secretary of Health and Human Services (HHS) (regulated product) may request a cost-sharing arrangement under which the applicant shall: (1) verify that intended clinical investigations involving humans or vertebrate animals have not been performed or initiated by another person; (2) make reasonable efforts
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Sponsored by: Sen. Bernard Sanders
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 08/02/2012
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Sequestration Prevention Act of 2012 [S.3473]
[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: Sen. James Inhofe
Sponsor Introductory Remarks On Measure. (cr S5880-5882) on 08/01/2012
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PACT Act [S.3376]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
[Children and Youth ]
Preventing Abuse of Cough Treatments Act of 2012 or the PACT Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale or offering for sale of a drug containing dextromethorphan, and not subject to practitioner supervision requirements, to an individual under age 18, except if the sale is: (1) made pursuant to a validly issued prescription; or (2) to an individual who provides proof of being married, the parent of a child, or actively enrolled in the military. Imposes civil monetary penalties that escalate upon repeated violation.
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Sponsored by: Sen. Robert Casey
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 07/11/2012
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Cody Miller Initiative for Safer Prescriptions Act [S.3212]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
[Data Privacy ]
Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act 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 language
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Sponsored by: Sen. Kirsten Gillibrand
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/22/2012
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US Congress 112th Congress
Food and Drug Administration Safety and Innovation Act [S.3187]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Food ]
Food and Drug Administration Safety and Innovation Act
Sponsored by: Sen. Michael Enzi
Became Public Law No: 112-144. on 07/09/2012
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US Congress 112th Congress
Preserving Access to Life-Saving Medications Act [S.296]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Preserving Access to Life-Saving Medications Act - Amends the Federal Food, Drug, and Cosmetic Act to require a prescription drug manufacturer to notify the Secretary of Health and Human Services (HHS) of a discontinuance, interruption, or other adjustment of the manufacture of the drug that would likely result in a shortage of such drug. Requires: (1) six months notice of any discontinuance or planned interruption or adjustment, and (2) notice as soon as practicable after becoming aware of such interruption or adjustment in the case of any other
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Sponsored by: Sen. Robert Casey
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 02/07/2011
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US Congress 112th Congress
Food and Drug Administration Safety and Innovation Act [S.2516]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Technology and Innovation ]
[Science ]
[Funding ]
[Grants ]
[Medicare and Medicaid ]
[Consumer Protection ]
[Food ]
Food and Drug Administration Safety and Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revises requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. Prescription Drug User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary of Health and Human Services
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Sponsored by: Sen. Tom Harkin
Committee On Health, Education, Labor, And Pensions. Original Measure Reported To Senate By Senator Harkin. Without Written Report. on 05/07/2012
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US Congress 112th Congress
Health Equity and Accountability Act of 2012 [S.2474]
[Healthcare ]
[Medicare and Medicaid ]
[Public Health ]
[Mental Health ]
[Overdose Prevention ]
[Pharmaceuticals ]
[Human Services ]
[Food ]
[Children and Youth ]
[Criminal Justice ]
[Science ]
[Funding ]
[Grants ]
[Veterans ]
[Data Privacy ]
[Technology and Innovation ]
[Public Safety ]
[Social Security ]
[Senior Citizens ]
[Disabilities ]
[Law Enforcement ]
[Poverty ]
[Human Rights ]
[Race and Civil Rights ]
[Crime ]
Health Equity and Accountability Act of 2012 - Amends the Public Health Service Act and the Social Security Act to expand the collection and analysis of data in programs of the Department of Health and Human Services (HHS). Sets forth provisions to improve cultural competence in federal health care programs and services, including by establishing the Robert T. Matsui Center for Cultural and Linguistic Competence in Health Care. Requires the Secretary of Health and Human Services (Secretary) to engage in activities to improve health workforce diversity,
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Sponsored by: Sen. Barbara Boxer
Sponsor Introductory Remarks On Measure. (cr S2830-2831) on 04/26/2012
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US Congress 112th Congress
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013 [S.2375]
[Agriculture ]
[Food ]
[Budget and Spending ]
[Small Business ]
[Energy ]
[Trade ]
[Healthcare ]
[Science ]
[Technology and Innovation ]
[Consumer Protection ]
[Public Health ]
[Economic Development ]
[Funding ]
[Grants ]
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 Tribal Relations; (3) Office of the Chief Economist; (4) National Appeals Division; (5) Office of Budget and Program Analysis; (6) Office of Homeland Security and Emergency Coordination; (7) Office of Advocacy and Outreach; (8) Office of
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Sponsored by: Sen. Herb Kohl
Committee On Appropriations. Original Measure Reported To Senate By Senator Kohl. With Written Report No. 112-163. on 04/26/2012
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US Congress 112th Congress
Tanning Transparency and Notification Act of 2012 [S.2301]
[Consumer Protection ]
[Healthcare ]
[Public Health ]
Tanning Transparency and Notification Act of 2012 - Directs the Commissioner of Food and Drugs (FDA) to carry out the recommendations made in the report submitted under the Food and Drug Administration Amendments Act of 2007 regarding the labeling of indoor tanning devices to provide information to consumers about the health risks posed by such devices.
Sponsored by: Sen. Jack Reed
Sponsor Introductory Remarks On Measure. (cr S2547-2548) on 04/19/2012
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US Congress 112th Congress
Patient Safety and Generic Labeling Improvement Act [S.2295]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
Patient Safety and Generic Labeling Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved abbreviated new drug application (generic drug approval) to change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application. Allows conforming changes to be ordered to the labeling of the equivalent listed drug and each drug approved under the abbreviated new drug application process that corresponds to such listed drug.
Sponsored by: Sen. Sheldon Whitehouse
Sponsor Introductory Remarks On Measure. (cr S2497-2498, S2499-2500) on 04/18/2012
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US Congress 112th Congress
PATIENTS' FDA Act [S.2292]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Science ]
Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act of 2012 or the PATIENTS' FDA Act - Requires the Secretary of Health and Human Services (HHS) to develop a strategy and implementation plan for advancing regulatory science for medical products in order to promote the public health and advance innovation in regulatory decision making. Expands reporting requirements related to Food and Drug Administration (FDA) progress reports, generic drugs, and biosimilar products. Requires the Secretary to: (1) document
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Sponsored by: Sen. Richard Burr
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 04/17/2012