Drug Safety, Medical Device, And Laboratory Regulation
US Congress 112th Congress
Prescription Drug Affordability Act [HB-147]
[Healthcare ]
[Pharmaceuticals ]
[Consumer Protection ]
[Public Health ]
Prescription Drug Affordability Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to repeal provisions restricting the importation of prescription drugs. Allows a person who meets applicable legal requirements to be an importer of prescription drugs upon application to the Secretary of Health and Human Services (HHS). Requires the Secretary to approve such an application if the drug meets all FFDCA requirements for admission into the United States, including that the drug has been approved by the Food and Drug Administration (FDA) and
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Sponsored by: Rep. Ron Paul
Referred To The Subcommittee On Health. on 02/01/2011
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Lung Cancer Mortality Reduction Act of 2011 [HB-1394]
[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: Rep. Raul Grijalva
Referred To The Subcommittee On Military Personnel. on 05/18/2011
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Stop Oxy Abuse Act of 2011 [HB-1316]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Overdose Prevention ]
Stop Oxy Abuse Act of 2011 - Directs the Commissioner of Food and Drugs (FDA), within 90 days, to take such actions as may be necessary to modify the approval of, and limit any subsequent approval of, any drug containing controlled-release oxycodone hychloride to use for the relief of severe-only pain instead of moderate-to-severe pain. Applies any such modification to drugs introduced into interstate commerce 180 days after enactment of this Act.
Sponsored by: Rep. Vern Buchanan
Referred To The Subcommittee On Health. on 04/07/2011
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Empowering Patients First Act [HB-105]
[Healthcare ]
[Finance ]
[Insurance ]
[Medicare and Medicaid ]
[Budget and Spending ]
[Small Business ]
[Student Loans ]
[Public Health ]
Empowering Patients First Act - Repeals the Patient Protection and Affordable Care Act and the health care provisions of the Health Care and Education and Reconciliation Act of 2010, effective as of their enactment. Restores or revives provisions amended or repealed by such Act or such health care provisions. Amends the Internal Revenue Code to allow a tax credit for qualified health insurance costs to residents of a state that implements a high-risk pool, a reinsurance pool, or other risk-adjustment mechanism. Amends the Public Health Service
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Sponsored by: Rep. Dan Burton
Referred To The Subcommittee On Health, Employment, Labor, And Pensions. on 02/25/2011
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Honoring the 25th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act). [SR-287]
[Pharmaceuticals ]
[Healthcare ]
Expresses the sense of Senate that: (1) enactment of the Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as the Hatch-Waxman Act) served to create the modern generic pharmaceutical industry, which has provided consumers with access to affordable drugs, yielding significant health and economic benefits for the nation's health care system; (2) Senator Orrin Hatch and Representative Henry Waxman deserve the nation's gratitude for authoring and championing this landmark bipartisan legislation; and (3) Congress should enact
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Sponsored by: Sen. Sherrod Brown
Sponsor Introductory Remarks On Measure. (cr S9853-9854) on 09/24/2009
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Family Smoking Prevention and Tobacco Control Act [S.982]
[Healthcare ]
[Public Health ]
[Consumer Protection ]
[Food ]
[Science ]
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 (FDA), including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. Directs the Secretary to establish the Center for Tobacco Products to implement this Act. Sets forth criteria by which tobacco products are deemed adulterated or misbranded. Allows the Secretary to require
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Sponsored by: Sen. Robert Casey
Committee On Health, Education, Labor, And Pensions. Ordered To Be Reported With Amendments Favorably. on 05/20/2009
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US Congress 111th Congress
Drug and Device Accountability Act of 2009 [S.882]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
[Law Enforcement ]
[Manufacturing ]
Drug and Device Accountability Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions regarding the registration of drug and device establishments, including to: (1) expand the information required to be included in a registration; and (2) provide for risk-based inspections. Includes in the definition of "drug" a precursor ingredient. Requires the Secretary of Health and Human Services (HHS) to assess the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.
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Sponsored by: Sen. Chuck Grassley
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 04/23/2009
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Promoting Innovation and Access to Life-Saving Medicine Act [S.726]
[Healthcare ]
[Pharmaceuticals ]
[Science ]
[Technology and Innovation ]
[Consumer Protection ]
[Public Health ]
Promoting Innovation and Access to Life-Saving Medicine Act - Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products. Defines "biosimilar" and "interchangeability" for purposes of this Act. Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product
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Sponsored by: Sen. Susan Collins
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/26/2009
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Preservation of Antibiotics for Medical Treatment Act of 2009 [S.619]
[Healthcare ]
[Public Health ]
[Animals ]
[Food ]
[Pharmaceuticals ]
[Consumer Protection ]
Preservation of Antibiotics for Medical Treatment Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services 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 animals
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Sponsored by: Sen. Jack Reed
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/17/2009
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A bill to prohibit the use of Federal funds to approve certain biologics license applications by the Food and Drug Administration. [S.613]
[Pharmaceuticals ]
[Healthcare ]
[International ]
[National Security ]
[Funding ]
Prohibits the use of funds by the Food and Drug Administration (FDA) to process a biologics license application for any biologic product that is, bears, or contains an agent or toxin listed in federal regulations as dangerous to life, property, or the environment and that has been marketed, sold, or distributed to the Islamic Republic of Iran by an entity under investigation for potential violations of the Iran Sanctions Act of 1996.
Sponsored by: Sen. Sam Brownback
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/17/2009
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Fair Prescription Drug Competition Act [S.501]
[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 exclusivity period granted to the generic manufacturer.
Sponsored by: Sen. Patrick Leahy
Sponsor Introductory Remarks On Measure. (cr S2569-2570) on 02/26/2009
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MCAP Act [S.45]
[Healthcare ]
[Insurance ]
[Pharmaceuticals ]
[Public Health ]
[Law Enforcement ]
[Consumer Protection ]
Medical Care Access Protection Act of 2009 or the MCAP Act - Sets forth provisions regulating lawsuits for health care liability claims related to the provision of health care services. Sets a statute of limitations of three years after the date of manifestation of injury or one year after the claimant discovers the injury, with certain exceptions. Requires a court to impose sanctions for the filing of frivolous lawsuits. Limits noneconomic damages to $250,000 from the provider or health care institution, but no more than $500,000 from multiple
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Sponsored by: Sen. Chuck Grassley
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 01/06/2009
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Heart Disease Education, Analysis Research, and Treatment for Women Act [S.422]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
[Science ]
[Medicare and Medicaid ]
[Funding ]
[Grants ]
Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary of Health and Human Services to deny a new drug application if the application fails to include required information on clinical investigations.Directs the Secretary to: (1) require that a new drug application include any clinical data possessed by the applicant that relates to the safety and effectiveness of the drug involved by gender, age, and racial subgroup; and (2) develop
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Sponsored by: Sen. Robert Casey
Sponsor Introductory Remarks On Measure. (cr S2230-2232) on 02/12/2009
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Fair Pricing for Prescription Drugs Act [S.3415]
[Healthcare ]
[Medicare and Medicaid ]
[Pharmaceuticals ]
[Consumer Protection ]
[Senior Citizens ]
Fair Pricing for Prescription Drugs Act - Pharmaceutical Market Access and Drug Safety Act of 2010 - 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
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Sponsored by: Sen. Russell Feingold
Sponsor Introductory Remarks On Measure. (cr S4218-4219) on 05/25/2010
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A bill to amend title XVIII of the Social Security Act to provide for the update under the Medicare physician fee schedule for years beginning with 2010 and to sunset the application of the sustainable growth rate formula, and for other purposes. [S.2997]
[Healthcare ]
[Medicare and Medicaid ]
[Funding ]
[Budget and Spending ]
[Pharmaceuticals ]
[Public Health ]
Physician Payment Update Commission Act - Amends title XVIII (Medicare) of the Social Security Act to: (1) require an update of 0% to the single conversion factor under (and thereby freeze) the Medicare physician fee schedule update for 2010 and 2011; and (2) sunset the Medicare sustainable growth rate formula effective January 1, 2012. Establishes the Physician Payment Update Commission to study and report to the appropriate congressional committees and the Medicare Payment Advisory Commission (MEDPAC) on all matters relating to payment rates under
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Sponsored by: Sen. Roger Wicker
Read Twice And Referred To The Committee On Finance. on 02/04/2010
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Strengthening Program Integrity and Accountability in Health Care Act [S.2964]
[Healthcare ]
[Medicare and Medicaid ]
[Public Health ]
[Pharmaceuticals ]
[Law Enforcement ]
[Criminal Justice ]
[Data Privacy ]
[Funding ]
[Grants ]
[Consumer Protection ]
[Crime ]
Strengthening Program Integrity and Accountability in Health Care Act - Amends title XVIII (Medicare) of the Social Security Act (SSA) to direct the Secretary of Health and Human Services (HHS) to: (1) establish new procedures for screening providers and suppliers under Medicare, Medicaid (SSA title XIX), and the State Children's Health Insurance Program (CHIP, formerly known as SCHIP) (SSA title XXI); and (2) determine the level of screening according to the risk of fraud, waste, and abuse with respect to each category of provider or supplier.
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Sponsored by: Sen. Chuck Grassley
Sponsor Introductory Remarks On Measure. (cr S345-346) on 01/28/2010
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Nanotechnology Safety Act of 2010 [S.2942]
[Science ]
[Technology and Innovation ]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
[Consumer Protection ]
Nanotechnology Safety Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to establish within the Food and Drug Administration (FDA) a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products to address: (1) the potential toxicology of such materials; (2) the effects of such materials on biological systems; and (3) the interaction of such materials with biological systems.
Sponsored by: Sen. Benjamin Cardin
Sponsor Introductory Remarks On Measure. (cr S123-124) on 01/21/2010
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US Congress 111th Congress
Control Spending Now Act [S.1808]
[Finance ]
[Taxes ]
[Budget and Spending ]
[Student Loans ]
[Pharmaceuticals ]
[Healthcare ]
[Trade ]
[Agriculture ]
[Mining ]
[Energy ]
[Telecommunications ]
[Medicare and Medicaid ]
[Defense ]
[Aerospace ]
[National Security ]
Control Spending Now Act - Fiscal Discipline, Earmark Reform, and Accountability Act - Amends the Standing Rules of the Senate to revise procedures for consideration of points of order against consideration of certain general appropriations bills in the Senate. Amends the Rules to require all conference reports to be searchable online. Congressional Accountability and Line Item Veto Act of 2009 - Amends the Congressional Budget and Impoundment Control Act of 1974 to authorize the President to propose the repeal of any congressional earmark or the
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Sponsored by: Sen. Russell Feingold
Sponsor Introductory Remarks On Measure. (cr S10573) on 10/20/2009
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Access to Affordable Medicines Act [S.1778]
[Healthcare ]
[Pharmaceuticals ]
[Consumer Protection ]
Access to Affordable Medicines Act - Amends the Federal Food, Drug, and Cosmetic Act to provide that an application for a generic drug the proposed labeling of which is different from the labeling at the time the Secretary of Health and Human Services (HHS) evaluates the application shall be eligible for approval (and such drug shall not be considered misbranded) if: (1) the revision has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period for the drug; (2) the Secretary has not determined the applicable
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Sponsored by: Sen. Jeanne Shaheen
Sponsor Introductory Remarks On Measure. (cr S10436-10437) on 10/14/2009
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Foreign Manufacturers Legal Accountability Act of 2009 [S.1606]
[Trade ]
[Consumer Protection ]
[Food ]
[Healthcare ]
[International ]
[Law Enforcement ]
[Public Health ]
[Agriculture ]
Foreign Manufacturers Legal Accountability Act of 2009 - Expresses the sense of Congress with respect to jurisdiction of courts in the United States over foreign manufacturers that import products into the United States. 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), and the Environmental Protection Agency (EPA) (with respect to chemical substances, new chemical substances, and pesticides) to require
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Sponsored by: Sen. Dianne Feinstein
Sponsor Introductory Remarks On Measure. (cr S9007-9008) on 08/06/2009