Drug Safety, Medical Device, And Laboratory Regulation
US Congress 111th Congress
A bill to establish a user fee for follow-up reinspections under the Federal Food, Drug, and Cosmetic Act. [S.1477]
[Food ]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
Directs the Secretary of Health and Human Services (HHS) to assess and collect a user fee from each food facility, drug or device facility, or biologics facility for which a follow-up inspection is required to ensure correction of a violation found by the Secretary during initial inspection of the facility or establishment of a good manufacturing practices requirement under the Federal Food, Drug, and Cosmetic Act.
Sponsored by: Sen. Russell Feingold
Sponsor Introductory Remarks On Measure. (cr S7783) on 07/21/2009
Spread the world
Gettr US Congress 111th Congress
Safe Drug Disposal Act of 2009 [S.1336]
[Public Health ]
[Pharmaceuticals ]
[Environmental ]
[Waste Management / Recycling ]
[Law Enforcement ]
[Overdose Prevention ]
[Healthcare ]
[Public Safety ]
[Crime ]
Safe Drug Disposal Act of 2009 - Amends the Controlled Substances Act to direct the Attorney General to promulgate regulations to: (1) authorize an ultimate user or care taker (a person responsible for taking care of one or more individuals or animals) to dispose of a controlled substance in accordance with a prescribed state program; (2) include five model state programs providing for such disposal through delivery to a designated facility; and (3) allow a state to work with the Attorney General to devise an alternative disposal program that is
(continued...)
Sponsored by: Sen. Patty Murray
Read Twice And Referred To The Committee On The Judiciary. on 06/24/2009
Spread the world
US Congress 111th Congress
Drug Price Competition Act of 2009 [S.1315]
[Pharmaceuticals ]
[Healthcare ]
[Consumer Protection ]
Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.
Sponsored by: Sen. Bill Nelson
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 06/22/2009
Spread the world
US Congress 111th Congress
Expressing the sense of the House of Representatives that biotechnology firms meeting small business standards are critical to the United States, its people and its economy because they create new medicines, services, and jobs and meet unmet needs related to populations and patients with infectious and chronic diseases, including those of medically underserved populations. [HR-1179]
[Healthcare ]
[Small Business ]
[Public Health ]
[Economic Development ]
[Funding ]
[Pharmaceuticals ]
Recognizes: (1) that the public deserves the safest, most effective, and efficient processes to save the lives of people living in the United States with infectious and chronic diseases; and (2) the need to coordinate existing public funding to help small business biotechnology firms whose products may be lost due to domestic economic conditions, and to fund critical paths for small biotechnology drug development and for regulatory review and commercial approval. Expresses support for: (1) the domestic development and commercialization of biotechnology
(continued...)
Sponsored by: Rep. Danny Davis
Referred To The House Committee On Energy And Commerce. on 03/12/2010
Spread the world
US Congress 111th Congress
To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs. [HB-573]
[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. Zach Wamp
Referred To The Subcommittee On Health. on 01/16/2009
Spread the world
US Congress 111th Congress
Stop Oxy Abuse Act of 2010 [HB-4956]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Overdose Prevention ]
Stop Oxy Abuse Act of 2010 - 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. John Duncan
Referred To The House Committee On Energy And Commerce. on 03/25/2010
Spread the world
US Congress 111th Congress
To repeal the Patient Protection and Affordable Care Act and enact the Empowering Patients First Act in order to provide incentives to encourage health insurance coverage. [HB-4910]
[Healthcare ]
[Insurance ]
[Medicare and Medicaid ]
[Public Health ]
Repeals the Patient Protection and Affordable Care Act (PPACA), effective as of enactment of such Act. Restores provisions of law amended by such Act. Enacts the Empowering Patients First Act (H.B. 3400), as introduced in the House of Representatives on July 30, 2009.
Sponsored by: Rep. David Roe
Referred To The Subcommittee On Health, Employment, Labor, And Pensions. on 04/30/2010
Spread the world
US Congress 111th Congress
Food and Drug Administration Improvement Act of 2010 [HB-4816]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Food ]
[Consumer Protection ]
Food and Drug Administration Improvement Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, animal drugs, or generic animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services (HHS) to review such applications. Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements. Requires
(continued...)
Sponsored by: Rep. Maurice Hinchey
Referred To The House Committee On Energy And Commerce. on 03/10/2010
Spread the world
US Congress 111th Congress
To provide for insurance reform (including health insurance reform), amend title XVIII of the Social Security Act to reform Medicare Advantage and reduce disparities in the Medicare Program, regulate the importation of prescription drugs, and for other purposes. [HB-4813]
[Healthcare ]
[Medicare and Medicaid ]
[Pharmaceuticals ]
[Insurance ]
[Reproductive Rights ]
[Consumer Protection ]
Amends the McCarran-Ferguson Act to restore application of the Clayton Act and other antitrust laws to insurers. Prohibits premium variation except by geographic premium rating area and by family enrollment. Requires each health benefits plan issuer that offers health insurance coverage in the individual or group market in a state to accept every employer and individual in the state that applies for such coverage. Places restrictions on federal funding of abortion, except in cases of certain physical conditions, rape, or incest. Limits a health
(continued...)
Sponsored by: Rep. Mike Rogers
Referred To The Subcommittee On Courts And Competition Policy. on 04/26/2010
Spread the world
US Congress 111th Congress
Compassionate Access Act of 2010 [HB-4732]
[Healthcare ]
[Medicare and Medicaid ]
[Pharmaceuticals ]
[Public Health ]
Compassionate Access Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) 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
(continued...)
Sponsored by: Rep. Gerald Connolly
Referred To The Subcommittee On Health. on 03/08/2010
Spread the world
US Congress 111th Congress
Tanning Bed Cancer Control Act of 2010 [HB-4520]
[Healthcare ]
[Public Health ]
[Consumer Protection ]
Tanning Bed Cancer Control Act of 2010 - Directs the Commissioner of Food and Drugs (FDA): (1) to complete a study to examine the classification of ultraviolet tanning lamps as class I medical devices; and (2) not later than one year after completion of such study, to either issue a rule providing for the reclassification of an ultraviolet tanning lamp as a class II or class III device or submit to Congress a report providing a justification for not issuing such a rule. Requires the Commissioner to: (1) complete a study on the adequacy of performance
(continued...)
Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Health. on 01/27/2010
Spread the world
US Congress 111th Congress
Medicare SGR Improvement and Reform Act of 2009 [HB-4138]
[Healthcare ]
[Medicare and Medicaid ]
[Pharmaceuticals ]
[Public Health ]
[Social Security ]
Medicare SGR Improvement and Reform Act of 2009 - Amends title XVIII (Medicare) of the Social Security Act to provide an increased annual update for the Sustainable Growth Mechanism (SGR) formula for determining rates in the fee schedule for Medicare physician payments. Sets a three-year time limit for the commencement of a health care lawsuit. Prescribes requirements for: (1) unlimited damages for a claimant's actual economic losses in health care lawsuits; (2) court supervision of arrangements for payment of such damages, including limitation
(continued...)
Sponsored by: Rep. Steve King
Referred To The Subcommittee On Health. on 12/01/2009
Spread the world
US Congress 111th Congress
Ending Defensive Medicine and Encouraging Innovative Reforms Act of 2009 [HB-4039]
[Healthcare ]
[Insurance ]
[Public Health ]
[Disaster Relief ]
[Nonprofit ]
[Law Enforcement ]
[Public Safety ]
Ending Defensive Medicine and Encouraging Innovative Reforms Act of 2009 - Provides for reform of health care lawsuits by: (1) allowing a party against whom a judgment for medical malpractice has been awarded to pay future damages of $50,000 or more in periodic payments; (2) making each party liable for that party's share of damages only; (3) requiring a court to appoint a qualified specialist to review a health care lawsuit and file a statement of opinion regarding whether such lawsuit has a reasonable and meritorious basis; (4) requiring the losing
(continued...)
Sponsored by: Rep. Charles Dent
Referred To The Subcommittee On Health. on 11/07/2009
Spread the world
US Congress 111th Congress
Common Sense Health Care Reform and Affordability Act [HB-4038]
[Healthcare ]
[Insurance ]
[Pharmaceuticals ]
[Public Health ]
Common Sense Health Care Reform and Affordability Act - Requires each state to mitigate the cost of high risk individuals in the state through: (1) a state reinsurance program; or (2) a state high risk pool. Prohibits a health insurance issuer from applying an annual or lifetime aggregate spending cap on any health insurance coverage or plan offered by such issuer. Requires the Secretary of Health and Human Services (HHS) to pay awards to states for reducing the premiums in the small group market or the individual market or reducing the percentage
(continued...)
Sponsored by: Rep. Steve Scalise
Referred To The Subcommittee On Health, Employment, Labor, And Pensions. on 12/08/2009
Spread the world
US Congress 111th Congress
Strengthening of FDA Integrity Act of 2009 [HB-3932]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Strengthening of FDA Integrity Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product. Requires the Secretary of Health
(continued...)
Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 10/28/2009
Spread the world
US Congress 111th Congress
Drug Price Competition Act of 2009 [HB-3777]
[Pharmaceuticals ]
[Healthcare ]
[Consumer Protection ]
Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.
Sponsored by: Rep. Alcee Hastings
Referred To The Subcommittee On Health. on 10/09/2009
Spread the world
US Congress 111th Congress
ACORN Act [HB-3679]
[Funding ]
[Grants ]
[Law Enforcement ]
[Ethics ]
[Pharmaceuticals ]
[Public Safety ]
[Elections ]
[Crime ]
Against Corporations Organizing to Rip-off the Nation Act or the ACORN Act - Prohibits the federal government from awarding contracts, grants, or other agreements to, providing any other federal funds to, or engaging in activities that promote, any corporation or company that has been found guilty of a felony criminal violation under federal or state law, that had its state corporate charter terminated due to its failure to comply with federal or state lobbying disclosure requirements, or that employs or otherwise retains a director, officer, or
(continued...)
Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Government Management, Organization, And Procurement. on 10/23/2009
Spread the world
US Congress 111th Congress
Empowering Patients First Act [HB-3400]
[Finance ]
[Healthcare ]
[Insurance ]
[Medicare and Medicaid ]
[Student Loans ]
[Taxes ]
[Budget and Spending ]
[Public Health ]
Empowering Patients First Act - 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 Act to provide for the establishment and governance of individual membership associations (IMAs) to make available health benefits coverage to IMA members and their dependents. Small Business Health Fairness Act of 2009 - Amends the Employee Retirement Income Security Act of 1974
(continued...)
Sponsored by: Rep. Steve Scalise
Referred To The Subcommittee On Health, Employment, Labor, And Pensions. on 10/22/2009
Spread the world
US Congress 111th Congress
Health Freedom Act [HB-3395]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Food ]
[Consumer Protection ]
Health Freedom Act - Prohibits the federal government from preventing the use of a claim describing any nutrient in a food or dietary supplement as mitigating, treating, or preventing any disease, disease symptom, or health-related condition, unless in a final order following a trial on the merits a federal court finds clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research that: (1) the claim is false and misleading in any material respect; and (2) there is no less speech restrictive alternative
(continued...)
Sponsored by: Rep. Jason Chaffetz
Referred To The Subcommittee On Health. on 07/30/2009
Spread the world
US Congress 111th Congress
DSHEA Full Implementation and Enforcement Act of 2009 [HB-3262]
[Healthcare ]
[Consumer Protection ]
[Science ]
[Food ]
[Public Health ]
[Pharmaceuticals ]
DSHEA Full Implementation and Enforcement Act of 2009 - Authorizes and makes appropriations to: (1) carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and all applicable regulatory requirements for dietary supplements under the Federal Food, Drug, and Cosmetic Act; and (2) expand research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH). Requires the Food and Drug Administration (FDA) to fully and appropriately use such funds to
(continued...)
Sponsored by: Rep. Jason Chaffetz
Referred To The Subcommittee On Health. on 07/21/2009