Drug Safety, Medical Device, And Laboratory Regulation
US Congress 112th Congress
Better Pharmaceuticals and Devices for Children Act of 2012 [S.2289]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Children and Youth ]
[Science ]
Better Pharmaceuticals and Devices for Children Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to make provisions extending market exclusivity for conducting pediatric studies permanent. Applies such provisions only to completed pediatric studies that are the subject of a written request by the Secretary of Health and Human Services (HHS). Requires the Secretary to issue internal standard operating procedures that provide for review by the Pediatric Review Committee of any significant modifications to pediatric study plans or written
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Sponsored by: Sen. Jack Reed
Sponsor Introductory Remarks On Measure. (cr S2395) on 04/17/2012
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Expanding and Promoting Expertise in Rare Treatments Act of 2012 [S.2281]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Expanding and Promoting Expertise in Rare Treatments Act of 2012 or EXPERT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to ensure that opportunities exist for consultation with external experts to promote the efficiency of and inform the review by the Food and Drug Administration (FDA) of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted. Requires the Center for Drug Evaluation and Research and the Center for Biologics
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Sponsored by: Sen. Bernard Sanders
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/29/2012
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Advancing Breakthrough Therapies for Patients Act of 2012 [S.2236]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Advancing Breakthrough Therapies for Patients Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Authorizes
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Sponsored by: Sen. Richard Burr
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/26/2012
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Transforming the Regulatory Environment to Accelerate Access to Treatments [S.2113]
[Healthcare ]
[Technology and Innovation ]
[Pharmaceuticals ]
[Public Health ]
Transforming the Regulatory Environment to Accelerate Access to Treatments or TREAT Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to establish an advisory council within the Food and Drug Administration (FDA) to be known as the Management Review Board in order to provide advice to the Secretary regarding the FDA's management and organization. Directs the Secretary to: (1) establish within the Office of the Commissioner an office to be known as the Office of the Chief Innovation Officer
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Sponsored by: Sen. Barbara Mikulski
Sponsor Introductory Remarks On Measure. (cr S702) on 02/15/2012
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Spending Reductions through Innovations in Therapies Agenda Act of 2012 [S.2069]
[Healthcare ]
[Medicare and Medicaid ]
[Public Health ]
[Funding ]
[Grants ]
[Pharmaceuticals ]
[Science ]
Spending Reductions through Innovations in Therapies Agenda Act of 2012 or the SPRINT Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services (HHS) to establish the Spending Reductions through Innovations in Therapies Program (SPRINT Program) to support development of therapies to reduce spending by federal health care programs for high-cost chronic conditions. Requires the Program to: (1) accelerate advanced research and development of such therapies, and (2) encourage innovation in technologies that may
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Sponsored by: Sen. Susan Collins
Sponsor Introductory Remarks On Measure. (cr S324-326) on 02/02/2012
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Medical Device Patient Safety Act [S.1995]
[Healthcare ]
[Public Health ]
[Consumer Protection ]
[Pharmaceuticals ]
Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls. Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding
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Sponsored by: Sen. Chuck Grassley
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 12/14/2011
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Food and Drug Administration Mission Reform Act of 2011 [S.1972]
[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. Kelly Ayotte
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 12/08/2011
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MCAP Act [S.197]
[Healthcare ]
[Insurance ]
[Pharmaceuticals ]
[Public Health ]
[Law Enforcement ]
[Consumer Protection ]
Medical Care Access Protection Act of 2011 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. Lamar Alexander
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 01/26/2011
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Foreign Manufacturers Legal Accountability Act of 2011 [S.1946]
[Trade ]
[Consumer Protection ]
[Food ]
[International ]
[Law Enforcement ]
[Agriculture ]
[Public Health ]
Foreign Manufacturers Legal Accountability Act of 2011 - 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 S8186-8187) on 12/05/2011
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Novel Device Regulatory Relief Act of 2011 [S.1943]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to allow a person to request the Secretary of Health and Human Services (HHS) to classify a device regardless of whether the person has received written notice of classification into class III (premarket approval) under the initial classification procedures applicable to devices introduced or delivered for introduction into interstate commerce before May 28, 1976. Allows a person that is required to submit a report preceding the introduction of device into
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Sponsored by: Sen. Scott Brown
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 12/05/2011
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Counterfeit Drug Penalty Enhancement Act of 2011 [S.1886]
[Pharmaceuticals ]
[Crime ]
[Public Health ]
[Criminal Justice ]
[Public Safety ]
Counterfeit Drug Penalty Enhancement Act of 2011 - Amends the federal criminal code to establish criminal penalties of a fine, imprisonment for not more than 20 years, or both for trafficking, or attempting to traffic, in counterfeit drugs. Doubles the potential fine for repeat offenders. Directs the United States Sentencing Commission to review and, if appropriate, amend its guidelines and policy statements applicable to persons convicted of that offense to reflect congressional intent that such penalties be increased.
Sponsored by: Sen. Robert Casey
Referred To The Subcommittee On Crime, Terrorism, And Homeland Security. on 03/15/2012
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Fair And Immediate Release of Generic Drugs Act [S.1882]
[Pharmaceuticals ]
[Healthcare ]
[Consumer Protection ]
Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand
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Sponsored by: Sen. Bernard Sanders
Sponsor Introductory Remarks On Measure. (cr S7616) on 11/16/2011
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Patient Access to Medical Innovation Act [S.1865]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Science ]
[Medicare and Medicaid ]
Patient Access to Medical Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to extend for five years and revise the program for humanitarian exemptions for pediatric medical devices. Removes provisions requiring the device to have been approved on or after September 27, 2007. Eliminates the authority of the Secretary of Health and Human Services (HHS) to establish an annual distribution number setting the maximum number of devices that could be distributed under the exemption. Sets such number as the number of devices needed to treat,
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Sponsored by: Sen. Lamar Alexander
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 11/15/2011
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Pandemic and All-Hazards Preparedness Act Reauthorization of 2011 [S.1855]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
[National Security ]
[Science ]
[Funding ]
[Grants ]
[Children and Youth ]
[Disaster Relief ]
[Veterans ]
[Defense ]
[Medicare and Medicaid ]
Pandemic and All-Hazards Preparedness Act Reauthorization of 2011 - 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. Requires the Strategy to include: (1) provisions for increasing the preparedness, response capabilities, and surge capacity of dental health facilities and critical care service systems;
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Sponsored by: Sen. Robert Casey
Message On Senate Action Sent To The House. on 03/08/2012
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Generating Antibiotic Incentives Now Act of 2011 [S.1734]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Science ]
Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines "qualified infectious disease product" to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen (certain pathogens that are resistant to antibiotics). Excludes drugs that are: (1) a supplement to a new drug
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Sponsored by: Sen. Robert Casey
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 10/19/2011
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Jobs Through Growth Act [S.1720]
[Labor, Jobs, Employment ]
[Finance ]
[Taxes ]
[Small Business ]
[Consumer Protection ]
[Energy ]
[Environmental ]
[Trade ]
[Budget and Spending ]
[Law Enforcement ]
[Healthcare ]
[Construction ]
[Mining ]
[Public Lands and National Parks ]
[Air Quality ]
[Water ]
[Economic Development ]
[Unemployment ]
[National Security ]
[Funding ]
[Grants ]
[Inflation ]
Jobs Through Growth Act - Expresses the sense of Congress that S.J. Res. 10 (a balanced budget amendment) should be passed and submitted to the states for ratification within 90 days after the enactment of this Act. Amends the Impoundment Control Act of 1974 to require the Office of Management and Budget (OMB) to transmit, within 45 calendar days after enactment of the funding in question, a message to Congress with specified information requesting any rescission the President proposes under the procedures in this Act. Prescribes requirements for
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Sponsored by: Sen. Chuck Grassley
Read The Second Time. Placed On Senate Legislative Calendar Under General Orders. Calendar No. 203. on 10/18/2011
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Medical Device Regulatory Improvement Act [S.1700]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
Medical Device Regulatory Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS), in determining the least burdensome appropriate means of evaluating device effectiveness, to: (1) not request information unrelated or irrelevant to demonstration of reasonable assurance of device safety and effectiveness; (2) consider alternative approaches to evaluating device safety and effectiveness; (3) use all reasonable mechanisms to lessen review times and render regulatory decisions; (4)
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Sponsored by: Sen. Amy Klobuchar
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 10/13/2011
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Drug Safety and Accountability Act of 2011 [S.1584]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
[Law Enforcement ]
[Public Safety ]
Drug Safety and Accountability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require each registered drug producer to have in effect and implement a quality management plan to ensure the quality and safety of: (1) each drug, (2) each active and inactive ingredient of each drug, and (3) materials used in the manufacture of each active ingredient. Authorizes the Secretary of Health and Human Services (HHS) to order an establishment to promptly revise its quality management plan in response to a significant threat to public
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Sponsored by: Sen. Richard Blumenthal
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 09/20/2011
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Preservation of Antibiotics for Medical Treatment Act of 2011 [S.1211]
[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: Sen. Jack Reed
Sponsor Introductory Remarks On Measure. (cr S3837-3839) on 06/15/2011
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Prize Fund for HIV/AIDS Act [S.1138]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
Prize Fund for HIV/AIDS Act - Prohibits any person from having the right to exclusively manufacture, distribute, sell, or use in interstate commerce a qualifying treatment for HIV/AIDS or a manufacturing process for such a treatment, 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. Makes the elimination of exclusive rights for
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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