Drug Safety, Medical Device, And Laboratory Regulation
US Congress 112th Congress
Medical Device Patient Safety Act [HB-5866]
[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: Rep. Bruce Braley
Referred To The Subcommittee On Health. on 06/01/2012
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Gray Market Drug Reform and Transparency Act of 2012 [HB-5853]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
Gray Market Drug Reform and Transparency Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) make it a prohibited act and a misbranding for a wholesale distributor of prescription drugs to purchase or receive a prescription drug from a pharmacy or a pharmacist, (2) require annual reporting by wholesale distributors of prescription drugs, (3) require the Secretary of Health and Human Services (HHS) to establish and maintain a national database of information reported by wholesale distributors of prescription drugs and to require
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Sponsored by: Rep. Elijah Cummings
Referred To The Subcommittee On Health. on 05/25/2012
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Food and Drug Administration Reform Act of 2012 [HB-5651]
[Pharmaceuticals ]
[Healthcare ]
[Public Health ]
[Food ]
[Science ]
Food and Drug Administration Reform Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and to revise and impose new requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; and (4) registration of drug manufacturers and reporting of drug shortages. Title I: Fees Relating to Drugs - Prescription Drug User Fee Amendments of 2012 - (Sec. 103) Extends through
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Sponsored by: Rep. Frank Pallone
Received In The Senate. Read Twice. Placed On Senate Legislative Calendar Under General Orders. Calendar No. 420. on 06/04/2012
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Sentinel Assurance for Effective Devices Act of 2012 [HB-5341]
[Healthcare ]
[Technology and Innovation ]
[Pharmaceuticals ]
[Public Health ]
Sentinel Assurance for Effective Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to: (1) amend the new drug approval application procedures to make the postmarket risk identification and analysis system applicable, with certain exceptions, to devices; (2) give priority to class II and class III devices; and (3) engage outside stakeholders in development of the system and gather information from them regarding the content of an effective sentinel program through measures
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Sponsored by: Rep. Lois Capps
Referred To The Subcommittee On Health. on 05/11/2012
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To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies. [HB-5334]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
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 the drug's sponsor to request the Secretary to designate
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Sponsored by: Rep. Diana DeGette
Referred To The Subcommittee On Health. on 05/11/2012
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To amend the Public Health Service Act to enhance the clinical trial registry data bank reporting requirements and enforcement measures. [HB-5283]
[Healthcare ]
[Public Health ]
[Pharmaceuticals ]
[Defense ]
[Funding ]
[Grants ]
Revises clinical trial registry data bank provisions of the Public Health Service Act to: (1) include a device or drug clinical trial whether or not it results in a positive or negative outcome, and (2) subject clinical trials funded by the Department of Defense (DOD) to requirements to certify information submissions to the Director of the National Institutes of Health (NIH). Restricts funding for a grantee and makes the grantee liable to the United States for repayment of any grant amount provided, if the grantee has not submitted clinical trial
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Sponsored by: Rep. Tom Reed
Referred To The House Committee On Energy And Commerce. on 04/27/2012
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Protecting Access to Healthcare Act [HB-5]
[Healthcare ]
[Medicare and Medicaid ]
[Insurance ]
[Public Health ]
[Disaster Relief ]
[Law Enforcement ]
Protecting Access to Healthcare Act - Title I: HEALTH Act - Help Efficient, Accessible, Low Cost, Timely Healthcare (HEALTH) Act of 2012 - (Sec. 101) Sets forth provisions regulating lawsuits for health care liability claims concerning the provision of health care goods or services or any medical product affecting interstate commerce. (Sec. 103) 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. (Sec. 104) Limits noneconomic damages
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Sponsored by: Rep. Steve Scalise
Read The Second Time. Placed On Senate Legislative Calendar Under General Orders. Calendar No. 353. on 04/16/2012
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Gluten in Medicine Identification Act of 2012 [HB-4972]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
[Food ]
Gluten in Medicine Identification Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be misbranded any drug intended for human use that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient and whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.
Sponsored by: Rep. Raul Grijalva
Referred To The House Committee On Energy And Commerce. on 04/27/2012
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Patient Safety and Drug Labeling Improvement Act [HB-4384]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Consumer Protection ]
Patient Safety and Drug 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. Chris Van Hollen
Referred To The Subcommittee On Health. on 04/20/2012
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Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012 [HB-4378]
[Healthcare ]
[Medicare and Medicaid ]
[Social Security ]
[Disabilities ]
[Public Health ]
Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act to cover, as medical and other health services, complex rehabilitation technology items designed and configured for a specific qualified individual to meet that individual's unique: (1) medical, physical, and functional needs related to a medical condition; and (2) capacities for basic activities of daily living (ADLs) and instrumental ADLs. Directs the Secretary of Health and Human Services (HHS) to: (1) designate
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Sponsored by: Rep. Gerald Connolly
Referred To The Subcommittee On Health. on 04/26/2012
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Generic Drug Application Review Fairness Act of 2012 [HB-4332]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Generic Drug Application Review Fairness Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to extend from 30 to 60 months after application the period for a first applicant of a generic drug to obtain tentative approval without forfeiting the 180-day exclusivity period with respect to such drug, unless the failure in meeting the extended period is caused by a change in or review of approval requirements. Limits extension coverage to applications filed within 30 months preceding the enactment of this Act. Reduces such extended period
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Sponsored by: Rep. Frank Pallone
Referred To The Subcommittee On Health. on 03/30/2012
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BPCA and PREA Reauthorization Act of 2012 [HB-4274]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Children and Youth ]
BPCA and PREA Reauthorization Act of 2012 - Makes permanent the provisions of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act of 2003 (PREA). Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning pediatric research requirements and the granting of exclusivity. Extends the period for mandatory reporting of adverse events to the Office of Pediatric Therapeutics to 18 months after an approved label change. Requires a product sponsor to submit an Initial Pediatric Plan as part of the
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Sponsored by: Sen. Edward Markey
Referred To The Subcommittee On Health. on 03/30/2012
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Cosmetics Safety Enhancement Act of 2012 [HB-4262]
[Consumer Protection ]
[Healthcare ]
[Public Health ]
Cosmetics Safety Enhancement Act of 2012 - Amends the the Federal Food, Drug, and Cosmetic Act to require the registration of cosmetic products and cosmetic manufacturing facilities, including, for each product: (1) a unique facility identifier, (2) every product's brand name, and (3) product ingredients. Sets registration fees. Requires a cosmetic manufacturer: (1) before the introduction into interstate commerce of a cosmetic product, to establish a file containing scientific evidence substantiating the product's safety; (2) to report any serious
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Sponsored by: Rep. Frank Pallone
Referred To The Subcommittee On Health. on 03/30/2012
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Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 [HB-4156]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 or EXPERRT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to establish a program for consultation with external experts to inform and strengthen the Food and Drug Administration's (FDA's) review of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted. Requires, under such program, each review division within the Center for Drug Evaluation and Research
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Sponsored by: Rep. James McGovern
Referred To The Subcommittee On Health. on 03/09/2012
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FAST Act [HB-4132]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Faster Access to Specialized Treatments Act or FAST Act - Expresses the sense of Congress that the Food and Drug Administration (FDA) should apply specified accelerated approval and the fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards. 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 new drug, to include
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Sponsored by: Rep. Alcee Hastings
Referred To The Subcommittee On Health. on 03/09/2012
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Science and Technology Regulatory Relief Act of 2012 [HB-4056]
[Science ]
[Technology and Innovation ]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
Science and Technology Regulatory Relief Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a state or political subdivision from conducting or requiring an inspection of a factory, warehouse, or establishment in which a drug or device is manufactured, processed, packed, or held by a manufacturer or wholesale distributor for introduction into interstate commerce, or after such introduction, for purposes of verifying compliance with such Act, Public Health Service Act requirements regarding the regulation of biological products,
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Sponsored by: Rep. Susan Davis
Referred To The House Committee On Energy And Commerce. on 02/16/2012
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Generic Drug and Biosimilar User Fee Act of 2012 [HB-3988]
[Pharmaceuticals ]
[Healthcare ]
[Budget and Spending ]
[Funding ]
[Medicare and Medicaid ]
[Small Business ]
Generic Drug and Biosimilar User Fee Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), beginning FY2013, to assess and collect the following fees related to generic drugs: (1) a one-time backlog fee for abbreviated new drug applications pending on October 1, 2012; (2) a drug master file fee; (3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional fee for active pharmaceutical ingredient information not included by reference
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Sponsored by: Rep. Frank Pallone
Referred To The Subcommittee On Health. on 02/10/2012
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To amend title V of the Federal Food, Drug, and Cosmetic Act to extend the provisions of the Pediatric Medical Device Safety and Improvement Act. [HB-3975]
[Healthcare ]
[Pharmaceuticals ]
[Public Health ]
[Science ]
[Children and Youth ]
Amends the Pediatric Medical Device Safety and Improvement Act to authorize appropriations through FY2017 for grants for demonstration projects to promote pediatric device development. Amends the Federal Food, Drug, and Cosmetic Act to allow an exception to the prohibition against selling a device that is designed to treat or diagnose a disease or condition which affects fewer than 4,000 individuals in the United States and that is exempt from the effectiveness requirements of such Act for an amount that exceeds the costs of research and development,
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Sponsored by: Sen. Edward Markey
Referred To The Subcommittee On Health. on 02/10/2012
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Reform Americans Can Afford Act of 2011 [HB-397]
[Healthcare ]
[Insurance ]
[Pharmaceuticals ]
[Public Health ]
Reform Americans Can Afford Act of 2011 - Repeals the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, effective as of their enactment. Restores provisions of law amended by such Acts. 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,
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 02/09/2011
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Spending Reductions through Innovations in Therapies Agenda Act of 2012 [HB-3891]
[Healthcare ]
[Medicare and Medicaid ]
[Pharmaceuticals ]
[Public Health ]
[Funding ]
[Grants ]
[Science ]
[Technology and Innovation ]
[Budget and Spending ]
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: Rep. Barbara Lee
Referred To The House Committee On Energy And Commerce. on 02/02/2012