Drug Safety, Medical Device, And Laboratory Regulation
US Congress 115th Congress
RACE for Children Act Research to Accelerate Cures and Equity for Children Act [S.456]
RACE for Children Act Research to Accelerate Cures and Equity for Children Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand Food and Drug Administration (FDA) requirements for sponsors of certain drugs and biological products for adult cancer to assess the use of their medications in pediatric populations. (Currently, applications for FDA approval of new medications or new uses of medications must include pediatric assessments of safety and effectiveness for claimed indications, with exceptions.) The pediatric assessment for
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Sponsored by: Sen. Angus King
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 02/27/2017
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OPEN Act Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 [HB-1223]
OPEN Act Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease). HHS may revoke an extension if the application submitted
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Sponsored by: Rep. Ted Poe
Referred To The Subcommittee On Health. on 03/03/2017
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Protecting Access to Care Act of 2017 [HB-1215]
Protecting Access to Care Act of 2017 This bill establishes provisions governing health care lawsuits where coverage for the care was provided or subsidized by the federal government, including through a subsidy or tax benefit. (Sec. 2) In general, the statute of limitations is three years after the occurrence of the breach or tort, three years after medical or health-care treatment for the injury is completed, or one year after the claimant discovers the injury, whichever occurs first. For a minor, the statute of limitations is three years after
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Sponsored by: Rep. Steve King
Received In The Senate And Read Twice And Referred To The Committee On The Judiciary. on 06/29/2017
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Recall Unsafe Drugs Act of 2017 [HB-1108]
Recall Unsafe Drugs Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require producers of medications to notify the Food and Drug Administration (FDA) of the identity and location of a medication if the producer has reason to believe: (1) that the medication is adulterated or misbranded; and (2) there is a reasonable probability that the use or consumption of, or exposure to, the medication will cause a threat of serious adverse health consequences or death to humans or animals. The FDA may: (1) request that the distributor
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Sponsored by: Rep. James Langevin
Referred To The Subcommittee On Digital Commerce And Consumer Protection. on 02/17/2017
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FDA Deeming Authority Clarification Act of 2017 [HB-1136]
FDA Deeming Authority Clarification Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to: (1) revise premarket review and reporting requirements for products newly deemed by the Food and Drug Administration (FDA) to be tobacco products; and (2) grant the FDA the authority to regulate vapor products, which include products that produce vapor with nicotine (e.g., e-cigarettes) and nicotine intended to be used with such a product (e.g., nicotine cartridges). A product is not subject to premarket review by the FDA if it is
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Sponsored by: Rep. David Valadao
Referred To The Subcommittee On Health. on 02/17/2017
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A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications. [S.404]
A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications. This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding Food and Drug Administration (FDA): (1) inspections of establishments that manufacture or process medical devices, and (2) certification of medical devices for export. The biannual inspection schedule for medical device establishments handling higher risk devices is replaced with a risk-based schedule. In
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Sponsored by: Sen. Joe Donnelly
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 02/15/2017
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Safe Drinking Water Act Amendments of 2017 [HB-1068]
Safe Drinking Water Act Amendments of 2017 This bill amends the Safe Drinking Water Act to revise regulations for drinking water contaminants, including by: requiring the Environmental Protection Agency (EPA) to determine whether or not to regulate no fewer than 10 contaminants every 3 years (current law requires 5 contaminants every 5 years); revising the process and requirements for setting maximum containment levels in national primary drinking water regulations; directing the EPA to revise national primary drinking water regulations for lead
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Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Environment. on 02/17/2017
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Assistance, Quality, and Affordability Act of 2017 [HB-1071]
Assistance, Quality, and Affordability Act of 2017 This bill amends the Safe Drinking Water Act to reauthorize for FY2018-FY2022 and revise the drinking water state revolving fund (SRF), including to require SRF-funded projects to use iron and steel produced in the United States. The bill revises requirements for state Intended Use Plans for SRF funds, including to require the plans to: (1) list systems that are not in compliance with national primary drinking water regulation, (2) reserve a specified amount of funding for assistance for disadvantaged
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Sponsored by: Rep. Gerald Connolly
Referred To The Subcommittee On Environment. on 02/17/2017
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Compassionate Freedom of Choice Act of 2017 [HB-1020]
Compassionate Freedom of Choice Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in that Act or in the Public Health Service Act prevents or restricts, and the Food and Drug Administration (FDA) may not prevent or restrict, the manufacture, importation, distribution, or sale of drugs or medical devices that are intended for terminally ill patients, have been the subject of a clinical trial, and have not been approved by the FDA. The FDA may not require the disclosure, collection, or reporting of certain
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 02/17/2017
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Opioid Abuse Prevention and Treatment Act of 2017 [HB-993]
Opioid Abuse Prevention and Treatment Act of 2017 This bill requires the Department of Health and Human Services (HHS) to award grants to states to develop a peer review process to identify and investigate questionable or inappropriate prescribing and dispensing patterns of drugs classified as schedule II or III under the Controlled Substances Act, which are drugs with an accepted medical use that have the potential to be abused and addictive. This bill amends the Public Health Service Act to require HHS to establish grant programs to: (1) facilitate
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Sponsored by: Rep. Sean Maloney
Referred To The Subcommittee On Health. on 02/10/2017
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Personal Drug Importation Fairness Act of 2017 [HB-934]
Personal Drug Importation Fairness Act of 2017 This bill allows a drug to be imported by a person other than the drug's manufacturer if the drug: (1) has the same active ingredients, route of administration, and strength as an approved drug; (2) may be lawfully marketed in, and is imported or reimported from, a country included on a list in this Act that the Food and Drug Administration determines has standards for ensuring drug safety and effectiveness that are at least as protective as U.S. standards; (3) is dispensed by a licensed pharmacist;
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Sponsored by: Rep. Keith Ellison
Referred To The Subcommittee On Health. on 02/10/2017
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DEVICE Act of 2017 Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017 [HB-872]
DEVICE Act of 2017 Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require medical device manufacturers to notify the Food and Drug Administration (FDA): (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Health. on 02/10/2017
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Right to Try Act of 2017 [HB-878]
Right to Try Act of 2017 This bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are: (1) intended to treat a patient who has been diagnosed with a terminal illness, and (2) authorized by state law. The federal government must allow unrestricted possession and use of such treatments by patients certified by a physician as having exhausted all other treatment options. A manufacturer, distributor, prescriber, dispenser,
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Sponsored by: Rep. Alexander Mooney
Referred To The Subcommittee On The Constitution And Civil Justice. on 03/02/2017
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Increasing Competition in Pharmaceuticals Act [S.297]
Increasing Competition in Pharmaceuticals Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them
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Sponsored by: Sen. Susan Collins
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 02/02/2017
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Childhood Cancer STAR Act Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2017 [HB-820]
Childhood Cancer STAR Act Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2017 This bill amends the Public Health Service Act to authorize the National Institutes of Health (NIH) to provide support to collect the medical specimens and information of children, adolescents, and young adults with selected cancers that have the least effective treatments in order to achieve a better understanding of these cancers and the effects of treatment. The national childhood cancer registry is reauthorized through FY2022 and revised to authorize
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Sponsored by: Rep. Alexander Mooney
Referred To The Subcommittee On Health. on 02/03/2017
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Childhood Cancer STAR Act Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018 [S.292]
Childhood Cancer STAR Act Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018 This bill amends the Public Health Service Act to authorize the National Institutes of Health (NIH) to provide support to collect the medical specimens and information of children, adolescents, and young adults with selected cancers that have the least effective treatments in order to achieve a better understanding of these cancers and the effects of treatment. The national childhood cancer registry is reauthorized through FY2022 and revised to authorize
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Sponsored by: Sen. Robert Casey
Became Public Law No: 115-180. on 06/05/2018
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Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017 [S.294]
Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to exempt traditional large and premium cigars from regulation by the Food and Drug Administration (FDA) and from user fees assessed on tobacco products by the FDA.
Sponsored by: Sen. Robert Casey
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 02/02/2017
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Ensuring Access to Quality Complex Rehabilitation Technology Act of 2017 [HB-750]
Ensuring Access to Quality Complex Rehabilitation Technology Act of 2017 This bill amends title XVIII (Medicare) of the Social Security Act to establish a separate Medicare benefit category for complex rehabilitation technology (CRT) items that: (1) are designed or configured to meet an individual's unique needs and capacities; (2) are primarily used to serve a medical or functional purpose; and (3) require certain services to ensure appropriate design, configuration, and use. The Centers for Medicare & Medicaid Services (CMS) shall designate CRT
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Sponsored by: Rep. Sean Maloney
Referred To The Subcommittee On Health. on 02/09/2017
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Lower Drug Costs through Competition Act [HB-749]
Lower Drug Costs through Competition Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within
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Sponsored by: Rep. Gus Bilirakis
Referred To The Subcommittee On Health. on 02/03/2017
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Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 [S.204]
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to exempt, from specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must report annually to the Food and
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Sponsored by: Sen. Chuck Grassley
Became Public Law No: 115-176. on 05/30/2018