Drug Safety, Medical Device, And Laboratory Regulation
US Congress 114th Congress
Microbead-Free Waters Act of 2015 [S.1424]
Microbead-Free Waters Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to ban cosmetics that contain synthetic plastic microbeads beginning on January 1, 2018.
Sponsored by: Sen. Richard Blumenthal
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/21/2015
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Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 [S.1421]
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 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”). Allows HHS to revoke an extension if the application submitted to the FDA
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Sponsored by: Sen. Cory Booker
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/21/2015
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Saving Access to Compounded Medications for Special Needs Patients Act [S.1406]
Saving Access to Compounded Medications for Special Needs Patients Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow drugs to be compounded (manufactured at a small scale) and distributed to practitioners for treatment of, or administration to, patients of that practitioner. Currently, drugs may be compounded only for identified individual patients. (Compounded drugs do not need to meet certain requirements for drugs regarding manufacturing, labeling, or FDA approval.) Compounded drugs must comply with United States Pharmacopeia
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Sponsored by: Sen. David Vitter
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/20/2015
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CCM-CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2015 [S.1391]
CCM-CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2015 This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to strengthen and coordinate its efforts concerning cerebral cavernous malformation (CCM). (CCM is a condition in which blood vessels in the brain and spinal cord become enlarged, which can lead to seizures, paralysis, hearing or vision loss, or bleeding in the brain.) The NIH may award grants and enter into cooperative agreements for CCM research.
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Sponsored by: Sen. Tom Udall
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/20/2015
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FAIR Generics Act Fair And Immediate Release of Generic Drugs Act [S.131]
FAIR Generics Act Fair And Immediate Release of Generic Drugs Act This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to disqualify from being a “first applicant” an applicant submitting an abbreviated new drug application (for a generic drug) to the Food and Drug Administration that has entered into a specified agreement. Currently, any generic drug applicant submitting an application on the first day an application is submitted for that drug is a “first applicant” and is granted a 180-day marketing exclusivity period. An agreement
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Sponsored by: Sen. Al Franken
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 01/08/2015
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Safe and Affordable Drugs from Canada Act of 2015 [S.122]
Safe and Affordable Drugs from Canada Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that: is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the
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Sponsored by: Sen. Susan Collins
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 01/08/2015
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MEDTECH Act Medical Electronic Data Technology Enhancement for Consumers' Health Act [S.1101]
MEDTECH Act Medical Electronic Data Technology Enhancement for Consumers' Health Act This bill amends the Federal Food, Drug, and Cosmetic Act to exclude from regulation by the Food and Drug Administration (FDA) as a medical device: administrative, operational, or financial records software used in health care settings; software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment; electronic patient records, excluding software for interpreting or analyzing medical image data; software for clinical laboratory testing,
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Sponsored by: Sen. Michael Bennet
Committee On Health, Education, Labor, And Pensions. Reported By Senator Alexander With An Amendment In The Nature Of A Substitute And An Amendment To The Title. Without Written Report. on 04/04/2016
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Advancing Breakthrough Devices for Patients Act of 2016 [S.1077]
Advancing Breakthrough Devices for Patients Act of 2016 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to revise requirements regarding priority review of breakthrough medical devices. Upon a sponsor's request, the Food and Drug Administration (FDA) must determine whether a device meets the criteria for designation as a breakthrough device. To expedite the development and review of designated medical devices, the FDA must: assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive
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Sponsored by: Sen. Joe Donnelly
Committee On Health, Education, Labor, And Pensions. Reported By Senator Alexander With An Amendment In The Nature Of A Substitute. Without Written Report. on 04/05/2016
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Personal Care Products Safety Act [S.1014]
Personal Care Products Safety Act This bill amends the Federal Food, Drug, and Cosmetic Act to require cosmetics companies to register their facilities with the Food and Drug Administration (FDA) and to submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients. Companies must pay a facility registration fee based on their annual gross sales of cosmetics. The collected fees can only be used for cosmetic safety activities. If the FDA determines that a cosmetic has a reasonable probability of causing serious
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Sponsored by: Sen. Susan Collins
Committee On Health, Education, Labor, And Pensions. Hearings Held. on 09/22/2016
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Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 [S.1013]
Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to cover, as medical and other health services, complex rehabilitation technology (CRT) items designed or individually configured for a specific qualified individual to meet that individual's unique: (1) medical, physical, or functional needs related to a medical condition; and (2) capacities for basic activities of daily living (ADLs) or instrumental ADLs. Directs the Secretary of Health and Human Services to: (1) designate
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Sponsored by: Sen. Edward Markey
Read Twice And Referred To The Committee On Finance. on 04/20/2015
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Recognizing the importance of transformative breakthroughs in biomedicine, biotechnology, and life sciences in the diagnosis, management, curing, and treatment of illness and the existence of a "Valley of Death" in biotechnology and life sciences funding that stifles innovation and impedes translational medical research. [HR-95]
Recognizing the importance of transformative breakthroughs in biomedicine, biotechnology, and life sciences in the diagnosis, management, curing, and treatment of illness and the existence of a "Valley of Death" in biotechnology and life sciences funding that stifles innovation and impedes translational medical research. Recognizes: the value of biomedicine, biotechnology, and life sciences; the challenges those industries face; and the ways those challenges can be addressed.
Sponsored by: Rep. Scott Peters
Referred To The Subcommittee On Health. on 02/06/2015
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Expressing the sense of the Congress that the National Institutes of Health should encourage a global pediatric clinical trial network, and for other purposes. [HCR-46]
Expressing the sense of the Congress that the National Institutes of Health should encourage a global pediatric clinical trial network, and for other purposes. Expresses the sense of Congress that: the National Institutes of Health (NIH) should encourage a global pediatric clinical trial network through the allocation of grants, contracts, or cooperative agreements to supplement the salaries of new and early investigators who participate in it; NIH grants, contracts, or cooperative agreements should be awarded to participating entities, solely for
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Sponsored by: Rep. Joseph Pitts
Referred To The Subcommittee On Health. on 05/15/2015
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Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 [HB-971]
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product 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”). Allows the FDA to revoke an extension if the application for the new indication contained an untrue material statement. Requires
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Sponsored by: Rep. Steve Scalise
Referred To The Subcommittee On Health. on 02/20/2015
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HEAL Act Helping Effective Antibiotics Last Act of 2015 [HB-931]
HEAL Act Helping Effective Antibiotics Last Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population. A product approved by this pathway must include in its prescribing information
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Health. on 02/13/2015
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CHIP Extension and Improvement Act of 2015 [HB-919]
CHIP Extension and Improvement Act of 2015 Revises and extends through FY2019 at generally increased levels the program under title XXI (State Children's Health Insurance) (CHIP) of the Social Security Act (SSAct), and adjusts CHIP allotment requirements accordingly, including the rebasing and growth factor update rules for computing state allotments. Makes appropriations for certain allotments. Directs the Secretary of Health and Human Services to make payments to shortfall states from the Child Enrollment Contingency Fund in each of FY2016-FY2019.
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Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Health. on 02/27/2015
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Andrea Sloan CURE Act Andrea Sloan Compassionate Use Reform and Enhancement Act [HB-909]
Andrea Sloan CURE Act Andrea Sloan Compassionate Use Reform and Enhancement Act Amends the Federal Food, Drug, and Cosmetic Act to require the sponsor of an “investigational drug” (which is a drug that is designated as a breakthrough therapy, fast track product, infectious disease product, or drug for a rare disease or condition) to submit to the Food and Drug Administration (FDA) and make available to the public the sponsor's policy on requests for expanded access to the unapproved drug, including the minimum criteria for considering or approving
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 02/13/2015
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Innovation Act [HB-9]
Innovation Act (Sec. 3) Directs a party alleging patent infringement in a civil action to include in the court pleadings, unless the information is not accessible after a reasonable inquiry, specified details concerning: all claims necessary to produce the identification of each process, machine, manufacture, or composition of matter ("accused instrumentalities") alleged to infringe any claim of each patent allegedly infringed; the name, model number, or description of each accused instrumentality; where each element of each claim is found within,
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Sponsored by: Rep. Hakeem Jeffries
Committee On Small Business And Entrepreneurship. Hearings Held. on 02/25/2016
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Compassionate Freedom of Choice Act of 2015 [HB-790]
Compassionate Freedom of Choice Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act prevents or restricts, and the Food and Drug Administration (FDA) must not prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients. The FDA is prohibited from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that the sponsor of a clinical
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 02/06/2015
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Vaccine Access, Certainty, and Innovation Act of 2015 [HB-786]
Vaccine Access, Certainty, and Innovation Act of 2015 This bill requires the Centers for Disease Control and Prevention (CDC) to report on the process used by the Advisory Committee on Immunization Practices (ACIP) in making recommendations on vaccines. The Department of Health and Human Services (HHS) must issue final guidance to facilitate the use of expedited pathways for the development and licensure of vaccines to prevent certain infectious diseases. The Public Health Service Act is amended to require the CDC to provide a vaccine developer,
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Sponsored by: Rep. G. Butterfield
Referred To The Subcommittee On Health. on 02/27/2015
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Medical Innovation Act of 2015 [HB-744]
Medical Innovation Act of 2015 This bill amends the Public Health Service Act to require certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a settlement agreement in the previous five years with a federal agency regarding specified violations must pay 1% of its net income to the Department of Health and Human Services (HHS) for each of its covered
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Sponsored by: Rep. Janice Schakowsky
Referred To The Subcommittee On Health. on 02/06/2015