Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
ACCESS Act of 2019 Accessible Care by Curbing Excessive lawSuitS Act of 2019 [HB-3656]
To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system.
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FDA Opioid Labeling Accuracy Act [S.2089]
A bill to prohibit the labeling of certain opioid drugs recommending use for long-term chronic pain.
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Medical Marijuana Research Act [HB-3797]
Establishes a new, separate registration process to facilitate medical marijuana research. Specifically, it directs the Drug Enforcement Administration to register (1) practitioners to conduct medical marijuana research, and (2) manufacturers and distributors to supply marijuana for such research. Additionally, the Department of Health and Human Services must continue to produce marijuana through the National Institute on Drug Abuse Drug Supply Program and offer to sell immature plants and seeds to researchers until manufacturers and distributors
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DISARM Act of 2019 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019 [HB-4100]
Requires additional payment under Medicare's inpatient prospective payment system for services that involve certain antimicrobial drugs, in accordance with specified limitations. Additionally, the Government Accountability Office must report on the barriers to developing such antimicrobial drugs and must recommend ways to address such barriers.
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REMEDY Act Reforming Evergreening and Manipulation that Extends Drug Years Act [HB-3812]
To amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications.
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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 [S.2161]
Establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there
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Turn the Tide Act [S.2102]
Funds through FY2023 the SUPPORT for Patients and Communities Act, which established various programs to address opioid addiction. Funded programs include (1) grants to increase access to substance use disorder treatments; (2) research, training, and developing best practices within the public health sector; (3) prevention and recovery services for youth, women, and infants; (4) overdose prevention and treatment; and (5) other community, judicial, and administrative programs. The bill also reauthorizes through FY2024 and increases funding for the
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GAIN Act Greater Access and Independence through Nonvisual Access Technology Act of 2019 [HB-3929]
Requires the Architectural and Transportation Barriers Compliance Board (Access Board) to establish access standards for home (1) medical devices, (2) appliances, and (3) exercise equipment that allow blind consumers to effectively use such products.
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Affordable Insulin Approvals Now Act [S.2103]
Requires the continued review and approval, as appropriate, of certain pending applications for generic insulin beyond the March 23, 2020, cutoff date previously established by the Food and Drug Administration. Beginning March 23, 2020, these approved generic insulin drugs also are deemed licensed biological products.
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CCM–CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2019 [HB-3573]
Requires the National Institutes of Health (NIH) and other agencies to expand and coordinate their efforts to research cerebral cavernous malformation. (Cerebral cavernous malformation 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, and bleeding in the brain.)The NIH must (1) award grants for medical, clinical, and pharmacological research; (2) award grants to support a network of clinical research centers intended to develop a cure for the condition;
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CCM–CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2019 [S.2010]
Requires the National Institutes of Health (NIH) and other agencies to expand and coordinate their efforts to research cerebral cavernous malformation. (Cerebral cavernous malformation 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, and bleeding in the brain.)The NIH must (1) award grants for medical, clinical, and pharmacological research; (2) award grants to support a network of clinical research centers intended to develop a cure for the condition;
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LAB Act Laboratory Access for Beneficiaries Act [HB-3584]
Revises the periods during which laboratories must report clinical diagnostic test information to the Centers for Medicare & Medicaid Services (CMS) for purposes of determining Medicare payment rates. The CMS must also contract with the National Academies of Sciences, Engineering, and Medicine to evaluate the methodology used to determine a specified laboratory fee schedule.
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Cannabidiol and Marihuana Research Expansion Act [S.2032]
Modifies provisions concerning the federal regulation of certain drugs that are deemed to pose a risk of abuse and dependence to facilitate research on, and the use of, medical treatments containing marijuana and its derivatives.
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CREATE Opportunities Act Community Re-Entry through Addiction Treatment to Enhance Opportunities Act [HB-3496]
Establishes the Medication-Assisted Treatment Corrections and Community Reentry Program in the Department of Justice. Under the program, the National Institute of Corrections may award grants to support local programs that provide medication-assisted treatment for incarcerated individuals who have opioid-use disorder; such treatment must be provided in accordance with specified requirements, including drug, screening, and personnel criteria.
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CREATE Opportunities Act Community Re-Entry through Addiction Treatment to Enhance Opportunities Act [S.1983]
Establishes the Medication-Assisted Treatment Corrections and Community Reentry Program in the Department of Justice. Under the program, the National Institute of Corrections may award grants to support local programs that provide medication-assisted treatment for incarcerated individuals who have opioid-use disorders; such treatment must be provided in accordance with specified requirements, including drug, screening, and personnel criteria.
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Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 [HB-3443]
To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.
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PRICED Act Price Relief, Innovation, and Competition for Essential Drugs Act [HB-3379]
Allows biosimilars to be marketed five years after the reference brand-name biological product is licensed. Currently, brand-name biological products are provided a 12-year marketing-exclusivity period. This shortened marketing-exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill.
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Lower Health Care Costs Act [S.1895]
Makes a series of changes relating to health care coverage, costs, and services. Among other things, the bill applies in-network cost-sharing requirements to certain emergency and related nonemergency services that are provided out-of-network, and prohibits health care facilities and practitioners from billing above the applicable in-network cost-sharing rate for such services; revises certain requirements in order to expedite the approval of generics and biosimilars, including requirements relating to citizen petitions, application effective dates,
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Affordability is Access Act [HB-3296]
Establishes several requirements relating to health-insurance coverage of, and access to, over-the-counter contraceptives. Specifically, the bill requires the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury to specify that private health-insurance plans must cover over-the-counter contraceptives that are approved by the Food and Drug Administration (FDA), even without a prescription. Under current law, private health-insurance plans (with some exceptions) must cover FDA-approved prescription contraceptives,
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Affordability is Access Act [S.1847]
Establishes several requirements relating to health-insurance coverage of, and access to, over-the-counter contraceptives. Specifically, the bill requires the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury to specify that private health-insurance plans must cover over-the-counter contraceptives that are approved by the Food and Drug Administration (FDA), even without a prescription. Under current law, private health-insurance plans (with some exceptions) must cover FDA-approved prescription contraceptives,
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