Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Affordable Medications Act [S.1801]
Revises and expands various requirements relating to prescription-drug pricing and affordability. Specifically, the bill expands financial reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance; adds reporting requirements for certain nonprofit patient-assistance programs; requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under Medicare; requires the Centers for Medicare and Medicaid Innovation within the CMS to test specified models
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Horseracing Integrity Act of 2019 [S.1820]
Establishes the Horseracing Anti-Doping and Medication Control Authority as an independent, private non-profit corporation with responsibility for developing and administering an anti-doping and medication control program for (1) Thoroughbred, Quarter, and Standardbred horses that participate in horse races; and (2) the personnel engaged in the care, training, or racing of such horses. The Federal Trade Commission shall have oversight over the authority. An interstate compact may be established after five years to take over the authority's duties.
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Improving Seniors’ Timely Access to Care Act of 2019 [HB-3107]
Establishes several prohibitions, requirements, and standards relating to prior authorization processes under Medicare Advantage (MA) plans. Specifically, the bill prohibits MA plans from instituting additional prior authorization requirements for surgeries (including related items) that are furnished to a patient during other surgeries for which prior authorization was not required or was already received. Additionally, MA plans must (1) establish an electronic prior authorization program that meets specified standards, including the ability to
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DISARM Act of 2019 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019 [S.1712]
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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Medical Device Sterilization Challenge Act of 2019 [HB-3044]
To establish the Medical Device Sterilization Challenge, and for other purposes.
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Advancing Education on Biosimilars Act of 2020 [S.1681]
A bill to educate health care providers and the public on biosimilar biological products, and for other purposes.
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Ensuring Innovation Act [S.1636]
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
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Second Look at Drug Patents Act of 2019 [S.1617]
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the listing of patents in the Orange Book.
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Opioid Crisis Accountability Act of 2019 [HB-2917]
Establishes a series of restrictions and requirements relating to opioid marketing and distribution practices. Specifically, the bill prohibits (1) knowingly making false advertising or marketing claims regarding the addictive nature of opioids; (2) knowingly supplying communities with quantities of opioids that are not medically reasonable; or (3) failing to report distribution orders, or patterns of orders, while knowing that the orders are not being dispensed in a medically reasonable manner. Employees of opioid manufacturers and distributors
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Respond NOW Act Respond to the Needs in the Opioid War Act [HB-2922]
Establishes the Opioid Epidemic Response Fund through FY2024 to fund programs and activities addressing the opioid and substance use epidemic, including Substance Abuse and Mental Health Services Administration demonstration grants; Centers for Disease Control and Prevention surveillance, prevention, and treatment programs; Food and Drug Administration support of innovation in non-opioid and nonaddictive medical products for pain treatment; National Institutes of Health research on creating longer-lasting or faster-acting antidotes for opioid overdoses;
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Medical Device Guardians Act [HB-2915]
To amend the Federal Food, Drug, and Cosmetic Act to require physicians and physician's offices to be treated as covered device users required to report on certain adverse events involving medical devices, and for other purposes.
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FORWARD Act of 2019 Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 [S.1567]
Establishes programs to support the research of endemic fungal diseases and the development of antifungal drugs. (Endemic fungal diseases are fungal infections, e.g., Valley fever, that tend to to occur in specific geographic areas and affect particular at-risk populations, e.g., older adults.)Specifically, the bill establishes the Endemic Fungal Disease Working Group to review, coordinate, and make recommendations about the Department of Health and Human Services' (HHS) efforts to address endemic fungal diseases. The working group is comprised
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FORWARD Act of 2019 Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 [HB-2858]
Establishes programs to support the research of endemic fungal diseases and the development of antifungal drugs. (Endemic fungal diseases are fungal infections, e.g., Valley fever, that tend to to occur in specific geographic areas and affect particular at-risk populations, e.g., older adults.)Specifically, the bill establishes the Endemic Fungal Disease Working Group to review, coordinate, and make recommendations about the Department of Health and Human Services' (HHS) efforts to address endemic fungal diseases. The working group is comprised
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Opioid Crisis Accountability Act of 2019 [S.1584]
Establishes a series of restrictions and requirements relating to opioid marketing and distribution practices. Specifically, the bill prohibits (1) knowingly making false advertising or marketing claims regarding the addictive nature of opioids; (2) knowingly supplying communities with quantities of opioids that are not medically reasonable; or (3) failing to report distribution orders, or patterns of orders, while knowing that the orders are not being dispensed in a medically reasonable manner. Employees of opioid manufacturers and distributors
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Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act [HB-2700]
To incentivize low-cost drug options and generic competition, and to provide extensions for community health centers and the National Health Service Corps, and for other purposes.
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Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act [HB-2700]
To incentivize low-cost drug options and generic competition, and to provide extensions for community health centers and the National Health Service Corps, and for other purposes.
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Patient Access to ESRD New Innovative Devices Act [HB-2710]
Requires the Centers for Medicare & Medicaid Services (CMS) to establish a process to provide a certain payment adjustment under the Medicare end-stage renal disease (ESRD) prospective payment system. Specifically, the CMS must establish a process to provide for an add-on payment adjustment for new medical devices used to diagnose, treat, or manage ESRD.
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LABEL Opioids Act Lessening Addiction By Enhancing Labeling Opioids Act of 2019 [HB-2732]
Requires prescription opioids to contain a warning label specifying that the opioids may cause dependence, addiction, and overdose.
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LABEL Opioids Act Lessening Addiction By Enhancing Labeling Opioids Act of 2019 [S.1449]
Requires prescription opioids to contain a warning label specifying that the opioids may cause dependence, addiction, and overdose.
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Comprehensive Addiction Resources Emergency Act of 2019 [HB-2569]
Establishes various programs to address substance use disorder and opioid addiction, including grants for treatment, recovery, and harm reduction services as well as a program to distribute overdose reversal drugs.