Prescription Drugs
US Congress 116th Congress
Prescription Drug Price Transparency Act [HB-1035]
Establishes additional requirements for prescription drug plan sponsors (PDPs) under Medicare and Medicare Advantage, as well as health insurance carriers under the Federal Employees Health Benefits Program, relating to the methodology of payments to pharmacies and the use of pharmacy benefits managers (PBMs). Specifically, such PDPs and carriers must disclose specified information to pharmacies regarding applicable standards for reimbursement that are based on drug costs, including the sources used to update such standards. Additionally, such PDPs
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Phair Pricing Act of 2019 [HB-1034]
Requires that certain negotiated prices for covered drugs under the Medicare prescription drug benefit be disclosed at the point-of-sale. Specifically, negotiated prices offered under a prescription drug plan (PDP) must be disclosed at the point-of-sale; the disclosed price must include specified adjustments, payments, and fees that are negotiated with the pharmacy (e.g., dispensing fees) by the PDP sponsor or pharmacy benefit manager. Additionally, the Centers for Medicare & Medicaid Services must establish certain quality measures for PDP sponsors
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Hatch-Waxman Integrity Act of 2019 [HB-990]
To amend the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other purposes.
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FAST Generics Act of 2019 Fair Access for Safe and Timely Generics Act of 2019 [HB-985]
To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes.
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CREATES Act of 2019 Creating and Restoring Equal Access to Equivalent Samples Act of 2019 [HB-965]
To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
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BLOCKING Act of 2019 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 [HB-938]
To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes.
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Right Rebate Act of 2019 [HB-937]
Requires drug manufacturers with Medicaid rebate agreements for covered outpatient drugs to disclose drug product information. Manufacturers are subject to civil penalties for knowingly misclassifying drugs. Manufacturers are also required to compensate for rebates that were initially underpaid as a result of misclassification (whether or not such misclassification was committed knowingly).
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North American Wetlands Conservation Extension Act [HB-925]
Reauthorizes the North American Wetlands Conservation Act through FY2024.
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DXM Abuse Prevention Act of 2019 [HB-863]
To amend the Federal Food, Drug, and Cosmetic Act to prevent the abuse of dextromethorphan, and for other purposes.
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Improving Transparency and Accuracy in Medicare Part D Spending Act [HB-803]
Prohibits Medicare prescription drug plan sponsors from retroactively reducing payment on clean claims submitted by pharmacies. (A "clean claim" is a Medicare claim that is free of defects such as incomplete documentation.)
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Improving Transparency and Accuracy in Medicare Part D Spending Act [HB-789]
Prohibits Medicare prescription drug plan sponsors from retroactively reducing payment on clean claims submitted by pharmacies. (A "clean claim" is a Medicare claim that is free of defects such as incomplete documentation.)
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Middle Class Health Benefits Tax Repeal Act of 2019 [HB-748]
Responds to the COVID-19 (i.e., coronavirus disease 2019) outbreak and its impact on the economy, public health, state and local governments, individuals, and businesses. DIVISION A--KEEPING WORKERS PAID AND EMPLOYED, HEALTH CARE SYSTEM ENHANCEMENTS, AND ECONOMIC STABILIZATION This division establishes the Paycheck Protection Program to provide eight weeks of cash flow assistance to small businesses through federally guaranteed loans to employers who maintain their payroll. Such assistance shall be to cover costs such as payroll, paid sick leave,
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Safe and Affordable Drugs from Canada Act of 2019 [HB-478]
Requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy if the drug 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 same active ingredients, route of administration, dosage form, and strength as a prescription drug approved by
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Prescription Drug Price Relief Act of 2019 [HB-465]
Establishes a series of oversight and disclosure requirements relating to the prices of brand-name drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to review at least annually all brand-name drugs for excessive pricing; HHS must also review prices upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar
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Medicare Drug Price Negotiation Act [HB-448]
Makes a series of changes relating to the prices of prescription drugs under the Medicare prescription drug benefit and Medicare Advantage (MA) prescription drug plans (PDPs). Under current law, the Centers for Medicare & Medicaid Services (CMS) may neither negotiate the prices of covered drugs nor establish a formulary. The bill repeals these restrictions and instead specifically requires the CMS to (1) negotiate the prices of covered drugs; and (2) either establish a formulary for covered drugs, or require changes to PDP formularies that take
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Affordable and Safe Prescription Drug Importation Act [HB-447]
Addresses the importation of drugs from Canada and other foreign countries. The bill requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting wholesalers, pharmacies, and individuals to import certain prescription drugs from Canada. After two years, The FDA, may permit the importation of prescription drugs from other countries. The bill establishes a process for certifying foreign sellers—a licensed foreign pharmacy or foreign wholesale distributor.
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Medicare Prescription Drug Price Negotiation Act of 2019 [HB-275]
Requires the Centers for Medicare & Medicaid Services (CMS) to negotiate with pharmaceutical companies regarding prices for drugs covered under the Medicare prescription drug benefit. Current law prohibits the CMS from doing so.
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Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 [HB-269]
(1) reauthorizes, revises, and establishes several programs and entities relating to public-health emergency preparedness and response; and (2) addresses the approval process for over-the counter (OTC) drugs. Among other programs, the bill reauthorizes through FY2023 and revises the Public Health Emergency Preparedness cooperative-agreement program administered by the Centers for Disease Control and Prevention (CDC), the Hospital Preparedness Program, the CDC situational-awareness and biosurveillance program, the Emergency System for Advance Registration
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LUMMA Legitimate Use of Medicinal Marihuana Act [HB-171]
Transfers marijuana from schedule I to schedule II of the Controlled Substances Act. It also specifies that no provision of the Controlled Substances Act prohibits or restricts activities related to medical marijuana that comply with a state's medical marijuana law. The bill does not affect any federal, state, or local law that regulates or prohibits smoking in public. Under current law, schedule I controlled substances are those that, among other factors, have no currently accepted medical use in treatment in the United States; such substances
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United States-Mexico Economic Partnership Act [HB-133]
Directs the Department of State to develop a strategy to enhance economic cooperation and expand professional and educational exchange programs between the United States and Mexico. The State Department shall develop strategies to encourage more academic exchanges between the countries, as well as exchanges to encourage strengthening business skills and entrepreneurship. The State Department shall also promote energy infrastructure coordination and educational development. It shall also assess ways to develop partnerships between the countries'
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