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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2024 · second_quarter · Q2
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 HR 8412 Clinical Trials Modernization Act
Source: Senate LDA
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefits Manager Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Pharmacy Benefit Manager Sunshine and Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Sunshine and Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Protecting Patients Against PBM Abuses Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Protecting Patients Against PBM Abuses Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Further Consolidated Appropriations Act, 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations H.R. 2882, P.L. 118-47, Further Consolidated Appropriations Act 2024 H.R. 4366, P.L. 118-42 Consolidated Appropriations Act 2024
Consolidated Appropriations Act, 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations H.R. 2882, P.L. 118-47, Further Consolidated Appropriations Act 2024 H.R. 4366, P.L. 118-42 Consolidated Appropriations Act 2024
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
BIOSECURE Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
BIOSECURE Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Clinical Trial Modernization Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 HR 8412 Clinical Trials Modernization Act
340B ACCESS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Drug Price Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Drug Price Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
SMART Prices Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
SMART Prices Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Pharmacy Benefit Manager Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Pharmacy Benefit Manager Reform Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Pharmacy Benefit Manager Reform Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Promising Pathway Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Biosimilar Red Tape Elimination Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pandemic and All-Hazards Preparedness and Response Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Modernizing and Ensuring PBM Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Modernizing and Ensuring PBM Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
A bill to prohibit contracting with certain biotechnology providers.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
A bill to prohibit contracting with certain biotechnology providers.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
Prohibiting Foreign Access to American Genetic Information Act of 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
Prohibiting Foreign Access to American Genetic Information Act of 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Pharmacy Benefit Manager Transparency Act of 2022
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Transparency Act of 2022
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Drug Price Transparency in Medicaid Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Medicaid VBPs for Patients Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation of 2023 Physician Fee Schedule rule related to Part B discarded drug policy; H.R. 2666, Medicaid VBPs for Patients Act or MVP Act - issues related to value based payment arrangements; E.O. 14087, Lowering Prescription Drug Costs for Americans - issues related to CMMI modeling; CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Pharmacy Benefits Manager Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Pharmacy Benefit Manager Sunshine and Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Protecting Patients Against PBM Abuses Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Drug Price Transparency in Medicaid Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Prescription Pricing for the People Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Drug Price Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Ending the Prescription Drug Kickback Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Pharmacy Benefit Manager Transparency Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Pharmacy Benefit Manager Reform Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
HELP Copays Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Pandemic and All-Hazards Preparedness and Response Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; S. 652, Safe Step Act - provisions related to step therapy policy; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Awareness of Rare Disease issues related to diagnosis and care access S. 4293, Pharmacy Benefit Manager Transparency Act of 2022
Pharmacy Benefit Manager Transparency Act of 2022
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Pharmacy Benefit Manager Transparency Act of 2022
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; S. 652, Safe Step Act - provisions related to step therapy policy; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Awareness of Rare Disease issues related to diagnosis and care access S. 4293, Pharmacy Benefit Manager Transparency Act of 2022
Speeding Therapy Access Today Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
Speeding Therapy Access Today Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;
Lower Costs, More Cures Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Lower Costs, More Cures Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;
Consolidated Appropriations Act, 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
FY2023, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations - issues related to Zika funding; H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023; H.R. 6833 Continuing Appropriations Act 2023 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); P.L. 117-328 (H.R. 2617), Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design;
Elijah E. Cummings Lower Drug Costs Now Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Plasma Donation Awareness Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;
Plasma Donation Awareness Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
Plasma Donation Awareness Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;
Plasma Donation Awareness Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Infrastructure Investment and Jobs Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
Newborn Screening Saves Lives Reauthorization Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;
Newborn Screening Saves Lives Reauthorization Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Newborn Screening Saves Lives Reauthorization Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
Newborn Screening Saves Lives Reauthorization Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;
PACE Part D Choice Act of 2021
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; H. Res. 1390, Expressing Support for the Six Medicare Protected Class; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F); P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation 2023 Physician Fee Schedule rule related to Part B discarded drug policy; H.R. 4941, PACE Part D Choice Action of 2021 - provisions related to Medicare PDP;
Reduced Costs and Continued Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Reduced Costs and Continued Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
Inflation Reduction Act of 2022
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;
Inflation Reduction Act of 2022
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2024 · first_quarter · Q1
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations H.R. 2882, P.L. 118-47, Further Consolidated Appropriations Act 2024 H.R. 4366, P.L. 118-42 Consolidated Appropriations Act 2024
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2023 · second_quarter · Q2
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; P.L. 117-328, Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design; FY2024, Department of Defense Appropriations;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation of 2023 Physician Fee Schedule rule related to Part B discarded drug policy; H.R. 2666, Medicaid VBPs for Patients Act or MVP Act - issues related to value based payment arrangements; E.O. 14087, Lowering Prescription Drug Costs for Americans - issues related to CMMI modeling; CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2023 · first_quarter · Q1
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; P.L. 117-328, Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation 2023 Physician Fee Schedule rule related to Part B discarded drug policy; E.O. 14087, Lowering Prescription Drug Costs for Americans - issues related to CMMI Modeling
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; S. 652, Safe Step Act - provisions related to step therapy policy; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Awareness of Rare Disease issues related to diagnosis and care access S. 4293, Pharmacy Benefit Manager Transparency Act of 2022
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2022 · fourth_quarter · Q4
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; H. Res. 1390, Expressing Support for the Six Medicare Protected Class; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F); P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation 2023 Physician Fee Schedule rule related to Part B discarded drug policy; H.R. 4941, PACE Part D Choice Action of 2021 - provisions related to Medicare PDP;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
FY2023, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations - issues related to Zika funding; H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023; H.R. 6833 Continuing Appropriations Act 2023 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); P.L. 117-328 (H.R. 2617), Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office
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2022 · third_quarter · Q3
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;
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2022 · second_quarter · Q2
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;
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2022 · first_quarter · Q1
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
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2021 · fourth_quarter · Q4
FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs; S. Con. Res. 14 -- A bill to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2022 - provisions related to drug pricing;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; E.O. 13951, An America-First Healthcare Plan;
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2021 · second_quarter · 2A
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor;
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
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2021 · first_quarter · 1A
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States;
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2021 · third_quarter · Q3
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Patient Affordability Value and Efficiency Act (Not Yet Introduced) - to amend titles XI, XVIII, and XIX of the Social Security Act to promote value-based arrangements; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (and reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O. 13950, Combating Race and Sex Stereotyping;
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2021 · second_quarter · Q2
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor;
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
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2021 · first_quarter · Q1
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals;
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2020 · fourth_quarter · 4A
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access;
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2020 · third_quarter · 3A
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2020 · fourth_quarter · Q4
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access;
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2020 · third_quarter · Q3
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2020 · second_quarter · Q2
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; H. Res. 1390 Expressing Support for the Six Medicare Protected Class; Medicare payment proposals; Medicare telehealth proposals; CMS Transparency in Coverage Final Rule (CMS-9915-F); CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F); P.L. 117-169 Inflaction Reduction Act - reconciliation package with provisions related to prescription drug prices and implementation issues; H.R. 7389 MVP Act; Implementation 2023 Physician Fee Schedule rule related to Part B discarded drug policy;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; CMS Transparency in Coverage Final Rule (CMS-9915-F); CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F);
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Policies related to Medicare accumulators; IVIG Medicare demonstration project; CMS Transparency in Coverage Final Rule (CMS-9915-F); CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F);
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Policies related to Medicare accumulators; IVIG Medicare demonstration project; CMS Transparency in Coverage Final Rule;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, drug pricing transparency, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs; S. Con. Res. 14 -- A bill to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2022 - provisions related to drug pricing;
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; The Patient Affordability, Value and Efficiency Act (not yet introduced); Discussions related to co-pay accumulators; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; The Patient Affordability, Value and Efficiency Act (not yet introduced); Discussions related to co-pay accumulators; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE