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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.
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms American Innovation and Jobs Act Foreign Direct Investment Expensing of R&D Expenditures Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
Sec. 301 pharmaceutical tariffs US-UK Framework Agreement Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International pharmaceutical pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs Pharmaceutical manufacturing policy and investment issues Outbound Investment Security Program H.R. 9102/S. 5316 - Biotech Investment National Security Act
Source: Senate LDA
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75)
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms American Innovation and Jobs Act Foreign Direct Investment Expensing of R&D Expenditures Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Federal Budget H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 6500: Continuing Appropriations and Extensions Act, 2027 (Public Law 119-103)
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75)
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
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.
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies 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.
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
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.
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Federal Budget H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 6500: Continuing Appropriations and Extensions Act, 2027 (Public Law 119-103)
Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75)
Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75)
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Federal Budget H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 6500: Continuing Appropriations and Extensions Act, 2027 (Public Law 119-103)
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75)
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75)
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Sec. 301 pharmaceutical tariffs US-UK Framework Agreement Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International pharmaceutical pricing and reimbursement policy issues Supply chain policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs Pharmaceutical manufacturing policy and investment issues Outbound Investment Security Program H.R. 9102 - Biotech Investment National Security Act
Sec. 301 pharmaceutical tariffs US-UK Framework Agreement Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International pharmaceutical pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs Pharmaceutical manufacturing policy and investment issues Outbound Investment Security Program H.R. 9102/S. 5316 - Biotech Investment National Security Act
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Sec. 301 pharmaceutical tariffs US-UK Framework Agreement Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International pharmaceutical pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs Pharmaceutical manufacturing policy and investment issues Outbound Investment Security Program H.R. 9102/S. 5316 - Biotech Investment National Security Act
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
Protecting Patient Access to Cancer and Complex Therapies Act
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Protecting Patient Access to Cancer and Complex Therapies Act
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act
Protecting Patient Access to Cancer and Complex Therapies Act
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Protecting Patient Access to Cancer and Complex Therapies Act of 2023
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act
Protecting Patient Access to Cancer and Complex Therapies Act of 2023
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Protecting Patient Access to Cancer and Complex Therapies Act of 2023
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Tax Relief for American Families and Workers Act Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Federal Budget H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 6500: Continuing Appropriations and Extensions Act, 2027 (Public Law 119-103)
Anti-Trust Reform
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Anti-Trust Reform
Sec. 301 pharmaceutical tariffs US-UK Framework Agreement Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International pharmaceutical pricing and reimbursement policy issues Supply chain policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs Pharmaceutical manufacturing policy and investment issues Outbound Investment Security Program H.R. 9102 - Biotech Investment National Security Act
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75)
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Anti-Trust Reform
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75)
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies
Sec. 301 pharmaceutical tariffs US-UK Framework Agreement Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International pharmaceutical pricing and reimbursement policy issues Supply chain policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs Pharmaceutical manufacturing policy and investment issues
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act)
340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research Breast Cancer Diagnostics H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy MAHA Commission Report - Make Our Children Healthy Again Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International Pharmaceuticals Pricing and reimbursement policy issues Pharmaceutical manufacturing policy and investment issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs
Anti-Trust Reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act)
340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program Accelerated Approval Breast Cancer Research Breast Cancer Diagnostics H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R.946: ORPHAN Cures Act H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation policy
H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Tax Relief for American Families and Workers Act Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy
Anti-Trust Reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act)
Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act)
2025 Appropriations Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act FY 2025 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Federal Budget Reconciliation 2026 Appropriations
S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues
Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Tax Cuts and Jobs Act Expensing of R&D Expenditures HR. 3665: Defending American Jobs and Investment Act
2025 Appropriations FY 2025 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) S. 4942/H.R. 9029: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 Federal Budget H.R. 10445: Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 H.R. 10515: American Relief Act, 2025 H.R. 10545: American Relief Act, 2025
Antitrust Legislation Artificial Intelligence patent policy issues (AI) Bayh-Dole Act March-In Rights Compulsory Licensing - 28 USC 1948 Government Use of Patents Coronavirus (COVID-19) Pandemic - TRIPS Waiver S.2780/H.R. 5429: Interagency Patent Coordination and Improvement Act S. 113: Prescription Pricing for the People Act of 2023 S. 148 Stop STALLING Act S. 150: Affordable Prescriptions for Patients Act of 2023 Restrictions on Intellectual Property Rights S. 2220/H.R. 4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Patent Litigation Reform Patenting of Biological Inventions - Section 101 Modernization H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues S. 3583/HR. 6986 - to address patent thickets - Provisions related to patents
2025 Appropriations Inflation Reduction Act of 2022 (P.L. 117-169) S. 4942/H.R. 9029: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 Federal Budget
Antitrust Legislation Artificial Intelligence (AI) Bayh-Dole Act March-In Rights Compulsory Licensing - 28 USC 1948 Government Use of Patents Coronavirus (COVID-19) Pandemic - TRIPS Waiver S.79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 S. 148 Stop STALLING Act S. 150: Affordable Prescriptions for Patients Act of 2023 Restrictions on Intellectual Property Rights S. 2220/H.R. 4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Patent Litigation Reform Patenting of Biological Inventions - Section 101 Modernization H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues
340 Drug Discount Program 340B Accountability Act PROTECT 340B Act H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5539: ORPHAN Cures Act H.R. 6283: DRUG Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 S. 127: Pharmacy Benefit Manager Transparency Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Average Manufacturers Price Calculations Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Relief Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2630/S. 652: SAFE STEP Act H.R. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) In-Home Administration of Part B Drugs Lower Costs, More Cures Act National Coverage Determination Protected Classes Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-Based Purchasing (VBP) Rule H.R. 3421: Medicare for All Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544 - 118th Congress (2023-2024) Facilitating Innovative Nuclear Diagnostics Act of 2023 H.R.1199 - 118th Congress (2023-2024) Facilitating Innovative Nuclear Diagnostics Act of 2023
Anti-Trust Reform
340 Drug Discount Program 340B Accountability Act PROTECT 340B Act RFI for SUSTAIN 340B Act Drug Pricing - FY 2024 Appropriations Drug Pricing - FY 2025 Appropriations H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5539: ORPHAN Cures Act H.R. 6283: DRUG Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 S. 127: Pharmacy Benefit Manager Transparency Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act S. 148: Stop STALLING Act PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Average Manufacturers Price Calculations Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Relief Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2630/S. 652: SAFE STEP Act H.R. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) In-Home Administration of Part B Drugs Lower Costs, More Cures Act National Coverage Determination Protected Classes Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-Based Purchasing (VBP) Rule H.R. 3421: Medicare for All Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance
CBO modeling Drug Pricing Fiscal year 2024 Appropriations H.R. 5376, Inflation Reduction Act H.R. 6363, the Further Continuing Appropriations and Other Extensions Act, 2024 Importation Value of Medicine
Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Tax Treaties U.S. Corporate Tax
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property BPCIA Compulsory licenses Data Exclusivity H.R. 5376, Inflation Reduction Act Intellectual Property Issues in Response to coronavirus Patents Reasonable Pricing Clause S. 1128, Ensuring Access to Generic Medications Act (use patents) Section 101 WTO TRIPS Waiver
CBO modeling Drug Pricing Fiscal year 2024 Appropriations H.R. 5376, Inflation Reduction Act H.R. 6363, the Further Continuing Appropriations and Other Extensions Act, 2024 Importation Value of Medicine
Anti-Trust Reform Federal Trade Commission's Non-Compete Clause Proposed Rule Non-competes
Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Tax Treaties U.S. Corporate Tax
S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act)
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research Breast Cancer Diagnostics H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
Sec. 301 pharmaceutical tariffs US-UK Framework Agreement Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International pharmaceutical pricing and reimbursement policy issues Supply chain policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs Pharmaceutical manufacturing policy and investment issues
Anti-Trust Reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research Breast Cancer Diagnostics H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy MAHA Commission Report - Make Our Children Healthy Again Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International Pharmaceuticals Pricing and reimbursement policy issues Pharmaceutical manufacturing policy and investment issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs
Anti-Trust Reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program Accelerated Approval Breast Cancer Research Breast Cancer Diagnostics H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R.946: ORPHAN Cures Act H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation policy
H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Tax Relief for American Families and Workers Act Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy
Anti-Trust Reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program Accelerated Approval Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R.946: ORPHAN Cures Act H.R. 1262: Give Kids a Chance Act of 2025 S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion
H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Tax Relief for American Families and Workers Act Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97
Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
Anti-Trust Reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Antitrust Legislation Artificial Intelligence patent policy issues (AI) Bayh-Dole Act March-In Rights S.2780/H.R. 5429: Interagency Patent Coordination and Improvement Act Restrictions on Intellectual Property Rights Patent Litigation Reform S. 3583/HR. 6986 - to address patent thickets - Provisions related to patents
S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act S. 5021/HR. 7635 - 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 HR. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Drug Shortages Supply Chain Integrity and Traceability Drug Patenting PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2630/S. 652: SAFE STEP Act H.R. 5378: Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues S. 2305: Biosimilar Red Tape Elimination Act IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies
H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) Lower Costs, More Cures Act Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544/H.R. 1199: Facilitating Innovative Nuclear Diagnostics Act of 2023
Anti-Trust Reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
H.R. 4307: Medical Supply Chain Resiliency Act S. 1834/H.R. 3858: No Free TRIPS Act S. 845: Short on Competition Act S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 HR. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues
Anti-Trust Reform
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms H.R. 7024: Tax Relief for American Families and Workers Act of 2024 S. 866: American Innovation and Jobs Act Foreign Direct Investment Tax Cuts and Jobs Act Expensing of R&D Expenditures
H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Average Manufacturers Price Calculations Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Relief Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2630/S. 652: SAFE STEP Act H.R. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) In-Home Administration of Part B Drugs Lower Costs, More Cures Act National Coverage Determination Protected Classes Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-Based Purchasing (VBP) Rule H.R. 3421: Medicare for All Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544/H.R. 1199: Facilitating Innovative Nuclear Diagnostics Act of 2023
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program - 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight 340B Drug Discount Program - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 COVID-19 Pricing Related Provisions PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5378: Lower Costs, More Transparency Act CMMI Authority Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) 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 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues
Anti-Trust Reform
2025 Appropriations Funding for FDA - FY 2025 Appropriations FY 2025 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) 2025 LHHS
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms H.R. 7024: Tax Relief for American Families and Workers Act of 2024 S. 866: American Innovation and Jobs Act Foreign Direct Investment Tax Cuts and Jobs Act Expensing of R&D Expenditures
H.R. 4307: Medical Supply Chain Resiliency Act S. 1834/H.R. 3858: No Free TRIPS Act S. 845: Short on Competition Act S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 Funding for FDA - FY 2025 Appropriations FY 2025 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) 2025 LHHS
Expensing of R&D Expenditures Foreign Drug Data Protection Laws H.R. 4307: Medical Supply Chain Resiliency Act S. 1834/H.R. 3858: No Free TRIPS Act S. 845: Short on Competition Act S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
340B Drug Discount Program - 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight 340B Drug Discount Program - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 S. 148: Stop STALLING Act S. 150: Affordable Prescriptions for Patients Act of 2023 CMMI Aurthority COVID-19 Pricing Related Provisions Implementation of the Inflation Reduction Act (IRA) of 2022 PBM Reform Funding for FDA - FY 2024 Appropriations Funding for FDA - FY 2025 Appropriations S. 127: Pharmacy Benefit Manager Transparency Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5378: Lower Costs, More Transparency Act CMMI Authority Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) 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 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues
Taxation/Internal Revenue Code Research & Development Tax Credit Reforms H.R. 7024: Tax Relief for American Families and Workers Act of 2024 S. 866: American Innovation and Jobs Act Foreign Direct Investment
Antitrust Legislation Artificial Intelligence (AI) Bayh-Dole Act March-In Rights Compulsory Licensing - 28 USC 1948 Government Use of Patents Coronavirus (COVID-19) Pandemic - TRIPS Waiver S.79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 S. 148 Stop STALLING Act S. 150: Affordable Prescriptions for Patients Act of 2023 S. 3583/H.R. 6986: A bill to address patent thickets Restrictions on Intellectual Property Rights S. 2220/H.R. 4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Patent Litigation Reform Patenting of Biological Inventions - Section 101 Modernization H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues H.R. 6986: To address patent thickets - Provisions related to patents S. 3583: A bill to address patent thickets
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
21st Century Cures Act 2.0 340B Contract Pharmacy Policy 340B Drug Discount Program Accelerated Approval Alternative Funding Programs Buy American Executive Order Cancer Moonshot CBO modeling Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 4822, Health Care Price Transparency Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 5378, Lower Costs, More Transparency Act H.R. 5416, The Give Kids a Chance Act H.R. 830/S. 1375, HELP Co-pays Act Health industry vertical integration Inflation Reduction Act Implementation Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Reauthorization of PAHPA S. 1131, Drug Price Transparency Act S. 1133, 340B Accountability Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542/H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2837, 340B Accountability Act 2021 S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 Step Therapy The Medicaid VBPs for Patients (MVP) Act Transparency policy issues
ASP reporting policy issues CBO modeling Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing H.R. 1613/S. 1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 2666, Medicaid for VBPs for Patients (MVP) Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3285, Fairness for Patient Medications Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 5376, Inflation Reduction Act Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products S. 1544/H.R. 1199, Facilitating Access to Innovative Diagnostics (FIND) Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567, The Maintaining Investments in New Innovations (MINI) Act Transparency policy issues Value-Based Purchasing (VBP) Rule
Artificial intelligence
Access to Medicines Issues Biopharmaceutical Innovation Policies Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy US Swiss Trade Relations WTO IP Waiver Fiscal year 2024 Appropriations H.R. 6363, the Further Continuing Appropriations and Other Extensions Act, 2024
Anti-Trust Reform Federal Trade Commission's Non-Compete Clause Proposed Rule Non-competes
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property BPCIA Compulsory licenses Data Exclusivity H.R. 5376, Inflation Reduction Act Intellectual Property Issues in Response to coronavirus Patents Reasonable Pricing Clause S. 1128, Ensuring Access to Generic Medications Act (use patents) Section 101 WTO TRIPS Waiver
Artificial intelligence
21st Century Cures Act 2.0 340B Contract Pharmacy Policy 340B Drug Discount Program Accelerated Approval Alternative Funding Programs Buy American Executive Order Cancer Moonshot CBO modeling Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 4822, Health Care Price Transparency Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 5378, Lower Costs, More Transparency Act H.R. 5416, The Give Kids a Chance Act H.R. 830/S. 1375, HELP Co-pays Act Health industry vertical integration Inflation Reduction Act Implementation Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Reauthorization of PAHPA S. 1131, Drug Price Transparency Act S. 1133, 340B Accountability Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542/H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2837, 340B Accountability Act 2021 S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 Step Therapy The Medicaid VBPs for Patients (MVP) Act Transparency policy issues
Access to Medicines Issues Biopharmaceutical Innovation Policies Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy US Swiss Trade Relations WTO IP Waiver Fiscal year 2024 Appropriations H.R. 6363, the Further Continuing Appropriations and Other Extensions Act, 2024
ASP reporting policy issues CBO modeling Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing H.R. 1613/S. 1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 2666, Medicaid for VBPs for Patients (MVP) Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3285, Fairness for Patient Medications Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 5376, Inflation Reduction Act Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products S. 1544/H.R. 1199, Facilitating Access to Innovative Diagnostics (FIND) Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567, The Maintaining Investments in New Innovations (MINI) Act Transparency policy issues Value-Based Purchasing (VBP) Rule
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office