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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 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.
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.
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 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
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 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 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
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 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. 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 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
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
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 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
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 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 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
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 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
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 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. 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 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. 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 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. 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 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
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 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
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
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
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 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
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
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.
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.
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 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
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
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
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