JOSEPH MCGOWAN

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

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

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

340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program Accelerated Approval Breast Cancer Research Breast Cancer Diagnostics H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R.946: ORPHAN Cures Act H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation policy

H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues

Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Tax Relief for American Families and Workers Act Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)

Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy

Anti-Trust Reform

H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues

Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Tax Relief for American Families and Workers Act Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97

Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

Anti-Trust Reform

Antitrust Legislation Artificial Intelligence patent policy issues (AI) Bayh-Dole Act March-In Rights S.2780/H.R. 5429: Interagency Patent Coordination and Improvement Act Restrictions on Intellectual Property Rights Patent Litigation Reform S. 3583/HR. 6986 - to address patent thickets - Provisions related to patents

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act S. 5021/HR. 7635 - 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 HR. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Drug Shortages Supply Chain Integrity and Traceability Drug Patenting PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2630/S. 652: SAFE STEP Act H.R. 5378: Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues S. 2305: Biosimilar Red Tape Elimination Act IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies

H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) Lower Costs, More Cures Act Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544/H.R. 1199: Facilitating Innovative Nuclear Diagnostics Act of 2023

Anti-Trust Reform

H.R. 4307: Medical Supply Chain Resiliency Act S. 1834/H.R. 3858: No Free TRIPS Act S. 845: Short on Competition Act S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 HR. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues

Anti-Trust Reform

Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms H.R. 7024: Tax Relief for American Families and Workers Act of 2024 S. 866: American Innovation and Jobs Act Foreign Direct Investment Tax Cuts and Jobs Act Expensing of R&D Expenditures

H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Average Manufacturers Price Calculations Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Relief Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2630/S. 652: SAFE STEP Act H.R. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) In-Home Administration of Part B Drugs Lower Costs, More Cures Act National Coverage Determination Protected Classes Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-Based Purchasing (VBP) Rule H.R. 3421: Medicare for All Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544/H.R. 1199: Facilitating Innovative Nuclear Diagnostics Act of 2023

340B Drug Discount Program - 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight 340B Drug Discount Program - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 COVID-19 Pricing Related Provisions PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5378: Lower Costs, More Transparency Act CMMI Authority Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues

Anti-Trust Reform

2025 Appropriations Funding for FDA - FY 2025 Appropriations FY 2025 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) 2025 LHHS

Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms H.R. 7024: Tax Relief for American Families and Workers Act of 2024 S. 866: American Innovation and Jobs Act Foreign Direct Investment Tax Cuts and Jobs Act Expensing of R&D Expenditures

H.R. 4307: Medical Supply Chain Resiliency Act S. 1834/H.R. 3858: No Free TRIPS Act S. 845: Short on Competition Act S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 Funding for FDA - FY 2025 Appropriations FY 2025 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) 2025 LHHS

Expensing of R&D Expenditures Foreign Drug Data Protection Laws H.R. 4307: Medical Supply Chain Resiliency Act S. 1834/H.R. 3858: No Free TRIPS Act S. 845: Short on Competition Act S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

340B Drug Discount Program - 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight 340B Drug Discount Program - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 S. 148: Stop STALLING Act S. 150: Affordable Prescriptions for Patients Act of 2023 CMMI Aurthority COVID-19 Pricing Related Provisions Implementation of the Inflation Reduction Act (IRA) of 2022 PBM Reform Funding for FDA - FY 2024 Appropriations Funding for FDA - FY 2025 Appropriations S. 127: Pharmacy Benefit Manager Transparency Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act H.R. 5378: Lower Costs, More Transparency Act CMMI Authority Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues

Taxation/Internal Revenue Code Research & Development Tax Credit Reforms H.R. 7024: Tax Relief for American Families and Workers Act of 2024 S. 866: American Innovation and Jobs Act Foreign Direct Investment

Antitrust Legislation Artificial Intelligence (AI) Bayh-Dole Act March-In Rights Compulsory Licensing - 28 USC 1948 Government Use of Patents Coronavirus (COVID-19) Pandemic - TRIPS Waiver S.79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 S. 148 Stop STALLING Act S. 150: Affordable Prescriptions for Patients Act of 2023 S. 3583/H.R. 6986: A bill to address patent thickets Restrictions on Intellectual Property Rights S. 2220/H.R. 4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Patent Litigation Reform Patenting of Biological Inventions - Section 101 Modernization H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues H.R. 6986: To address patent thickets - Provisions related to patents S. 3583: A bill to address patent thickets

21st Century Cures Act 2.0 340B Contract Pharmacy Policy 340B Drug Discount Program Accelerated Approval Alternative Funding Programs Buy American Executive Order Cancer Moonshot CBO modeling Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 4822, Health Care Price Transparency Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 5378, Lower Costs, More Transparency Act H.R. 5416, The Give Kids a Chance Act H.R. 830/S. 1375, HELP Co-pays Act Health industry vertical integration Inflation Reduction Act Implementation Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Reauthorization of PAHPA S. 1131, Drug Price Transparency Act S. 1133, 340B Accountability Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542/H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2837, 340B Accountability Act 2021 S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 Step Therapy The Medicaid VBPs for Patients (MVP) Act Transparency policy issues

ASP reporting policy issues CBO modeling Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing H.R. 1613/S. 1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 2666, Medicaid for VBPs for Patients (MVP) Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3285, Fairness for Patient Medications Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 5376, Inflation Reduction Act Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products S. 1544/H.R. 1199, Facilitating Access to Innovative Diagnostics (FIND) Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567, The Maintaining Investments in New Innovations (MINI) Act Transparency policy issues Value-Based Purchasing (VBP) Rule

Artificial intelligence

Access to Medicines Issues Biopharmaceutical Innovation Policies Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy US Swiss Trade Relations WTO IP Waiver Fiscal year 2024 Appropriations H.R. 6363, the Further Continuing Appropriations and Other Extensions Act, 2024

Anti-Trust Reform Federal Trade Commission's Non-Compete Clause Proposed Rule Non-competes

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property BPCIA Compulsory licenses Data Exclusivity H.R. 5376, Inflation Reduction Act Intellectual Property Issues in Response to coronavirus Patents Reasonable Pricing Clause S. 1128, Ensuring Access to Generic Medications Act (use patents) Section 101 WTO TRIPS Waiver

Artificial intelligence

21st Century Cures Act 2.0 340B Contract Pharmacy Policy 340B Drug Discount Program Accelerated Approval Alternative Funding Programs Buy American Executive Order Cancer Moonshot CBO modeling Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 4822, Health Care Price Transparency Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 5378, Lower Costs, More Transparency Act H.R. 5416, The Give Kids a Chance Act H.R. 830/S. 1375, HELP Co-pays Act Health industry vertical integration Inflation Reduction Act Implementation Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Reauthorization of PAHPA S. 1131, Drug Price Transparency Act S. 1133, 340B Accountability Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542/H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2837, 340B Accountability Act 2021 S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 Step Therapy The Medicaid VBPs for Patients (MVP) Act Transparency policy issues

Access to Medicines Issues Biopharmaceutical Innovation Policies Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy US Swiss Trade Relations WTO IP Waiver Fiscal year 2024 Appropriations H.R. 6363, the Further Continuing Appropriations and Other Extensions Act, 2024

ASP reporting policy issues CBO modeling Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing H.R. 1613/S. 1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 2666, Medicaid for VBPs for Patients (MVP) Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3285, Fairness for Patient Medications Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 5376, Inflation Reduction Act Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products S. 1544/H.R. 1199, Facilitating Access to Innovative Diagnostics (FIND) Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567, The Maintaining Investments in New Innovations (MINI) Act Transparency policy issues Value-Based Purchasing (VBP) Rule

Anti-Trust Reform Non-competes Federal Trade Commission's Non-Compete Clause Proposed Rule

H.R. 555, Securing America's Vaccines for Emergencies Act of 2023

340B Drug Discount Program H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 2534, PROTECT 340B Act of 2023 340B Contract Pharmacy Policy S. 1133, 340B Accountability Act Accelerated Approval Advanced Research Projects Agency for Health (ARPA-H) Alternative Funding Programs Biosimilar approval and reimbursement policy issues Buy American Executive Order Cancer Moonshot Cell, gene and radioligand therapies Co-pay accumulator programs Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 2534, Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 5376, Inflation Reduction Act H.R. 4822, Health Care Price Transparency Act of 2023 Inflation Reduction Act Implementation H.R. 5416, The Give Kids a Chance Act The Medicaid VBPs for Patients (MVP) Act H.R. 830/S. 1375, HELP Co-pays Act H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Priority Review Voucher (PRV) Reauthorization of PAHPA Regulatory efficiencies policy issues S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 S. 2837, 340B Accountability Act 2021 S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act H.R. 5539, ORPHAN Cures Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542, Delinking Reveue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act H.R. 5378, Lower Costs, More Transparency Act H.R. 2880, Protecting Patients Against PBM Abuses Act Step Therapy Transparency policy issues Utilization management issues Health industry vertical integration CBO modeling 340B Program Implementation & Oversight 340B Accountability Act S. 1182: The 340B Reporting and Accountability Act H.R.2534: PROTECT 340B Act of 2023 H.R.2408: Access to Innovative Treatments Act of 2023 H.R.1790: Biologics Competition Act of 2023 S.113: Prescription Pricing for the People Act of 2023 S.150: Affordable Prescriptions for Patients Act of 2023 Drug Benefit Design

Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD) Tax Treaties U.S. Corporate Tax OECD Pillar Two H.R.2673: American Innovation and R&D Competitiveness Act S.866: American Innovation and Jobs Act

Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing H.R. 1613/S. 1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 2666, Medicaid for VBPs for Patients (MVP) Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3285, Fairness for Patient Medications Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Inflation Reduction Act Impact on Innovative Pharmaceuticals Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues Advanced Safe Testing at Residence Telehealth Act of 2023 S. 2052, Protect Patient Access to Pharmacies Act S. 476/HR. 5567, The Maintaining Investments in New Innovations (MINI) Act H.R. 5539, ORPHAN Cures Act Value-Based Purchasing (VBP) Rule CBO modeling H.R.2139/S.908: Medicare Drug Price Negotiation Act H.R.2148/S.909: Prescription Drug Price Relief Act H.R.5125: Strengthening Innovation in Medicare and Medicaid Act S.127: Pharmacy Benefit Manager Transparency Act of 2023 S.142: Preserve Access to Affordable Generics and Biosimilars Act S.150: Affordable Prescriptions for Patients Act of 2023 S.775: Increasing Transparency in Generic Drug Applications Act S.1067: Ensuring Timely Access to Generics of 2023 COVID-19 Pricing-Related Provisions National Coverage Determination Alternative Payment Arrangements for Gene Therapies Average Manufacturer Price Calculations Medicaid Drug Rebate Program Rule (MDRP) Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Protected Classes Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications

Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2024 Appropriations H.R. 5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2024 Value of Medicine CBO modeling

Anti-Trust Reform Federal Trade Commission's Non-Compete Clause Proposed Rule

Biosimilars Drug Pricing Fiscal year 2024 Appropriations H.R. 5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2024 Value of Medicine

340B Drug Discount Program 340B Accountability Act Accelerated Approval Advanced Research Projects Agency for Health (ARPA-H) Alternative Funding Programs Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American Executive Order Cancer Moonshot Cell, gene and radioligand therapies Co-pay accumulator programs Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 2534, Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 5376, Inflation Reduction Act Inflation Reduction Act Implementation H.R. 5416, The Give Kids a Chance Act The Medicaid VBPs for Patients (MVP) Act H.R. 830/S. 1375, HELP Co-pays Act H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Priority Review Voucher (PRV) Reauthorization of PAHPA Regulatory efficiencies policy issues S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 S. 2837, 340B Accountability Act 2021 S. 476, The Maintaining Investments in New Innovations (MINI) Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act Step Therapy Transparency policy issues Utilization management issues H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program (Bucshon Bill) 340B Contract Pharmacy Policy

Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization U.S. Corporate Tax OECD Pillar 2

Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing H.R. 1613/S. 1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 2666, Medicaid for VBPs for Patients (MVP) Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3285, Fairness for Patient Medications Act Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Inflation Reduction Act Impact on Innovative Pharmaceuticals Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell and gene therapy and radioligand products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues S. 2052, Protect Patient Access to Pharmacies Act S. 476, The Maintaining Investments in New Innovations (MINI) Act Value-Based Purchasing (VBP) Rule

Non-competes policies Federal Trade Commission's Non-Compete Clause Proposed Rule

ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing H.R. 5376, Inflation Reduction Act Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Inflation Reduction Act Impact on Innovative Pharmaceuticals and implementation Medicaid Medicare Part A, B and D Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap National coverage determination policies Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues Advanced Safe Testing at Residence Telehealth Act of 2023 S. 476, The Maintaining Investments in New Innovations (MINI) Act

Antitrust Legislation Bayh-Dole Act/March-In Rights Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2883/S. 148, Stop Stalling Access to Affordable Medications H.R. 2884/S. 150, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891/S. 142, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 5376, Inflation Reduction Act Implementation S. 79, Patent Coordination and Improvement Act of 2023 S. 113, Prescription Pricing for the People Act of 2023 Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 Section 101 WTO TRIPS Waiver

Pharmaceutical supply chain incentives R&D Amortization U.S. Corporate Tax

340B Drug Discount Program Accelerated Approval Alternative Funding Programs Biosimilar approval and reimbursement policy issues BLOCKING Act Cancer Moonshot Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R, 2534 - Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act H.R. 5376 - Inflation Reduction Act Implementation H.R. 5416, The Give Kids a Chance Act The Medicaid VBPs for Patients (MVP) Act H.R. 830, HELP Co-pays Act H.R. 1613, The Drug Price Transparency in Medicaid Act Intellectual property Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Priority Review Voucher (PRV) Regulatory efficiencies policy issues S. 2837, 340B Accountability Act 2021 S. 476, The Maintaining Investments in New Innovations (MINI) Act S.127, The Pharmacy Benefit Manager Transparency Act of 2023 Transparency policy issues Utilization management policies Vaccines

H.R, 555 Securing America's Vaccines for Emergencies Act of 2023

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver March in rights

Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing Drug wastage rebates policy issues Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Medicaid rebates and waiver policy issues Medicare Part A, B and D Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues H.R. 5376 - Inflation Reduction Act Implementation

Health care collaboration opportunities

Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Fiscal year 2023 Appropriations H.R. 6833 - Continuing Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2023 Prescription Drug User Fee Act (PDUFA) VII Value of Medicine

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot

Administrations FY 2023 Revenue Proposals Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Tax Treaties Thin Capitalization Rules 163(j) U.S. Corporate Tax

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver March in rights

Access to Medicines Issues Biopharmaceutical Innovation Policies China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement Regulatory Cooperation Tariffs Trade Policy US Swiss Trade Agreement USTR Special 301 Report/National Trade Estimate WTO IP Waiver

Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing Drug wastage rebates policy issues Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Medicaid rebates and waiver policy issues Medicare Part A, B and D Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues H.R. 5376 - Inflation Reduction Act Implementation

Access to Medicines Issues Biopharmaceutical Innovation Policies US China Agreement US Swiss Trade Relations US Switzerland Mutual Recognition Agreement on GMP Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy WTO IP Waiver

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot

Health care collaboration opportunities

Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2023 Appropriations H.R. 6833 - Continuing Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2023 Prescription Drug User Fee Act (PDUFA) VII Value of Medicine

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act

Access to Medicines Issues Biopharmaceutical Innovation Policies CFIUS China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Sub-standards Medicines Supply chain and China Task Force policy issues Tariffs Trade Policy USMCA USTR Special 301 Report/National Trade Estimate WTO IP Waiver US Switzerland Trade Issues

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot

Anti-Trust Reform The Competition and Antitrust Law Enforcement Reform Act (S.225)

Increasing domestic supply of Actinium 225

Health care collaboration opportunities

AMP Cap Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Drug Pricing Drug wastage rebates policy issues Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Non-covered drugs policy issues Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues

ACA Pharmaceutical Industry Fee Administration's FY 2022 Revenue Proposals Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD) Tax Treaties Thin Capitalization Rules 163(j) U.S. Corporate Tax

Access to Medicines Issues Biopharmaceutical Innovation Policies China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy USTR Special 301 Report/National Trade Estimate WTO IP Waiver

Health care collaboration opportunities

Increasing domestic supply of Actinium 225

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO IP Waiver

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative

ACA Pharmacetuical Industry Fee Administration's FY 2022 Revenue Proposals Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD) Tax Treaties Thin Capitalization Rules 163(j) U.S. Corporate Tax

Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine

Health care collaboration opportunities

Anti-Trust Reform The Competition and Antitrust Law Enforcement Reform Act (S.225):

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Reponse to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act HR 1629/S. 250 - Fairness in Orphan Drug Exclusivity Act

Access to Medicines Issues Biopharmaceutical Innovation Policies China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy USTR Special 301 Report/National Trade Estimate WTO IP Waiver Export Controls

Increasing domestic supply of Actinium 225

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeit policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Part D Benefit Re-design H.R. 6000: Cures 2.0 Act H.R.19 - Lower Costs, More Cures Act of 2021

ACA Pharmaceutical Industry Fee Administration's FY 2022 Revenue Proposals Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD) Tax Treatries Thin Capitalization Rules 163(j) U.S. Corporate Tax

Access to Medicines Issues Biopharmaceutical Innovation Policies China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy USTR Special 301 Report/National Trade Estimate WTO IP Waiver

Increasing domestic supply of Actinium 225 Climate Change Environmental sustainability and climate change issues Climate risk disclosures

Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations act for FY 2020 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Health Defense Operations Funding Designation Implementation of the Prescription Drug User Fee Act (PDUFA) VI

AMP Cap Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Drug Pricing Drug wastage rebates policy issues Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues S.2911, Seniors Prescription Drug Relief Act of 2019 Medicare Negotiations Inflation penalties in Medicare Part B and Part D Part D Benefit Redesign

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Reponse to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act 35 USC Section 101 on Patent Eligibility

Health care collaboration opportunities

Anti-Trust Reform The Competition and Antitrust Law Enforcement Reform Act (S.225):

Access to Medicines Issues Biopharmaceutical Innovation Policies CFIUS China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Sub-standards Medicines Supply chain and China Task Force policy issues Tariffs Trade Policy UK Agreement US Swiss Trade Agreement USMCA USTR Special 301 Report/National Trade Estimate WTO IP Waiver

Health care collaboration opportunities

Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Data Exclusivity Intellectual Property Issues in Response to coronavirus Patents Section 101 Compulsory licenses Antitrust Legislation S.225, Competition and Antitrust Law Enforcement Reform Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 S.1435, Affordable Prescriptions for Patients Act of 2021

ACA Pharmaceutical Industry Fee Exclusions Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives Tax Treaties Thin Capitalization Rules 163(j) R&D Amortization U.S. Corporate Tax Administration's FY 2022 Revenue Proposals Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD)

The Competition and Antitrust Law Enforcement Reform Act (S.225): Anti-Trust Reform

AMP Cap Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Drug Pricing Drug wastage rebates policy issues Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Non-covered drugs policy issues Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues Medicare Negotiations

Biosimilars Drug Pricing Fiscal year 2022 Appropriations Importation Value of Medicine H.R.133, Consolidated Appropriations Act for FY 2021 H.R.1319, American Rescue Plan Act of 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Prescription Drug User Fee Act (PDUFA) VII Priorities Advanced Research Projects Agency for Health (ARPA-H)

Anti-Trust Reform

AMP Cap Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Drug Pricing Drug wastage rebates policy issues Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues Tenncare III 1115 Medicaid Demonstration - Closed formulary issues S.2543: Prescription Drug Pricing Reduction Act of 2019 [116th Congress] H.R. 3: Lower Drug Costs Now Act of 2019 [116th Congress] H.R. 19: Lower Costs, More Cures Act of 2019 [116th Congress] S. 386/H.R. 1227: Medicare-X Choice Act of 2021

Access to Medicines Issues Biopharmaceutical Innovation Policies CFIUS China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Sub-standards Medicines Supply chain and China Task Force policy issues Tariffs Trade Policy UK Agreement USMCA USTR Special 301 Report/National Trade Estimate WTO IP Waiver

Health care collaboration opportunities

Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Data Exclusivity Intellectual Property Issues in Response to coronavirus Patents Section 101

Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives Thin Capitalization Rules 163(j) U.S. Corporate Tax

Biosimilars Drug Pricing Fiscal year 2022 Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 Importation Value of Medicine

CFIUS Reform Foreign Agents Registration Act (FARA) Reform S.1762 - Foreign Agents Disclosure and Registration Enhancement Act of 2019

OECD Digital Tax ACA Pharmaceutical Industry Fee Exclusions Orphan Drug Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Anti-Abuse Tax (BEAT) Tax Cuts & Jobs Act Implementation Innovation Box Tax Treaties Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (HR 748)(S. 3548) Pharmaceutical supply chain incentives U.S. Corporate Tax

Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377 - Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772 - The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129 - Lower Costs, More Cures Act of 2019 S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457 - Preserving Patient Access to Home Infusion Act H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P) Reimbursement for cell therapy products S. 3353/H.R. 5534 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134 - Increasing Access to Biosimilars Act of 2020 S. 102 - Prescription Drug Price Relief Act of 2019 CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P) H.R. 8624 - Protecting Access to Innovation During COVID-19 Act H.R. 8702 - Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 S. 1895 - Lower Health Care Costs Act S. 4199 - Prescription Drug Pricing Reduction Act of 2020 S. 4274 - Legalizing Drug Discounts for Seniors Act of 2020 Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related issues ASP reporting policy issues Non-covered drugs policy issues Drug wastage rebates policy issues

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act CARES Act, Pub. L. 116-136 H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R.2374 - Stop STALLING Act H.R. 5239 - Prescription Drug Price Reporting Act H.R. 6258 - Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 H.R. 6390 - To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak H.R. 6410 - To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 H.R. 6395/S. 4049 - National Defense Authorization Act for Fiscal Year 2021 HHS PREP Act declaration relating to COVID-19 Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues FDA modernization policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatory recall authority policy issues COVID-19 policy issues Transparency Issues Policy Issue H.R. 2477 - Beneficiary Enrollment Notification and the Eligibility Simplification (BENES) Act of 2019 H.R. 6800 - Heroes Act

Health care collaboration opportunities

Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements China Agreement UK Agreement Intellectual Property Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy Tariffs CFIUS USMCA Pharmaceutical supply chain H.R. 2209 - Fixing Global Freeloading Act H.R. 6049 - Medical Supply Chain Security Act H.R. 6482 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 H.R. 6690 - Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6731 - Securing America's Pharmaceutical Supply Chain Act H.R. 6879 - Buy American Medical Supply Chain Act of 2020 H.R. 7492 - To designate all of Puerto Rico as an opportunity zone H.R. 7505 - American Innovation Act of 2020: Provisions related to manufacturing tax incentives H.R. 7574 - Strengthening America's Strategic National Stockpile Act of 2020 H.R. 7955 - 21st Century Buy American Act S. 3343 - Medical Supply Chain Security Act S. 3478 - To establish a commission to assess, evaluate, and address the dependence of the United States on medications, devices, and medical equipment from foreign countries S. 3537 - A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes S. 3942 - Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act S. 3945 - A bill to amend the Internal Revenue Code of 1986 to provide incentives for relocating manufacturing of pharmaceuticals and medical supplies and devices to the United States H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6393 - Strengthening America's Supply Chain and National Security Act H.R. 6930 - MADE in America Act of 2020 H.R. 8943 - Pandemic Supplies Production Act H.R. 8987 - Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020 H.R. 8905 - Supply Chain Security and Pharmaceutical Authentication Act of 2020 S. 3635 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 S. 4175 - Pharmaceutical Supply Chain Defense and Enhancement Act S. 4194 - National Institute of Manufacturing Act Pricing and reimbursement policy issues Supply chain and China Task Force policy issues

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain HR 6800 - Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act S. 3548 - CARES Act H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act

CFIUS Reform Foreign Agents Registration Act (FARA) Reform S.1762 - Foreign Agents Disclosure and Registration Enhancement Act of 2019

Certified Importer Program (CIP) Biosimilars Importation Drug Pricing Value of Medicine Fiscal year 2021 Appropriations HR 6395 - National Defense Authorization Act FY 2021 (NDAA)

OECD Digital Tax ACA Pharmaceutical Industry Fee Exclusions Orphan Drug Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Anti-Abuse Tax (BEAT) Tax Cuts & Jobs Act Implementation Innovation Box Tax Treaties Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (HR 748)(S. 3548) Pharmaceutical supply chain incentives U.S. Corporate Tax

Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377 - Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772 - The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129 - Lower Costs, More Cures Act of 2019 S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457 - Preserving Patient Access to Home Infusion Act H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P) Reimbursement for cell therapy products S. 3353/H.R. 5534 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134 - Increasing Access to Biosimilars Act of 2020 S. 102 - Prescription Drug Price Relief Act of 2019 CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)

Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538, Strengthening Americas Supply Chain and Medical Security Act H.R. 6431, Made in America Emergency Preparedness Act HR 6080, Prevent Drug Shortages Act S. 3432, Securing Americas Medicine Cabinet Act of 2020 H.R. 6670, Prescription for American Drug Independence Act of 2020 H.R. 6930, MADE in America Act HR 4439, Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772, Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370: Coronavirus Vaccine Act S. 3548: CARES Act H.R. 6080: Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400, The Advancing Education on Biosimilars Act of 2019 Vaccines

Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior Intellectual Property Issues in Response to coronavirus S. 2387, We Protect American Investment in Drugs Act of 2019 S. 64, Preserve Access to Affordable Generics & Biosimilars Act of 2019

Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy Tariffs CFIUS USMCA US Swiss Trade Agreement Pharmaceutical supply chain

OECD Digital Tax ACA Pharmaceutical Industry Fee Exclusions Orphan Drug Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Anti-Abuse Tax (BEAT) Tax Cuts & Jobs Act Implementation Innovation Box Treasury Proposed BEAT Regulations Tax Treaties Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (HR 748)(S. 3548) Pharmaceutical supply chain incentives

Certified Importer Program (CIP) Biosimilars Importation Drug Pricing Value of Medicine Blocking Act Fiscal year 2021 Appropriations

OECD Digital Tax ACA Pharmaceutical Industry Fee Exclusions Orphan Drug Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Tax Cuts & Jobs Act Implementation Innovation Box Treasury Proposed BEAT Regulations Tax Treaties Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (HR 748)(S. 3548)

Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform S.1762 - Foreign Agents Disclosure and Registration Enhancement Act of 2019

Certified Importer Program (CIP) Biosimilars Importation Drug Pricing Value of Medicine Blocking Act Fiscal year 2021 Appropriations

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Generic drug approval process policy issues PDUFA implementation policy issues 340B drug discount program policy issues Cancer drug vial size policy issues Pharmaceutical supply chain Pharmaceutical quality H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act (COVID 2) H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 2740: Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes H.R. 3772, Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 H.R. 748: CARES Act - Provisions related to Part B, Part D, vaccines, transparency, and transportation H.R. 6074: Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - Provisions related to biomedical research and prescription drug pricing S. 3370: Coronavirus Vaccine Act - Provisions related to NIH funding S. 3548: CARES Act - Provisions related to supplemental appropriations and federal health programs H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues

S.659 - Biologic Patent Transparency Act Data Exclusivity Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole march-in rights policy issues Section 101 H.R.1520 - Purple Book Continuity Act of 2019 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior

OECD Digital Tax ACA Pharmaceutical Industry Fee Exclusions Orphan Drug Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Tax Cuts & Jobs Act Implementation Innovation Box Expended FDII Treasury Proposed BEAT Regulations Tax Treaties

Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS USMCA US Swiss Trade Agreement

S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.4633 - Investing in Safety and Innovation Act of 2019 H.R.5239 - Prescription Drug Price Reporting Act H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Generic drug approval process policy issues Risk Evaluation and Mitigation Strategy (REMS) policy issues PDUFA implementation policy issues 340B drug discount program policy issues Cancer drug vial size policy issues

Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform S.1762 - Foreign Agents Disclosure and Registration Enhancement Act of 2019

S.659 - Biologic Patent Transparency Act Data Exclusivity Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.990 - Hatch-Waxman Integrity Act of 2019 H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 H.R.2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R.2700 - Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act S.64 - Preserve Access to Affordable Generics and Biosimilars Act S.102 - Prescription Drug Price Relief Act of 2019 Bayh-Dole march-in rights policy issues S.440 - Preserving Access to Cost Effective Drugs Act (PACED Act)(Sovereign immunity issues before the PTAB) Section 101 H.R.1344 - Competitive DRUGS Act of 2019 H.R.1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R.1503 - Orange Book Transparency Act of 2019 H.R.1520 - Purple Book Continuity Act of 2019 H.R.2374 - Stop STALLING Act H.R.3666 - STRONGER Patents Act of 2019 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R.4712 - Born-Alive Abortion Survivors Protection Act H.R.4850 - Biologic Patent Transparency Act H.R.5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R.5444 - Taxpayer First Act S.344 - Hatch-Waxman Integrity Act of 2019 S.1416 - Affordable Prescriptions for Patients Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 S.2082 - Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019

S.659 - Biologic Patent Transparency Act Data Exclusivity Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.990 - Hatch-Waxman Integrity Act of 2019 H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 H.R.2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R.2700 - Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act S.64 - Preserve Access to Affordable Generics and Biosimilars Act S.102 - Prescription Drug Price Relief Act of 2019 Bayh-Dole march-in rights policy issues S.440 - Preserving Access to Cost Effective Drugs Act (PACED Act)(Sovereign immunity issues before the PTAB) Section 101

Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS USMCA US Swiss Trade Agreement

AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.937 - Right Rebate Act of 2019 Medicare Part A

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 3 H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019

Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform S.1762 - Foreign Agents Disclosure and Registration Enhancement Act of 2019

ACA Pharmaceutical Industry Fee Exclusions Orphan Drug Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Tax Cuts & Jobs Act Implementation Innovation Box Expended FDII Treasury Proposed BEAT Regulations Tax Treaties

FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) Reconciliation Gx Drug Labeling Biosimilars Importation Drug Pricing Value of Medicine Blocking Act H.R.21 - Consolidated Appropriations Act, 2019 H.R.265 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 H.R.648 - Consolidated Appropriations Act, 2019 H.R.2500 - National Defense Authorization Act for Fiscal Year 2020 H.R.2740 - Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020

Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Columbia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS USMCA

HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Virtual Clinical Trials Part D Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019

Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform Treasury

HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Clinical Trials Virtual Clinical Trials Part D Donut Hole Biosimilar Pass Through Payments Value Based Pricing

S.659 - Biologic Patent Transparency Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars

FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) Reconciliation Gx Drug Labeling Biosimilars Importation Drug Pricing Value of Meds

Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform Treasury

Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models

ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction Debt Equity Regulations Tax Cuts & Jobs Act Implementation Innovation Box Expanded FDII

Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS

Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars

Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models

Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS

ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction Debt Equity Regulations Tax Cuts & Jobs Act Implementation Innovation Box Expanded FDII

H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing

Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models

Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS

ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction Debt Equity Regulations Tax Cuts & Jobs Act Implementation

Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars

Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars

Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing

FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2018 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars 2018 Agriculture Appropriations Bill Importation Drug Pricing Value of Meds

Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform Treasury

ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction Debt Equity Regulations Tax Cuts & Jobs Act Implementation

Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models

Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars

Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO

Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS

Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017

ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction

Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy

Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017

Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals

Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher

Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy