ELIZABETH BROOKS

Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to clinical trial diversity. Issues related to lung cancer screening. Issues related to drug shortages. Issues related to workforce development. Issues related to the biopharmaceutical supply chain. Issues related to reauthorization of the Pandemics and All-Hazards Preparedness Act (PAHPRA). Issues related to rare disease patients with employer sponsored insurance. Issues related to Reform of pharmacy benefit managers. Issues related to the Cancer Moonshot Initiative. Issues related to Medicare reimbursement of patient navigators. Issues related to 340B. Issues related to drug shortages. Issues related to electronic prescribing labeling. FDA modernization policy issues. Reauthorization of newborn screening programs. General issues related to rare disease and orphan drugs. General issues related to health equity in rare disease and clinical trials. General issues related to diagnostics for patients with rare diseases. H.R. 1503, Prescription Information Modernization Act of 2023. H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act.

Issues related to clinical trial diversity; Issues related to workforce development; Issues related to the biopharmaceutical supply chain; Pandemic and All-Hazards Preparedness Reauthorization; General issues related to rare disease and orphan drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases; Issues related to rare disease patients with employer sponsored insurance; 340b reform; Sustainability; Discussions with USG (BARDA/HHS team) to discuss possible contracts; Issues related to Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations; Medicare Part D; Medicare Part B; Medicare oncology populations; Drug Pricing, including H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (117th Congress); H.R. 1503, Prescription Information Modernization Act of 2023; H.R. 1613, Drug Pricing Transparency in Medicaid Act of 2023; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Issues related to the orphan drug exclusion of the Inflation Reduction Act; Specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; Issues related to lung cancer screening. Issues related to Pharmacy Benefit Managers (PBMs), including S. 127, Pharmacy Benefit Manager Transparency Act of 2023; S. 113, Prescription Pricing for the People Act of 2023.

Issues related to Pharmacy Benefit Managers (PBMs). Issues related to 340B reform. Issues related to prescription drug shortages. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). S. 113, Prescription Pricing for the People Act of 2023. S. 127, Pharmacy Benefit Manager Transparency Act of 2023. S. 1038, Drug Price Transparency in Medicaid Act of 2023. H.R. 1613 Drug Pricing Transparency in Medicaid Act of 2023. H.R. 3561, PATIENT Act of 2023.

Issues related to clinical trial diversity; Issues related to workforce development; Issues related to the biopharmaceutical supply chain; Pandemic and All-Hazards Preparedness Reauthorization; General issues related to rare disease and orphan drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases; Issues related to rare disease patients with employer sponsored insurance; 340b reform; Sustainability; Discussions with USG (BARDA/HHS team) to discuss possible contracts; Issues related to Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations; Medicare Part D; Medicare Part B; Medicare oncology populations; Drug Pricing, including H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (117th Congress); H.R. 1503, Prescription Information Modernization Act of 2023; H.R. 1613, Drug Pricing Transparency in Medicaid Act of 2023; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Issues related to the orphan drug exclusion of the Inflation Reduction Act; Specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; Issues related to lung cancer screening. Issues related to Pharmacy Benefit Managers (PBMs), including S. 127, Pharmacy Benefit Manager Transparency Act of 2023; S. 113, Prescription Pricing for the People Act of 2023.

Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to clinical trial diversity. Issues related to lung cancer screening. Issues related to drug shortages. Issues related to workforce development. Issues related to the biopharmaceutical supply chain. Issues related to reauthorization of the Pandemics and All-Hazards Preparedness Act (PAHPRA). Issues related to rare disease patients with employer sponsored insurance. Issues related to Reform of pharmacy benefit managers. Issues related to the Cancer Moonshot Initiative. Issues related to Medicare reimbursement of patient navigators. Issues related to 340B. Issues related to drug shortages. Issues related to electronic prescribing labeling. FDA modernization policy issues. Reauthorization of newborn screening programs. General issues related to rare disease and orphan drugs. General issues related to health equity in rare disease and clinical trials. General issues related to diagnostics for patients with rare diseases. H.R. 1503, Prescription Information Modernization Act of 2023. H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act.

Issues related to clinical trial diversity; Issues related to workforce development; Issues related to the biopharmaceutical supply chain; Pandemic and All-Hazards Preparedness Reauthorization; General issues related to rare disease and orphan drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases; Issues related to rare disease patients with employer sponsored insurance; 340b reform; Sustainability; Discussions with USG (BARDA/HHS team) to discuss possible contracts; Issues related to Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations; Medicare Part D; Medicare Part B; Medicare oncology populations; Drug Pricing, including H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (117th Congress); H.R. 1503, Prescription Information Modernization Act of 2023; H.R. 1613, Drug Pricing Transparency in Medicaid Act of 2023; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Issues related to the orphan drug exclusion of the Inflation Reduction Act; Specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; Issues related to lung cancer screening. Issues related to Pharmacy Benefit Managers (PBMs), including S. 127, Pharmacy Benefit Manager Transparency Act of 2023; S. 113, Prescription Pricing for the People Act of 2023.

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act

Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures H.R. 1350, Camerons Law H.R. 2673, American Innovation and R&D Competitiveness Act of 2023

-Issues related to the Orphan Drug Tax Credit. -Issues related to the deduction of research and development expenditures. -H.R. 1350, Camerons Law. -H.R.2673, American Innovation and R&D Competitiveness Act of 2023.

Issues related to the Orphan Drug Tax Credit. Issues related to the deduction of research and development expenditures. H.R. 1350, Camerons Law. H.R.2673, American Innovation and R&D Competitiveness Act of 2023.

Issues related to Pharmacy Benefit Managers (PBMs). Issues related to 340B reform. Issues related to prescription drug shortages. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). S. 113, Prescription Pricing for the People Act of 2023. S. 127, Pharmacy Benefit Manager Transparency Act of 2023. S. 1038, Drug Price Transparency in Medicaid Act of 2023. H.R. 1613 Drug Pricing Transparency in Medicaid Act of 2023. H.R. 3561, PATIENT Act of 2023.

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act

-Issues related to implementation of the Inflation Reduction Act of 2022 (Public Law No. 117-169). -Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub. L. 117-169. -Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies. -Issues related to the Medicaid Drug Rebate Program -CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure. -Centers for Medicare and Medicaid Innovation (CMMI) policy issues. -Medicare patient access to rare disease therapies, Part B and Part D drugs. -Medicaid (Medicaid Drug Rebate Program) stacking issues. -Value-based payment arrangements. -Efforts to improve coding, coverage, and access for rare disease therapies. -General issues related to diagnostic reimbursement. -S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act -H.R. 3876 Access to Genetic Counselor Services Act of 2023. -HR 5539, Orphan Cures Act (expanding orphan drug exclusion in IRA)

H.R. 4368, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024. H. Rept. 118-24, S. Rept. 118-44 -- Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations. S. 2131, To provide for a limitation on availability of funds for Independent Agencies, National Historical Publications and Records Commission, Grants Program for fiscal year 2024.

FDA modernization policy issues Reauthorization of newborn screening programs General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to diagnostics for patients with rare diseases Issues related to FDA proposed regulation of lab developed tests Issues related to drug pricing Issues related to reform of pharmacy benefit managers Issues related to RSV vaccination Issues related to the price and manufacture of inhaled medicines Issues related to implementation of AMP Cap repeal Issues related to a Medicaid Drug Rebate Program proposed rule Issues related to importation of drugs Issues related to march-in rights Issues related to artificial intelligence (AI) Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties S. 1339, Pharmacy Benefit Manager Reform Act H.R. 5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act) H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act

-Issues related to implementation of the Inflation Reduction Act of 2022 (Public Law No. 117-169). -Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub. L. 117-169. -Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies. -Issues related to the Medicaid Drug Rebate Program -CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure. -Centers for Medicare and Medicaid Innovation (CMMI) policy issues. -Medicare patient access to rare disease therapies, Part B and Part D drugs. -Medicaid (Medicaid Drug Rebate Program) stacking issues. -Value-based payment arrangements. -Efforts to improve coding, coverage, and access for rare disease therapies. -General issues related to diagnostic reimbursement. -S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act -H.R. 3876 Access to Genetic Counselor Services Act of 2023. -HR 5539, Orphan Cures Act (expanding orphan drug exclusion in IRA)

FDA modernization policy issues Reauthorization of newborn screening programs General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to diagnostics for patients with rare diseases Issues related to FDA proposed regulation of lab developed tests Issues related to drug pricing Issues related to reform of pharmacy benefit managers Issues related to RSV vaccination Issues related to the price and manufacture of inhaled medicines Issues related to implementation of AMP Cap repeal Issues related to a Medicaid Drug Rebate Program proposed rule Issues related to importation of drugs Issues related to march-in rights Issues related to artificial intelligence (AI) Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties S. 1339, Pharmacy Benefit Manager Reform Act H.R. 5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act) H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA

-Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare negotiation and Medicare Part D reform and redesign and inflation penalties. -Issues related to the orphan drug exclusion of the Inflation Reduction Act. -Issues related to reauthorization of the Pandemics and All-Hazards Preparedness Act (PAHPRA). General issues related to rare disease and orphan drugs. -General issues related to health equity in rare disease and clinical trials. -General issues related to diagnostics for patients with rare diseases. -PBM reform -FDA modernization policy issues -FDA reform initiatives -Reauthorization of newborn screening programs. -H.R. 5539 ORPHAN Cures Act.

Issues related to Pharmacy Benefit Managers (PBMs). Issues related to 340B reform. Issues related to prescription drug shortages. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). S. 113, Prescription Pricing for the People Act of 2023. S. 127, Pharmacy Benefit Manager Transparency Act of 2023. S. 1038, Drug Price Transparency in Medicaid Act of 2023. H.R. 1613 Drug Pricing Transparency in Medicaid Act of 2023. H.R. 3561, PATIENT Act of 2023.

Issues related to clinical trial diversity; Issues related to workforce development; Issues related to the biopharmaceutical supply chain; Pandemic and All-Hazards Preparedness Reauthorization; General issues related to rare disease and orphan drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases; Issues related to rare disease patients with employer sponsored insurance; 340b reform; Sustainability; Discussions with USG (BARDA/HHS team) to discuss possible contracts; Issues related to Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations; Medicare Part D; Medicare Part B; Medicare oncology populations; Drug Pricing, including H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (117th Congress); H.R. 1503, Prescription Information Modernization Act of 2023; H.R. 1613, Drug Pricing Transparency in Medicaid Act of 2023; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Issues related to the orphan drug exclusion of the Inflation Reduction Act; Specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; Issues related to lung cancer screening. Issues related to Pharmacy Benefit Managers (PBMs), including S. 127, Pharmacy Benefit Manager Transparency Act of 2023; S. 113, Prescription Pricing for the People Act of 2023.

Issues related to Pharmacy Benefit Managers (PBMs). Issues related to 340B reform. Issues related to prescription drug shortages. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). S. 113, Prescription Pricing for the People Act of 2023. S. 127, Pharmacy Benefit Manager Transparency Act of 2023. S. 1038, Drug Price Transparency in Medicaid Act of 2023. H.R. 1613 Drug Pricing Transparency in Medicaid Act of 2023. H.R. 3561, PATIENT Act of 2023.

Pharmaceutical IP and patent reform. S. 142, Preserve Access to Affordable Generics and Biosimilars Act. S. 150, Affordable Prescriptions for Patients Act of 2023. S. 1214, RARE Act.

Issues pertaining to pharmacy benefit management (PBM) reform, including S. 127, the Pharmacy Benefit Manager Transparency Act

Issues related to clinical trial diversity; Issues related to workforce development; Issues related to the biopharmaceutical supply chain; Pandemic and All-Hazards Preparedness Reauthorization; General issues related to rare disease and orphan drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases; Issues related to rare disease patients with employer sponsored insurance; 340b reform; Sustainability; Discussions with USG (BARDA/HHS team) to discuss possible contracts; Issues related to Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations; Medicare Part D; Medicare Part B; Medicare oncology populations; Drug Pricing, including H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (117th Congress); H.R. 1503, Prescription Information Modernization Act of 2023; H.R. 1613, Drug Pricing Transparency in Medicaid Act of 2023; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Issues related to the orphan drug exclusion of the Inflation Reduction Act; Specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; Issues related to lung cancer screening. Issues related to Pharmacy Benefit Managers (PBMs), including S. 127, Pharmacy Benefit Manager Transparency Act of 2023; S. 113, Prescription Pricing for the People Act of 2023.

Issues related to Pharmacy Benefit Managers (PBMs). Issues related to 340B reform. Issues related to prescription drug shortages. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). S. 113, Prescription Pricing for the People Act of 2023. S. 127, Pharmacy Benefit Manager Transparency Act of 2023. S. 1038, Drug Price Transparency in Medicaid Act of 2023. H.R. 1613 Drug Pricing Transparency in Medicaid Act of 2023. H.R. 3561, PATIENT Act of 2023.

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act

FDA modernization policy issues Reauthorization of newborn screening programs General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to diagnostics for patients with rare diseases Issues related to FDA proposed regulation of lab developed tests Issues related to drug pricing Issues related to reform of pharmacy benefit managers Issues related to RSV vaccination Issues related to the price and manufacture of inhaled medicines Issues related to implementation of AMP Cap repeal Issues related to a Medicaid Drug Rebate Program proposed rule Issues related to importation of drugs Issues related to march-in rights Issues related to artificial intelligence (AI) Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties S. 1339, Pharmacy Benefit Manager Reform Act H.R. 5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act) H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA

S. 142, Preserving Access to Affordable Generics and Biosimilars Act; S. 150, Affordable Prescriptions for Patients Act of 2023; Pharmaceutical IP Patent Reform TRIPS waiver

Pharmaceutical IP and patent reform. S. 142, Preserve Access to Affordable Generics and Biosimilars Act. S. 150, Affordable Prescriptions for Patients Act of 2023. S. 1214, RARE Act.

Pharmaceutical IP and patent reform. S. 142, Preserve Access to Affordable Generics and Biosimilars Act. S. 150, Affordable Prescriptions for Patients Act of 2023. S. 1214, RARE Act.

S. 142, Preserving Access to Affordable Generics and Biosimilars Act; S. 150, Affordable Prescriptions for Patients Act of 2023; Pharmaceutical IP Patent Reform TRIPS waiver

-Issues related to implementation of the Inflation Reduction Act of 2022 (Public Law No. 117-169). -Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub. L. 117-169. -Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies. -Issues related to the Medicaid Drug Rebate Program -CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure. -Centers for Medicare and Medicaid Innovation (CMMI) policy issues. -Medicare patient access to rare disease therapies, Part B and Part D drugs. -Medicaid (Medicaid Drug Rebate Program) stacking issues. -Value-based payment arrangements. -Efforts to improve coding, coverage, and access for rare disease therapies. -General issues related to diagnostic reimbursement. -S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act -H.R. 3876 Access to Genetic Counselor Services Act of 2023. -HR 5539, Orphan Cures Act (expanding orphan drug exclusion in IRA)

H.R. 4368, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024. H. Rept. 118-24, S. Rept. 118-44 -- Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations. S. 2131, To provide for a limitation on availability of funds for Independent Agencies, National Historical Publications and Records Commission, Grants Program for fiscal year 2024.

FDA modernization policy issues Reauthorization of newborn screening programs General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to diagnostics for patients with rare diseases Issues related to FDA proposed regulation of lab developed tests Issues related to drug pricing Issues related to reform of pharmacy benefit managers Issues related to RSV vaccination Issues related to the price and manufacture of inhaled medicines Issues related to implementation of AMP Cap repeal Issues related to a Medicaid Drug Rebate Program proposed rule Issues related to importation of drugs Issues related to march-in rights Issues related to artificial intelligence (AI) Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties S. 1339, Pharmacy Benefit Manager Reform Act H.R. 5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act) H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA

FDA modernization policy issues Reauthorization of newborn screening programs General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to diagnostics for patients with rare diseases Issues related to FDA proposed regulation of lab developed tests Issues related to drug pricing Issues related to reform of pharmacy benefit managers Issues related to RSV vaccination Issues related to the price and manufacture of inhaled medicines Issues related to implementation of AMP Cap repeal Issues related to a Medicaid Drug Rebate Program proposed rule Issues related to importation of drugs Issues related to march-in rights Issues related to artificial intelligence (AI) Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties S. 1339, Pharmacy Benefit Manager Reform Act H.R. 5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act) H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act

Issues related to clinical trial diversity; Issues related to workforce development; Issues related to the biopharmaceutical supply chain; Pandemic and All-Hazards Preparedness Reauthorization; General issues related to rare disease and orphan drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases; Issues related to rare disease patients with employer sponsored insurance; 340b reform; Sustainability; Discussions with USG (BARDA/HHS team) to discuss possible contracts; Issues related to Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations; Medicare Part D; Medicare Part B; Medicare oncology populations; Drug Pricing, including H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (117th Congress); H.R. 1503, Prescription Information Modernization Act of 2023; H.R. 1613, Drug Pricing Transparency in Medicaid Act of 2023; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Issues related to the orphan drug exclusion of the Inflation Reduction Act; Specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; Issues related to lung cancer screening. Issues related to Pharmacy Benefit Managers (PBMs), including S. 127, Pharmacy Benefit Manager Transparency Act of 2023; S. 113, Prescription Pricing for the People Act of 2023.

CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Centers for Medicare and Medicaid Innovation (CMMI) policy issues; Issues pertaining to implementation of the Inflation Reduction Act,H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Medicare patient access to rare disease therapies, Part B and Part D drugs; Value-based payment arrangements; efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement.

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act

Issues related to clinical trial diversity; Issues related to workforce development; Issues related to the biopharmaceutical supply chain; Pandemic and All-Hazards Preparedness Reauthorization; General issues related to rare disease and orphan drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases; Issues related to rare disease patients with employer sponsored insurance; 340b reform; Sustainability; Discussions with USG (BARDA/HHS team) to discuss possible contracts; Issues related to Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations; Medicare Part D; Medicare Part B; Medicare oncology populations; Drug Pricing, including H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (117th Congress); H.R. 1503, Prescription Information Modernization Act of 2023; H.R. 1613, Drug Pricing Transparency in Medicaid Act of 2023; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Issues related to the orphan drug exclusion of the Inflation Reduction Act; Specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; Issues related to lung cancer screening. Issues related to Pharmacy Benefit Managers (PBMs), including S. 127, Pharmacy Benefit Manager Transparency Act of 2023; S. 113, Prescription Pricing for the People Act of 2023.

Issues related to Pharmacy Benefit Managers (PBMs). Issues related to 340B reform. Issues related to prescription drug shortages. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). S. 113, Prescription Pricing for the People Act of 2023. S. 127, Pharmacy Benefit Manager Transparency Act of 2023. S. 1038, Drug Price Transparency in Medicaid Act of 2023. H.R. 1613 Drug Pricing Transparency in Medicaid Act of 2023. H.R. 3561, PATIENT Act of 2023.

Issues related to Pharmacy Benefit Managers (PBMs) Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to pharmacy benefit manager (PBM) reform

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies. Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub. L. 117-169. CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure. Centers for Medicare and Medicaid Innovation (CMMI) policy issues. Issues pertaining to implementation of the Inflation Reduction Act, H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). Medicare patient access to rare disease therapies, Part B and Part D drugs. Value-based payment arrangements. Efforts to improve coding, coverage, and access for rare disease therapies. General issues related to diagnostic reimbursement. S 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act.

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies. Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub. L. 117-169. CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure. Centers for Medicare and Medicaid Innovation (CMMI) policy issues. Issues pertaining to implementation of the Inflation Reduction Act, H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). Medicare patient access to rare disease therapies, Part B and Part D drugs. Value-based payment arrangements. Efforts to improve coding, coverage, and access for rare disease therapies. General issues related to diagnostic reimbursement. S 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act.

H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act

H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act

H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot S. 3799, the PREVENT Pandemics Act S. 3509 Creating Efficiency in Foreign Facility Inspections Act Prescription Drug User Fee Act (PDUFA)

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 1730/S. 670- Speeding Therapy Access Today Act H.R. 1946, S. 1873. Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 5030/ S. 2706 DIVERSE Trials Act HR 5376, Inflation Reduction Act reconciliation bill; Medicare price negotiation provision and Part D redesign; Preventative healthcare services and screenings; Issues related to preventative services and screenings for underrepresented communities H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 Accelerating Access for Patients Act; H.R.7667 - Food and Drug Amendments of 2022; S. 1548, H.R. 3085/H.R. 7845. ENACT Act of 2021 S.4348 - FDASLA Act of 2022; General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases; general issues related to pharmacy benefit managers (PBMs); general issues related to insurance coverage of specialty treatments Issues related to clinical trial diversity COVID-19; COVID-19 vaccine and therapy development Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. E-Labeling EVUSHELD Issues related to repeal of the Medicaid AMP Cap. Issues related to drug pricing, IRA Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees;

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - The Inflation Reduction Act of 2022; General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure General issues related to diagnostic reimbursement

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act - General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot S. 3799, the PREVENT Pandemics Act S. 3509 Creating Efficiency in Foreign Facility Inspections Act Prescription Drug User Fee Act (PDUFA)

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - The Inflation Reduction Act of 2022; General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure General issues related to diagnostic reimbursement

H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 1946, S. 1873. Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 2617-accelerated approval in the Omnibus year end H.R. 4065, S. 1971 (section 101), P.L. 117-328, H.R. 2617 Kidney disease screening, Expanding Medicare annual wellness benefit to include kidney disease screening. H.R. 5260 - Reduced Costs and Continued Cures Act; HR. 5376- Inflation Reduction Act; Build Back Better Act; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Preventative healthcare services and screenings Issues related to preventative services and screenings for underrepresented communities IRA implementation, Pub. L. 117-169 Medicare Reform(s); Issues related to Medicare Part B and Part D pricing reform. General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding, coverage, and access for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to diagnostic reimbursement

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act - General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act - General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - The Inflation Reduction Act of 2022; General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure General issues related to diagnostic reimbursement

H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 1946, S. 1873. Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 2617-accelerated approval in the Omnibus year end H.R. 4065, S. 1971 (section 101), P.L. 117-328, H.R. 2617 Kidney disease screening, Expanding Medicare annual wellness benefit to include kidney disease screening. H.R. 5260 - Reduced Costs and Continued Cures Act; HR. 5376- Inflation Reduction Act; Build Back Better Act; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Preventative healthcare services and screenings Issues related to preventative services and screenings for underrepresented communities IRA implementation, Pub. L. 117-169 Medicare Reform(s); Issues related to Medicare Part B and Part D pricing reform. General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding, coverage, and access for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to diagnostic reimbursement

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act - General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities

H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 1730/S. 670- Speeding Therapy Access Today Act H.R. 1946, S. 1873. Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 5030/ S. 2706 DIVERSE Trials Act HR 5376, Inflation Reduction Act reconciliation bill; Medicare price negotiation provision and Part D redesign; Preventative healthcare services and screenings; Issues related to preventative services and screenings for underrepresented communities H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 Accelerating Access for Patients Act; H.R.7667 - Food and Drug Amendments of 2022; S. 1548, H.R. 3085/H.R. 7845. ENACT Act of 2021 S.4348 - FDASLA Act of 2022; General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases; general issues related to pharmacy benefit managers (PBMs); general issues related to insurance coverage of specialty treatments Issues related to clinical trial diversity COVID-19; COVID-19 vaccine and therapy development Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. E-Labeling EVUSHELD Issues related to repeal of the Medicaid AMP Cap. Issues related to drug pricing, IRA Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees;

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - The Inflation Reduction Act of 2022; General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure General issues related to diagnostic reimbursement

Issues related to an appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts (PI); Appropriations, FY 2022 and FY 2023; H.R. 2471, Consolidated Appropriations Act, 2022 H.R. 2471; Public Service Retirement Fairness Act of 2021

H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 1946, S. 1873. Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 2617-accelerated approval in the Omnibus year end H.R. 4065, S. 1971 (section 101), P.L. 117-328, H.R. 2617 Kidney disease screening, Expanding Medicare annual wellness benefit to include kidney disease screening. H.R. 5260 - Reduced Costs and Continued Cures Act; HR. 5376- Inflation Reduction Act; Build Back Better Act; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Preventative healthcare services and screenings Issues related to preventative services and screenings for underrepresented communities IRA implementation, Pub. L. 117-169 Medicare Reform(s); Issues related to Medicare Part B and Part D pricing reform. General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding, coverage, and access for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to diagnostic reimbursement

H.R. 2617,Consolidated Appropriations Act, 2023 H.R. 7559 E-labeling; and issues related to appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts (PI). H.R. 8239/S. 4661, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act H.R. 8295/S. 4659,Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, H. Rept. 117-392, H. Rept. 117-403, H. Res. 1531. CTD, accelerated approval in the Omnibus year end, Consolidated Appropriations Act, 2023; P.L. 117-328.

H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act

H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act

H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act

H.R. 2623 - Camerons Law; H.R. 5376 - Build Back Better Act; Issues related to the Orphan Drug Tax Credit; Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform

H.R. 2623 - Camerons Law; H.R. 5376 - Build Back Better Act; Issues related to the Orphan Drug Tax Credit; Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform

H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1425- Stop STALLING Act S. 1435- Affordable Prescriptions for Patients Act of 2021 TRIPS / IP Waiver Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform, and Antitrust;

H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

IP and Antitrust; H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435- Affordable Prescriptions for Patients Act of 2021 S. 1425- Stop STALLING Act Trade; Supply Chain and Manufacturing; H.R. 4521-United States Innovation and Competition Act of 2021, H. Rept. 117-235 Trade; Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

Issues relating to Intellectual Property protections for Covid-19 treatments and vaccines. H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act. H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521 America COMPETES Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act

Issues relating to Intellectual Property protections for Covid-19 treatments and vaccines. H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act. H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521 America COMPETES Act of 2022

H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1425- Stop STALLING Act S. 1435- Affordable Prescriptions for Patients Act of 2021 TRIPS / IP Waiver Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform, and Antitrust;

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot S. 3799, the PREVENT Pandemics Act S. 3509 Creating Efficiency in Foreign Facility Inspections Act Prescription Drug User Fee Act (PDUFA)

H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

IP and Antitrust; H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435- Affordable Prescriptions for Patients Act of 2021 S. 1425- Stop STALLING Act Trade; Supply Chain and Manufacturing; H.R. 4521-United States Innovation and Competition Act of 2021, H. Rept. 117-235 Trade; Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

Issues relating to Intellectual Property protections for Covid-19 treatments and vaccines. H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act. H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521 America COMPETES Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act

H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1425- Stop STALLING Act S. 1435- Affordable Prescriptions for Patients Act of 2021 TRIPS / IP Waiver Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform, and Antitrust;

H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

IP and Antitrust; H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435- Affordable Prescriptions for Patients Act of 2021 S. 1425- Stop STALLING Act Trade; Supply Chain and Manufacturing; H.R. 4521-United States Innovation and Competition Act of 2021, H. Rept. 117-235 Trade; Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

Issues relating to Intellectual Property protections for Covid-19 treatments and vaccines. H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act. H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521 America COMPETES Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act