STEVEN TILTON

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation of 2023 Physician Fee Schedule rule related to Part B discarded drug policy; H.R. 2666, Medicaid VBPs for Patients Act or MVP Act - issues related to value based payment arrangements; E.O. 14087, Lowering Prescription Drug Costs for Americans - issues related to CMMI modeling; CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; Administration's Global Tax Proposal; S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization; H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries.

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; Administration's Global Tax Proposal; S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization; H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries.

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; P.L. 117-328, Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design; H.R. 5860, Making continuing appropriations for fiscal year 2024, and for other purposes;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; S. 652, Safe Step Act - provisions related to step therapy policy; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Awareness of Rare Disease issues related to diagnosis and care access S. 4293, Pharmacy Benefit Manager Transparency Act of 2022

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

S. 866, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization;

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; Administration's Global Tax Proposal; S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization; H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries.

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; S. 652, Safe Step Act - provisions related to step therapy policy; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Awareness of Rare Disease issues related to diagnosis and care access S. 4293, Pharmacy Benefit Manager Transparency Act of 2022

Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; Administration's Global Tax Proposal; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to tax issues;

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to tax issues;

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; Administration's Global Tax Proposal; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to tax issues;

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; Administration's Global Tax Proposal; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to tax issues;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

FY2023, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations - issues related to Zika funding; H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023; H.R. 6833 Continuing Appropriations Act 2023 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); P.L. 117-328 (H.R. 2617), Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; H. Res. 1390, Expressing Support for the Six Medicare Protected Class; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F); P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation 2023 Physician Fee Schedule rule related to Part B discarded drug policy; H.R. 4941, PACE Part D Choice Action of 2021 - provisions related to Medicare PDP;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; Administration's Global Tax Proposal; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to tax issues;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; Administration's Global Tax Proposal; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to tax issues;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;

FY2023, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations - issues related to Zika funding; H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023; H.R. 6833 Continuing Appropriations Act 2023 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA);

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;

FY2023, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations - issues related to Zika funding; H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023; H.R. 6833 Continuing Appropriations Act 2023 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); P.L. 117-328 (H.R. 2617), Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design;

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;