mr DAVID BURT

Issues related to Medicare and Medicaid coverage and reimbursement Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars Issues related to CMMI

Issues related to R&D tax deductions and expense amortization Issues related to international taxation, including foreign-derived intangible income and interest deductions Issues related to supply chain incentives

Issues related to FDA and HHS program funding for the FY25 Labor, HHS, Education and Related Agencies, and FY25 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Strategic National Stockpile (SNS) Funding and Oversight Funding for FDA e-labeling rule implementation Patient access to Part B medicineS Issues related to 340B program oversight Support for increased investments to address antimicrobial resistance Deficit reduction, reconciliation

Intellectual property and process patent issues Patent litigation reforms PTAB and IPR processes Section 101 Reform Domestic and international compulsory licensing issues March-in Rights

Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver Issues related to compulsory licensing of foreign patents Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Issues related to public health protection including influenza development and preparedness Issues related to antimicrobial and antiviral research and product development Issues related to research and product development Issues related to drug development including PDUFA

Drug pricing issues Prescription Drug User Fee Act reauthorization Issues related to prescription drug value Issues related to the 340B Drug Discount Program

Issues relating to limits and restrictions on the immigration of high skilled workers Issues relating to the immigration of medical researchers

Intellectual property and process patent issues Patent litigation reforms PTAB and IPR processes Section 101 Reform Domestic and international compulsory licensing issues March-in Rights

Issues related to the 340B Drug Discount Program Issues relating to drug pricing Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. Issues related to healthcare legislation Patient access to Part B medicines during the COVID-19 public health emergency Issues related to health equity, diversity, and inclusion in clinical trials Issues related to advanced development and procurement of medical countermeasures (MCMs) Issues related to patient assistance and access Issues relating to privacy and securing the data of and personal information of consumers Issues relating to medical research data Issues relating to screening and diagnostics Issues related to public health preparedness and response Issues related to awareness about diabetic eye diseases in minority populations Issues related to public health preparedness. Issues related to access to drugs for minority communities Issues related to healthcare education and screening

Issues related to R&D tax deductions and expense amortization Issues related to international taxation, including foreign-derived intangible income and interest deductions Issues related to supply chain incentives

Issues related to FDA and HHS program funding for the FY24 Labor, HHS, Education and Related Agencies, and FY24 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Strategic National Stockpile (SNS) Funding and Oversight Funding for FDA e-labeling rule implementation Patient access to Part B medicines during the COVID-19 public health emergency Issues related to 340B program oversight Support for increased investments to address antimicrobial resistance. Deficit reduction, reconciliation

Issues related to Medicare and Medicaid coverage and reimbursement Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars Issues related to CMMI

Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver Issues related to compulsory licensing of foreign patents Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Issues related to FDA and HHS program funding for the FY24 Labor, HHS, Education and Related Agencies, and FY24 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Strategic National Stockpile (SNS) Funding and Oversight Funding for FDA e-labeling rule implementation Patient access to Part B medicines during the COVID-19 public health emergency Issues related to 340B program oversight Support for increased investments to address antimicrobial resistance. Deficit reduction, reconciliation

Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver Issues related to compulsory licensing of foreign patents Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Issues related to R&D tax deductions and expense amortization Issues related to international taxation, including foreign-derived intangible income and interest deductions Issues related to supply chain incentives

Issues related to Medicare and Medicaid coverage and reimbursement Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars Issues related to CMMI

Drug pricing issues Prescription Drug User Fee Act reauthorization Issues related to prescription drug value Issues related to the 340B Drug Discount Program

Issues related to the 340B Drug Discount Program Issues relating to drug pricing Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. Issues related to healthcare legislation Patient access to Part B medicines during the COVID-19 public health emergency Issues related to health equity, diversity, and inclusion in clinical trials Issues related to advanced development and procurement of medical countermeasures (MCMs) Issues related to patient assistance and access Issues relating to privacy and securing the data of and personal information of consumers Issues relating to medical research data Issues relating to screening and diagnostics Issues related to public health preparedness and response Issues related to awareness about diabetic eye diseases in minority populations Issues related to public health preparedness. Issues related to access to drugs for minority communities Issues related to healthcare education and screening

Issues related to Medicare and Medicaid coverage and reimbursement Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars Issues related to CMMI

Issues related to R&D tax deductions and expense amortization Issues related to international taxation, including foreign-derived intangible income and interest deductions Issues related to supply chain incentives

Drug pricing issues Prescription Drug User Fee Act reauthorization Issues related to prescription drug value Issues related to the 340B Drug Discount Program

Intellectual property and process patent issues Patent litigation reforms PTAB and IPR processes Section 101 Reform Domestic and international compulsory licensing issues March-in Rights

Issues related to public health protection including influenza development and preparedness Issues related to antimicrobial and antiviral research and product development Issues related to novel coronavirus and COVID-19 research and product development Issues related to drug development including PDUFA and Cures 2.0

Issues related to FDA and HHS program funding for the FY23 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Strategic National Stockpile (SNS) Funding and Oversight Funding for FDA e-labeling rule implementation Patient access to Part B medicines during the COVID-19 public health emergency Issues related to 340B program oversight Support for increased investments to address antimicrobial resistance. Deficit reduction, reconciliation

Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver Issues related to compulsory licensing of foreign patents Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Issues related to public health protection including influenza development and preparedness Issues related to antimicrobial and antiviral research and product development Issues related to novel coronavirus and COVID-19 research and product development Issues related to drug development including PDUFA and Cures 2.0

Issues related to R&D tax deductions and expense amortization Issues related to international taxation, including foreign-derived intangible income and interest deductions Issues related to supply chain incentives

Drug pricing issues Prescription Drug User Fee Act reauthorization Issues related to prescription drug value Issues related to the 340B Drug Discount Program

Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver Issues related to compulsory licensing of foreign patents Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Issues related to FDA and HHS program funding for the FY23 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Strategic National Stockpile (SNS) Funding and Oversight Funding for FDA e-labeling rule implementation Patient access to Part B medicines during the COVID-19 public health emergency Issues related to 340B program oversight Support for increased investments to address antimicrobial resistance. Deficit reduction, reconciliation

Issues related to Medicare and Medicaid coverage and reimbursement Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars Issues related to CMMI

Issues related to R&D tax deductions and expense amortization Issues related to international taxation, including foreign-derived intangible income and interest deductions Issues related to supply chain incentives

Issues related to FDA and HHS program funding for the FY23 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Strategic National Stockpile (SNS) Funding and Oversight Funding for FDA e-labeling rule implementation Patient access to Part B medicines during the COVID-19 public health emergency Issues related to 340B program oversight Support for increased investments to address antimicrobial resistance. Deficit reduction, reconciliation

Issues related to public health protection including influenza development and preparedness Issues related to antimicrobial and antiviral research and product development Issues related to novel coronavirus and COVID-19 research and product development Issues related to drug development including PDUFA and Cures 2.0

Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver Issues related to compulsory licensing of foreign patents Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Drug pricing issues Prescription Drug User Fee Act reauthorization Issues related to prescription drug value Issues related to the 340B Drug Discount Program

Issues related to Medicare and Medicaid coverage and reimbursement Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars Issues related to CMMI

Intellectual property and process patent issues Patent litigation reforms PTAB and IPR processes Section 101 Reform Domestic and international compulsory licensing issues March-in Rights

H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5125 - the Strengthening Innovation in Medicare and Medicaid Act H.R. 5376 - Build Back Better Act -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -Issues related to CMMI

Bills -S. 4417 Patent Trial and Appeal Board Reform Act -S. 4734 Patent Eligibility Restoration Act -S. 1435 - Affordable Prescriptions for Patients Act of 2021 -H.R. 2873 Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 -H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act Issues -Intellectual property and process patent issues -Patent litigation reforms -PTAB and IPR processes -Section 101 Reform -Domestic and international compulsory licensing issues -March-in Rights

-Issues relating to limits and restrictions on the immigration of high skilled workers -Issues relating to the immigration of medical researchers

H.R. 2163/S. 464 - Safe Step Act H.R. 5376 - Build Back Better Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -Drug pricing issues -Prescription Drug User Fee Act reauthorization -Issues related to prescription drug value -Issues related to the 340B Drug Discount Program

H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.7667 - Food and Drug Amendments of 2022 S.4348 - FDASLA Act of 2022 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act H.R.3085 - ENACT Act of 2021 -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0

H.R. 1304, the American Innovation and R&D Competitiveness Act and S. 749 American Innovation and Jobs Act S.1260 - United States Innovation and Competition Act of 2021 -Issues related to R&D tax deductions and expense amortization -Issues related to international taxation, including foreign-derived intangible income and interest deductions -Issues related to supply chain incentives

Bills -H.R. 2617 Consolidated Appropriations Act, FY2023 Issues -Issues related to FDA and HHS program funding for the FY23 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills -Strategic National Stockpile (SNS) Funding and Oversight -Funding for FDA e-labeling rule implementation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to 340B program oversight -Support for increased investments to address antimicrobial resistance -Deficit reduction, reconciliation

H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.7667 - Food and Drug Amendments of 2022 S.4348 - FDASLA Act of 2022 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act H.R.3085 - ENACT Act of 2021 -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0

H.R. 2163/S. 464 - Safe Step Act H.R. 5376 - Build Back Better Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -Drug pricing issues -Prescription Drug User Fee Act reauthorization -Issues related to prescription drug value -Issues related to the 340B Drug Discount Program

H.R. 1304, the American Innovation and R&D Competitiveness Act and S. 749 American Innovation and Jobs Act S.1260 - United States Innovation and Competition Act of 2021 -Issues related to R&D tax deductions and expense amortization -Issues related to international taxation, including foreign-derived intangible income and interest deductions -Issues related to supply chain incentives

-Issues relating to limits and restrictions on the immigration of high skilled workers -Issues relating to the immigration of medical researchers

H.R. 3788, the Protecting American Innovation Act H.R. 3811, the Trade Related Intellectual Property Protection Act H.R. 7185, the Federal Contracting for Peace and Security Act -Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver -Issues related to compulsory licensing of foriegn patents -Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

H.R.8152 - American Data Privacy and Protection Act -Issues relating to privacy and securing the data of and personal health information of patients/consumers -Issues relating to medical research data

-Issues relating to limits and restrictions on the immigration of high skilled workers -Issues relating to the immigration of medical researchers

H.R. 3788, the Protecting American Innovation Act H.R. 3811, the Trade Related Intellectual Property Protection Act H.R. 7185, the Federal Contracting for Peace and Security Act -Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver -Issues related to compulsory licensing of foriegn patents -Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

H.R. 2163/S. 464 - Safe Step Act S.1773 - Prescription Drug Pricing Dashboard Act H.R. 5376 - Build Back Better Act H.R. 3684- Infrastructure Investment and Jobs Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S.2076/H.R. 3932 PASTEUR Act S. 3799- PREVENT Pandemics Act H.R.4521 - COMPETES Act of 2022 S.1260 - United States Innovation and Competition Act of 2021 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics -Issues related to public health preparedness and response

H.R. 2163/S. 464 - Safe Step Act S.1773 - Prescription Drug Pricing Dashboard Act H.R. 5376 - Build Back Better Act H.R. 3684- Infrastructure Investment and Jobs Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S.2076/H.R. 3932 PASTEUR Act S. 3799- PREVENT Pandemics Act H.R.4521 - COMPETES Act of 2022 S.1260 - United States Innovation and Competition Act of 2021 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics -Issues related to public health preparedness and response

S. 2891 - Restoring the America Invents Act -Intellectual property and process patent issues -Patent litigation reforms -PTAB and IPR processes -Section 101 Reform -Domestic and international compulsory licensing issues -March-in Rights

H.R. 2163/S. 464 - Safe Step Act H.R. 5376 - Build Back Better Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -Drug pricing issues -Prescription Drug User Fee Act reauthorization -Issues related to prescription drug value -Issues related to the 340B Drug Discount Program

H.R. 1304, the American Innovation and R&D Competitiveness Act and S. 749 American Innovation and Jobs Act H.R. 5376 - Build Back Better Act H.R.4521 - COMPETES Act of 2022 S.1260 - United States Innovation and Competition Act of 2021 -Issues related to R&D tax deductions and expense amortization -Issues related to international taxation, including foreign-derived intangible income and interest deductions -Issues related to supply chain incentives

H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5125 - the Strengthening Innovation in Medicare and Medicaid Act H.R. 5376 - Build Back Better Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -Issues related to CMMI

H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.____, the "Prescription Drug User Fee Amendments of 2022" S..____, the "Prescription Drug User Fee Amendments of 2022" H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0

H.R. 1304, the American Innovation and R&D Competitiveness Act and S. 749 American Innovation and Jobs Act H.R. 5376 - Build Back Better Act H.R.4521 - COMPETES Act of 2022 S.1260 - United States Innovation and Competition Act of 2021 -Issues related to R&D tax deductions and expense amortization -Issues related to international taxation, including foreign-derived intangible income and interest deductions -Issues related to supply chain incentives

-Issues relating to limits and restrictions on the immigration of high skilled workers -Issues relating to the immigration of medical researchers

H.R. 3788, the Protecting American Innovation Act H.R. 3811, the Trade Related Intellectual Property Protection Act H.R. 7185, the Federal Contracting for Peace and Security Act -Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver -Issues related to compulsory licensing of foriegn patents -Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

H.R. 5402 - FY 2022 Labor, HHS, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R. 5305 Extending Government Funding and Delivering Emergency Assistance Act H.R. 2471 Consolidated Appropriations Act, FY2022 -Issues related to FDA and HHS program funding for the FY22 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills -Strategic National Stockpile (SNS) Funding and Oversight -Funding for FDA e-labeling rule implementation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to 340B program oversight -Support for increased investments to address antimicrobial resistance. -Deficit reduction, reconciliation

S.1435 - Affordable Prescriptions for Patients Act of 2021 H.R. 2873 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S. 2774 - Pride in Patent Ownership Act S. 2773 - Unleashing American Innovators Act S. 2891 - Restoring the America Invents Act ​​H.R. 2891 - Preserve Access to Affordable Generics and Biosimilars Act -Intellectual property and process patent issues -Patent litigation reform -PTAB and IPR processes -Section 101 Reform -Domestic and international compulsory licensing issues -March-in Rights -Product hopping -Orange and purple book disclosures -Hatch Waxman litigation -Trade secret protections

H.R. 3788, the Protecting American Innovation Act -Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver -Issues related to compulsory licensing of foriegn patents -Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

H. R. 1177, The U.S. Citizenship Act H.R. 3648, The Equal Access to Green cards for Legal Employment (EAGLE) Act of 2021 -Issues relating to limits and restrictions on the immigration of high skilled workers -Issues relating to the immigration of medical researchers

S.2782 - National Defense Authorization Act for Fiscal Year 2022 H.R.4350 - National Defense Authorization Act for Fiscal Year 2022 -Issues related to pharmaceutical supply chains and related security issues

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.551, REFUND Act of 2019 H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 S. 2428- False Claims Amendments Act of 2021 S.1773 - Prescription Drug Pricing Dashboard Act H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5125, the Strengthening Innovation in Medicare and Medicaid Act H.R. 5376 - Build Back Better Act -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation -Issues related to the International Pricing Index for Medicare Part B and general reference pricing -Issues related to CMMI

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) H.R. 2113 - The Prescription Drug STAR Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.551 - REFUND Act of 2019 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 2163/S. 464 - Safe Step Act S.4796, The Fair Care Act of 2020 S.2076/H.R. 3932 PASTEUR Act S.1773 - Prescription Drug Pricing Dashboard Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program S. 658- ADAPT Act- Accelerated Drug Approval for Prescription Therapies H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5376 - Build Back Better Act H.R. 3684- Infrastructure Investment and Jobs Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.133 - Consolidated Appropriations Act, 2021 S.2076/H.R. 3932 PASTEUR Act -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0

H.R. 1304, the American Innovation and R&D Competitiveness Act and -Issues related to R&D tax deductions and expense amortization -Issues related to supply chain incentives -Issues related to corporate tax rate as well as international taxation, including foreign-derived intangible income

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.551, REFUND Act of 2019 S.4796, The Fair Care Act of 2020 H.R.5260 - Reduced Costs and Continued Cures Act - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value - Issues related to the 340B Drug Discount Program

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 S.Con.Res 14- FY2022 Budget Resolution H.R. 1319 - American Rescue Plan Act, 2021 H.R. 5402 - FY 2022 Labor, HHS, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R. 5305 Extending Government Funding and Delivering Emergency Assistance Act - Issues related to FDA and HHS program funding for the FY22 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Funding for FDA e-labeling rule implementation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to 340B program oversight - Support for increased investments to address antimicrobial resistance. - Deficit reduction, reconciliation

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.551, REFUND Act of 2019 H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 S.1773 - Prescription Drug Pricing Dashboard Act H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5125, the Strengthening Innovation in Medicare and Medicaid Act H.R. 5376 - Build Back Better Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI

H.R. 3788, the Protecting American Innovation Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver - Issues related to compulsory licensing of foriegn patents - Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

H. R. 1177, The U.S. Citizenship Act H.R. 3648, The Equal Access to Green cards for Legal Employment (EAGLE) Act of 2021 - Issues relating to limits and restrictions on the immigration of high skilled workers - Issues relating to the immigration of medical researchers

S.1435 - Affordable Prescriptions for Patients Act of 2021 H.R.2873 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S. 2774 - Pride in Patent Ownership Act S. 2773 - Unleashing American Innovators Act S. 2891 - Restoring the America Invents Act - Intellectual property and process patent issues - Patent litigation reform - PTAB and IPR processes - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections

S.2782 - National Defense Authorization Act for Fiscal Year 2022 H.R.4350 - National Defense Authorization Act for Fiscal Year 2022 - Issues related to pharmaceutical supply chains and related security issues

H.R. 1304, the American Innovation and R&D Competitiveness Act and S. 749 American Innovation and Jobs Act - Issues related to R&D tax deductions and expense amortization - Issues related to supply chain incentives - Issues related to corporate tax rate as well as international taxation, including foreign-derived intangible income

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.133 - Consolidated Appropriations Act, 2021 S.2076/H.R. 3932 PASTEUR Act - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development - Issues related to drug development including PDUFA and Cures 2.0

- Issues relating to limits and restrictions on the immigration of high skilled workers - Issues relating to the immigration of medical researchers

H.R. 1304, the American Innovation and R&D Competitiveness Act) and S. 749 American Innovation and Jobs Act - Issues related to R&D tax deductions and expense amortization - Issues related to supply chain incentives

- Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program S.4796, The Fair Care Act of 2020 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

S.4049 - National Defense Authorization Act for Fiscal Year 2021 H.R.2500 - National Defense Authorization Act for Fiscal Year 2021 H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains and related security issues

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.551 - REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319 , American Rescue Plan Act of 2021 H.R. xx - Safe Step Act (no bill number yet) S.4796, The Fair Care Act of 2020 H.R.1966/S.946 - Henrietta Lacks Enhancing Cancer Research Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021, 116th Congress (2019-2020) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 8337 - Continuing Appropriations Act of 2021 H.R. 1319 - American Rescue Plan Act, 2021 H.R. XX - FY 2022 Labor, HHS, Education and Related Agencies Appropriations H.R. XX - FY 2022 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation - Issues related to FDA and HHS program funding for the FY22 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Funding for FDA e-labeling rule implementation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to 340B program oversight

H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 S.1773 - Prescription Drug Pricing Dashboard Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI

H.R. 3788, the Protecting American Innovation Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry including the TRIPS IP Waiver - Issues related to the United States-Mexico-Canada Agreement - Issues related to other Free Trade Agreements (UK, Kenya, Chile, Colombia, Peru, CAFTA-DR) - Issues related to compulsory licensing of foriegn patents - Issues related to WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) H.R. 2113 - The Prescription Drug STAR Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.551 - REFUND Act of 2019 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 2163/S. 464 - Safe Step Act S.4796, The Fair Care Act of 2020 S.2076/H.R. 3932 PASTEUR Act S.1773 - Prescription Drug Pricing Dashboard Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act S. 3300, Data Protection Act of 2021 H.R.3801, Data Localization Compendium Legislation - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues related to patient assistance and acces - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

H.R. 1304, the American Innovation and R&D Competitiveness Act and S. 749 American Innovation and Jobs Act - Issues related to R&D tax deductions and expense amortization - Issues related to supply chain incentives - Issues related to corporate tax rate as well as international taxation, including foreign-derived intangible income

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 8337 - Continuing Appropriations Act of 2021 H.R. 1319 - American Rescue Plan Act, 2021 H.R. XX - FY 2022 Labor, HHS, Education and Related Agencies Appropriations H.R. XX - FY 2022 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation - Issues related to FDA and HHS program funding for the FY22 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Funding for FDA e-labeling rule implementation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to 340B program oversight

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program S.4796, The Fair Care Act of 2020 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

S.1435 - Affordable Prescriptions for Patients Act of 2021 H.R.2873 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Intellectual property and process patent issues - Patent litigation reform - PTAB and IPR processes - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections

H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.551 - REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319 , American Rescue Plan Act of 2021 H.R. xx - Safe Step Act (no bill number yet) S.4796, The Fair Care Act of 2020 H.R.1966/S.946 - Henrietta Lacks Enhancing Cancer Research Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021, 116th Congress (2019-2020) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

H.R. 1304, the American Innovation and R&D Competitiveness Act) and S. 749 American Innovation and Jobs Act - Issues related to R&D tax deductions and expense amortization - Issues related to supply chain incentives

- Issues relating to limits and restrictions on the immigration of high skilled workers - Issues relating to the immigration of medical researchers

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program S.4796, The Fair Care Act of 2020 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 8337 - Continuing Appropriations Act of 2021 H.R. 1319 - American Rescue Plan Act, 2021 H.R. XX - FY 2022 Labor, HHS, Education and Related Agencies Appropriations H.R. XX - FY 2022 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation - Issues related to FDA and HHS program funding for the FY22 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Funding for FDA e-labeling rule implementation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to 340B program oversight

- Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections

H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

H.R.4549 - American Innovation and Competitiveness Act of 2019 S. 4822 - American Innovation and Jobs Act - Issues related to R&D tax deductions and expense amortization - Issues related to supply chain incentives

S. 1224, Stop STALLING Act S. 1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 3991-Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 5133--Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 1503 - the Orange Book Transparency Act; and H.R. 1520 - Orange Book Transparency Act of 2019; H.R. 3 - Lower Drug Costs Now Act of 2019 - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI

H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor, Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 H.R.3164, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 and H.R.3055, the FY2020 Consolidated measure. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020 and the FY2020 Consolidated measure. Reimbursement and vial size issues. H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.133 - Consolidated Appropriations Act, 2021 H.R. 4378 - Continuing Appropriations Act and Health Extenders Act H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 8337 - Continuing Appropriations Act of 2021 - Issues related to FDA and HHS program funding for the FY20 Labor, HHS, Education and Related Agencies, and FY20 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Patient access to Part B medicines during the COVID-19 public health emergency

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (No bill number yet) H.R.133 - Consolidated Appropriations Act, 2021 - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development

S.4049 - National Defense Authorization Act for Fiscal Year 2021 H.R.2500 - National Defense Authorization Act for Fiscal Year 2021 H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains and related security issues

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

S. 386 - Fairness for High-Skilled Immigrants Act of 2019 S. 328 - Startup Act S. 2603 - RELIEF Act H.R. 1044 - Fairness for High-Skilled Immigrants Act of 2020 H.R. 5327 - Resolving Extended Limbo for Immigrant Employees and Families Act - Issues relating to limits and restrictions on the immigration of high skilled workers - Issues relating to the immigration of medical researchers

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement - Issues related to other Free Trade Agreements (Chile, Colombia, Peru, CAFTA-DR)

H.R.4549 - American Innovation and Competitiveness Act of 2019 - Issues related to the tax reform bill and implementation - Issues related to supply chain incentives

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation -Issues related to the International Pricing Index for Medicare Part B -Issues related to CMMI

S.4049 - National Defense Authorization Act for Fiscal Year 2021 H.R.2500 - National Defense Authorization Act for Fiscal Year 2021 H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains and related security issues

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (No bill number yet) - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development

H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor, Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 H.R.3164, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 and H.R.3055, the FY2020 Consolidated measure. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020 and the FY2020 Consolidated measure. Reimbursement and vial size issues. H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act S. 3548 - CARES Act (Coronavirus Stimulus 3) - Issues related to FDA and HHS program funding for the FY20 Labor, HHS, Education and Related Agencies, and FY20 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Patient access to Part B medicines during the COVID-19 public health emergency

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 7288 Taxpayer Research and Coronavirus Knowledge (TRACK) Act - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency Medical Supply Chain - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

S.4049 - National Defense Authorization Act for Fiscal Year 2021 H.R.2500 - National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains and related security issues

- Issues related to the tax reform bill and implementation - Issues related to supply chain incentives

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement

- Issues related to the tax reform bill and implementation - Issues related to supply chain incentives

H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor, Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 H.R.3164, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 and H.R.3055, the FY2020 Consolidated measure. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020 and the FY2020 Consolidated measure. Reimbursement and vial size issues. H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act S. 3548 - CARES Act (Coronavirus Stimulus 3) - Issues related to FDA and HHS program funding for the FY20 Labor, HHS, Education and Related Agencies, and FY20 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Patient access to Part B medicines during the COVID-19 public health emergency

S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 - Issues related to Intellectual property and process patent - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues

S. 1224, Stop STALLING Act S. 1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 3991-Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 5133--Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 1503 - the Orange Book Transparency Act; and H.R. 1520 - Orange Book Transparency Act of 2019; H.R. 3 - Lower Drug Costs Now Act of 2019 - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act (HCR) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Ac - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

S.4049 - National Defense Authorization Act for Fiscal Year 2021 H.R.2500 - National Defense Authorization Act for Fiscal Year 2021 H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains and related security issues

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

H.R.4549 - American Innovation and Competitiveness Act of 2019 S. 4822 - American Innovation and Jobs Act - Issues related to R&D tax deductions and expense amortization - Issues related to supply chain incentives

S. 386 - Fairness for High-Skilled Immigrants Act of 2019 S. 328 - Startup Act S. 2603 - RELIEF Act H.R. 1044 - Fairness for High-Skilled Immigrants Act of 2020 H.R. 5327 - Resolving Extended Limbo for Immigrant Employees and Families Act - Issues relating to limits and restrictions on the immigration of high skilled workers - Issues relating to the immigration of medical researchers

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement - Issues related to other Free Trade Agreements (UK, Kenya, Chile, Colombia, Peru, CAFTA-DR) - Issues related to compulsory licensing of foriegn patents

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (No bill number yet) H.R.133 - Consolidated Appropriations Act, 2021 - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development

H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement - Issues related to other Free Trade Agreements (Chile, Colombia, Peru, CAFTA-DR)

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation -Issues related to the International Pricing Index for Medicare Part B -Issues related to CMMI

H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor, Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 H.R.3164, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 and H.R.3055, the FY2020 Consolidated measure. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020 and the FY2020 Consolidated measure. Reimbursement and vial size issues. H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act S. 3548 - CARES Act (Coronavirus Stimulus 3) - Issues related to FDA and HHS program funding for the FY20 Labor, HHS, Education and Related Agencies, and FY20 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Patient access to Part B medicines during the COVID-19 public health emergency

H.R.4549 - American Innovation and Competitiveness Act of 2019 - Issues related to the tax reform bill and implementation - Issues related to supply chain incentives

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (No bill number yet) - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development

H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

S.4049 - National Defense Authorization Act for Fiscal Year 2021 H.R.2500 - National Defense Authorization Act for Fiscal Year 2021 H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains and related security issues

S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 7288 Taxpayer Research and Coronavirus Knowledge (TRACK) Act H.R. 4398 Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues

H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 H.R.3164, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 and H.R.3055, the FY2020 Consolidated measure. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020 and the FY2020 Consolidated measure. Reimbursement and vial size issues. H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act S. 3548 - CARES Act (Coronavirus Stimulus 3) - Issues related to FDA and HHS program funding for the FY20 Labor, HHS, Education and Related Agencies, and FY20 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Patient access to Part B medicines during the COVID-19 public health emergency

H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement

- Issues related to the tax reform bill and implementation - Issues related to supply chain incentives

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency Medical Supply Chain - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 7288 Taxpayer Research and Coronavirus Knowledge (TRACK) Act - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency

S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 - Issues related to Intellectual property and process patent - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement

- Issues related to the tax reform bill and implementation - Issues related to supply chain incentives

H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor, Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 H.R.3164, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 and H.R.3055, the FY2020 Consolidated measure. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020 and the FY2020 Consolidated measure. Reimbursement and vial size issues. H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act S. 3548 - CARES Act (Coronavirus Stimulus 3) - Issues related to FDA and HHS program funding for the FY20 Labor, HHS, Education and Related Agencies, and FY20 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Patient access to Part B medicines during the COVID-19 public health emergency

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 Issues - Drug pricing issues - Prescription Drug User Fee Act reauthorization - HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Issues related to prescription drug value

- Issues related to the tax reform bill and implementation

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement

- Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S.2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S.3013, Encourging Innovative Benefti Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B

H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.

H.R.3 - Lower Drug Costs Now Act of 2019 Prescription Drug Pricing Reduction Act (PDPRA) of 2019 S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development

H.R.1892, Bipartisan Budget Act of 2018 H.R.1625, Consolidated Appropriations Act, 2018 H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor, Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 H.R.3164, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 and H.R.3055, the FY2020 Consolidated measure. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020 and he FY2020 Consolidated measure. Reimbursement and vial size issues. Issues related to FDA and HHS program funding for the FY20 Labor, HHS, Education and Related Agencies, and FY20 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development

H.R.1892, Bipartisan Budget Act of 2018 H.R.1625, Consolidated Appropriations Act, 2018 H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor, Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 H.R.3164, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 and H.R.3055, the FY2020 Consolidated measure. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020 and he FY2020 Consolidated measure. Reimbursement and vial size issues. - Issues related to FDA and HHS program funding for the FY20 Labor, HHS, Education and Related Agencies, and FY20 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills

HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization

S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D

H.R.1, Tax Reform Act of 2017 (Public Law No. 115-97) H.R.88, Retirement, Savings, and Other Tax Relief Act of 2018 and Taxpayer First Act of - Issues related to the tax reform bill and implementation

S.1416 - Affordable Prescriptions for Patients Act of 2019 S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S.2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S.3013, Encourging Innovative Benefti Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 Issues - Drug pricing issues - Prescription Drug User Fee Act reauthorization - HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Issues related to prescription drug value

H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor, Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 H.R.3164, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 and H.R.3055, the FY2020 Consolidated measure. H.R.2740, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2020 and he FY2020 Consolidated measure. Reimbursement and vial size issues. Issues related to FDA and HHS program funding for the FY20 Labor, HHS, Education and Related Agencies, and FY20 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement

H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation

H.R.2209 - Fixing Global Freeloading Act - Issues relating to trade policy and negotiations impacting the biopharmaceutical industry

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.

H.R.3 - Lower Drug Costs Now Act of 2019 Prescription Drug Pricing Reduction Act (PDPRA) of 2019 S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation

H.R.1, Tax Reform Act of 2017 (Public Law No. 115-97) H.R.88, Retirement, Savings, and Other Tax Relief Act of 2018 and Taxpayer First Act of - Issues related to the tax reform bill and implementation

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development

S.1416 - Affordable Prescriptions for Patients Act of 2019 S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform

S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development

S.1416 - Affordable Prescriptions for Patients Act of 2019 S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform

- Drug pricing issues - Prescription Drug User Fee Act reauthorization - HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program

- Issues relating to trade policy and negotiations impacting the biopharmaceutical industry

H.R.1892, Bipartisan Budget Act of 2018 H.R.1625, Consolidated Appropriations Act, 2018 H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor , Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; H.J.Res.31, Consolidated Appropriations Act, 2019 (P.L.116-6); FY 2020 - Issues related to FDA and HHS program funding for the FY19 Labor, HHS, Education and Related Agencies, and FY19 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills

S.3738 - Hatch-Waxman Integrity Act of 2018 - Intellectual property and process patent issues - Patent litigation reform - IPR process

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety, and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement, and pricing. - Issues related to healthcare legislation

- Drug pricing issues - Prescription Drug User Fee Act reauthorization - HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 - Issues related to public health protection including influenza development and preparedness - Issues related to Right to Try - Issues related to antimicrobial and antiviral research and product development

S.3738 - Hatch-Waxman Integrity Act of 2018 : - Intellectual property and process patent issues - Patent litigation reform - IPR process

H.R.1892, Bipartisan Budget Act of 2018 H.R.1625, Consolidated Appropriations Act, 2018 H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245) S. 3158, Department of Labor , Health & Human Services, and Education, and Related Agencies Appropriations Act of 2019; - Issues related to FDA and HHS program funding for the FY19 Labor, HHS, Education and Related Agencies, and FY19 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills

Issues relating to trade policy and negotiations impacting the biopharmaceutical industry

H.R.1, Tax Reform Act of 2017 (Public Law No. 115-97) Issues related to the tax reform bill and implementation

S.3158/H.R.6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019; H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R. 1892, the Bipartisan Budget H.R. 1625, Consolidated Appropriation Act H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245); Issues related to FDA and HHS program funding for the FY19 Labor, HHS, Education and Related Agencies, and FY19 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Issues related to Direct-To-Consumer Advertising, 340B, biosimilars, and public health

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R. 6378 - To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 Issues related to the 340B Drug Discount Program Issues relating to drug pricing, reimbursement, step therapy, anti-kickback statute, biosimilars Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. General education about policies impacting pharmaceutical development, approval, reimbursement and pricing

Drug Pricing Issues HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program

Intellectual property and process patent issues Patent litigation reform

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R. 6378 - To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act Issues related to public health protection including influenza development and preparedness Issues related to antimicrobial and antiviral research and product development

H.R. 3358/S 1771 Departments of Labor, Health, and Human Services, and Education, and Related Agencies Appropriations Act, 2018 H.R.3268/S.1603, Agriculture, Rural Development, Food, and Drug Administration, and Related Agencies Appropriations Act, 2018 H.R.1370, Further Additional Continuing Appropriations Act, 2018 H.R.1892, Bipartisan Budget Act of 2018 H.R.1625, Consolidated Appropriations Act, 2018 Issues related to FDA and HHS program funding for the FY18 Labor, HHS, Education and Related Agencies, and FY18 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Issues related to FDA and HHS program funding for the FY19 Labor, HHS, Education and Related Agencies, and FY19 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills

Intellectual property and process patent issues Patent litigation reform

H.R.1, Tax Reform Act of 2017 (Public Law No. 115-97) Issues related to the tax reform bill and implementation

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 Issues related to public health protection including influenza development and preparedness Issues related to Right to Try Issues related to antimicrobial and antiviral research and product development

Drug Pricing Issues HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program

Issues relating to trade policy and negotiations impacting the biopharmaceutical industry

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act. S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). Issues related to Medicare and Medicaid coverage and reimbursement Issues related to the 340B Drug Discount Program Issues related to RX drug pricing Medicare reimbursement for biosimilars MACRA treatment and reimbursement of Part B drugs Medicare payments for inpatient antimicrobials

Drug Pricing Issues Prescription Drug User Fee Act reauthorization. HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program

H.R.3358/S.1771, Departments of Labor, Health, and Human Services, and Education, and Related Agencies Appropriations Act, 2018 H.R.3268/S.1603, Agriculture, Rural Development, Food, and Drug Administration, and Related Agencies Appropriations Act, 2018 H.R.1370, Further Additional Continuing Appropriations Act, 2018 H.R.1892, Bipartisan Budget Act of 2018 H.R.1625, Consolidated Appropriations Act, 2018 Issues related to FDA and HHS program funding for the FY18 Labor, Health and Human Services, and Education and Related Agencies, and FY18 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Issues related to FDA and HHS program funding for the FY19 Labor, Health and Human Services, and Education and Related Agencies, and FY18 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills

Issues related to Right to Try

Trade Policy Issues. Trade Negotiations.

Intellectual property and process patent issues. General IP issues. Patent litigation reform.

Medicare payment policies for Part B drugs. HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program CHIP reauthorization and Medicare Extenders package. Issues related to Medicare and Medicaid coverage and reimbursement; Issues relating to biosimilar reimbursement; Issues related to RX drug pricing. Medicare payment for inpatient antimicrobial therapy.

General tax issues. H.R. 1, Tax Cuts and Jobs Act. Tax Reform Act of 2017 - Issues related to tax reform

Medicare payment policies for Part B drugs. HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program CHIP reauthorization and Medicare Extenders package. Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 S.204/H.R.878, Trickett Wendler Right to Try Act of 2017 H.J.Res.123, Making further continuing appropriations for fiscal year 2018, and for other purposes H.J.Res.124, Making further additional continuing appropriations for fiscal year 2018, and for other purposes H.R.1370, Further Additional Continuing Appropriations Act, 2018 Pharmaceutical benefits for TRICARE beneficiaries Issues related to pharmaceutical drug pricing Development of policies to advance the antimicrobial research and novel product development environment, including advancing new market incentives. Pharmaceutical distribution and supply chain security American Health Care Act of 2017 Issues relating to biosimilar reimbursement

Intellectual property and process patent issues. General IP issues. Patent litigation reform.

Medicare payment policies for Part B drugs. HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program CHIP reauthorization and Medicare Extenders package. Issues related to Medicare and Medicaid coverage and reimbursement; Issues relating to biosimilar reimbursement; Issues related to RX drug pricing. Medicare payment for inpatient antimicrobial therapy.

General tax issues. H.R. 1, Tax Cuts and Jobs Act. Tax Reform Act of 2017 - Issues related to tax reform

Drug Pricing Issues Prescription Drug User Fee Act reauthorization. HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program

Issues related to FDA and HHS program funding in the FY18 Labor, Health and Human Services, and Education and Related Agencies, and FY18 Agriculture, Rural Development, Food and Drug Administrations, Related Agencies Appropriation bills

Trade Policy Issues. Trade Negotiations.

Trade Policy Issues. Trade Negotiations.

H.R. 1628 American Health Care Act of 2017; Better Care Reconciliation Act; General education, guidance and strategic counsel about policies impacting pharmaceutical development, approval and reimbursement; H.R. 2430/S. 934, FDA Reauthorization Act of 2017 General education about FDA approval policies including pediatric trial design, and right-to-try proposals Advocated to include market incentives for antimicrobials in H.R. 2430 / S. 934 - FDA Reauthorization Act of 2017 Implementation issues related to the Pharmaceutical Quality, Security and Accountability Act (P.L. 113-54) Issues related to drug pricing Education around issues relating to the 340B Drug Discount Program Issues related to FDA and HHS program funding in the FY18 Labor, Health and Human Services, and Education and Related Agencies, and FY18 Agriculture, Rural Developments, Food and Drug Administrations, and Related Agencies Appropriation bills

Issues relating to drug pricing Education on policies pertaining to the 340B Drug Discount Program

Intellectual property and process patent issues. General IP issues. Patent litigation reform.

340B Drug Discount Program.

Implementation of Medicare pharmaceutical coverage and reimbursement issues Policies relating to 340B Drug Discount Program Issues relating to the repeal and replacement of the Affordable Care Act (HR 1628, The American Health Care Act). Medicare Part B reimbursement issues for physicians and implementation of related provisions of MACRA Payment policies for prescription drugs

Trade negotiations, Transatlantic Trade and Investment Partnership (TTIP), NAFTA. Issues related to trade policy.

Issues related to the development of medical countermeasures for neurotoxins; Biomedical Advanced Research and Development Authority

Issues related to FDA and HHS program funding in the FY17 Labor, Health and Human Services, and Education and Related Agencies, and FY17 Agriculture, Rural Developments, Food and Drug Administrations, and Related Agencies Appropriations bills. FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; FY2018, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations; H.R.244, Consolidated Appropriations Act 2017 (P.L.115-31); vial size issues. Issues related to establishing the budget for the United States Government for FY 2018, Bipartisan Budget Act of 2015

Intellectual property and process patent issues. General IP issues. Patent litigation reform.

Trade negotiations and Transatlantic Trade Partnership (TTIP). Issues related to trade policy.

Bioterrorism preparedness and development of medical countermeasures.

Implementation of Medicare pharmaceutical coverage and reimbursement issues; Medicare Part B reimbursement for physicians and implementation of related provisions of the Affordable Care Act; reimbursement adequacy and patient access issues associated with potential CMMI implementation of the proposed Medicare Part B drug payment model. Policies relating to 340B Program. Issues relating to the repeal and replacement of the Affordable Care Act (HR 1628, The American Health Care Act).

Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.

Implementation of Medicare pharmaceutical coverage and reimbursement issues; Medicare Part B reimbursement for physicians and implementation of related provisions of the Affordable Care Act; reimbursement adequacy and patient access issues associated with potential CMMI implementation of the proposed Medicare Part B drug payment model. Policies relating to 340B Program. Issues relating to the repeal and replacement of the Affordable Care Act (HR 1628, The American Health Care Act).

Issues related to corporate tax reform. General Tax Issues.

Intellectual Property and Process Patent Issues. Patent Litigation Reform.

Issues related to FDA and HHS program funding in the FY17 Labor, Health and Human Services, and Education and Related Agencies, and FY17 Agriculture, Rural Developments, Food and Drug Administrations, and Related Agencies Appropriations bills.

Monitor Drug Safety and pedigree legislation. 340B Drug Discount Program.

Intellectual Property and Process Patent Issues. General IP Issues; Patent Litigation Reform; Transpacific Partnership Agreement.

S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.

Issues relating to U.S. trade policy and TransPacific Partnership.

Issues related to several tax issues and tax reform. Issues relating to corporate tax reform including taxation of foreign-owned US corporations. Issues relating to proposed regulations under Section 385 of the Internal Revenue Code.

Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. 21st Century Cures initiative. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars. H.R.5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

Issues relating to U.S. trade policy and TransPacific Partnership.

H.R. 6 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.

Implementation of the Pharmaceutical, Quality, Safety & Accountability Act (P.L. 113-54). 340B drug discount program.

Intellectual Property and Process Patent Issues. General IP Issues; Patent Litigation Reform; Transpacific Partnership Agreement.

Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. 21st Century Cures initiative. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars.

Issues relating to U.S. trade policy and TransPacific Partnership.

FY 2017 Labor, Health and Human Services, Education and Related Agencies Appropriations annual spending bill; Influenza antiviral allotment with the Centers for Disease Control Strategic National Stockpile Issues related to establishing the budget for the United States Government for fiscal year 2017 Budget/Labor HHS Appropriations Act, FY2017 Bipartisan Budget Act of 2015 Issues related to FDA and HHS program funding in the FY16 Labor, Health and Human Services, and Education and Related Agencies. FY16 Agriculture, Rural Developments, Food and Drug Administration and Related Agencies Appropriations bills

Payment policies for prescription drugs. Implementation of Medicare pharmaceutical coverage and reimbursement, 340B Program, dual eligible demonstrations, Medicare Part B reimbursement for physicians, and related provisions of the Affordable Care Act. Reimbursement adequacy and patient access issues associated with potential CMMI implementation of the proposed Medicare Part B Drug Payment Model.

General IP Issues. Transpacific Partnership Agreement. Patent Litigation Reform. Intellectual Property and Process Patent Issues. Implementation of P.L. 108-173,

Issues related to tax reform and tax extenders; Issues relating to corporate tax reform including the R&D tax credit and taxation of foreign-owned corporations;

Concerns regarding Medicare policies for Part B drugs. Issues related to the 340B Drug discount program; general IP issues, transpacific partnership agreement;

issues related to H.R. 6, the 21st Century CURES Act; Concerns regarding Medicare policies for Part B drugs. Issues related to the 340B Drug discount program; Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and Medicare Part B reimbursement for physicians and related provisions of The Affordable Care Act; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics; HR 1470 and S.810, the SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Medicare physician payment reform, payment for Part B drugs; Public Law 114-110, the Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform and CHIP extension, payment for PART B drugs.

intellectual property & process patent issues; MMM: Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B

: 340B, Patent Terms, Appropriations, Pandemic Preparedness, Tamiflu Stockpile; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Publaw 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit; Meetings with Administration and congressional staff on coverage/payment issues related to cancer biotherapeutics, 340B program; Meetings with Administration staff concerning the President's precision medicine initiative; Issues related to the implementation of the follow-on biologiecs provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementationof Patient Protection and Afforedable Care Act; Drug pricing under 340B program; : Implementation issues related to the Pharmaceutical Quality, Security and Accountabilty Act (P.L. 113-54) S. 2007, Preventing Regulatory Overreach to Enhance Care Technology Act of 2014, Cancer Patient Protection Act of 2013 pharma supply chain issues, issues related to the 340B Program;

Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics; HR 1470 and S.810, the SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Medicare physician payment reform, payment for Part B drugs; Pbulic Law 114-110, the Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform and CHIP extension, payment for PART B drugs; Concerns regarding Medicare policies for Part B drugs. Issues related to the 340B Drug discount program; Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstratins and Medicare Part B reimbursement for physicians and related provisions of The Affordable Care Act;

Patent Terms, Pandemic Preparedness, Tamiflu Stockpile, Appropriations; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Pubic law 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit; Meetings with Administration and congressional staff on coverage/payment issues related to cancer biotherapeutics, 340B program; Meetings with Administration staff concerning the President's precision medicine initiative; Ongoing issues related to the implementation of the Affordable Care Act of 2010; Drug pricing under 340B program; issues related to H.R. 6, the 21st Century CURES Act; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program;

Public Law 111-148, the Patient Protection and Affordable Care Act 0 Implementation issues related to FDA approval of follow on biologics and length of data exclusivity period, 340B drug pricing program, structure of the Medicare prescription drug benefit.; Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid reimbursement, fees assessed on the pharmaceutical industry, design and structure of the Medicare prescription; General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis.; Held discussions with Administration staff about 340B program requirements on participating pharmaceutical manufacturers., Held preliminary discussion with Administration staff on anti-viral drugs in the strategic national stockpile.

general tax issues and tax extenders (R&D tax credit) and tax treatment of foreign-owned US corporations. Follow issues related tax reform; Corporate tax reform; Issues relating to corporate tax reform including the R&D tax credit andtaxation of foreign-owned corporations with US subsidiaries

Public Law 112-144, the Food and Drug Administration Safety and Innovation Act - legislation related to reauthorization of user fees for prescription drug, medical device, and bilogics approval. All aspects. General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and and Lucentis. S. 959 - Pharmaceutical Quality, Security, and Accountability Act- legislation regardng pharmacy compounding and track and trace proposals. Public Law 113-67, Continuing Appropriations Resolution for 2014 - General public health spending. Public law 113-54- The Drug quality and drug compounding and track/trace issues

Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow-on biologics; Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit; Regulatory and legislative activities regarding 340B program; Issues relating to biologics; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; Issues related to the implementation of the Affordable Care Act of 2010; issues related to biosimilars; Issues concerning clinical trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act. Federal Drug. Drug pricing under 340B program; Medical reimbursement - advocacy on behalf of maintaining ASP+6%, 340B Drug Discounting Program - education of Congress on unintended growth of program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.

Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow-on biologics. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.

Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies, 340(b) Drug Discount Program, Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to FDA approval of follow-on biologics and length of data exclusivity period, 340B drug pricing program, structure of the Medicare presciption drug benefit. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010- Implementation issues related to Medicare and Medicaid reimbursement, fees assessed on the pharmaceutical industry, design and structure of the Medicare prescription drug benefit. Public Law 112-144, the Food and Drug Administration Safety and Innovation Act - legislation related to reauthorization of user fees for prescription drug, medical device, and biologics approval. All aspects. General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis. S. 959 - Pharmaceutical Quality, Security, and Accountability Act- legislation regarding pharmacy compounding and track and trace proposals. Public Law 113-67, Continuing Appropriations Resolution for 2014 - General public health spending. Public law 113-54- The Drug quality and Security Act - drug compounding and track trace issues.

Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow-on biologics. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.

Intellectual Property and Process Patent Issues - HR 1908 Patent Reform Act (all provisions, Cyber security, Transpacific partnership

Research and Development Tax credit,general tax issues and tax extenders (R&D tax credit) and tax treatment of foreign-owned US corporations; tax reform, Issues related to comprehensive tax reformand the tax treatment of foreign-owned U.S. corporations. S__, Expiring Provisions Improvement Reform and Efficiency (EXPIRE) Act (tax extenders), including the R&D tax credit.

S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow-on biologics. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics

Research and Development Tax credit,general tax issues and tax extenders (R&D tax credit) and tax treatment of foreign-owned US corporations; tax reform, Issues related to comprehensive tax reformand the tax treatment of foreign-owned U.S. corporations. S__, Expiring Provisions Improvement Reform and Efficiency (EXPIRE) Act (tax extenders), including the R&D tax credit.

S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow-on biologics. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics

Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. P.L. 112-240, the American Taxpayer Relief Act of 2012 - Medicare payment issues. H. Con. Res. 25, Establishing the budget for the United States Government ofr fiscal year 2014 and settin forth appropriate budgetary levels for fiscal years 2015 through 2023; and S. Con. Res. 8, An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.

tax reform, general corporate and international taxation; Genteral tax issues and tax extenders (R&D tax credit) and tax treatment of foreign-owned U.S. corporations; Research and Development Tax credit; Issues related to comprehensive tax reform, tax treatment of and tax extenders, including R&D tax credit. Corporate tax reform issues. International trade issues and patent protection abroad.

Monitoring of the FY 14 appropriations bills and issues related to comprehensive tax reform; R&D Tax Credit issues; S. 3521, Family and Business Tax Cut Certainty Act of 2012; S. 1577 Greater Research Opportunities with Tax Help Act; H.R. 942, American Research and Competitiveness Act of 2011; H.R. 8; Research and Development Tax credit, general tax issues and tax extenders (R&D tax credit) and tax treatment of foreign-owned US corporations.

Monitor DrugSafety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.

FY13 Labor, HHS and Education Approporation related to preparedness for pandemic influenza, HIV/AIDS programs, heptatis screening, care and treatment, and access to breast cancer treatment; Following issues related to the budget and apropriations process FY13 appropriations for FDA as well as the potential outcomes fore negotiations on altering sequestration targets via legislation; Issues related to FDA and HHS program funding, FY13 Labor Health and Human Services, and Education, and Related agencies Appropriations bill; Budget/Appropriations (House and Senate Contact Only): Monitor FY13 appropriations process: FDA funding issues and drug approval/review oversight process. Monitor the potential outcomes for negotiations on altering sequestration targets via legislation. Monitor plans for issues related to comprehensive tax reform, tax treatment of foreign-owned U.S. corporations, and tax extenders (R & D tax credit).

R&D Tax Credit (H.R. 942), FDA Appropriations, PDUFA Reauthorization; general tax issues and tax extenders (R&D tax credit) and tax treatment of foreign-owned U.S. corporations; Worked to garner support for H.R. 942, the AmericanResearch and Competitiveness Act of 2011; Monitoring proposals on US tax treatment of foreign-owned U.S. corporations;

Implementation of H.R. 1: Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA,stimulus. Issues relating to comparative effectiveness and CMS coverage of FDA approved therapties. Issues related to the PPS ruel involving stroke guidelines. Implementation of the follow-on biologice provisions in P.L. 111-148- "Patient Protection and Affordable Care Act"; legislation on public health preparedness and response related to pandemic influenza. Influenz Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; FDA Approval and enforcement issues. Issues relating to S.3187, FDA Safety and Innovation Act. Issues relating to antibiotic development incentives in HR 2182 and S 1734, "Generating Antibiotic Incentives Now Act of 2011"; Prescription Drug User Fee Act (PDUFA) Reauthorization;Issues related to the implementationof the Affordable Care Act of 2010;

Monitor and report and food safety and supply chain issues

Medicare Issues; Monitor implementation of Medicare Pharmaceutical converage and reimbursement provisions of the Affordable Care Act, Medicare coverage and payment of Part B drugs and biologicals. Support for H.R 452 "Medicare Decision Accountability Act of 2011 and S.668 "Health Care Bureaucrats Elmination Act".

Monitor and report on Food safety and supply chain issues

Budget/Appropriations: FY12 appropriations process, including H.R. 2112 and various continuing resolutions: FDA funding issues and drug approval/review oversight process.

Medicare coverage and payment of Part B drugs and biologicals; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics. Participated in discussions with House and Senate staff on Medicare coverage/payment issues related to cance biotherapeutics, including Avastin and Lucentis.; Implementationof H.R. 1: Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus. Issues relating to comparative effectiveness and CMS coverage of FDA approved therapies. Issues related to the PPS rule involving stroke guidelines; Public Law 111-148, the Patient Protectiona and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics. Participated in discussions with House and Senate staff on Medicare coverage/payment issues related to cancer biotherapeutics, including Avastin and Lucentis; Monitor implentation of Medicine pharmaceutical coverage and reimbursement provisions of the Affordable Care Act; medicare issues; Implementation of P.L. 108-173, matters related to Medicare and Medicare Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); Issues relating to prescription Drud User Fee Act: issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin, Issues related to coverage of Lucentis and Avastin.

Montior issues related to export rules and regulations, international patent issues, WTO matters, the Trans-Pacific, Partnership and other international issues impacting biotech and pharmaceuticals

Monitor issues related to export rules and regulations, international patent issues,; matters and other international issues impacting biotech and pharmaceuticals

monitor and report and food safety and supply chain issues

Various issues related to the budget and appropriations process

Monitor and report on corporate tax issues; general tax issues and tax extenders

Monitor and report on food safety and supply chain issues

Medicare issues; payment policies for prescription drugs; implementation of H.R.1; Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus; physician payment disclosure including S.301; Physician Payments Sunshine Act of 2009; HR 3962, Affordable Health Care for Americans Act; HR 3590, Patient Protection and Affordable Care Act; H.R.4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S726/H.R. 1427 Promoting innovation and access to Life Savings Medicines Act; HR 3962, Affordable Health Care for America Act; Compartiveffectiveness legislation S. 1213; Patient-Centered Outcomes Research Act of 2009; HR 3200, America's Health Future Act; H.R. 1548-Pathway for Dissimilar Act; Legislative changes in health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act", Affordable Health Choice Act; American Health Future Act of 2009; Pharmaceutical Import Safety legislation.

Monitor and report on corporate tax issues; general tax issues and tax extenders

Labor HHS appropriations stock piling anti-virals for pandemic influenza; Cancer Research Issues - S.3686/HR__, Labor, HHS Appropriations Bill for FY2011; Monitoring the implementation of the Patient Protection and Affordable Care Act, including provisions related to comparative effectiveness research and a regulatory pathway for biosimilars; H.R.1 - Pandemic influenza funding: H.R. 1105 Omnibus Appropriations Act of 2010, Food Safety Bill, H.R. 4872 Health Care & Education Reconciliation Act of 2010; issues concerning clincial trials; general health care refore (Patient Protection and Affordable Care Act); Congressional oversight issues; FDA approval and enforcement issues; Pandemic preparedness; Tamiflu; Avastin-breast cancer ; following all issues related to health care reform; S.726/HR 1427 - promoting innovation and access to life-saving Medicine Act; HR 1548 - Pathway for Biosimilars Act; General support for Genentech products; monitor and report on issues related to the implementation of health care reform; H.R. 1548 - Pathway for Biosimilars Act;

Medicare issues; payment policies for prescription drugs; implementation of H.R. 1; Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus; physician payment disclosure including S.301; Physician Payments Sunshine Act of 2009; HR 3962, Affordable Health Care for Americans Act; HR 3590, Patitient Protection and Affordable Care Act; H.R> 4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S. 726/H.R.1427, Promoting innovation and access to Life Savings Medicines Act; HR 3962, Affordable Health Care for America Act; Comparativ effectiveness legislation S. 1213; Patient-Centered Outcomes Research Act of 2009; HR 3200, America's Health Future Act; H.R. 1548-Pathway for Dissimilar Act; Legislative changes in health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act", Affordable Health Choice Act;, American Health Future Act of 2009; Pharmaceutical Import safety legislation.

Labor HHS Appropriations - S. 3230 & H.R. 3042, Homeland Security Appropriations S.3181 and HR 6947; Congress and Federal Agencies: U.S. House of Representatives: US Senate: HHS; Dept. of Homeland Security; Executive Office of the President; Office of Personnel Management; Dept.of Veteran Affairs

Labor HHS Appropriations - S. 3230 and H.R. 3042 Homeland Security Appropriations S.3181 and H.R. 6947

Monitor and report on corporate tax issues; Monitoring proposals on U.S. tax treatment of foreign corporations; S. 506, Stop Tax Haven Abuse Act;

Following issues related to the budget and appropriations process; Issues related to government purchases of pandemic drugs: Tamiflu; Seek Federal appropriations in the FY11 Labor, Health and Human Services and Education bill regarding pandemic influenza;HIV/AIDS programs and HCV screening, care and treatment; Implementation of H.R. 2346, S. 10554; FY09 Supplemental Appropriations related to preparedness for pandemic influenza; FY11 State Foreign Operations appropriations related to USAID and funding for Pandemic Influenza

Pandemic Preparedeness: Tamiflu; Advocate on legislative changes in the health care reform bill regarding biosimilars; Monitor changes to outpatient 340B presecription drug discount program, including related provisions included in HR 4213 - American Jobs and Closing Tax Loopholes Act; S. 3793, Job Creation and TAx Cuts Act; All healthcare and biotechnology legislation. Stockpiling of antiviral in preparation of a pandemic, HHS Appropriations bill H.R. 1548 - Pathway for Biosimilars Act FDA Approval and Enforcement Issues Cancer Research Issues S. 3686 FY 2011 Appropriations, HHS HCR issues concerning clinical trials Congressional oversight issues Implementation issues related to the Patient Protection and Affordable Care Act H.R. 1 - Pandemic influenza funding H.R. 1105 Omnibus Appropriations Act, Pandemic Funding Issues Food Safety Bill, H.R. 4872 Health Care and Education Reconciliation Act of 2010 H.R. 3974 Viral Hepatitis and LIver Cancer Control and Prevention Act of 2009 H.R. 3590 Patient Projection and Affordable Care Act-FTC issue Ryan White CARE Act reauthorization S. 726/HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act Educational meetings in Senate with candiate for Patient Centered Outcomes Research Institute Board (PCORI)

Monitor and report on corporate tax issues; Monitoring proposals on U.S. tax treatment of foreign corporations; S. 506, Stop Tax Haven Abuse Act;

Labor HHS Appropriations - S. 3230 and H.R. 3042 Homeland Security Appropriations S.3181 and H.R. 6947

Pandemic Preparedeness: Tamiflu; Advocate on legislative changes in the health care reform bill regarding biosimilars; Monitor changes to outpatient 340B presecription drug discount program, including related provisions included in HR 4213 - American Jobs and Closing Tax Loopholes Act, and ddraft Senate amendments to the legislation; Labor, Health and Human Services Appropriations bill; H.R. 1548 - Pathway for Biosimilars Act; Health care and biotechnology legislation, including H.R. 3490; Implementation of P.L. 111-148, "Patient Protection and Affordable Care Act" and P.L. 111-152, "Reconciliation Act of 2010", including comparative effectiveness provisions; S. 726/H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicine Act; H.R. 1548 - Pathway for Biosimilars Act; Physician payment disclosure including S. 301; Physician Payments Sunshine Act of 2009; H.R. 3962, Affordable Health Care for Americans Act; H.R. 3590; Patient Protection and Affordable Care Act H.R. 4872, the Reconciliation Act of 2010; Follow on biologics includuing H.R. 154, the Pathway to Biosimilars Act; S. 726/H.R. 1427, Promoting Innovation and Access to Life Savings Medicines Act; H.R. 3962, Affordable health care for America Act; Comparative effectiveness legislation including S. 1213; Patient-Centered Outcomes Research Act of 2009; H.R. 3200, America's Health Future Act; H.R. 1548 - Pathway for Dissimilar Act; Legislative changes in the heatlh care reform bill regarding dissimilars; S. 1679 Affordeable Health Choice Act; S.1796, America's Health future Act of 2009; Pharmacuetical import safety legislation. H.R. 1105 Omnibus Appropriations Act of 2010; Supplemental Appropriations Act of 2010, Food Safety Issues concerning clinlical trials; H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 H.R. 3590 Patient Protetion and Affordable Care Act - FTC issue Ryan White CARE Act reauthorization

Patent Settlement Issues; Intellectual Property and Process Patent Issues; H.R. 1908; S. 515 & HR. 1260 - Patent Reform Act of 2009; Monitor legislation regarding brand name and generic pharmaceutical agreement, patent fees, and post-grant review reforms.

Following issues related to the budget and appropriations process; Issues related to government purchases of pandemic drugs: Tamiflu; Seek Federal appropriations in the FY11 Labor, Health and Human Services and Education bill regarding pandemic influenza;HIV/AIDS programs and HCV screening, care and treatment; Implementation of H.R. 2346, S. 10554; FY09 Supplemental Appropriations related to preparedness for pandemic influenza; FY11 State Foreign Operations appropriations related to USAID and funding for Pandemic Influenza

Monitor food safety and supply chain issues

Monitor food safety and supply chain issues

H.R. 1908 Intellectual Property and Process Patent Issues S. 515 & H.R. 1260 - Patent Reform Act of 2009

S. 565/H.R. 1458 - providing extended coverage for immunosuppressive drugs to beneficiaries under ther Medicare Program that have received a kidney transplant

Labor HHS Appropriations - S. 3230 and H.R. 3042 Homeland Security Appropriations S.3181 and H.R. 6947

Physician payment disclosure including S.301 Physician Payments Sunshine Act of 2009 H.R. 3962, Affordable health Care for Americans Act H.R. 3590, Patient Protection and Affordable Care Act H.R. 4872, the Reconciliation Act of 2010 Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act S. 726/H.R. 1427, Promoting Innovationo and Access to Life Saving Medicines Act H.R. 3962, Affordable Health Care for America Act Comparative effectiveness legislation including S. 1213 Patient-Centered Outcomes Research Act of 2009 H.R. 3200, America's Health Future Act H.R. 1548 - Pathway for Dissimilar Act Legislative changes in the health care reform bill regarding dissimilar Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act." Pandemic Preparedness - Tamiflu Exploring additional funding for antiviral stockpiling in response to H1N1 and H5N1 Pandemic Influenza H.R. 1105 - omnibus Appropriations Act FY10 labor HHS Appropriations Legislation H.R. 1105 - Omnibus Appropriations Act FY10 Labor HHS Appropriations legislation H.R. 2346 supplemental Appropriations Act of 2009 FY11 Labor, HHS and Education Appropriates related to preparedness for pandemic influenza, HIV/AIDS programs and HCV screening, care and treatment FY11 State Foreign Operations Appropriations related to USAID and funding for pandemic influenza H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 Ryan White CARE Act reauthorization S. 1679, Affordable Health Choices Act S. 1796, America's Healthy Future Act of 2009 Pharmaceutical import safety legislation

Implementation of HR1 Medicare Prescription Drug and Modernization Act of 2003 Issues relating to PDUFA, stimulus

Issues relating to government purchases and stockpiling of pandemic drugs - Tamiflu

Monitoring proposals on U.S. tax treatment of foreign corporations S. 506, Stop Tax Haven Abuse Act

S. 565/H.R. 1458 - providing extended coverage for immunosuppressive drugs to beneficiaries under ther Medicare Program that have received a kidney transplant

Physician payment disclosure including S.301 Physician Payments Sunshine Act of 2009 H.R. 3962, Affordable health Care for Americans Act H.R. 3590, Patient Protection and Affordable Care Act H.R. 4872, the Reconciliation Act of 2010 Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act S. 726/H.R. 1427, Promoting Innovationo and Access to Life Saving Medicines Act H.R. 3962, Affordable Health Care for America Act Comparative effectiveness legislation including S. 1213 Patient-Centered Outcomes Research Act of 2009 H.R. 3200, America's Health Future Act H.R. 1548 - Pathway for Dissimilar Act Legislative changes in the health care reform bill regarding dissimilar Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act." Pandemic Preparedness - Tamiflu Exploring additional funding for antiviral stockpiling in response to H1N1 and H5N1 Pandemic Influenza H.R. 1105 - omnibus Appropriations Act FY10 labor HHS Appropriations Legislation H.R. 1105 - Omnibus Appropriations Act FY10 Labor HHS Appropriations legislation H.R. 2346 supplemental Appropriations Act of 2009 FY11 Labor, HHS and Education Appropriates related to preparedness for pandemic influenza, HIV/AIDS programs and HCV screening, care and treatment FY11 State Foreign Operations Appropriations related to USAID and funding for pandemic influenza H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 Ryan White CARE Act reauthorization S. 1679, Affordable Health Choices Act S. 1796, America's Healthy Future Act of 2009 Pharmaceutical import safety legislation

H.R. 1260 Patent Reform S. 515 Patent Reform S. 610 Patent Reform H. R. 1909 Intellectual Property and Process Patent Issues S. 1145/H.R. 1908; Patent Reform Act of 2007 S. 623 Access to Life-Saving Medicine Act H.R. 5629 Pathways and Biosimilars Act

Kennedy American Affordable Health Choices Act of 2009 H.R. 3200 American Affordable Health Choices Act of 2009 Tri Caucus Healthcare Reform Bill Baucus/Finance healthcare Reform Bill - America's Healthy Future Act of 2009 S. 1110 Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 H.R. 2502 Comparative Effectiveness Research Act of 2009 S. 1213 Patient-Centered Outcomes Research Act of 2009 S. 301 Physican Payments Sunshine Act of 2009 Senate Finance Committee Chairman's Mark, America's Healthy Future Act H.R. 1548 The Pathway to Biosimilars Act S. 726/H.R. 1427 Promoting Innovation and Access to Life Saving Medicines Act H.R. 1, The American Recovery and Reinvestment Act

H.R. 1427 Promoting Innovation and Access to Life-Saving Medicine Act H.R. 1548 Pathway for Biosimilars Act of 2009 S. 726 Promoting INnovation and Access to Life-Saving Medicine Act H.R. 3200, America's Affordable Health Choices Act S. 1679, the Affordable Health Choices Act Senate Finance committee Chairman's Mark, America's health Future Act S. 1232, the Pharmaceutical Market Access and Drug Safety Act

General tax issues and tax extenders

H.R. 1 American Recovery and Reinvestment Act of 2009 S. Con. Res. 13 H. Con. Res. 85 Comparative Effectiveness

Medicare Issues comparative Effectiveness S. 301 Physician Payments sunshine Act of 2009 Oncology Quality Care Improvement Act Kennedy Healthcare Reform Bill House Tri Committee Healthcare Reform Bill Tri Caucus healthcare Reform Bill Senate Finance healthcare Reform Bill S. 1110 Medicare Payment Adisory Commission (MedpAC) Reform Act of 2009 H.R. 2502 Comparative Effectiveness Research Act of 2009 S. 1213 Patient-Centered Outcomes Research Act of 2009

H.R. 1427 Promoting Innovation and Access to Life-Saving Medicine Act H.R. 1548 Pathway for Biosimilars Act of 2009 S. 726 Promoting Innovation and Access to Life-Saving Medicine Act

H.R. 1427 Promoting Innovation and Access to Life-Saving Medicine Act H.R. 1548 Pathway for Biosimilars Act of 2009 S. 726 Promoting Innovation and Access to Life-Saving Medicine Act

H.R. 1038, Acces to Life-Saving Medicine Act, follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics H.R. 5629, Pathway for Biosimilars Act H.R. 5839, Safeguarding America's Pharmaceuticals Act S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 2029, Physician Payments Sunshine Act of 2007 S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions

Tax legislation/R&D tax credit

LHHS Appropriations (CMS and comparative effectiveness related matters)

H.R. 6331 Medicare Improvements for Patients and Providers Act of 2008 S. 3101 Improvements for Patients and Providers Act of 2008 H.R. 5629 Pathway for Biosimilars Act

H.R. 1038, Acces to Life-Saving Medicine Act, follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics H.R. 5629, Pathway for Biosimilars Act H.R. 4911, Human Growth Hormone Restriction Act of 2007 H.R. 5839, Safeguarding America's Pharmaceuticals Act S. 1505 Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 2029, Physician Payments Sunshine Act of 2007 S. 596, Safe Internet Pharmacy Act of 2007, clinical trials/drug safety provisions S. 623, Access to Life-Saving Medicine Act, follow-on biologics S. 877, Controlling Abuse of Prescription Drugs Act of 2007