Loading…
Reported covered position: N/A
How to read the money
Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2023 Appropriations H.R. 6833 - Continuing Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2023 Prescription Drug User Fee Act (PDUFA) VII Value of Medicine
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
ACA Pharmacetuical Industry Fee Administration's FY 2022 Revenue Proposals Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD) Tax Treaties Thin Capitalization Rules 163(j) U.S. Corporate Tax
Access to Medicines Issues Biopharmaceutical Innovation Policies US China Agreement US Swiss Trade Relations US Switzerland Mutual Recognition Agreement on GMP Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy WTO IP Waiver
Source: Senate LDA
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Fiscal Year 2023 Appropriations Coronavirus Supplemental Appropriations HR 4521 Competes Act
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2023 Appropriations H.R. 6833 - Continuing Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2023 Prescription Drug User Fee Act (PDUFA) VII Value of Medicine
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Fiscal Year 2023 Appropriations Coronavirus Supplemental Appropriations HR 4521 Competes Act
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2023 Appropriations H.R. 6833 - Continuing Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2023 Prescription Drug User Fee Act (PDUFA) VII Value of Medicine
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO IP Waiver
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO IP Waiver
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO IP Waiver
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Preserve Access to Affordable Generics and Biosimilars Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act
Preserve Access to Affordable Generics and Biosimilars Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO IP Waiver
Preserve Access to Affordable Generics and Biosimilars Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Fiscal Year 2023 Appropriations Coronavirus Supplemental Appropriations HR 4521 Competes Act
Medicare Negotiation and Competitive Licensing Act of 2021
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2023 Appropriations H.R. 6833 - Continuing Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2023 Prescription Drug User Fee Act (PDUFA) VII Value of Medicine
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Fiscal Year 2023 Appropriations Coronavirus Supplemental Appropriations HR 4521 Competes Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2023 Appropriations H.R. 6833 - Continuing Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2023 Prescription Drug User Fee Act (PDUFA) VII Value of Medicine
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO IP Waiver
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO IP Waiver
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Fiscal Year 2023 Appropriations Coronavirus Supplemental Appropriations HR 4521 Competes Act
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
To reduce Federal spending and the deficit by terminating taxpayer financing of Presidential election campaigns.
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
To reduce Federal spending and the deficit by terminating taxpayer financing of Presidential election campaigns.
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
To designate the facility of the United States Postal Service located at 30 East Somerset Street in Raritan, New Jersey, as the "Gunnery Sergeant John Basilone Post Office".
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
To designate the facility of the United States Postal Service located at 30 East Somerset Street in Raritan, New Jersey, as the "Gunnery Sergeant John Basilone Post Office".
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
Protecting Taxpayer Confidentiality Through Safeguards Act
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
A bill to direct the Secretary of the Interior to reissue the final rules relating to the listing of the gray wolf in the Western Great Lakes and the State of Wyoming under the Endangered Species Act of 1973.
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
A bill to direct the Secretary of the Interior to reissue the final rules relating to the listing of the gray wolf in the Western Great Lakes and the State of Wyoming under the Endangered Species Act of 1973.
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings.
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations act for FY 2020 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Health Defense Operations Funding Designation Implementation of the Prescription Drug User Fee Act (PDUFA) VI
Biosimilars Drug Pricing Fiscal year 2022 Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 Importation Value of Medicine
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine
340B Drug Discount Program AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies COVID-19 21st Century Cures Act 2.0 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2022 Labor-HHS Appropriations Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Priority Review Voucher (PRV) Regulatory efficiencies policy issues Transparency policy issues Vaccines H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.133, Consolidated Appropriations Act for FY 2021 H.R.1319, American Rescue Plan Act of 2021 Defense Production Act Advanced Research Projects Agency for Health (ARPA-H) Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act S.164, Advancing Education on Biosimilars Act of 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement White House National Biodefense Strategy
Biosimilars Drug Pricing Fiscal year 2022 Appropriations Importation Value of Medicine H.R.133, Consolidated Appropriations Act for FY 2021 H.R.1319, American Rescue Plan Act of 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Prescription Drug User Fee Act (PDUFA) VII Priorities Advanced Research Projects Agency for Health (ARPA-H)
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeit policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Part D Benefit Re-design H.R. 6000: Cures 2.0 Act H.R.19 - Lower Costs, More Cures Act of 2021
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and conterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Healthcare Disparities R&D Funding for Medical Countermeasures Reference Pricing in Drug Reimbursement Senate Finance Committee Drug Pricing Principles Senate HELP Pandemic Preparedness White Paper Step Therapy
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations act for FY 2020 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Health Defense Operations Funding Designation Implementation of the Prescription Drug User Fee Act (PDUFA) VI
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine
Biosimilars Drug Pricing Fiscal year 2022 Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 Importation Value of Medicine
Biosimilars Drug Pricing Fiscal year 2022 Appropriations Importation Value of Medicine H.R.133, Consolidated Appropriations Act for FY 2021 H.R.1319, American Rescue Plan Act of 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Prescription Drug User Fee Act (PDUFA) VII Priorities Advanced Research Projects Agency for Health (ARPA-H)
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeit policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Part D Benefit Re-design H.R. 6000: Cures 2.0 Act H.R.19 - Lower Costs, More Cures Act of 2021
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine
340B Drug Discount Program AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies COVID-19 21st Century Cures Act 2.0 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2022 Labor-HHS Appropriations Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Priority Review Voucher (PRV) Regulatory efficiencies policy issues Transparency policy issues Vaccines H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.133, Consolidated Appropriations Act for FY 2021 H.R.1319, American Rescue Plan Act of 2021 Defense Production Act Advanced Research Projects Agency for Health (ARPA-H) Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act S.164, Advancing Education on Biosimilars Act of 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement White House National Biodefense Strategy
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and conterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Healthcare Disparities R&D Funding for Medical Countermeasures Reference Pricing in Drug Reimbursement Senate Finance Committee Drug Pricing Principles Senate HELP Pandemic Preparedness White Paper Step Therapy
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2023 Appropriations H.R. 6833 - Continuing Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.5376, Inflation Reduction Act Importation National Defense Authorization Act FY 2023 Prescription Drug User Fee Act (PDUFA) VII Value of Medicine
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act
Artificial intelligence Data and digital technologies
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine
Access to Medicines Issues Biopharmaceutical Innovation Policies CFIUS China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Sub-standards Medicines Supply chain and China Task Force policy issues Tariffs Trade Policy USMCA USTR Special 301 Report/National Trade Estimate WTO IP Waiver US Switzerland Trade Issues
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Cancer Moonshot
Artificial intelligence Data and digital technologies
ACA Pharmaceutical Industry Fee Administration's FY 2022 Revenue Proposals Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD) Tax Treaties Thin Capitalization Rules 163(j) U.S. Corporate Tax
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Fiscal Year 2023 Appropriations Coronavirus Supplemental Appropriations HR 4521 Competes Act
Access to Medicines Issues Biopharmaceutical Innovation Policies China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy USTR Special 301 Report/National Trade Estimate WTO IP Waiver
Artificial intelligence Data and digital technologies
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO IP Waiver
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act HR 5376 Build Back Better Act of 2021 S. 7399 Prevent Pandemics Act HR 19/S. 2164 Lower Costs, More Cures Act of 2021 Healthcare Disparities Accelerated Approval (HR 6963 and HR 6996) Cancer Moonshot Initiative
ACA Pharmacetuical Industry Fee Administration's FY 2022 Revenue Proposals Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD) Tax Treaties Thin Capitalization Rules 163(j) U.S. Corporate Tax
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
ACA Pharmaceutical Industry Fee Administration's FY 2022 Revenue Proposals Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD) Tax Treaties Thin Capitalization Rules 163(j) U.S. Corporate Tax Build Back Better Act Tax Provisions
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Reponse to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act HR 1629/S. 250 - Fairness in Orphan Drug Exclusivity Act
Access to Medicines Issues Biopharmaceutical Innovation Policies China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy USTR Special 301 Report/National Trade Estimate WTO IP Waiver Export Controls
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeit policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Part D Benefit Re-design H.R. 6000: Cures 2.0 Act H.R.19 - Lower Costs, More Cures Act of 2021
Artificial intelligence Data and digital technologies
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
Artificial intelligence Data and digital technologies
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and conterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Healthcare Disparities R&D Funding for Medical Countermeasures Reference Pricing in Drug Reimbursement Senate Finance Committee Drug Pricing Principles Senate HELP Pandemic Preparedness White Paper Step Therapy
ACA Pharmaceutical Industry Fee Administration's FY 2022 Revenue Proposals Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives R&D Amortization Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD) Tax Treatries Thin Capitalization Rules 163(j) U.S. Corporate Tax
Access to Medicines Issues Biopharmaceutical Innovation Policies China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Supply chain and China Task Force policy issues Tariffs Trade Policy USTR Special 301 Report/National Trade Estimate WTO IP Waiver
Advanced Research Projects Agency for Health (ARPA-H) Biosimilars Drug Pricing Fiscal year 2022 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.5376, Build Back Better Act Importation National Defense Authorization Act FY 2022 Prescription Drug User Fee Act (PDUFA) VII Priorities Value of Medicine Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations act for FY 2020 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Health Defense Operations Funding Designation Implementation of the Prescription Drug User Fee Act (PDUFA) VI
Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Reponse to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act 35 USC Section 101 on Patent Eligibility
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
Artificial intelligence Data and digital technologies
340B Drug Discount Program AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies COVID-19 21st Century Cures Act 2.0 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2022 Labor-HHS Appropriations Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Priority Review Voucher (PRV) Regulatory efficiencies policy issues Transparency policy issues Vaccines H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.133, Consolidated Appropriations Act for FY 2021 H.R.1319, American Rescue Plan Act of 2021 Defense Production Act Advanced Research Projects Agency for Health (ARPA-H) Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act S.164, Advancing Education on Biosimilars Act of 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement White House National Biodefense Strategy
340B Drug Discount Program AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies COVID-19 Cures 2.0 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and conterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2022 Labor-HHS Appropriations Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Priority Review Voucher (PRV) Transparency policy issues H.R. 1873/S. 164: Advancing Education on Biosimilars Act of 2021 Pharmaceutical Regulatory Policy Issues Defense Production Act (DPA) policy issues Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favored Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020)
Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019
Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy Tariffs CFIUS USMCA US Swiss Trade Agreement Pharmaceutical supply chain H.R. 2209 - Fixing Global Freeloading Act H.R. 6049 - Medical Supply Chain Security Act H.R. 6482 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 H.R. 6690 - Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6731 - Securing America's Pharmaceutical Supply Chain Act H.R. 6879 - Buy American Medical Supply Chain Act of 2020 H.R. 7492 - To designate all of Puerto Rico as an opportunity zone H.R. 7505 - American Innovation Act of 2020: Provisions related to manufacturing tax incentives H.R. 7574 - Strengthening America's Strategic National Stockpile Act of 2020 H.R. 7955 - 21st Century Buy American Act S. 3343 - Medical Supply Chain Security Act S. 3478 - To establish a commission to assess, evaluate, and address the dependence of the United States on medications, devices, and medical equipment from foreign countries S. 3537 - A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes S. 3942 - Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act S. 3945 - A bill to amend the Internal Revenue Code of 1986 to provide incentives for relocating manufacturing of pharmaceuticals and medical supplies and devices to the United States
S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538, Strengthening Americas Supply Chain and Medical Security Act H.R. 6431, Made in America Emergency Preparedness Act HR 6080, Prevent Drug Shortages Act S. 3432, Securing Americas Medicine Cabinet Act of 2020 H.R. 6670, Prescription for American Drug Independence Act of 2020 H.R. 6930, MADE in America Act HR 4439, Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772, Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370: Coronavirus Vaccine Act S. 3548: CARES Act H.R. 6080: Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400, The Advancing Education on Biosimilars Act of 2019 Vaccines
Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy Tariffs CFIUS USMCA US Swiss Trade Agreement Pharmaceutical supply chain
S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Generic drug approval process policy issues PDUFA implementation policy issues 340B drug discount program policy issues Cancer drug vial size policy issues Pharmaceutical supply chain Pharmaceutical quality H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act (COVID 2) H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 2740: Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes H.R. 3772, Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 H.R. 748: CARES Act - Provisions related to Part B, Part D, vaccines, transparency, and transportation H.R. 6074: Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - Provisions related to biomedical research and prescription drug pricing S. 3370: Coronavirus Vaccine Act - Provisions related to NIH funding S. 3548: CARES Act - Provisions related to supplemental appropriations and federal health programs H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues
Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS USMCA US Swiss Trade Agreement
S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.4633 - Investing in Safety and Innovation Act of 2019 H.R.5239 - Prescription Drug Price Reporting Act H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Generic drug approval process policy issues Risk Evaluation and Mitigation Strategy (REMS) policy issues PDUFA implementation policy issues 340B drug discount program policy issues Cancer drug vial size policy issues
Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS USMCA US Swiss Trade Agreement
S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 3 H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019
Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Columbia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS USMCA
HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Virtual Clinical Trials Part D Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019
Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Columbia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Clinical Trials Virtual Clinical Trials Part D Donut Hole Biosimilar Pass Through Payments Value Based Pricing
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines . Trade Promotion Authority . Trans-pacific Partnership . Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA USTR Special 301 Report/National Trade Estimate
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines . Trade Promotion Authority . Trans-pacific Partnership . Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines . Trade Promotion Authority . Trans-pacific Partnership . Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Columbia Intellectual Property
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Elibibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Elibibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Elibibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health IssuesIndia and Canada IP and Market Access Issues Trans-Pacific Partnership FTA Sub-Standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-Pacific Partnership - Trans Atlantic Trade and Investment Partnership HR 3830/S 1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health IssuesIndia and Canada IP and Market Access Issues Trans-Pacific Partnership FTA Sub-Standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-Pacific Partnership - Trans Atlantic Trade and Investment Partnership HR 3830/S 1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesIndia IP Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
S1128 Preserving Access to Orphan Drugs Act of 2013 H.R.2315 Preserving Access to Orphan Drugs Act of 2013
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesIndia IP Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill - FY 2014 Labor HHS Appropriations Bill
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
Orphan Drug Tax Credit
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices
Orphan Drug Tax Credit
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesTrans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues/Global Pandemic Influenza Planning Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (PREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program S.1855, HR 2405 Pandemic and All-Hazards Preparedness Act Reauthorization of 2011
Orphan Drug Tax Credit
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues/Global Pandemic Influenza Planning Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions FY 2013 - Labor HHS Appropriations Bill
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (RREA) Drug Distribution Security (Track & Trace)
H.R.1249 - America Invents Act S.23 - America Invents Act Patent Settlement Legislation - 2011
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues/Global Pandemic Influenza Planning
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues/Global Pandemic Influenza Planning Trans-Pacific Partnership FTA Sub-standards Medicines
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
Wage vs. Hour
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues
H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA
H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA
H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA
Free Trade Agreements: - Intellectual Property Provisions in Panama, Columbia, Korea Access to Medicines Global Health Issues
H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA
Free Trade Agreements: - Intellectual Property Provisions in Panama, Columbia, Korea Access to Medicines Global Health Issues
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs HR 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2010 Labor HHS Appropriations Bill - Pandemic Funding, Section 317 Program FY 2010 DoD Appropriations Bill - Transformational Medical Technologies Initiative Pandemic Funding
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs HR 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2010 Labor HHS Appropriations Bill - Pandemic Funding, Section 317 Program FY 2010 DoD Appropriations Bill - Transformational Medical Technologies Initiative Pandemic Funding
Vaccines for Children Program Vaccines for Adults Coverage Provide Medicare Part B Coverage for Vaccines Currenlty Under Part D Medicaid Coverage of Vaccines HR 3200 America's Affordable Health Choices Act of 2009 HR 2502 Comparative Effectiveness Research Act of 2009 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension
HR 1260 Patent Reform Act of 2009 S 515 Patent Reform Act of 2009 Patent Settlement Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Columbia, Korea
S 301 Physician Payments Sunshine Act of 2009 Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs HR 7110 Job Creatin and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2010 Labor HHS Appropriations Bill - Pandemic Funding, Section 317 Program FY 2010 DoD Appropriations Bill - Transformational Medical Technologies Initiative Pandemic Funding
Vaccines for Children Program Vaccines for Adults Coverage Provide Medicare Part B Coverage for Vaccines Currenlty Under Part D Medicaid Coverage of Vaccines HR 3200 America's Affordable Health Choices Act of 2009 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 2502 Comparative Effectiveness Research Act of 2009 S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension
DoD Authorization Language - Section 701 - Dealing with TriCare HR 3282 - Comprehensive Immunosuppressive drug Coverage for Kidney Transplant Patients Act of 2007 FY 2009 - Labor HHS Appropriations Bill - Pandemic Influenza Funding and Weldon Ammendment on Thimerosal and Vaccines LHHS Appropriations, Pandemic Influenza Funding HR 2642, S 3230 - 2008 Supplemental Appropriations Bill FY 2009 Department of Defense Appropriations Bill - Transformational Medical Initiative HR 2638 - Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 S 3604 - A bill making supplemental appropriations for economic recovery for fiscal year ending 9/30/08 (economic stimulus package) HR 7110 - Job Creation and Unemployment Relief Act of 2008 HR 1 - American Recovery and Reinvestment Act FY 2010 Labor HHS Appropriations Bill FY 2010 DoD Appropriations Bill
S 1145 - Patent Reform Act of 2007 HR 1908 - Patent Reform Act of 2007
HR 4703, S 2467, HR 4991 - Vaccine Shortage preparedness Act of 2008 S 2464, HR 4992, HR 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare Part B S 2465 - Vaccines for Children Access Act of 2008 HR 5839 - Safeguarding America's Pharmaceuticals Act of 2008 S 3408 - Comparative Effectiveness Research Act of 2008 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 970 and S 1378 - Dextromethorphan Distribution Act of 2007 S 103 - Combat Meth Act of 2005 HR 2207 - Agricultural Disaster Assistance and Western States Emergency - Unfinished business Appropriations Act of 2007 HR 1908 and S 1710 Patent Reform Act of 2007 HR 1 - Implementing the 9/11 Commission recommendations Act of 2007 HR 3162 - Children's Health and Medicare Protection Act of 2007 S 1505 - Affordable Biologics for Consumers Act S 1695 - Biologics Price Competition and Innovation Act of 2007 HR 1956 - Patent Protection and Innovative Biologic Medicines Act of 2007 HR 1038, S623 - Access to Life-Saving Medicine Act HR 4083 - Non-prescription Drug Modernization Act of 2007 HR 1308 - Legal Immigrant Children's Health Improvement Act of 2007 HR 5629 - Pathway for Biosimilars Act Comparative Effectiveness Research Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension
S 2029 - Physician Payments Sunshine Act of 2007 HR 6111 - Tax Relief and Healthcare Act (Medicare) Access to Life Saving Medicines Act Medicare Part B and Part D - Part D: Non-Interference/Part B: Prompt Pay Removal from Average Sales Price Calculation HR 6331 - Medicare Improvements for Patients and Providers Act of 2008 HR 2184 - Enhanced Health Care Value for all Act of 2007 HR 3023 Drug and Medical Device Company Gift Disclosure Act HR 3963 Children's Health Insurance Program Reauthorization Act of 2007 S 2041, HR 4854 - False Claims Act of Correction Act of 2007 HR 3610 - Food and Drug Import Safety Act of 2007 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
HR 4703, S 2467, HR 4991 - Vaccine Shortage preparedness Act of 2008 S 2464, HR 4992, HR 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare Part B S 2465 - Vaccines for Children Access Act of 2008 HR 5839 - Safeguarding America's Pharmaceuticals Act of 2008 S 3408 - Comparative Effectiveness Research Act of 2008 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 970 and S 1378 - Dextromethorphan Distribution Act of 2007 S 103 - Combat Meth Act of 2005 HR 2207 - Agricultural Disaster Assistance and Western States Emergency - Unfinished business Appropriations Act of 2007 HR 1908 and S 1710 Patent Reform Act of 2007 HR 1 - Implementing the 9/11 Commission recommendations Act of 2007 HR 3162 - Children's Health and Medicare Protection Act of 2007 S 1505 - Affordable Biologics for Consumers Act S 1695 - Biologics Price Competition and Innovation Act of 2007 HR 1956 - Patent Protection and Innovative Biologic Medicines Act of 2007 HR 1038, S623 - Access to Life-Saving Medicine Act HR 4083 - Non-prescription Drug Modernization Act of 2007 HR 1308 - Legal Immigrant Children's Health Improvement Act of 2007 HR 5629 - Pathway for Biosimilars Act Comparative Effectiveness Research Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension
DoD Authorization Language - Section 701 - Dealing with TriCare HR 3282 - Comprehensive Immunosuppressive drug Coverage for Kidney Transplant Patients Act of 2007 FY 2009 - Labor HHS Appropriations Bill - Pandemic Influenza Funding and Weldon Ammendment on Thimerosal and Vaccines LHHS Appropriations, Pandemic Influenza Funding 2009 - Supplemental Appropriations Bill FY 2009 Department of Defense Appropriations Bill - Transformational Medical Initiative
S 2029 - Physician Payments Sunshine Act of 2007 HR 6111 - Tax Relief and Healthcare Act (Medicare) Access to Life Saving Medicines Act Medicare Part B and Part D - Part D: Non-Interference/Part B: Prompt Pay Removal from Average Sales Price Calculation HR 6331 - Medicare Improvements for Patients and Providers Act of 2008 HR 2184 - Enhanced Health Care Value for all Act of 2007 HR 3023 Drug and Medical Device Company Gift Disclosure Act HR 3963 Children's Health Insurance Program Reauthorization Act of 2007 S 2041, HR 4854 - False Claims Act of Correction Act of 2007 HR 3610 - Food and Drug Import Safety Act of 2007 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
HR4703, S2467, HR4991 - Vaccine Shortage Preparedness Act of 2008 S2464, HR4992, HR4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare part B S. 2465, HR 4702, HR 4990 A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. S. 2467, HR 4703, HR 4991 A bill to amend the Social Security Act, the Federal Food, Drug and Cosmetic Act, and the Public Health Service Act to ensure a sufficient supply of vaccines, and for other purposes. HR4705 - Vaccines for the Uninsured Adult Act of 2008 S3678 H.R. 970 and S. 1378 - Dextromethorphan Distribution Act of 2007 S.3678 Pandemic All Hazards Preparedness Act (Biodefense) S.103 Combat Meth Act of 2005 H.R. 2207 - Agricultural Disaster Assistance and Western States Emergency Unfinished Business Appropriations Act of 2007 H.R. 1908 and S. 1710 - Patent Reform Act of 2007 H.R 1 - Implementing the 9/11 Commission Recommendations Act of 2007 H.R. 3162 - Children's Health and Medicare Protection Act of 2007 S. 1505 Affordable Biologics for Consumers Act S. 1695 Biologics Price Competition and Innovation Act of 2007 H.R. 1956 Patient Protection and Innovative Biologic Medicines Act of 2007 H.R. 1038 Access to Life-Saving Medicine Act S.623 Access to Life-Saving Medicine Act H.R. 4083 Non-Prescription Drug Modernization Act of 2007 S. 2311 Non-Prescription Drug Modernization Act of 2007 Comparative Effectiveness Research Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension Best Pharmaceuticals for Children's Act Pediatric Research Equity Act Pharmaceuticals in water FDA Funding Reagan/Udall Foundation Counter Detailing
DoD Authorization language - Section 701, Dealing with TriCare H.R. 2764 Consolidated Approps Bill - Pandemic Influenza Funding H.R. 3222 DoD Approps Bill - TMTI Program Funding H.R. 4156 FY '08 Iraq Supplemental Bill - Pandemic Influenza
S.1145 Patent Reform Act of 2007 H.R.1908 Patent Reform Act of 2007
Free Trade Agreements: - Peru, Columbia, Korea and Intellectual Property Issues USTR
H.R. 3428 OTC Medicine Tax Fairness Act of 2005 S. 1514 OTC Medicine Tax Fairness Act of 2005 H.R. 5280 Distribution Act of 2006 H.R. 6111 Tax Relief and health Care Act (Medicare) S.3678 Pandemic All Hazards Preparedness Act (Biodefense) S.103 Combat Meth Act of 2005 H.R. 314 Combat Meth Act of 2005 S.950 Elimination of Neglected Diseases Act of 2005 H.R. 3057 Dept. of State, Foreign Operations, and Related Programs Appropriations Act, 2006 H.R. 2744 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2006 Federal Food, Drug and Cosmetic Act (Section 767) H.R. 5762 Contact Lens Consumer Protection Act H.R. 5337 National Security Foreign Investment Reform and Strengthened Transparency Act of 2006 H.R. 2206 - Suplemental Appropriations H.R. 2207 - Agricultural Disaster Assistance and Western States Emergency Unfinished Business Appropriations Act of 2007 H.R. 1591 and S. 965 - US Troops Readiness, Veteran's Health, and Iraq Accountability Act of 2007 H.R. 3043 and S. 1710 - Department of Labor, Health and Human Services and Related Agenices Appropriations Act, 2008 H.R. 1908 and S. 1710 - Patent Reform Act of 2007 H.R 1 - Implementing the 9/11 Commission Recommendations Act of 2007 S. 1082 - Prescription Drug User Fee H.R. 2900 - Food and Drug Administration Amendments Act of 2007 H.R. 3282 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2007 H.R. 3162 - Children's Health and Medicare Protection Act of 2007 Access to Life Saving Medicines Act Citizens Petition Access to Generics Public Health Service Act Drug Importation Medicare Part B and Part D Sickle Cell Anemia Immunosuppressant Legislation Gene Therapy Direct to Consumer Advertising Medicare Prescription Drugs and Modernization Act Follow-on Biologics Patent Law Reform Authorized Generics Drug Safety Legislation DoD Authorization Language Global Hypertension Best Pharmaceuticals for Children's Act Pediatric Research Equity Act H.R. 970 and S. 1378 - Dextromethorphan Distribution Act of 2007 S. 930 - Food and Drug Administration Safety Act of 2005 H.R. 2090 - Food and Drug Administration Improvement Act of 2005 S. 470 FACT Act
H.R. 3428 OTC Medicine Tax Fairness Act of 2005 S. 1514 OTC Medicine Tax Fairness Act of 2005 S. 3807 To amend the Federal Food, Drug and Cosmetic Act to provide for the regulation of all contact lenses as medical devices,and for other purposes H.R. 371 To amend the Federal Food, Drug and Cosmetic Act to provide for the regulation of all contaact lenses as medical devices, and for other purposes H.R. 5280 Distribution Act of 2006 H.R. 6111 Tax Relief and health Care Act (Medicare) S.3678 Pandemic All Hazards Preparedness Act (Biodefense) S.103 Combat Meth Act of 2005 H.R. 314 Combat Meth Act of 2005 S.950 Elimination of Neglected Diseases Act of 2005 H.R. 3057 Dept. of State, Foreign Operations, and Related Programs Appropriations Act, 2006 H.R. 2744 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2006 Federal Food, Drug and Cosmetic Act (Section 767) H.R. 5762 Contact Lens Consumer Protection Act H.R. 5337 National Security Foreign Investment Reform and Strengthened Transparency Act of 2006 Access to Life Saving Medicines Act Citizens Petition Access to Generics Public Health Service Act Drug Importation Medicare Part B and Part D Sickle Cell Anemia Immunosuppressant Legislation Cancer Therapies Legislation Gene Therapy Direct to Consumer Advertising Medicare Prescription Drugs and Modernization Act Follow-on Biologics Patent Law Reform Authorized Generics Drug Safety Legislation 1-800 Contacts DoD Authorization Language H.R. 2218 Regulation of non corrective contact lens as medical devises S. 930 Food and Drug Administration Safety Act of 2005 H.R. 2090 Food and Drug Administration Improvement Act of 2005 S. 470 FACT Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
China/World Trade Organization Free Trade Agreements
H.R.2218 Regulation of non corrective contact lens as medical devices S.930 Food and Drug Administration Safety Act of 2005 H.R.2090 Food and Drug Administration Improvement Act of 2005 H.R.3196 - Fair Access to Clinical Trials Act S. 470 - FACT Act H.R.3428 - OTC Medicine Tax Fairness Act of 2005 S.1514 - OTC Medicine Tax Fairness Act of 2005 S.172 - To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of all contact lenses as medical devices, and for other purposes. H.R.371 - To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of all contact lenses as medical devices, and for other purposes. S.103 - Combat Meth Act of 2005 H.R.314 - Combat Meth Act of 2005 S.950 Elimination of Neglected Diseases Act of 2005 H.R.3057 Dept. of State, Foreign Operations, and Related Programs Appropriations Act, 2006 Drug Importation Medicare Part B and Part D Sickle Cell Anemia Immunosuppressant Legislation Cancer Therapies Legislation Gene Therapy Direct to Consumer Advertising Medicare Prescription Drugs & Modernization Act
S1225 Greater Access to Affordable Pharmaceuticals Act
H.R.2218 Regulation of non corrective contact lens as medical devices S.1 Prescription Drug and Medicare Improvement Act of 2003 H.R.1 Medicare Prescription Drug Modernization Act of 2003 H.R.2427 Pharmaceutical Market Access Act of 2003 H.R.1288/S.1037 Access to Cancer Therapies Act of 2003 S.178 Comprehensive Immunosuppressive Drug Coverage for Transplant patients Act of 2003 S.191/H.R.2223 Immunosuppressive drug Coverage Act of 2003 H.R.2356 Prescription Drug Comparative Effectiveness Act of 2003 S.650/H.R.2857 Pediatric Research Equity Act of 2003 H.R.2769 Save our Seniors Act of 2003 H.R.2427 Pharmaceutical Market Access Act of 2003 H.R.1170 Child Medication Safety Act of 2003 H.R.2218 Federal Food, Drug, and Cosmetic Act Medicare Prescription Drugs Breaux/Thomas Medicare Reform Plan Health Insurance Portability and Accessibility Act FDA Modernization Act Medical Records Privacy - Senator jeffords, Bennett, Leahy, Kennedy bills Prospective Payment system Gene Therapy Drug Reimportation Medicare Reform Agriculture Appropriation 2001 - Drug Reimportation Agriculture Appropriation 2001 (FDA Funding) Stem Cell Research Pediatric Exclusivity Direct-to-Consumer Advertising The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill)
H.R.2218 Regulation of non corrective contct lens as medical devices S1 Prescription Drug and Medicare Improvement oAct of 2003 H.R.1 Medicare Prescription Drug Modernization Act of 2003 H.R.2427 Pharmaceutical market Access Act of 2003 H.R.2857 Pediatric Research Equity Act of 2003 H.R.1170 Child Medication Safety Act of 2003 Medicare Prescription Drugs & Modernization Act the Bipartisan Medicare Prescription Drug Act of 2001 (Sen.Kennedy-Draft Bill) Prospective Payment System Medicare Reform
H.R.2896 American Jobs Creation Act of 2003 S.1637 Jumpstart Our Business Strength (JOBS) Act
H.R.2218, Regulation of non corrective contact lens as medical devices S.1, Prescription Drug and Medicare Improvement Act of 2003 H.R.1, Medicare Prescription Drug Modernization Act of 2003 H.R.2427, Pharmaceutical Market Access Act of 2003 HR1288/S1037, Access to Cancer Therapies Act of 2003 S178, Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2003 S191/HR2223, Immunosuppressive Drug Coverage Act of 2003 HR588, Medicare Fairness for Organ Transplant Recipients Act of 2003 HR2356, Prescription Drug Comparative Effectiveness Act of 2003 S.650/HR2857, Pediatric Research Equity Act of 2003 HR2769, Save our Seniors Act of 2003 HR2427 Pharmaceutical Market Access Act of 2003 HR1170, Child Medication Safety Act of 2003 Medicare Prescription Drugs Breaux/Thomas Medicare Reform Plan Health Insurance Portability and Accessibility Act FDA Modernization Act Medical Records Privacy – Senators Jeffords, Bennett, Leahy, Kennedy Bills Prospective Payment System Gene Therapy Drug Reimportation Medicare Reform Agriculture appropriation 2001 – Drug Reimportation Agriculture appropriation 2001 (FDA funding) Stem Cell Research Pediatric Exclusivity Direct-to-Consumer Advertising The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill)
S.1225, Greater Access to Affordable Pharmaceuticals Act
H.R.2218, Regulation of non corrective contact lens as medical devices S.1, Prescription Drug and Medicare Improvement Act of 2003 H.R.1, Medicare Prescription Drug Modernization Act of 2003 H.R.2427, Pharmaceutical Market Access Act of 2003 HR1288/S1037, Access to Cancer Therapies Act of 2003 S178, Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2003 S191/HR2223, Immunosuppressive Drug Coverage Act of 2003 HR588, Medicare Fairness for Organ Transplant Recipients Act of 2003 HR2356, Prescription Drug Comparative Effectiveness Act of 2003 S.650, Pediatric Research Equity Act of 2003 HR2769, Save our Seniors Act of 2003 HR2427 Pharmaceutical Market Access Act of 2003 HR2857, Pediatric Research Equity Act of 2003 HR1170, Child Medication Safety Act of 2003 Medicare Prescription Drugs & Modfernization Act The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill) Prospective Payment System Medicare Reform
H.R.2218 Regulation of non corrective contact lens as medical devices S.1 Prescription Drug and Medicare Improvement Act of 2003 H.R.1 Medicare Prescription Drug Modernization Act of 2003 H.R.2427 Pharmaceutical Market Access Act of 2003 H.R 1288/S.1037 Access to Cancer Therapies Act of 2003 S.178 Comprehensive Immunospuppressive Drug Coverage for Transplant patients Act of 2003 S.191/H.R.2223 Immunosuppressive drug Coverage Act of 2003 H.R.588 Medicare Fairness for Organ Transplant Recipients Act of 2003 H.R.2356 Prescription Drug Comparative Effectiveness Act of 2003 S.650/H.R.2857 Pediatric Research Equity Act of 2003 H.R.2769 Save our Seniors Act of 2003 H.R.2427 Pharmaceutical Market Access Act of 2003 H.R. 1170 Child Medication Safety Act of 2003 H.R.2218 Federal Food, Drug, and Cosmetic Act Medicare Prescription Drugs Breaux/Thomas Medicare Reform Plan Health Insurance Portability and Accessibility Act FDA Modernization Act Medical Records Privacy - Senator Jeffords, Bennett, Leahy, Kennedy Bills Prospective Payment System Gene Therapy Drug Reimportation Medicare Reform Agriculture Appropriation 2001 - Drug Reimportation Agriculture Appropriation 2001 (FDA Funding) Stem Cell Research Pediatric Exclusivity Direct-to-Consumer Advertising The Bipartisan Medicare Prescription Drug Act of 2001 (Sen.Kennedy-Draft Bill)
H.R.2218, Regulation of non corrective contact lens as medical devices S.1, Prescription Drug and Medicare Improvement Act of 2003 H.R.1, Medicare Prescription Drug Modernization Act of 2003 H.R.2427, Pharmaceutical Market Access Act of 2003 HR1288/S1037, Access to Cancer Therapies Act of 2003 S178, Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2003 S191/HR2223, Immunosuppressive Drug Coverage Act of 2003 HR588, Medicare Fairness for Organ Transplant Recipients Act of 2003 HR2356, Prescription Drug Comparative Effectiveness Act of 2003 S.650, Pediatric Research Equity Act of 2003 HR2769, Save our Seniors Act of 2003 HR2427 Pharmaceutical Market Access Act of 2003 HR2857, Pediatric Research Equity Act of 2003 HR1170, Child Medication Safety Act of 2003 Medicare Prescription Drugs & Modfernization Act The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill) Prospective Payment System Medicare Reform
S970/HR1769, Job Protection Act of 2003 Economic Sanction SRM Ban/BSE China/World Trade Organization Fast Track Negotiating Authority Capital Market Sanctions Chile and Singapore FTAs
H.R.2218, Regulation of non corrective contact lens as medical devices S.1, Prescription Drug and Medicare Improvement Act of 2003 H.R.1, Medicare Prescription Drug Modernization Act of 2003 H.R.2427, Pharmaceutical Market Access Act of 2003 HR1288/S1037, Access to Cancer Therapies Act of 2003 S178, Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2003 S191/HR2223, Immunosuppressive Drug Coverage Act of 2003 HR588, Medicare Fairness for Organ Transplant Recipients Act of 2003 HR2356, Prescription Drug Comparative Effectiveness Act of 2003 S.650/HR2857, Pediatric Research Equity Act of 2003 HR2769, Save our Seniors Act of 2003 HR2427 Pharmaceutical Market Access Act of 2003 HR1170, Child Medication Safety Act of 2003 Medicare Prescription Drugs Breaux/Thomas Medicare Reform Plan Health Insurance Portability and Accessibility Act FDA Modernization Act Medical Records Privacy – Senators Jeffords, Bennett, Leahy, Kennedy Bills Prospective Payment System Gene Therapy Drug Reimportation Medicare Reform Agriculture appropriation 2001 – Drug Reimportation Agriculture appropriation 2001 (FDA funding) Stem Cell Research Pediatric Exclusivity Direct-to-Consumer Advertising The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill)
National Uniformity for Food Genetically Engineered Food Right to Know Act Country of Origin Labeling GMO Labeling
Economic Sanctions SRM Ban/BSE China/World Trade Organization Fast Track Negotiating Authority Capital Market Sanctions Chile and Singapore FTA's
HR1387, Drug Availability and Health Care Access Improvement Act of 2001 HR1530, Prescription Drug Competition Act of 2001 HR1624/S913, Access to Cancer Therapies Act of 2001 S1239, Medicare Rx Drug Discount and Security Act of 2001 S10, Medicare Prescription Drug Coverage Act of 2001 S1135, Medicare Reform Act of 2001 S1185, Seniors Prescription Insurance Coverage Equity Act of 2001 S838, Better Pharmaceuticals for Children Act S880/HR1839, Immunosuppressive Drug Coverage Act of 2001 S982/HR2058, Medicare Wellness Act of 2001 Medicare Prescription Drugs Snow/Wyden The Senior Prescription Insurance Coverage Equity Act (S1185) Breaux/Thomas Medicare Reform Plan Health Insurance Portability and Accessibility Act FDA Modernization Act Medical Records Privacy- Senators Jeffords, Bennett, Leahy, Kennedy Bills Prospective payment System Gene Therapy Drug Reimporation Medicare Reform Agriculture Appropriations 2001 - Drug Reimportation Agriculture Apropriation 2001 (FDA Funding) Stem Cell Research Pediatric Exclusivity Direct-to-Consumer Advertising PDUFA The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill) President Bush's "Helping Hand" proposal
National Uniformity for Food Genetically Engineered Food Right to Know Act Country of Origin Labeling GMO Labeling
HR1387, Drug Availability and Health Care Access Improvement Act of 2001 HR1530, Prescription Drug Competition Act of 2001 HR1624/S913, Access to Cancer Therapies Act of 2001 S1239, Medicare Rx Drug Discount and Security Act of 2001 S10, Medicare Prescription Drug Coverage Act of 2001 S1135, Medicare Reform Act of 2001 S1185, Seniors Prescription Insurance Coverage Equity Act of 2001 S838, Better Pharmaceuticals for Children Act S880/HR1839, Immunosuppressive Drug Coverage Act of 2001 S982/HR2058, Medicare Wellness Act of 2001 Medicare Prescription Drugs Snow/Wyden The Senior Prescription Insurance Coverage Equity Act (S1185) Breaux/Thomas Medicare Reform Plan Health Insurance Portability and Accessibility Act FDA Modernization Act Medical Records Privacy- Senators Jeffords, Bennett, Leahy, Kennedy Bills Prospective payment System Gene Therapy Drug Reimporation Medicare Reform Agriculture Appropriations 2001 - Drug Reimportation Agriculture Apropriation 2001 (FDA Funding) Stem Cell Research Pediatric Exclusivity Direct-to-Consumer Advertising PDUFA The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill) President Bush's "Helping Hand" proposal
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
Filing targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE
Filing targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS)
Access to Medicines Issues Biopharmaceutical Innovation Policies CFIUS China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Sub-standards Medicines Supply chain and China Task Force policy issues Tariffs Trade Policy UK Agreement US Swiss Trade Agreement USMCA USTR Special 301 Report/National Trade Estimate WTO IP Waiver
Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Data Exclusivity Intellectual Property Issues in Response to coronavirus Patents Section 101 Compulsory licenses Antitrust Legislation S.225, Competition and Antitrust Law Enforcement Reform Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 S.1435, Affordable Prescriptions for Patients Act of 2021
ACA Pharmaceutical Industry Fee Exclusions Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives Tax Treaties Thin Capitalization Rules 163(j) R&D Amortization U.S. Corporate Tax Administration's FY 2022 Revenue Proposals Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n)) Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD)
Biosimilars Drug Pricing Fiscal year 2022 Appropriations Importation Value of Medicine H.R.133, Consolidated Appropriations Act for FY 2021 H.R.1319, American Rescue Plan Act of 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Prescription Drug User Fee Act (PDUFA) VII Priorities Advanced Research Projects Agency for Health (ARPA-H)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
Access to Medicines Issues Biopharmaceutical Innovation Policies CFIUS China Agreement Free Trade Agreements - Intellectual Property and Transparency Provisions Global Health Issues India, China and Canada IP and Market Access Issues Intellectual property International Market Access and Intellectual Property Issues Pharmaceutical Supply Chain Pricing and reimbursement policy issues Quality of Medicines Regulatory Cooperation Sub-standards Medicines Supply chain and China Task Force policy issues Tariffs Trade Policy UK Agreement USMCA USTR Special 301 Report/National Trade Estimate WTO IP Waiver
Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Data Exclusivity Intellectual Property Issues in Response to coronavirus Patents Section 101
Base Erosion Anti-Abuse Tax (BEAT) OECD Digital Tax Orphan Drug Tax Pharmaceutical supply chain incentives Thin Capitalization Rules 163(j) U.S. Corporate Tax
Artificial intelligence Data and digital technologies
Biosimilars Drug Pricing Fiscal year 2022 Appropriations H.R.1, For the People Act of 2021 H.R.1319, American Rescue Plan Act of 2021 Importation Value of Medicine
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act CARES Act, Pub. L. 116-136 H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R.2374 - Stop STALLING Act H.R. 5239 - Prescription Drug Price Reporting Act H.R. 6258 - Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 H.R. 6390 - To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak H.R. 6410 - To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 H.R. 6395/S. 4049 - National Defense Authorization Act for Fiscal Year 2021 HHS PREP Act declaration relating to COVID-19 Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues FDA modernization policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatory recall authority policy issues COVID-19 policy issues Transparency Issues Policy Issue H.R. 2477 - Beneficiary Enrollment Notification and the Eligibility Simplification (BENES) Act of 2019 H.R. 6800 - Heroes Act
Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements China Agreement UK Agreement Intellectual Property Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy Tariffs CFIUS USMCA Pharmaceutical supply chain H.R. 2209 - Fixing Global Freeloading Act H.R. 6049 - Medical Supply Chain Security Act H.R. 6482 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 H.R. 6690 - Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6731 - Securing America's Pharmaceutical Supply Chain Act H.R. 6879 - Buy American Medical Supply Chain Act of 2020 H.R. 7492 - To designate all of Puerto Rico as an opportunity zone H.R. 7505 - American Innovation Act of 2020: Provisions related to manufacturing tax incentives H.R. 7574 - Strengthening America's Strategic National Stockpile Act of 2020 H.R. 7955 - 21st Century Buy American Act S. 3343 - Medical Supply Chain Security Act S. 3478 - To establish a commission to assess, evaluate, and address the dependence of the United States on medications, devices, and medical equipment from foreign countries S. 3537 - A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes S. 3942 - Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act S. 3945 - A bill to amend the Internal Revenue Code of 1986 to provide incentives for relocating manufacturing of pharmaceuticals and medical supplies and devices to the United States H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6393 - Strengthening America's Supply Chain and National Security Act H.R. 6930 - MADE in America Act of 2020 H.R. 8943 - Pandemic Supplies Production Act H.R. 8987 - Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020 H.R. 8905 - Supply Chain Security and Pharmaceutical Authentication Act of 2020 S. 3635 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 S. 4175 - Pharmaceutical Supply Chain Defense and Enhancement Act S. 4194 - National Institute of Manufacturing Act Pricing and reimbursement policy issues Supply chain and China Task Force policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain HR 6800 - Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act S. 3548 - CARES Act H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act
Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy Tariffs CFIUS USMCA US Swiss Trade Agreement Pharmaceutical supply chain
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesIndia IP Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Orphan Drug Tax Credit
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesIndia IP Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesIndia IP Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of VaccinesHR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (Track & Trace) Certified Importer Program MDUFA (MIdical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions FY 2013 - Labor HHS Appropriations Bill
Orphan Drug Tax Credit
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions FY 2013 - Labor HHS Appropriations Bill
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (PREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program S.1855, HR 2405 Pandemic and All-Hazards Preparedness Act Reauthorization of 2011
Filing targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Free Trade Agreements: - Intellectual Property Provisions Access to Medicines Global Health Issues/Global Pandemic Influenza Planning Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Orphan Drug Tax Credit
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (RREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)
Orphan Drug Tax Credit
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions FY 2013 - Labor HHS Appropriations Bill
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions Access to Medicines Global Health Issues/Global Pandemic Influenza Planning Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Wage vs. Hour
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Wage vs. Hour
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
Orphan Drug Tax Credit
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
H.R.1249 - America Invents Act S.23 - America Invents Act Patent Settlement Legislation - 2011
Orphan Drug Tax Credit
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Orphan Drug Tax Credit
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
H.R.1249 - America Invents Act S.23 - America Invents Act Patent Settlement Legislation - 2011
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues/Global Pandemic Influenza Planning
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues/Global Pandemic Influenza Planning
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues/Global Pandemic Influenza Planning
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs HR 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2010 Labor HHS Appropriations Bill - Pandemic Funding, Section 317 Program FY 2010 DoD Appropriations Bill - Transformational Medical Technologies Initiative Pandemic Funding
HR 1260 Patent Reform Act of 2009 S 515 Patent Reform Act of 2009 Patent Settlement Legislation
Filing targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs HR 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2010 Labor HHS Appropriations Bill - Pandemic Funding, Section 317 Program FY 2010 DoD Appropriations Bill - Transformational Medical Technologies Initiative Pandemic Funding
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues
HR 1260 Patent Reform Act of 2009 S 515 Patent Reform Act of 2009 Patent Settlement Legislation
Filing targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues
Filing targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Filing targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
HR 1260 Patent Reform Act of 2009 S 515 Patent Reform Act of 2009 Patent Settlement Legislation
H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA
Filing targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
S 301 Physician Payments Sunshine Act of 2009 Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
HR 1260 Patent Reform Act of 2009 S 515 Patent Reform Act of 2009 Patent Settlement Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Columbia, Korea
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
Vaccines for Children Program Vaccines for Adults Coverage Provide Medicare Part B Coverage for Vaccines Currenlty Under Part D Medicaid Coverage of Vaccines HR 3200 America's Affordable Health Choices Act of 2009 HR 2502 Comparative Effectiveness Research Act of 2009 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs HR 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2010 Labor HHS Appropriations Bill - Pandemic Funding, Section 317 Program FY 2010 DoD Appropriations Bill - Transformational Medical Technologies Initiative Pandemic Funding
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
HR 1260 Patent Reform Act of 2009 S 515 Patent Reform Act of 2009 Patent Settlement Legislation
S 301 Physician Payments Sunshine Act of 2009 Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Columbia, Korea
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
Free Trade Agreements: - Intellectual Property Provisions in Panama, Columbia, Korea
HR 4703, S 2467, HR 4991 - Vaccine Shortage preparedness Act of 2008 S 2464, HR 4992, HR 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare Part B S 2465 - Vaccines for Children Access Act of 2008 HR 2 - Children's Health Insurance Program Reauthorization Act of 2009 S 75 - Generics First Act 2009 S 80 - Importation of Prescription Drugs S 301 - Physician Payments Sunshine Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 5839 - Safeguarding America's Pharmaceuticals Act of 2008 S 3408 - Comparative Effectiveness Research Act of 2008 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 970 and S 1378 - Dextromethorphan Distribution Act of 2007 S 103 - Combat Meth Act of 2005 HR 2207 - Agricultural Disaster Assistance and Western States Emergency - Unfinished business Appropriations Act of 2007 HR 1908 and S 1710 Patent Reform Act of 2007 HR 1 - Implementing the 9/11 Commission recommendations Act of 2007 HR 3162 - Children's Health and Medicare Protection Act of 2007 S 1505 - Affordable Biologics for Consumers Act S 1695 - Biologics Price Competition and Innovation Act of 2007 HR 1956 - Patent Protection and Innovative Biologic Medicines Act of 2007 HR 1038, S623 - Access to Life-Saving Medicine Act HR 4083 - Non-prescription Drug Modernization Act of 2007 HR 1308 - Legal Immigrant Children's Health Improvement Act of 2007 HR 5629 - Pathway for Biosimilars Act HR 1427 - To amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes S 726 - A bill to amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes Comparative Effectiveness Research Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension
S 2029 - Physician Payments Sunshine Act of 2007 HR 6111 - Tax Relief and Healthcare Act (Medicare) Access to Life Saving Medicines Act Medicare Part B and Part D - Part D: Non-Interference/Part B: Prompt Pay Removal from Average Sales Price Calculation HR 6331 - Medicare Improvements for Patients and Providers Act of 2008 HR 2184 - Enhanced Health Care Value for all Act of 2007 HR 3023 Drug and Medical Device Company Gift Disclosure Act HR 3963 Children's Health Insurance Program Reauthorization Act of 2007 S 2041, HR 4854 - False Claims Act of Correction Act of 2007 HR 3610 - Food and Drug Import Safety Act of 2007 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
S 2029 - Physician Payments Sunshine Act of 2007 HR 6111 - Tax Relief and Healthcare Act (Medicare) Access to Life Saving Medicines Act Medicare Part B and Part D - Part D: Non-Interference/Part B: Prompt Pay Removal from Average Sales Price Calculation HR 6331 - Medicare Improvements for Patients and Providers Act of 2008 HR 2184 - Enhanced Health Care Value for all Act of 2007 HR 3023 Drug and Medical Device Company Gift Disclosure Act HR 3963 Children's Health Insurance Program Reauthorization Act of 2007 S 2041, HR 4854 - False Claims Act of Correction Act of 2007 HR 3610 - Food and Drug Import Safety Act of 2007 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions in Peru, Columbia, Korea
S 1145 - Patent Reform Act of 2007 HR 1908 - Patent Reform Act of 2007
DoD Authorization Language - Section 701 - Dealing with TriCare HR 3282 - Comprehensive Immunosuppressive drug Coverage for Kidney Transplant Patients Act of 2007 FY 2009 - Labor HHS Appropriations Bill - Pandemic Influenza Funding and Weldon Ammendment on Thimerosal and Vaccines LHHS Appropriations, Pandemic Influenza Funding HR 2642, S 3230 - 2008 Supplemental Appropriations Bill FY 2009 Department of Defense Appropriations Bill - Transformational Medical Initiative HR 2638 - Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 S 3604 - A bill making supplemental appropriations for economic recovery for fiscal year ending 9/30/08 (economic stimulus package) HR 7110 - Job Creation and Unemployment Relief Act of 2008
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
Free Trade Agreements: - Intellectual Property Provisions in Peru, Columbia, Korea
S 1145 - Patent Reform Act of 2007 HR 1908 - Patent Reform Act of 2007
DoD Authorization Language - Section 701 - Dealing with TriCare HR 3282 - Comprehensive Immunosuppressive drug Coverage for Kidney Transplant Patients Act of 2007 FY 2009 - Labor HHS Appropriations Bill - Pandemic Influenza Funding and Weldon Ammendment on Thimerosal and Vaccines LHHS Appropriations, Pandemic Influenza Funding HR 2642, S 3230 - 2008 Supplemental Appropriations Bill FY 2009 Department of Defense Appropriations Bill - Transformational Medical Initiative HR 2638 - Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 S 3604 - A bill making supplemental appropriations for economic recovery for fiscal year ending 9/30/08 (economic stimulus package) HR 7110 - Job Creation and Unemployment Relief Act of 2008
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
HR 4703, S 2467, HR 4991 - Vaccine Shortage preparedness Act of 2008 S 2464, HR 4992, HR 4704 - A bill to amend title XVIII of the Social Security Act to provide for coverage of federally recommended vaccines under Medicare Part B S 2465 - Vaccines for Children Access Act of 2008 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 S 2467 - Vaccine shortage preparedness Act of 2008 S 3678 - /PL 109-417 All pandemic and all-hazards act - Section 317 program issues HR 970 and S 1378 - Dextromethorphan Distribution Act of 2007 S 103 Combat Meth Act of 2005 HR 2207 - Agricultural Disaster Assistance and Western States Emergency - Unfinished business Appropriations Act of 2007 HR 1908 and S 1710 Patent Reform Act of 2007 HR 1 - Implementing the 9/11 Commission recommendations Act of 2007 HR 3162 - Children's Health and Medicare Protection Act of 2007 S 1505 Affordable Biologics for Consumers Act S 1695 Biologics Price Competition and Innovation Act of 2007 HR 1956 - Patent Protection and Innovative Biologic Medicines Act of 2007 HR 1038, S623 - Access to Life-Saving Medicine Act HR 4083 - Non-prescription Drug Modernization Act of 2007 HR 1308 - Legal Immigrant Children's Health Improvement Act of 2007 HR 5629 - Pathway for Biosimilars Act Comparative Effectiveness Research Public Health Service Act Drug Importation Gene Therapy Direct to Consumer Advertising Drug Safety Legislation Global Hypertension
S 1145 - Patent Reform Act 2007 HR 1908 - Patent Reform Act of 2007
Free Trade Agreements: - Intellectual Property Provisions in Peru, Columbia, Korea
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
DoD Authorization language - Section 701, Dealing with TriCare H.R. 3282 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2007 FY 2009 Labor HHS Appropriations Bill - Pandemic Influenza Funding and Weldon Ammendment on Thimerosal and Vaccines 2009 Supplemental Appropriations Bill FY 2009 Department of Defense Appropriations Bill - Transformational Medical Technologies Initiative
S.1145 Patent Reform Act of 2007 H.R.1908 Patent Reform Act of 2007
S. 2029 Physician Payments Sunshine Act of 2007 H.R. 6111 Tax Relief and health Care Act (Medicare) Access to Life Saving Medicines Act Medicare Part B and Part D - Part D: Non-Interference Part B: Prompt Pay Removal from Average Sales Price Calculation Immunosuppressant Legislation Medicare Prescription Drugs and Modernization Act H.R.2184 Enhanced Health Care Value for All Act of 2007 H.R.3023 Drug and Medical Device Company Gift Disclosure Act H.R. 3963Children's Health Insurance Program Reauthorization Act of 2007 S.2041 False Claims Act Correction Act of 2007 HR 4854 False Claims Act Correction Act of 2007 HR3610 Food and Drug Import Safety Act of 2007
Free Trade Agreements: - Intellectual Property Provisions in Peru, Columbia, Korea
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
S. 2029 Physician Payments Sunshine Act of 2007 H.R. 6111 Tax Relief and health Care Act (Medicare) Access to Life Saving Medicines Act Medicare Part B and Part D - Part D: Non-Interference Part B: Prompt Pay Removal from ASP Calculation
H.R. 970 and S. 1378 - Dextromethorphan Distribution Act of 2007 S.3678 Pandemic All Hazards Preparedness Act (Biodefense) S.103 Combat Meth Act of 2005 H.R. 2206 - Suplemental Appropriations
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
China/World Trade Organization Free Trade Agreements Commerce USTR
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
China/World Trade Organization Free Trade Agreements Commerce USTR
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
H.R.2896 American Jobs Creation Act of 2003 S.1637 Jumpstart Our Business Strength (JOBS) Act
H.R.2218 Regulation of non corrective contct lens as medical devices S1 Prescription Drug and Medicare Improvement oAct of 2003 H.R.1 Medicare Prescription Drug Modernization Act of 2003 H.R.2427 Pharmaceutical market Access Act of 2003 H.R.2857 Pediatric Research Equity Act of 2003 H.R.1170 Child Medication Safety Act of 2003 Medicare Prescription Drugs & Modernization Act the Bipartisan Medicare Prescription Drug Act of 2001 (Sen.Kennedy-Draft Bill) Prospective Payment System Medicare Reform
Economic Sanction China/World Trade Organization Free Trade Agreements
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
H.R.2218 Regulation of non corrective contact lens as medical devices S.1 Prescription Drug and Medicare Improvement Act of 2003 H.R.1 Medicare Prescription Drug Modernization Act of 2003 H.R.2427 Pharmaceutical Market Access Act of 2003 H.R.1288/S.1037 Access to Cancer Therapies Act of 2003 S.178 Comprehensive Immunosuppressive Drug Coverage for Transplant patients Act of 2003 S.191/H.R.2223 Immunosuppressive drug Coverage Act of 2003 H.R.2356 Prescription Drug Comparative Effectiveness Act of 2003 S.650/H.R.2857 Pediatric Research Equity Act of 2003 H.R.2769 Save our Seniors Act of 2003 H.R.2427 Pharmaceutical Market Access Act of 2003 H.R.1170 Child Medication Safety Act of 2003 H.R.2218 Federal Food, Drug, and Cosmetic Act S.874/H.R.1736 Sickle Cell Treatment Act Medicare Prescription Drugs Breaux/Thomas Medicare Reform Plan Health Insurance Portability and Accessibility Act FDA Modernization Act Medical Records Privacy - Senator jeffords, Bennett, Leahy, Kennedy bills Prospective Payment system Gene Therapy Drug Reimportation Medicare Reform Agriculture Appropriation 2001 - Drug Reimportation Agriculture Appropriation 2001 (FDA Funding) Stem Cell Research Pediatric Exclusivity Direct-to-Consumer Advertising The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill)
S1225 Greater Access to Affordable Pharmaceuticals Act
Economic Sanction SRM Ban/BSE China/World Trade Organization Fast Track Negotiating Authority Free Trade Agreements
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
S.1225, Greater Access to Affordable Pharmaceuticals Act
H.R.2218, Regulation of non corrective contact lens as medical devices S.1, Prescription Drug and Medicare Improvement Act of 2003 H.R.1, Medicare Prescription Drug Modernization Act of 2003 H.R.2427, Pharmaceutical Market Access Act of 2003 HR1288/S1037, Access to Cancer Therapies Act of 2003 S178, Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2003 S191/HR2223, Immunosuppressive Drug Coverage Act of 2003 HR588, Medicare Fairness for Organ Transplant Recipients Act of 2003 HR2356, Prescription Drug Comparative Effectiveness Act of 2003 S.650, Pediatric Research Equity Act of 2003 HR2769, Save our Seniors Act of 2003 HR2427 Pharmaceutical Market Access Act of 2003 HR2857, Pediatric Research Equity Act of 2003 HR1170, Child Medication Safety Act of 2003 Medicare Prescription Drugs & Modfernization Act The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill) Prospective Payment System Medicare Reform
S970/HR1769, Job Protection Act of 2003 Economic Sanction SRM Ban/BSE China/World Trade Organization Fast Track Negotiating Authority Capital Market Sanctions Chile and Singapore FTAs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
S970/HR1769, Job Protection Act of 2003 Economic Sanction SRM Ban/BSE China/World Trade Organization Fast Track Negotiating Authority Capital Market Sanctions Chile and Singapore FTAs
H.R.2218, Regulation of non corrective contact lens as medical devices S.1, Prescription Drug and Medicare Improvement Act of 2003 H.R.1, Medicare Prescription Drug Modernization Act of 2003 H.R.2427, Pharmaceutical Market Access Act of 2003 HR1288/S1037, Access to Cancer Therapies Act of 2003 S178, Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2003 S191/HR2223, Immunosuppressive Drug Coverage Act of 2003 HR588, Medicare Fairness for Organ Transplant Recipients Act of 2003 HR2356, Prescription Drug Comparative Effectiveness Act of 2003 S.650/HR2857, Pediatric Research Equity Act of 2003 HR2769, Save our Seniors Act of 2003 HR2427 Pharmaceutical Market Access Act of 2003 HR1170, Child Medication Safety Act of 2003 Medicare Prescription Drugs Breaux/Thomas Medicare Reform Plan Health Insurance Portability and Accessibility Act FDA Modernization Act Medical Records Privacy – Senators Jeffords, Bennett, Leahy, Kennedy Bills Prospective Payment System Gene Therapy Drug Reimportation Medicare Reform Agriculture appropriation 2001 – Drug Reimportation Agriculture appropriation 2001 (FDA funding) Stem Cell Research Pediatric Exclusivity Direct-to-Consumer Advertising The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
HR2218 Regulation of non corrective contact lens as medical devices S1 Prescription Drug and Medicare Improvement Act of 2003 HR1 Medicare Prescription Drug Modernization Act of 2003 HR2427 Pharmaceutical Market Access Act of 2003 HR2857 Pedicatric Research Equity Act of 2003 HR1170 Child Medication Safety Act of 2003 Medicare Prescription Drugs & Modernization Act The Bipartisan Medicare prescription Drug Act of 2001 (Sen.Kennedy-Draft Bill) Prospective Payment System Medicare Reform
S1225 Greater Access to Affordable Pharmaceuticals Act
Economic Sanction SRM Ban/BSE China/World Trade Organization Fast Track Negotiating Authority Capital Market Sanctions Chile and Singapore FTAs
HR2896 American Jobs Creation Act of 2003 S1637 Jumpstart Our Business Strength (JOBS) Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
S.1225, Greater Access to Affordable Pharmaceuticals Act
H.R.2218, Regulation of non corrective contact lens as medical devices S.1, Prescription Drug and Medicare Improvement Act of 2003 H.R.1, Medicare Prescription Drug Modernization Act of 2003 H.R.2427, Pharmaceutical Market Access Act of 2003 HR1288/S1037, Access to Cancer Therapies Act of 2003 S178, Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2003 S191/HR2223, Immunosuppressive Drug Coverage Act of 2003 HR588, Medicare Fairness for Organ Transplant Recipients Act of 2003 HR2356, Prescription Drug Comparative Effectiveness Act of 2003 S.650/HR2857, Pediatric Research Equity Act of 2003 HR2769, Save our Seniors Act of 2003 HR2427 Pharmaceutical Market Access Act of 2003 HR1170, Child Medication Safety Act of 2003 Medicare Prescription Drugs Breaux/Thomas Medicare Reform Plan Health Insurance Portability and Accessibility Act FDA Modernization Act Medical Records Privacy – Senators Jeffords, Bennett, Leahy, Kennedy Bills Prospective Payment System Gene Therapy Drug Reimportation Medicare Reform Agriculture appropriation 2001 – Drug Reimportation Agriculture appropriation 2001 (FDA funding) Stem Cell Research Pediatric Exclusivity Direct-to-Consumer Advertising The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
H.R.2218, Regulation of non corrective contact lens as medical devices S.1, Prescription Drug and Medicare Improvement Act of 2003 H.R.1, Medicare Prescription Drug Modernization Act of 2003 H.R.2427, Pharmaceutical Market Access Act of 2003 HR1288/S1037, Access to Cancer Therapies Act of 2003 S178, Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2003 S191/HR2223, Immunosuppressive Drug Coverage Act of 2003 HR588, Medicare Fairness for Organ Transplant Recipients Act of 2003 HR2356, Prescription Drug Comparative Effectiveness Act of 2003 S.650, Pediatric Research Equity Act of 2003 HR2769, Save our Seniors Act of 2003 HR2427 Pharmaceutical Market Access Act of 2003 HR2857, Pediatric Research Equity Act of 2003 HR1170, Child Medication Safety Act of 2003 Medicare Prescription Drugs & Modfernization Act The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill) Prospective Payment System Medicare Reform
S.1225, Greater Access to Affordable Pharmaceuticals Act
S970/HR1769, Job Protection Act of 2003 Economic Sanction SRM Ban/BSE China/World Trade Organization Fast Track Negotiating Authority Capital Market Sanctions Chile and Singapore FTAs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
S754/HR1063, Increasing Ability to Enforce Anti-trust laws S812/HR 1862, Greater Access to Affordable Pharmaceuticals Act
HR1530, Prescription Drug Competition Act of 2001 HR1387, Drug Availability and Health Care Access Improvement Act of 2001 HR1624/S913, Access to Cancer Therapies Act S10, Medicare Prescription Drug Coverage Act of 2001 S1135, Medicare Reform Act 2001 S1185, Seniors Prescription Insurance Coverage Equity Act of 2001 S1239, Medicare Rx Drug Discount & Security Act of 2001 S880/HR1839, Immunosuppressive Drug Coverage Act of 2001 S982IS/HR2058IH, Medicare Wellness Act of 2001 Medicare Prescription Drug & Modernization Act The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill) President Bush's "Helping Hand" proposal Prospective payment system Medicare Reform Medicare Prescription Drug Benefit
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
S754/HR1063, Increasing Ability to Enforce Anti-trust laws S812/HR 1862, Greater Access to Affordable Pharmaceuticals Act
Economic Sanctions SRM Ban/BSE China/World Trade Organization Fast Track Negotiating Authority Capital Market Sanctions Chile and Singapore FTA's
HR1530, Prescription Drug Competition Act of 2001 HR1387, Drug Availability and Health Care Access Improvement Act of 2001 HR1624/S913, Access to Cancer Therapies Act S10, Medicare Prescription Drug Coverage Act of 2001 S1135, Medicare Reform Act 2001 S1185, Seniors Prescription Insurance Coverage Equity Act of 2001 S1239, Medicare Rx Drug Discount & Security Act of 2001 S880/HR1839, Immunosuppressive Drug Coverage Act of 2001 S982IS/HR2058IH, Medicare Wellness Act of 2001 Medicare Prescription Drug & Modernization Act The Bipartisan Medicare Prescription Drug Act of 2001 (Sen. Kennedy-Draft Bill) President Bush's "Helping Hand" proposal Prospective payment system Medicare Reform Medicare Prescription Drug Benefit
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE