LORI REILLY

H.R. 1: One Big Beautiful Bill Act (Public Law 119-21) Inflation Reduction Act of 2022 (Public Law 117-169) implementation policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule

Proclamation: Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States (April 2, 2026) S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) H.R. 4780: USTRx Act H.R. 6089: Biomanufacturing Excellence Act of 2025 H.R. 9102: Biotech Investment National Security Act of 2026 (BINSA) H.R. 9142: Prohibiting Adversarial Patents Act of 2026 (PAPA) Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Tariff policy issues Most Favored Nation (MFN) policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues COINS Act implementation policy issues China outbound investment policy issues including COINS Act US-UK Framework Agreement

S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 1387: National Biotechnology Initiative Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 3521: Clinical Trial Modernization Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 6610: Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT H.R. 8269: CLEAR LABELS Act H.R. 9661: Expedited Access to Biosimilars Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) 340B Drug Pricing Integrity and Affordability for Patients Act (draft) SECURE Act of 2026 (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First

S. 43: Skinny Labels, Big Savings Act S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act S. 3452: Biological Intellectual Protection Act of 2025 H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act H.R. 6624: Biological Intellectual Property Protection Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues

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

H.R. 3334: STOP CCP Act H.R. 4307: Medical Supply Chain Resiliency Act H.R. 8333: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2024 S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6986: To address patent thickets. - Provisions related to patents S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act S. 3583: A bill to address patent thickets. - Provisions related to patents S. 4878: REMEDY Act S. 5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues AI patent policy issues

H.R. 4307: Medical Supply Chain Resiliency Act H.R. 7085: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2024 S. 2115: Medical Supply Chain Resiliency Act S. 3558: Prohibiting Foreign Access to American Genetic Information Act of 2024 Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues H.R. 6986: To address patent thickets. - Provisions related to patents S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act S. 3569: Improving Efficiency to Increase Competition Act S. 3583: A bill to address patent thickets. - Provisions related to patents Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues AI patent policy issues

H.R. 4368: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 5894: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 S. 2226: National Defense Authorization Act for Fiscal Year 2024 S. 2131: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 FY 2025 President's Budget Request H.R. 9027: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 S. 4690: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 H.R. 9029: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 S. 4942: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 H.R. 9026: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 S. 4795: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180) H.R. 8070: Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025 S. 4638: National Defense Authorization Act for Fiscal Year 2025

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 1691: Ensuring Patient Access to Critical Breakthrough Products Act of 2023 H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act H.R. 8261: Preserving Telehealth, Hospital, and Ambulance Access Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 7085: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2023 S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

H.R. 4368: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 5894: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 H.R. 2670: National Defense Authorization Act for Fiscal Year 2024 (P.L. 118-31) S. 2226: National Defense Authorization Act for Fiscal Year 2024 S. 2131: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 FY 2025 President's Budget Request H.R.___: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 S.____: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 H.R.___: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 S.____: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 H.R.___: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 S.____: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180) H.R. 8070: Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025 S. 4638: National Defense Authorization Act for Fiscal Year 2025

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act S. 1450: Cutting Medicare Prescription Drugs in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] ___ IPAY 2026 and Solicitation of Comments CMS Medicare Drug Price Negotiation Revised Guidance CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)

H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues H.R. 6986: To address patent thickets - Provisions related to patents S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act S. 3583: A bill to address patent thickets - Provisions related to patents Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues AI patent policy issues

H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 3858: No Free TRIPS Act H.R. 7085: BIOSECURE Act S. 845: Short on Competition Act S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3134: Emergency Access to Insulin Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act of 2023 H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues Artificial intelligence policy issues

H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act S. 1491: Pharmacy and Medically Underserved Areas Enhancement Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] IPAY 2026 and Solicitation of Comments CMS Medicare Drug Price Negotiation Revised Guidance CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)

H.R. 4368: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 5894: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 H.R. 2670: National Defense Authorization Act for Fiscal Year 2024 S. 2226: National Defense Authorization Act for Fiscal Year 2024 S. 2131: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 FY 2024 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180)

H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] IPAY 2026 and Solicitation of Comments CMS Medicare Drug Price Negotiation Revised Guidance CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)

H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] IPAY 2026 and Solicitation of Comments CMS Medicare Drug Price Negotiation Revised Guidance CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefit Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 (117th Congress) H.R. 7653: Modern Authentication of Pharmaceuticals Act of 2022 (117th Congress) S. 6: Biosimilar Red Tape Elimination Act (117th Congress) S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 1128: Ensuring Access to Generic Medications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act (117th Congress) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act policy issues Cybersecurity policy issues Anticounterfeiting policy issues

S. 79: Interagency Patent Coordination and Improvement Act of 2023 - Provisions related to Interagency Task Force S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues

H.R. 2617: Consolidated Appropriations Act, 2023 (P.L. 117-328) H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180) S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 H.R. ____: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. ____: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 H.R.___: National Defense Authorization Act for Fiscal Year 2024 S._____: National Defense Authorization Act for Fiscal Year 2024 S._____: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. ____: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 FY 2024 Presidents Budget Request

H.R. 485: Protecting Health Care for All Patients Act of 2023 - Prohibits all federal health care programs from using prices that are based on quality-adjusted life years to determine relevant thresholds for coverage, reimbursements, or incentive programs H.R. 830: Help Ensure Lower Patient Copays Act or the HELP Copays Act - Requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs National coverage determination policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Pharmacy Benefit Manager reform and policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] IPAY 2026 and Solicitation of Comments CMS Guidance on Medicare Part B and D Inflation Rebates

S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to medical supply chains and prescription drug pricing transparency policy issues S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chain policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Pharmacy Benefit Manager reform and policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Notice of Benefit and Payment Parameters (NBPP)

H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

H.R. 2617: Consolidated Appropriations Act, 2023 (PL. 117-328) H.R. 3932: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 8256: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2023 H.R. 8295: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 S. 2076: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 FY 2023 Presidents Budget Request

H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H. Res. 1285: Requesting the President to transmit certain information to the House of Representatives relating to a waiver of intellectual property commitments under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3694: To direct the Secretary of Health and Human Services, in consultation with the United States Trade Representative and other heads of Federal agencies, to submit to Congress a report on the impact of a waiver of certain obligations of member nations under the Agreement on Trade-Related Aspects of Intellectual Property Rights on global COVID-19 vaccine access, and for other purposes - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3811: TRIPP Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

H.R. 1319: American Rescue Plan Act of 2021 - Public Law 117-2 H.R. 2471: Consolidated Appropriations Act, 2022 - Public Law 117-103 H.R. 3932: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections H.R. 4350: National Defense Authorization Act for Fiscal Year 2022 H.R. 5376: Build Back Better Act H.R. 8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 8256: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2023 H.R. 8295: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 S. 2076: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections S. 2792: National Defense Authorization Act for Fiscal Year 2022 S. Con. Res. 14: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031 CARES Act, Pub. L. 116-136 FY 2023 Presidents Budget Request

H.R. 5: Equality Act H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Projects Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021 - Provisions related to FDA policy and exclusivity H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act of 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

H.R. 1319: American Rescue Plan Act of 2021 - Public Law 117-2 H.R. 2471: Consolidated Appropriations Act, 2022 - Public Law 117-103 H.R. 4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R. 4350: National Defense Authorization Act for Fiscal Year 2022 H.R. 4356: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022 H.R. 5376: Build Back Better Act S. 2599: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022 S. 2792: National Defense Authorization Act for Fiscal Year 2022 S. 3062: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022 CARES Act, Pub. L. 116-136 FY 2023 Presidents Budget Request

H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2179: Affordable Insulin for the COVID-19 Emergency Act - Provisions related to Part D and insulin H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Insulin policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - To amend the Public Health Service Act to improve the diversity of participants in research on Alzheimers disease, and for other purposes S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Nomination of Robert Califf to FDA Commissioner Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3236: AMIGOS Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3694: To direct the Secretary of Health and Human Services, in consultation with the United States Trade Representative and other heads of Federal agencies, to submit to Congress a report on the impact of a waiver of certain obligations of member nations under the Agreement on Trade-Related Aspects of Intellectual Property Rights on global COVID-19 vaccine access, and for other purposes - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1366: Pharmaceutical Supply Chain Defense and Enhancement Act - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)

H.R. 1319: American Rescue Plan Act of 2021 H.R. 4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R. 4505: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2022 H.R. 4350: National Defense Authorization Act for Fiscal Year 2022 H.R. 5376: Build Back Better Act S. 2599: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022 S. 2792: National Defense Authorization Act for Fiscal Year 2022 S. Con. Res. 14: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031 CARES Act, Pub. L. 116-136 FY 2022 Presidents Budget

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5463: Drug Pricing Transparency and Accountability Act - To increase reporting requirements and transparency requirements in the 340B Drug Pricing Program, and for other purposes S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 1287: REFUND Act of 2021 - Provisions related to Part B and vial sizes S. 1773: Prescription Drug Pricing Dashboard Act - Provisions related to Medicare, Medicaid and prescription drug pricing transparency S. 1898: Affordable Medications Act - Provisions related to prescription drug pricing, Part D, non-interference, Part B, and intellectual property S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues VA drug pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

H.R. 1024: COVID-19 Supply Chain Resiliency Act of 2021 - Provisions related to medical supply chains H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3788: To establish limitations on modifications to trade agreements, and for other purposes H.R. 3811: To direct the President to oppose any waiver of obligations of members of the World Trade Organization under the Agreement on Trade-Related Aspects of Intellectual Property Rights unless a statute is enacted expressly authorizing such a waiver - Provisions related to WTO TRIPS patent waivers and intellectual property S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1366: Pharmaceutical Supply Chain Defense and Enhancement Act - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 1693: To amend the Public Health Service Act to authorize the use of the Strategic National Stockpile to enhance medical supply chain elasticity and establish and maintain domestic reserves of critical medical supplies, and for other purposes - Provisions related to medical supply chains Protecting American Innovation Act - Provisions related to waiver Trade Agreements including USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1167: Advancing Enrollment and Reducing Drug Costs Act of 2021 - Provisions related to Part D H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2868: Protecting Access to Affordable Medicines Act of 2021 - Provisions related to Medicaid and prescription drug pricing and rebates S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 1323: End Price Gouging for Medications Act - Provisions related to Medicare, Medicaid and prescription drug pricing S. 2164: A bill to provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, and for other purposes Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

H.R. 1319: American Rescue Plan Act of 2021 CARES Act, Pub. L. 116-136 FY2022 Presidents Budget FY2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act FY2022 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act FY2022 Commerce, Justice, Science, and Related Agencies Appropriations Act Senate infrastructure bills (no bill numbers)

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 387: Vaccinate More Americans Act of 2021 - Provisions related to COVID-19 vaccines H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to drug pricing and COVID-19 vaccines and treatments H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1391: Taxpayer Research and Coronavirus Knowledge Act of 2021 - Provisions related to COVID-19 health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2078: Social and Economic Equity Promotion Act - CBO analyses H.R. 2181: To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals - Provisions related to prescription drug importation H.R. 2347: To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes - Provisions related to COVID-19 vaccines S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions - Provisions related to citizen petitions S. 670: To amend the Federal Food, Drug, and Cosmetic Act to accelerate development of therapies across the spectrum of rare diseases and conditions and facilitate patient access to such therapies, and for other purposes - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 898: A bill to require reporting regarding certain drug price increases, and for other purposes - Provisions related to prescription drug pricing transparency S. 917: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages S. 920: To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals - Provisions related to prescription drug importation HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation policy issues Expanded access policy issues Supply chain policy issues Real world evidence policy issues Regenerative medicine policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs 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) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of HHS Secretary Xavier Becerra Nominaton of USTR Katherine Tai Nomination of HHS Assistant Secretary Rachel Levine Nomination of OMB Deputy Director Shalanda Young Nomination of CMS Administrator Chiquita Brooks-LaSure

H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to intellectual property H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1857: To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity - Provisions related to FDA policy and exclusivity H.R. 2148: To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries - Provisions related to prescription drug pricing and march-in rights S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 908: To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries - Provisions related to prescription drug pricing and intellectual property S. 917: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

H.R. 171: Resilient Manufacturing Task Force Act of 2021 - Provisions related to medical supply chains and domesic manufacturing H.R. 1024: COVID-19 Supply Chain Resiliency Act of 2021 - Provisions related to medical supply chains H.R. 1186: Supply Chain Security and Pharmaceutical Authentication Act of 2021 - Provisions related to medical supply chains H.R. 2279: To establish the Office of Manufacturing and Industrial Innovation Policy and strategic national manufacturing policy for the United States, to provide manufacturing and industrial perspective and advice to the President, to provide for a comprehensive survey and cross administration management of efforts to ensure global leadership in manufacturing critical to the long-term economic health and national security of the United States, and for other purposes - Provisions related to medical supply chains S. 298: Pharmacy Benefit Manager Accountability Study Act of 20201 - To require the Government Accountability Office to study the role pharmaceutical benefit managers play in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations, and for other purposes Trade Agreements including USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues

H.R. 1319: American Rescue Plan Act of 2021 CARES Act, Pub. L. 116-136

H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals 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 - Provisions related to the Defense Production Act 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 - Provisions related to the Defense Production Act H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency H.R. 7647: To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - Provisions related to accumulator adjustment programs H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers S. 4427: SAVE Act - Provisions related to the FDA drug approval process S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and 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 Pharmaceutical supply chain policy issues COVID-19 policy issues Final Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020) 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, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26)

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 8624: Protecting Access to Innovation During COVID-19 Act - Provisions related to Medicare and prescription drug pricing H.R. 8702: Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 - Provisions related to Part B and physician reimbursement S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4199: Prescription Drug Pricing Reduction Act of 2020 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4274: Legalizing Drug Discounts for Seniors Act of 2020 - Provisions related to Part D and manufacturer rebates Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related issues Medicare Part B policy issues relating to ASP reporting, payment for drugs with non-covered versions, and drug wastage rebates AMP cap policy issues Vial size policy issues Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (RIN 0938-AT98) Final Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (RIN 0938-AT82) Final Rule: Transparency in Coverage (RIN 0938-AU04) Interim Final Rule with comment period: Most Favored Nation (MFN) Model (RIN 0938-AT91) Final Rule: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees (RIN 0936-AA08)

H.R. 133: Consolidated Appropriations Act, 2021 H.R. 6395: National Defense Authorization Act for Fiscal Year 2021 H.R. 6800: The Heroes Act - Provisions related to supplemental appropriations and federal health programs H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 H.R. 8406: The Heroes Act - Provisions related to supplemental appropriations and federal health programs H.R. 8900: Further Continuing Appropriations Act, 2021, and Other Extensions Act S. 4049: National Defense Authorization Act for Fiscal Year 2021 S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4381: Coronavirus Assistance for American Families Act S. 4755: Delivering Immediate Relief to America's Families, Schools and Small Businesses Act S. 4800: The Heroes Act CARES Act, Pub. L. 116-136

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 1425: Patient Protection and Affordable Care Enhancement Act - Provisions related to affordability fund S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4199: Prescription Drug Pricing Reduction Act of 2020 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4274: Legalizing Drug Discounts for Seniors Act of 2020 - Provisions related to Part D and manufacturer rebates Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-F) CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: Medical Supply Chain Emergency Act of 2020 - Provisions related to the Defense Production Act 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 - Provisions related to the Defense Production Act H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6457: Disaster and Emergency Pricing Abuse Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6472: COVID-19 Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7269: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes - Provisions related to FDA provisional approval pathways H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways S. 3932: TRICARE Retail Pharmacy Prescription Medication Expansion Act of 2020 - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: Creating Hope Reauthorization Act - Provisions related to priority review vouchers Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues PDUFA 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 Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

H.R. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 5430: United States-Mexico-Canada Agreement Implementation Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues H.R. 6049: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety H.R. 6393: Strengthening America's Supply Chain and National Security Act - Provisions related to prescription drug supply chains H.R. 6482: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains H.R. 6690: Bring Entrepreneurial Advancements To Consumers Here In North America Act - Provisions related to prescription drug supply chains and manufacturing tax incentives H.R. 6731: Securing America's Pharmaceutical Supply Chain Act - Provisions related to prescription drug supply chains H.R. 6879: Buy American Medical Supply Chain Act of 2020 - Provisions related to prescription drug and medical device supply chains H.R. 6930: MADE in America Act of 2020 - Provisions related prescription drug supply chains and manufacturing tax incentives S. 3343: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety S. 3478: Commission on America's Medical Security Act - Provisions related to prescription drug supply chains and drug safety S. 3537: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains and drug safety S. 3538: Strengthening America's Supply Chain and National Security Act - Provisions related to prescription drug supply chains and drug safety S. 3635: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains S. 3781: PART Act - Reporting provisions S. 3942: Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Provisions related to prescription drug supply chains S. 3945: Bring Entrepreneurial Advancements To Consumers Here in North America Act - Provisions related to prescription drug supply chains and manufacturing tax incentives Trade Agreements including USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues

H.R. 6395: National Defense Authorization Act for Fiscal Year 2021 H.R. 6800: The Heroes Act - Provisions related to supplemental appropriations and federal health programs S. 4049: National Defense Authorization Act for Fiscal Year 2021 CARES Act, Pub. L. 116-136

H.R. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 748: CARES Act - Provisions related to Part B, Part D, vaccines, transparency, and transportation H.R. 1158: Consolidated Appropriations Act, 2020 - Provisions related to prescription drugs, Medicare funding, and other provisions H.R. 1865: Consolidated Appropriations Act, 2020 - Provisions related to prescription drugs, Medicare funding, and other provisions H.R. 2401: American Cures Act - Provisions related to biomedical research funding H.R. 2500: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs 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 H.R. 2745: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2020 - VA provisions related to prescription drugs H.R. 2922: Respond NOW Act - Provisions related to funding to address opioid crisis H.R. 2968: Department of Defense Appropriations Act, 2020 - DoD provisions related to prescription drugs H.R. 3055: Making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes - FDA provisions related to prescription drugs H.R. 3164: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs H.R. 4378: Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 - Provisions related to Medicare funding H.R. 6074: Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - Provisions related to biomedical research and prescription drug pricing H.R. 6201: Families First Coronavirus Response Act - Provisions related to Medicare funding H.R. 6373: To increase the amount available under the Defense Production Act of 1950 to respond to the coronavirus epidemic, and for other purposes - Provisions related to the Defense Production Act and medical devices H.R. 6379: Take Responsibility for Workers and Families Act - Provisions related to supplemental appropriations and federal health programs H. Res. 28: Providing for consideration of the bill (H.R. 264) making appropriations for financial services and general government for the fiscal year ending September 30, 2019, and for other purposes; providing for consideration of the bill (H.R. 265) making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2019, and for other purposes; providing for consideration of the bill (H.R. 266) making appropriations for the Department of the Interior, environment, and related agencies for the fiscal year ending September 30, 2019, and for other purposes; providing for consideration of the bill (H.R. 267) making appropriations for the Department of Transportation, and Housing and Urban Development, and related agencies for the fiscal year ending September 30, 2019, and for other purposes; and waiving a requirement of clause 6(a) of rule XIII with respect to consideration of certain resolutions reported from the Committee on Rules. H. Res. 293: Providing for budget enforcement for fiscal year 2020 H. Res. 436: Providing for further consideration of the bill (H.R. 2740) 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. Res. 4455: Providing for consideration of the bill (H.R. 3055) making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes; relating to consideration of the bill (H.R. 2740) 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; and providing for proceedings during the period from June 28, 2019, through July 8, 2019 S. 1215: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs S. 1250: American Cures Act - Provisions related to biomedical research funding S. 2474: Department of Defense Appropriations Act, 2020 - DoD provisions related to prescription drugs S. 2522: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs S. 3161: National Biomedical Research Act - Provisions related to federal biomedical research funding S. 3370: Coronavirus Vaccine Act - Provisions related to NIH funding S. 3548: CARES Act - Provisions related to supplemental appropriations and federal health programs S. ___: 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. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and prescription drug price negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 2650: Medicare Prescription Drug Savings and Choice Act of 2019 - Provisions related to Part D and prescription drug pricing S. 2817: End Price Gouging for Insulin Act - Provisions related to prescription drug international reference pricing S. 2911: Seniors Prescription Drug Relief Act of 2019 - Provisions related to Part D and patient cost-sharing S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Policy issues related to patient medication information Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tennessee Section 1115 Medicaid waiver CMS Healthy Adult Opportunity (HAO) initiative and related policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P)

H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 4955: Protecting Access to Safe and Effective Medicines Act of 2019 - Provisions related to new chemical exclusivity H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 5444: To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes. - Provisions related to BPCIA and biological products S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity S. 2082: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Trademark legislative proposals Bayh-Dole march-in rights policy issues

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models H.R. 3925: Reducing Barriers to Substance Use Treatment Act - Provisions related to prior authorization requirements H.R. 4178: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates H.R. 4455: BIOSIM Act - Provisions related to biosimilar approval and reimbursement H.R. 4619: Pharmaceutical Rebates for Excessive Pricing Above Inflation Act - Provisions related to Part D and manufacturer rebates H.R. 4628: Better Tools to Lower Costs Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4649: Capping Drug Costs for Seniors Act of 2019 - Provisions related to Part D and patient cost-sharing H.R. 4650: Medicare Dental Act of 2019 - Provisions related to Medicare coverage of dental procedures H.R. 4655: Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4663: Freedom from Price Gouging Act - Provisions related to Part B and manufacturer rebates H.R. 4669: Maximizing Drug Coverage for Low-Income Seniors Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4913: Ensuring Access to Lower-Cost Medicines for Seniors Act - Provisions related to Part D prescription drug plans and formularies H.R. 5039: Life-Sustaining Prescription Drug Price Relief Act of 2019 - Provisions related to Part D, prescription drug negotiation, reference pricing and other provisions H.R. 5057: Pass-Through Technical Corrections Act - Provisions related to Medicare prescription drug pass-through payment status H.R. 5242: Opioid Settlement Accountability Act - Provisions related to Medicaid and opioid litigation related funds H.R. 5364: End Price Gouging for Insulin Act - Provisions related to prescription drug international reference pricing S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 709: Prescription Drug Pricing Dashboard Act - Provisions related to prescription drug pricing transparency S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Policy issues related to patient medication information Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tennessee Section 1115 Medicaid waiver Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, 84 Fed. Reg. 55694 (10/17/19)

H.R. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues H.R. 5430: United States-Mexico-Canada Agreement Implementation Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues Trade Agreements including NAFTA, USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing 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 - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2401: American Cures Act - Provisions related to pharmaceutical research and development H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues 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 Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

H.R. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 2500: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs 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 H.R. 2745: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2020 - VA provisions related to prescription drugs H.R. 2968: Department of Defense Appropriations Act, 2020 - DoD provisions related to prescription drugs H.R. 3055: Making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes - FDA provisions related to prescription drugs H.R. 3164: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs H.R. 4378: Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 - Provisions related to Medicare funding H. Res. 28: Providing for consideration of the bill (H.R. 264) making appropriations for financial services and general government for the fiscal year ending September 30, 2019, and for other purposes; providing for consideration of the bill (H.R. 265) making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2019, and for other purposes; providing for consideration of the bill (H.R. 266) making appropriations for the Department of the Interior, environment, and related agencies for the fiscal year ending September 30, 2019, and for other purposes; providing for consideration of the bill (H.R. 267) making appropriations for the Department of Transportation, and Housing and Urban Development, and related agencies for the fiscal year ending September 30, 2019, and for other purposes; and waiving a requirement of clause 6(a) of rule XIII with respect to consideration of certain resolutions reported from the Committee on Rules H. Res. 293: Providing for budget enforcement for fiscal year 2020 H. Res. 436: Providing for further consideration of the bill (H.R. 2740) 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. Res. 4455: Providing for consideration of the bill (H.R. 3055) making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes; relating to consideration of the bill (H.R. 2740) 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; and providing for proceedings during the period from June 28, 2019, through July 8, 2019 S. 1215: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs S. 1790: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs S. 2474: Department of Defense Appropriations Act, 2020 - DoD provisions related to prescription drugs S. 2522: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs S. ___: 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. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug patent issues H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3199: Terminating the Extension of Rights Misappropriated Act of 2019 - Provisions related to prescription drug patents H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity S. 2082: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents Biopharmaceutical innovation, intellectual property, and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

H.R. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues Trade Agreements including NAFTA, USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues

H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug patent issues H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3199: Terminating the Extension of Rights Misappropriated Act of 2019 - Provisions related to prescription drug patents S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues

H.R. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 2500: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs 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 H.R. 3055: Making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes - FDA provisions related to prescription drugs H.R. 3164: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs H. Res. 436: Providing for further consideration of the bill (H.R. 2740) 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. Res. 4455: Providing for consideration of the bill (H.R. 3055) making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes; relating to consideration of the bill (H.R. 2740) 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; and providing for proceedings during the period from June 28, 2019, through July 8, 2019 S. 1215: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs S. 1790: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs Presidents FY 2020 Budget Request - Medicare and Medicaid provisions and other issues

H.R. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 2500: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs 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 H.R. 3055: Making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes - FDA provisions related to prescription drugs H.R. 3164: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs H. Res. 436: Providing for further consideration of the bill (H.R. 2740) 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. Res. 4455: Providing for consideration of the bill (H.R. 3055) making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes; relating to consideration of the bill (H.R. 2740) 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; and providing for proceedings during the period from June 28, 2019, through July 8, 2019 S. 1215: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs S. 1790: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs Presidents FY 2020 Budget Request - Medicare and Medicaid provisions and other issues

H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - Provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products H.R. 2020: STEER Act - Provisions related to encapsulating & tableting machine registration H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing 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 - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2584: To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings - Provisions related to CBO scoring of preventive health savings H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: To amend title XI of the Social Security Act to require that direct-to-consumer television advertisements for prescription drugs and biological products include the list price of such drugs and products, and for other purposes - Provisions related to direct-to-consumer prescription drug advertising H.R. 3379: Price Relief, Innovation, and Competition for Essential Drugs or PRICED Act - Provisions related to exclusivity H.R. 3408: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3415: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes - Provisions related to FDA over-the-counter drug approvals S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 989: STEER Act - Provisions related to encapsulating & tableting machine registration S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization 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 Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

H.R. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs House H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H. J. Res. 31: Consolidated Appropriations Act, 2019 - FDA funding H. Res. 293: Providing for budget enforcement for fiscal year 2020 S. Con. Res. 12: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2020 and setting forth the appropriate budgetary levels for fiscal years 2021 through 2024 - Provisions related to prescription drugs Presidents FY 2020 Budget Request - Provisions related to prescription drugs FY 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations FY 2020 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1323: Rural Hospital Frontier Fairness Act - Provisions related to the 340B drug pricing program H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing 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. 2069: To amend title XI of the Social Security Act to provide for drug manufacturer price transparency H.R. 2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act - Price transparency S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 418: FDA Accountability for Public Safety Act - Provisions related to FDA drug approvals S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals S. 474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: To amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. __: Transparent Drug Pricing Act - Provisions related to transparency and drug pricing S. __: Patient Affordability Value and Efficiency Act - To amend titles XI, XVIII, and XIX of the Social Security Act to promote value-based arrangements Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues 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 Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing and patents H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act of 2019 - Provisions related to patent listings H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to 180 day exclusivity and patent litigation H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologics patent listings H.R. 2011: To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009 S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing and patents S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug exclusivity periods and pricing S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms H.R. 7251: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 3738: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

Trade Agreements including NAFTA, USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder records H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 - Provisions related to substance use disorder information H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to loan repayment program H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3428: Lessening Addiction by Enhancing Labeling Opiods Act of 2018 S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues 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 Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 974 Amendment: Hatch-Waxman Integrity Act of 2018 - Provisions related to inter partes review process S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms S. 2601: BIG Data for IP Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors Access to Medicare Act - Provisions related to repeal of the IPAB H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.R. 3922: CHAMPIONING HEALTHY KIDS Act - CHIP and CHC reauthorization H.J.Res. 51: Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Patient Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program S.J.Res. 16: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S.J.Res. 17: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)

H.R. 195: Making further continuing appropriation for the fiscal year ending September 30, 2018, and for other purposes. H.R. 1625: Consolidated Appropriations Act, 2018 H.R. 1892: Bipartisan Budget Act of 2018

S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 3245: Medicare Civil and Criminal Penalties Update Act - Civil and criminal penalty provisions H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.R. 3922: Championing Healthy Kids Act - CHIP and CHC reauthorization H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4192-P)

Trade Agreements and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Canada intellectual property and market access policy issues NAFTA policy issues Korea Trade Agreement (KORUS) policy issues China intellectual property and market access policy issues Japan market access and pricing policy issues

S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 892: Opioid Addiction Prevention Act of 2017 - Scheduling issues S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing H.R. 1: Tax Cuts and Jobs Act - An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (Public Law 115-97) H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Scheduling issues H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 4710: 340B Protecting Access for the Underserved and Safety-Net Entities Act or PAUSE Act - 340B program Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (Public Law No. 114-145) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues Confirmation of Alex Azar TRICARE pharmacy pilot program

S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services. Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues Venue in patent cases policy issues

S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program H.R. __: Stark Law Modernization Act of 2017 - Provisions related to Stark and Anti-Kickback policy issues H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 3245: Medicare Civil and Criminal Penalties Update Act - Civil and criminal penalty provisions H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Proposed Rule; Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (CMS-1678-P) (July 13, 2017) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018

Better Care Reconciliation Act of 2017 - Provisions related to repeal of the Affordable Care Act (ACA) and changes to Medicaid (discussion draft) S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues

S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues

S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 820: Childhood Cancer STAR Act - Provisions related to expanded access and other policy issues H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing Repeal of the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148) and related policy issues including the pharmaceutical manufacturer fee Prescription Drug User Fee Act (PDUFA) reauthorization Biologics User Fee Act (BsUFA) reauthorization Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Interim Final Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AA89 (82 Fed. Reg. 14332 (March 20, 2017)) Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Final Rule on Intended Use (82 Fed. Reg. 2193 (Jan. 9, 2017)) Biologics Price Competition and Innovation Act (BPCIA) policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Biomarker policy issues Drug compounding policy issues Clinical trial policy issues Cancer drug vial size policy issues Antibiotic development policy issues Nomination and Confirmation of Tom Price as HHS Secretary Nomination and Confirmation of Scott Gottlieb as FDA Commissioner

S.Con.Res 3: Budget Resolution - Provisions related to the biopharmaceutical industry including importation and non-interference Continuing Resolution - Provisions related to HHS, FDA, and NIH funding and other issues FY2018 Presidents Budget - Provisions related to HHS, FDA, and NIH funding and other issues Senate and House budget process

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 9: Innovation Act - Provisions related to patent litigation reform Provisions related to exclusivity Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole Act march-in rights policy issues

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model H.R. 5273: Helping Hospitals Improve Patient Care Act of 2016 - Provisions related to exemption of hospitals that had off-site facilities under development Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Final rule [CMS-2390-F] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference policy issues

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 4829: Trade Protection Not Troll Protection Act - Provisions related to proceedings at the International Trade Commission (ITC) H.R. 5573: Price Relief, Innovation, and Competition for Essential Drugs Act or PRICED Act - Provisions related to exclusivity Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole Act march-in rights policy issues

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 4829: Trade Protection Not Troll Protection Act - Provisions related to proceedings at the International Trade Commission (ITC) H.R. 5573: Price Relief, Innovation, and Competition for Essential Drugs Act or PRICED Act - Provisions related to exclusivity Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole Act march-in rights policy issues

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model H.R. 5273: Helping Hospitals Improve Patient Care Act of 2016 - Provisions related to exemption of hospitals that had off-site facilities under development Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Final rule [CMS-2390-F] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference policy issues

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 8, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues Chronic Care Working Group - Medicare policy affecting drugs

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act issues including the Charitable Donation Exemption Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy policy issues Prescription drug abuse policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing Proposals to address synthetic drug crisis (discussion draft) Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues

S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 337: FOIA Improvement Act of 2015 - Provisions related to the Freedom of Information Act (FOIA) S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1406: Saving Access to Compounded Medications for Special Needs Patients Act - Provisions related to the Drug Quality and Security Act regarding compounding H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 786: Vaccine Access, Certainty, and Innovation Act of 2015 - Provisions related to vaccine development H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Government Accountability Office (GAO) study on generic versions of complex drug products H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of certain covered products to generic manufacturers for bioequivalence testing Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Drug Supply Chain Security Act implementation issues Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program issues General FDA advocacy Biopharmaceutical and medical innovation policy issues Drug development ecosystem issues Drug cost and pricing policy issues NIH Funding issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy issues Prescription drug abuse issues

H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration H.R. 1735: National Defense Authorization Act for Fiscal Year 2016 - Provisions related to Tricare prescription reimbursement in this bill, which authorizes FY2016 appropriations and sets forth policies for Department of Defense (DOD) programs and activities FY 2016 Labor, Health and Human Services, and Education Appropriations Bill - Provisions related to drug reimbursement, Part D, and biopharmaceutical research FY 2016 Agriculture Appropriations Bill - Provisions related to compounding and e-labeling The Presidents FY 2016 Budget - Provisions related to prescription drug reimbursement and data exclusivity FY 2016 Budget Resolution - Provisions related to biopharmaceutical policy issues Budget Control Act - Provisions related to sequestration

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues

Sen. Con. Res. 11: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025 - Amendments related to the biopharmaceutical industry including compounding/right to try; patent litigation reform; and non-interference, among others H. Con. Res. 27: Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025 - Issues related to the biopharmaceutical industry including Part D and National Institutes of Health (NIH) funding H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 861: Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2014 -Provisions related to anti-fraud proposals affecting federal programs H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 - Provisions related to Sustainable Growth Rate (SGR) reform and other Medicare, Medicaid, and CHIP amendments H.R. 1021: Protecting the Integrity of Medicare Act of 2015 - Provisions related to Part D lock-in program and other Medicare anti-fraud provisions H.R. 1190: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1470: SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Provisions related to SGR reform and other Medicare, Medicaid, and CHIP amendments H.R. 3796: Comprehensive Care Payment Innovation Act - Provisions related to ensuring access to innovative treatments in delivery reform model (113th Congress) H.R. 4857: Ensuring Access to Treatment Act (discussion draft) - Provisions related to changes to Part B hospital outpatient drug payment policy (113th Congress) H.R. 5183: Value Based Insurance Design for Better Care Act of 2014 - Provisions related to changes to the Medicare Advantage Program (113th Congress) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft): Provisions related to oncology medical home demonstration Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Part D lock-in related legislation Medicare exclusion issues Medicare Part D rebates issues

H.R. 83, Making consolidated appropriations for the fiscal year ending September 30, 2015, and for other purposes: Provisions related to Food and Drug Administration (FDA) funding and oversight, 340B Drug Pricing Program, and other issues H.R. 3230, Veterans Access to Care through Choice, Accountability, and Transparency Act of 2014: Provisions related to TRICARE health care program H.R. 4486, Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015: Provisions related to TRICARE health care program H.R. 4660, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015: Provisions related to United State Trade Representative (USTR) and Patent and Trademark Office (PTO) H.R. 4800, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015: Provisions related to FDA funding and oversight H.R. 4870, Department of Defense Appropriations Act, 2015: Provisions related to defense health programs and bio-defense H.R. 4903, Department of Homeland Security Appropriations Act, 2015: Provisions related to Customs and Border security H.R. 5464, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015: Provisions related to 340B program, National Institutes of Health (NIH), Independent Payment Advisory Board (IPAB), and Agency for Healthcare Research & Quality (AHQR) Preparation for the FY 2016 budget

H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act: Provisions related to cost sharing in the specialty tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part D H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2753 Securing Care for Seniors Act: Provisions related to Value Based Insurance Design H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to Office of Inspector General (OIG) enforcement of fraud and abuse laws H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 3890 Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to sustainable growth rate (SGR) and Medicare provider payment reform H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014: Provisions related to Part D preferred pharmacy networks H.R. 5183, Value Based Insurance Design for Better Care Act of 2014: Provisions related to valued base insurance design demonstration program H.R. 5558 ACO Improvement Act: Provisions related to alternate payment models H.R. 5780, Protecting Integrity in Medicare Act of 2014: Provisions related to addressing fraud and prescription drug abuse S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 557, Medication Therapy Management Empowerment Act of 2013: Provisions related to Part D and medication therapy management S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Hospital Improvements for Payment (HIP) Act of 2014: Provisions related to Medicare reform (no bill number) Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking Issues related to better use of medicine and adherence

H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisions H.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2639, Patent Litigation and Innovation Act: Patent litigation provisions H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements H.R. 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions H.R. 5233, Trade Secrets Protection Act of 2014: Provisions related to trade secrets H.R. 5750, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014: Provisions related to targeted IP incentives for new indications for rare diseases or conditions S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act: Patent litigation provisions S. 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S. 2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition S. 2267, Defend Trade Secrets Act of 2014: Provisions related to trade secrets S. 3004, Dormant Therapies Act of 2014: Provisions related to incentives to develop biopharmaceutical products Biopharmaceutical innovation and patent policy issues Biologics data protection issues Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act Issues related to biopharmaceutical economic incentives and intellectual property

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to DEA scheduling S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking 21st Century Cures legislation and policy issues Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues

H.R. 3230, Veterans Access to Care through Choice, Accountability, and Transparency Act of 2014: Provisions related to TRICARE health care program H.R. 4486, Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015: Provisions related to TRICARE health care program H.R. 4660, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015: Provisions related to United State Trade Representative (USTR) and Patent and Trademark Office (PTO) H.R. 4800, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015: Provisions related to Food and Drug Administration (FDA) funding and oversight H.R. 4870, Department of Defense Appropriations Act, 2015: Provisions related to defense health programs and bio-defense H.R. 4903, Department of Homeland Security Appropriations Act, 2015: Provisions related to Customs and Border security FY 2015 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act: Provisions related to 340B Drug Pricing Program, National Institutes of Health (NIH), Independent Payment Advisory Board (IPAB), Agency for Healthcare Research & Quality (AHQR) (no bill number) H.J. Res. 124, Continuing Appropriations Resolution

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4069, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, DEA regulation and related issuesH.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) S. 264, Excellence in Mental Health Act: Sets forth criteria for the certification of federally-qualified community behavioral health centers S. 957, Drug Supply Chain Security Act: Provisions related to supply chain security S. 959, Pharmaceutical Compounding Quality and Accountability Act: Provisions related to pharmaceutical compounding S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Secretary of Health and Human Services nomination Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues

H.R. 3230, Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014: Provisions related to TRICARE health care program H.R. 4486, Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015: Provisions related to TRICARE health care programH.R. 4660, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015: Provisions related to United States Trade Representative (USTR) and Patent and Trademark Office (PTO) H.R. 4800, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015: Provisions related to Food and Drug Administration (FDA) funding and oversight H.R. 4870, Department of Defense Appropriations Act, 2015: Provisions related to defense health programs and bio-defense H.R. 4903, Department of Homeland Security Appropriations Act, 2015: Provisions related to Customs and Border security FY 2015 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act: Provisions related to 340B Drug Pricing Program, National Institutes of Health (NIH), Independent Payment Advisory Board (IPAB), Agency for Healthcare Research & Quality (AHRQ) (no bill number)

H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part DH.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to fraud and abuse H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients' Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issuesH.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to Sustainable Growth Rate (SGR) reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to fraud and abuse H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits H.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug importsH.R. 2397, Department of Defense Appropriations Act, 2014: Provisions related to bio-defense H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importation H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013: Provisions related to FDA user fees H.R. 3547, Consolidated Appropriations Act: Provisions in the appropriations bills identified above H.J. Res. 59, FY14 Continuing Resolution Issues related to implementation of The Budget Control Act of 2011: Public Law No. 112-25: Provisions related to sequestration

H.J. Res. 59, FY14 Continuing Resolution Issues related to implementation of The Budget Control Act of 2011: Public Law No. 112-25 H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importationH.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug imports H.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits H.R. 2397, Department of Defense Appropriations Act, 2014: Provisions related to bio-defense H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013: Provisions related to FDA user fees

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tierH.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013 S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors' Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issuesH.R. 460, Patients Access to Treatments Act of 2013: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 2410, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014: Provisions related to FDA regulation and funding, sequestration, drug importation H.R. 2217, Department of Homeland Security Appropriations Act, 2014: Provisions related to Customs and Border Control Agency funding, drug importsH.R. 2216, Military Construction and Veterans Affairs, and Related Agencies Appropriations Act, 2014: Provisions related to Veterans Affairs Administration regulation and funding, VA health benefits Department of Defense Appropriations Act, 2014 [no bill number]: Provisions related to bio-defense

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions relating to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation S. 214, The Preserve Access to Affordable Generics Act: Provisions related to patent settlementsS. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements Patents for Humanity Program Biopharmaceutical innovation policy issues Potential legislation regarding patent litigation issues America Invents Act issues including estoppel for post grant review Biologics data protection issues Counterfeit drug issues Premerger Notification; Reporting and Waiting Period Requirements; Notice of proposed rulemaking (77 Federal Register 50057)

H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions (112th Congress) H.R. 351, Protecting Seniors Access to Medicare Act of 2013 H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 2190, Medicare Drug Savings Act of 2011: Provisions related to Part D issues (112th Congress)H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier (112th Congress) S. 117, Medicare Prescription Drug Price Negotiation Act of 2013 S. 351, Protecting Seniors Access to Medicare Act of 2012 S. 408, Medicare Prescription Drug Savings and Choice Act of 2013 Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 5, Protecting Access to Healthcare Act: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 8, American Taxpayer Relief Act of 2012: Medicare and tax related provisions H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 4209, Patients Access to Treatments Act of 2012: Provisions related to capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B, 340B, least costly alternative, and other provisions Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 5, Protecting Access to Healthcare Act: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 4209, Patients Access to Treatments Act of 2012: Capping specialty tier drugs and no cost-sharing above the non-preferred brand tier S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: Provisions related to Medicare Part B, 340B, least costly alternative, and other provisions Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking Dual eligibles coordination policy issues Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

H.R. 4966, Sequester Replacement Act of 2012: Provisions related to overall healthcare related funding, government functions, and Medicare policy changes H.R. 5652, Sequester Replacement Reconciliation Act of 2012: Provisions related to overall healthcare related funding, government functions, and Medicare policy change H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013: FDA related provisions H. 5326, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2013: Provisions related to prescription drug abuse H. 5855, Department of Homeland Security Appropriations Act, 2013: Provisions related to Customs and Border Patrol funding and regulatory riders S. 2323, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2013: Provisions related to prescription drug abuse S. 2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013: FDA related provisions S. 3216, Department of Homeland Security Appropriations Act, 2013: Provisions related to Customs and Border Patrol funding and regulatory riders Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013: HHS related provisions [no bill number]

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S.2002, Online Pharmacy Safety Act: Provisions to improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S.2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: Provisions to strengthen the FDAs ability to seek advice from external experts regarding rare diseases. Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues S. 365, Budget Control Act of 2011: Deficit reduction issues related to Medicare/Medicaid S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues S. 1251, Medicare and Medicaid FAST Act: Provisions related to Part D issues. S. 1699, Prescription Drug Cost Reduction Act: All provisions including Medicare Part B and 340B Deficit reduction policy issues Medicaid Program, Covered Outpatient Drugs rulemaking: Provisions related to the AMP calculation, definition of line extension, and extension of the rebate to the territories Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking: Provisions related to implementation of the Sunshine reporting provisions of the Affordable Care Act Dual eligibles coordination policy issues

H.R. 2017, Department of Homeland Security Appropriations Act, 2012: Provisions relating to Customs and Border Protection H.R. 2112, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012: FDA related provisions H.R. 2055, Consolidated Appropriations Act, 2012: Provisions relating to health and trade H.R. 2608, Continuing Appropriations Act, 2012: FDA funding and related provisions H.R. 3671, Consolidated Appropriations Act, 2012: Provisions relating to health and trade S. 1599, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2012: HHS related provisions H.J. RES. 79, Continuing Appropriations Resolutions, 2012

H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provision related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting International intellectual property issues Biopharmaceutical innovation policy issues

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Best Pharmaceuticals for Children Act (BPCA) reauthorization Pediatric Research Equity Act (PREA) reauthorization Health care reform implementation issues General HHS and FDA related advocacy Prescription Drug User Fee Act (PDUFA) reauthorization Anti-counterfeiting and supply chain issues Biopharmaceutical innovation policy issues

H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability H.R. 1065, Pill Mill Crackdown Act of 2011: Provisions related to prescription drug abuse H.R. 1266, Fraudulent Prescription Prevention Act of 2011: Provisions related to prescription drug abuse H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 2119, Ryan Creedon Act of 2011: Provisions related to drug diversion H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages S. 218, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011: Provisions related to FDA and product liability S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011: Provisions related to importation S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011: Provisions related to prescription drug abuse S. 2672, Preserving Access to Orphan Drugs Act of 2011: Provisions related to orphan drug definition and health reform fee Health care reform implementation issues, including health reform fee and essential benefits General FDA related advocacy Prescription Drug User Fee Reauthorization Anti-counterfeiting issues Biopharmaceutical innovation policy issues

H.R. 452, Medicare Decisions Accountability Act of 2011: Provisions related to Independent Payment Advisory Board (IPAB) H.R. 675, Strengthening Medicare Anti-Fraud Measures Act of 2010: Provisions related to exclusion issues H.R. 999, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues H.R. 2190 Medicare Drug Savings Act of 2011: Provisions related to Part D issues H.R. 2248, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D non-interference issues S. 31, Prescription Drug and Health Improvement Act of 2011: Provisions related to Part D non-interference provisions S. 44, Medicare Prescription Drug Price Negotiation Act of 2011: Provisions related to Part D issues S. 454, Strengthening Program Integrity and Accountability in Health Care Act of 2011: Provisions related to exclusion issues S. 560, Medicare Prescription Drug Savings and Choice Act of 2011: Provisions related to Part D issues S. 668, Health Care Bureaucrats Elimination Act: Provisions related to Independent Payment Advisory Board (IPAB) S. 1206, Medicare Prescription Drug Savings Act of 2011: Provisions related to Part D issues

H.R. 243, Patent Lawsuit Reform Act of 2011: false patent marking H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generics H.R. 1056, Patent Continuing Disclosure Act: false patent marking H.R. 1249, America Invents Act: reforms of the patent laws S. 23, America Invents Act: reforms of the patent laws and other provisions S. 27, Preserve Access to Affordable Generics Act: patent settlements S. 373, Fair Prescription Drug Competition Act: authorized generics International intellectual property issues Biopharmaceutical innovation policy issues

H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4994: Medicare and Medicaid Extenders Act of 2010: exclusion issues H.R. 6130 Strengthening Medicare Anti-Fraud Measures Act of 2010: exclusion issues

H.R. 1586, FAA Air Transportation Modernization and Safety Improvements: AMP issues H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: average manufacturer price (AMP) issues H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4899, Supplemental Appropriations Act, 2010: AMP issues

H.R. 444, 340B Program Improvement and Integrity Act: 340B drug pricing program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B drug pricing program issues, drug labeling, access to clinical trials, and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B drug pricing program and average manufacturer price (AMP) issues H.R. 4489, Federal Employees Health Benefits Plan (FEHBP) Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B drug pricing program issues H.R. 4899, Supplemental Appropriations Act, 2010: average manufacturer price (AMP) issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues User fee issues

H.R. 3590, Patient Protection and Affordable Care Act: Part D coverage gap discounts, Part D rebates, Part D issues generally, Medicare payment issues, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: Part D coverage gap, Part D rebates, Part D issues generally, Medicaid rebate issues, transparency issues, comparative effectiveness, and health reform issues generally H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee and health reform issues generally

H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation [S.A. 2793], health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, health reform issues generally S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation S. 1796, Americas Healthy Future Act of 2009: comparative effectiveness, importation, health reform issues generally

H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issues H.R. 3200, Americas Affordable Health Choices Act: Medicaid rebate issues, Part D issues, health reform issues S. 301, Physician Payments Sunshine Act of 2009: transparency issues S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009: Medicare payment issues S. 1380, Medicare Payment Advisory Commission Reform Act of 2009: Medicare payment issues Americas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: Medicaid rebate issues, Part D issues, health reform issues Senate Finance Committee options papers

H.R. 2346, Supplemental Appropriations Act, 2009: pandemic flu funding H.R. 2847, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010: trade infringement H.R. 2892, Department of Homeland Security Appropriations Act, 2010: importation H.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding S. 1298, Department of Homeland Security Appropriations Act, 2010: importation H.Con.Res. 85, 2010 Budget Resolution: health care reform funding provisions S.Con.Res.13, 2010 Budget Resolution: health care reform funding provisions Labor - Health and Human Services - Education Appropriations for Fiscal Year 2010: comparative effectiveness, NIH funding, pandemic flu funding

H.R. 1260, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: establishing a pilot program for district court judges concerning patent litigation S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 515, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation S. 610, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues

H.R. 2, Childrens Health Insurance Program Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate, 340B H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issues H.R. 904, Medicaid Prescription Drug Rebate Equalization Act of 2009: managed care organization (MCO) rebate H.R. 1788, False Claims Act Correction Act of 2009: liability issues S. 275, Childrens Health Insurance Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate S. 301, Physician Payments Sunshine Act of 2009: transparency issues S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 458, False Claims Act Clarification Act of 2009: liability issues S. 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009: Medicare payment issues Health care reform issues Senate Finance Committee options papers

H.R. 4, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues H.R. 758, Price Disclosure Regarding Treatment of Breast Cancer: transparency H.R. 2184, Enhanced Health Care Value for All Act of 2007: comparative effectiveness H.R. 3162, Children's Health and Medicare Protection Act of 2007: Medicaid rebate H.R. 4854, False Claims Act Correction Act of 2007: liability issues H.R. 5605, Physician Payments Sunshine Act of 2008: transparency issues H.R. 6684, Medicare Prescription Drug Cost Equalization Act: Part D issues H.R. 6752, The Independent Drug Education and Outreach Act of 2008: direct to physician marketing S. 3, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues S. 2029, Physician Payments Sunshine Act of 2007: transparency issues S. 2041, False Claims Act Correction Act of 2007: liability issues S. 3118, Preserving Access to Medicare Act of 2008: electronic prescribing, Part D data disclosure, and other issues S. 3396, The Independent Drug Education and Outreach Act of 2008: direct to physician marketing S. 3408, Comparative Effectiveness Research Act of 2008: comparative effectiveness

H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1014, Heart Disease Education, Analysis Research, and Treatment for Women Act: reporting and analysis of patient data H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5683, The Government Accountability Office Act: disclosure of data H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: direct-to-consumer drug advertising H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008: on-line pharmacy issues H.R. 6378, Strengthening of FDA Integrity Act of 2008: debarment H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6388 The Government Accountability Office Improvement Act of 2008: disclosure of data H.R. 6432, Animal Drug User Fee Amendments of 2008: technical corrections to FDAAA H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs

H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007: Medicaid rebate H.R. 3162, Children's Health and Medicare Protection Act of 2007: Medicaid rebate H.R. 4854, False Claims Act Correction Act of 2007: liability issues H.R. 5605, Physician Payments Sunshine Act of 2008: transparency issues H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008: comparative effectiveness, federal upper limit for Medicaid pharmacy reimbursement, electronic prescribing, Part D data disclosure, and other issues S. 558, Mental Health Parity Act of 2007: health insurance issues S. 2029, Physician Payments Sunshine Act of 2007: transparency issues S. 2041, False Claims Act Correction Act of 2007: liability issues S. 3101, Medicare Improvements for Patients and Providers Act of 2008: comparative effectiveness, federal upper limit for Medicaid pharmacy reimbursement, electronic prescribing, Part D data disclosure, and other issues S. 3118, Preserving Access to Medicare Act of 2008: electronic prescribing, Part D data disclosure, and other issues Medicaid Program; Prescription Drugs; Final Rule, 72 Fed. Reg 39142 (July 17, 2007) (AMP Rule): Medicaid

HR. 2900, Food and Drug Administration Amendments Act of 2007 (Drug Safety and PDUFA) S. 1693, Wired for Health Care Quality Act of 2007 H.R. 3610, Food and Drug Import Safety Act of 2007 (Importation) H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007

S. Con Res 21, Senate Budget Resolution, FDA & Medicare Issues H. Con Res 99, House Budget Resolution, FDA & Medicare Issues

HR 4 Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit S. 3 Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit

S 3678, Pandemic and All Hazards Preparedness Act HR 5533, Biodefense and Pandemic Vaccine and Drug Development Act of 2006

HR 5970, Estate Tax and Extention of Tax Relief Act of 2006

S 1955, Health Care Modernization and Affordability Act, small business health plans HR 4157, Health Technology Promotion Act of 2006, health information technology HR 4939, Emergency Supplemental Appropriations Act, pandemic flu issues S 2766 Department of Defense Reauthorization Act, Tricare HR 5122, Department of Defense Reauthorization Act, Tricare HR 5441, Homeland Security Appropriations, Importation HR 5384, Agriculture Appropriations, Importation

Executive Branch Medicare reimbursement issues