GSK (FKA GLAXOSMITHKLINE INC.) for GSK (FKA GLAXOSMITHKLINE INC.)

Budget/Appropriations BUD

H.R. 2617: Consolidated Appropriations Act, 2023 (P.L. 117-328) H.R. 2811: Limit, Save, Grow Act of 2023 H.R. 3746: Fiscal Responsibility Act of 2023 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. 4368: 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. 2131: 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

Contacted: SENATE; HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB)

Bills named: H.R. 4368 (118th), H.R. 5376 (118th), H.R. 2811 (118th), H.R. 6833 (118th), H.R. 2617 (118th), S. 2131 (118th), H.R. 3746 (118th)

Copyright/Patent/Trademark CPT

H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. ___: PREVAIL Act - PTAB-related provisions 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.___: PREVAIL Act - PTAB-related provisions S.___: Patent Eligibility Restoration Act of 2023 - Provisions related to patents Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues

Contacted: HOUSE OF REPRESENTATIVES; SENATE; Patent & Trademark Office (PTO)

Bills named: S. 142 (118th), S. 79 (118th), S. 2140 (118th), S. 574 (118th), S. 150 (118th), H.R. 1717 (118th)

Health Issues HCR

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 830/ 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 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. 2679: Pharmacy Benefit Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2940/S 1355 PASTEUR Act/Incentives to increase novel antibiotic medicines 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/Transparency Legislation 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. 4390: Protect 340B Act - Provisions related to 340B Program (117th Congress) H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169)/Implementation of $0 Vaccine co-pay; maximum fair price provisions H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 - This bill requires the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why) (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. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Provisions related to drug pricing (117th Congress) S. 1967: Patients Before Middlemen (PBM Act) 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 Chronic Kidney Disease Improvement in Research and Treatment Act. H.R.2534 - PROTECT 340B Act of 2023 House Draft Language for PAHPA Reauthorization HR 3665 - Defending American Jobs and Investment Act Senate Draft Language for PAHPA Reauthorization Pandemic and All Hazards Preparedness Act reauthorization (discussion draft) Labor HHS appropriations (ongoing discussion) Under Taxed Profit Rule, Ways and Means Committee discussion Vaccine Injury Compensation Program reform discussion

Contacted: HOUSE OF REPRESENTATIVES; SENATE; Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB)

Bills named: H.R. 2500 (118th), S. 148 (118th), H.R. 3285 (118th), S. 1067 (118th), H.R. 3561 (118th), H.R. 3810 (118th), H.R. 4390 (118th), S. 1264 (118th), H.R. 5376 (118th), H.R. 7653 (118th), S. 1967 (118th), S. 1355 (118th), S. 1114 (118th), S. 1375 (118th), H.R. 2679 (118th), H.R. 7032 (118th), H.R. 3665 (118th), S. 6 (118th), S. 113 (118th), H.R. 3793 (118th), S. 775 (118th), S. 1339 (118th), S. 898 (118th), H.R. 3433 (118th), H.R. 3791 (118th), H.R. 2534 (118th), S. 1542 (118th), H.R. 2816 (118th), S. 3799 (118th), S. 315 (118th), S. 476 (118th), H.R. 2880 (118th), H.R. 3281 (118th), S. 1128 (118th), H.R. 3290 (118th), H.R. 198 (118th), H.R. 830 (118th), H.R. 3008 (118th), S. 1214 (118th), S. 127 (118th), H.R. 2940 (118th), H.R. 1790 (118th)

Medicare/Medicaid MMM

H.R. 485: Protecting Health Care for All Patients Act of 2023 - This bill prohibits all federal health care programs, including the Federal Employees Health Benefits Program, and federally funded state health care programs (e.g., Medicaid) from using prices that are based on quality-adjusted life years (i.e., measures that discount the value of a life based on disability) to determine relevant thresholds for coverage, reimbursements, or incentive 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)

Contacted: Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); SENATE

Bills named: H.R. 5376 (118th), H.R. 485 (118th), H.R. 2666 (118th)

Trade (domestic/foreign) TRD

H.R. 3858: No Free TRIPS Act S. 1834: No Free TRIPS Act S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 (117th Congress) S. __: 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

Contacted: U.S. Trade Representative (USTR); SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 3858 (118th), S. 2495 (118th), S. 1834 (118th)