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

Budget/Appropriations BUD

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 Inflation Reduction Act of 2022 (P.L. 117-169) Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180)

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

Bills named: S. 2624 (118th), S. 2131 (118th), S. 2226 (118th), H.R. 4368 (118th), H.R. 5894 (118th), H.R. 2670 (118th)

Copyright/Patent/Trademark CPT

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

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

Bills named: H.R. 4370 (118th), S. 2140 (118th), H.R. 6275 (118th), H.R. 1717 (118th), S. 150 (118th), S. 142 (118th), S. 3583 (118th), H.R. 6684 (118th), S. 79 (118th), S. 2780 (118th), H.R. 5475 (118th), S. 574 (118th), H.R. 4692 (118th), H.R. 5429 (118th), H.R. 6986 (118th), H.R. 6436 (118th), S. 2220 (118th)

Health Issues HCR

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. 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. 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. 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. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act 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 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. 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. 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. 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. 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. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act 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 Antimicrobial resistance (AMR) policy issues Supply chain 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 COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues H.R.7024 - Tax Relief for American Families and Workers Act of 2024 Vaccine provisions of the Inflation Reduction Act

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

Bills named: S. 1250 (118th), H.R. 1503 (118th), H.R. 885 (118th), S. 775 (118th), H.R. 3008 (118th), H.R. 198 (118th), H.R. 4988 (118th), S. 1067 (118th), H.R. 2893 (118th), H.R. 2707 (118th), H.R. 2679 (118th), H.R. 2816 (118th), S. 3393 (118th), S. 1214 (118th), H.R. 1613 (118th), S. 1476 (118th), H.R. 4421 (118th), H.R. 3093 (118th), H.R. 7174 (118th), S. 1355 (118th), S. 2456 (118th), H.R. 3433 (118th), H.R. 5391 (118th), H.R. 6664 (118th), S. 2474 (118th), S. 1542 (118th), S. 935 (118th), H.R. 4895 (118th), S. 1967 (118th), H.R. 1790 (118th), S. 1375 (118th), S. 1264 (118th), H.R. 2500 (118th), H.R. 6283 (118th), H.R. 5547 (118th), H.R. 830 (118th), H.R. 7248 (118th), H.R. 5539 (118th), S. 1114 (118th), H.R. 2534 (118th), H.R. 2959 (118th), H.R. 167 (118th), H.R. 4263 (118th), H.R. 4115 (118th), H.R. 2408 (118th), S. 1130 (118th), S. 2305 (118th), H.R. 5376 (118th), S. 2973 (118th), S. 1906 (118th), H.R. 3561 (118th), H.R. 3290 (118th), H.R. 2880 (118th), S. 113 (118th), S. 1339 (118th), H.R. 5378 (118th), H.R. 3839 (118th), H.R. 3285 (118th), S. 127 (118th), S. 4953 (118th), S. 1128 (118th), S. 1589 (118th), H.R. 7024 (118th), S. 2333 (118th), S. 148 (118th)

Medicare/Medicaid MMM

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 Value-based purchasing arrangements 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); SENATE; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB)

Bills named: H.R. 2666 (118th), H.R. 3421 (118th), H.R. 485 (118th), S. 1450 (118th), H.R. 133 (118th)

Trade (domestic/foreign) TRD

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

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

Bills named: S. 2115 (118th), H.R. 4307 (118th), H.R. 7085 (118th), H.R. 3858 (118th), S. 3558 (118th), S. 845 (118th), H.R. 405 (118th), S. 1834 (118th)