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

Copyright/Patent/Trademark CPT

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. 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 or 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 matter 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 S. 4704: Patent Examination and Quality Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

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

Bills named: S. 1435 (117th), H.R. 5635 (117th), H.R. 5874 (117th), H.R. 1629 (117th), S. 2891 (117th), S. 4430 (117th), H.R. 2884 (117th), S. 2910 (117th), S. 4704 (117th), H.R. 2873 (117th), S. 4918 (117th), S. 1428 (117th), H.R. 2148 (117th), S. 415 (117th), S. 2773 (117th), H.R. 2891 (117th), S. 250 (117th), S. 4417 (117th), S. 2774 (117th)

Health Issues HCR

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 HR 1978 - Protecting Seniors Through Immunization Act 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. 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. 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- Diversifying Investigations Via Equitable Research Studies for Everyone 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, patient assistance 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. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property 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. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act 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. 7900: National Defense Authorization Act for Fiscal Year 2023 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. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals 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 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 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 and fentanyl 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 Issues related to HFC's 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 Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)

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

Bills named: S. 259 (117th), H.R. 6000 (117th), H.R. 4472 (117th), H.R. 6973 (117th), S. 1645 (117th), S. 4535 (117th), H.R. 1730 (117th), H.R. 7667 (117th), H.R. 2843 (117th), H.R. 1873 (117th), H.R. 7845 (117th), S. 1644 (117th), S. 1462 (117th), S. 2837 (117th), H.R. 724 (117th), H.R. 7047 (117th), H.R. 5585 (117th), S. 2076 (117th), H.R. 2831 (117th), S. 4430 (117th), S. 4918 (117th), S. 164 (117th), S. 920 (117th), H.R. 5801 (117th), H.R. 623 (117th), H.R. 5030 (117th), S. 2983 (117th), S. 773 (117th), H.R. 6963 (117th), H.R. 4390 (117th), H.R. 1978 (117th), H.R. 4511 (117th), H.R. 6972 (117th), H.R. 8152 (117th), S. 2706 (117th), H.R. 2181 (117th), H.R. 3932 (117th), H.R. 2565 (117th), H.R. 3761 (117th), H.R. 5376 (117th), S. 4215 (117th), H.R. 7900 (117th), S. 4348 (117th), H.R. 7008 (117th), H.R. 6833 (117th), S. 3799 (117th), S. 1425 (117th), H.R. 1400 (117th), S. 154 (117th), H.R. 832 (117th), S. 562 (117th), H.R. 6584 (117th), H.R. 5416 (117th)

Budget/Appropriations BUD

H.R. 2617: Consolidated Appropriations Act, 2023 (PL. 117-328) - various funding levels; FDA provisions 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. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169), prescription drug provisions 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 National Coverage Determination (NCD) for Apretude (cabotegravir long-acting [CAB-LA] for Pre-Exposure Prophylaxis [PrEP]) PAHPA Reauthorization Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates

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

Bills named: H.R. 7900 (117th), H.R. 6833 (117th), H.R. 8256 (117th), H.R. 8295 (117th), H.R. 4121 (117th), H.R. 5376 (117th), S. 4543 (117th), S. 2076 (117th), H.R. 3684 (117th), H.R. 8239 (117th), H.R. 2617 (117th), H.R. 3932 (117th)

Medicare/Medicaid MMM

Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) 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 and drug pricing 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); provisions related to drug pricing S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access 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 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)

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

Bills named: S. 2164 (117th), H.R. 19 (117th), S. 2416 (117th), S. 4293 (117th), H.R. 1976 (117th), H.R. 5376 (117th), H.R. 3 (117th)

Trade (domestic/foreign) TRD

H.R. Res. 1285 - WTO TRIPS Waiver Resolution, Waiver Expansion 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 H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade NegotiatorS. 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 Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

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

Bills named: S. 2495 (117th), H.R. 3927 (117th), H.R. 2653 (117th), H.R. 3683 (117th), S. 1203 (117th), H.R. 4376 (117th), H.R. 3788 (117th), H.R. 4369 (117th), S. 2740 (117th)