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

Health Issues HCR

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. 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.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2347: Strengthening the Vaccines for Children Program Act of 2021 - Provisions related to COVID-19 vaccines 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. 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. 3684: Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates 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. 4418: SPIKE Act - Provisions related to prescription drug pricing transparency H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5416: Give Kids a Chance Act (RACE 2.0) - Provisions related to pediatric investigations 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. 917: Short on Competition Act - Provisions related to FDA policy and prescription drug pricing 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. 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. 2814: Vital Medication Affordability Act - Provisions related to 340B drug discount program S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program 21st Century Cures 2.0 (discussion draft) American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 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 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 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 Executive Order 14036, Promoting Competitition in the American Economy (July 9, 2021) Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14005, Ensuring the Future Is Made in All of America by All of Americas Workers (January 25, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13987, Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security (January 20, 2021) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients DSHEA 2.0 HSA/FSA eligibility for Dietary Supplements Quit because of COVID Act Provisions related to Medicare's noninterference clause 340B Drug Pricing Program Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates S. Con. Res. 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. House of Representatives Build Back Better Act package- Rx and tax offset provisions Senate Build Back Better deliberations

Contacted: HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); SENATE; Patent & Trademark Office (PTO); U.S. Trade Representative (USTR)

Bills named: S. 1425 (117th), S. 164 (117th), H.R. 2831 (117th), H.R. 5030 (117th), H.R. 3684 (117th), H.R. 2181 (117th), H.R. 1978 (117th), S. 917 (117th), S. 1644 (117th), S. 2706 (117th), H.R. 5416 (117th), H.R. 3761 (117th), S. 773 (117th), H.R. 3932 (117th), S. 2429 (117th), S. 259 (117th), S. 2837 (117th), H.R. 2347 (117th), H.R. 2883 (117th), H.R. 2869 (117th), H.R. 2565 (117th), S. 1645 (117th), S. 2814 (117th), H.R. 832 (117th), S. 1462 (117th), H.R. 4418 (117th), H.R. 1873 (117th), H.R. 1400 (117th), H.R. 724 (117th), H.R. 2843 (117th), S. 920 (117th), S. 1427 (117th), S. 2076 (117th), S. 2428 (117th), H.R. 4390 (117th), S. 562 (117th), S. 154 (117th), H.R. 853 (117th)

Medicare/Medicaid MMM

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. 550: Immunization Infrastructure Modernization Act H.R.3684 - Infrastructure Investment and Jobs Act - provisions related to vial size wastage policy H.R.5260 - Reduced Costs and Continued Cures Act 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. 4100/S. 1712: DISARM Act of 2019 a Provisions related to antimicrobial drug development H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to prescription drug pricing and access 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. 1619/H.R. 2862: VACCINES Act S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 2304: Strategies To Address Antibiotic Resistance Act a Provisions related to antimicrobial resistance (AMR) and other issues S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4760/H.R. 8920: PASTEUR Act (AMR) S. 4864/H.R. 8725: HAP Act; Medicaid financial barriers 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 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

Contacted: Centers For Medicare and Medicaid Services (CMS); SENATE; Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO)

Bills named: S. 1619 (117th), H.R. 7616 (117th), H.R. 5075 (117th), S. 833 (117th), H.R. 2071 (117th), H.R. 8920 (117th), H.R. 8725 (117th), S. 1773 (117th), H.R. 1227 (117th), H.R. 1976 (117th), H.R. 7614 (117th), S. 908 (117th), H.R. 19 (117th), H.R. 2862 (117th), S. 4320 (117th), H.R. 5260 (117th), H.R. 2139 (117th), S. 983 (117th), H.R. 3 (117th), H.R. 4100 (117th), S. 2327 (117th), H.R. 3684 (117th), S. 1898 (117th), S. 4864 (117th), S. 1123 (117th), S. 1287 (117th), S. 1872 (117th), S. 386 (117th), S. 1712 (117th), H.R. 550 (117th), S. 2304 (117th), H.R. 5463 (117th), H.R. 2010 (117th), S. 4760 (117th), S. 2164 (117th), H.R. 6222 (117th)

Copyright/Patent/Trademark CPT

H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements 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. 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. 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: 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. - Provisions related to USPTO policy S. 2910: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes. - Provisions related to FDA exclusivity periods Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

Contacted: U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); SENATE; Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO)

Bills named: S. 250 (117th), H.R. 2853 (117th), S. 2773 (117th), H.R. 2873 (117th), S. 1428 (117th), S. 415 (117th), S. 2774 (117th), H.R. 153 (117th), S. 1435 (117th), H.R. 2884 (117th), H.R. 2891 (117th), S. 2910 (117th), H.R. 1629 (117th), H.R. 2148 (117th), S. 2891 (117th)

Trade (domestic/foreign) TRD

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. 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 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. 3851: Continuous Manufacturing Research Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4121, PRO Seniors Act, provisions related to drug rebates 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 international trade policy and 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. 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 Trade Agreements including USMCA and related policy issues Biopharmaceutical innovation policy issues nternational intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

Contacted: HOUSE OF REPRESENTATIVES; SENATE; Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR)

Bills named: H.R. 4369 (117th), S. 298 (117th), H.R. 2870 (117th), H.R. 4376 (117th), S. 1367 (117th), H.R. 3694 (117th), H.R. 3683 (117th), S. 1683 (117th), S. 2495 (117th), H.R. 2731 (117th), H.R. 3811 (117th), H.R. 3851 (117th), H.R. 2653 (117th), H.R. 3927 (117th), S. 1176 (117th), S. 1366 (117th), S. 1388 (117th), H.R. 4121 (117th), S. 1260 (117th), S. 1203 (117th), H.R. 3035 (117th), H.R. 3236 (117th), H.R. 3788 (117th)

Budget/Appropriations BUD

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

Contacted: Patent & Trademark Office (PTO); SENATE; HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS)

Bills named: S.Con.Res. 14 (117th), H.R. 5376 (117th), S. 2599 (117th), H.R. 4502 (117th), H.R. 4350 (117th), H.R. 4505 (117th), H.R. 1319 (117th), S. 2792 (117th)