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

Trade (domestic/foreign) TRD

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

Contacted: Health Resources & Services Administration (HRSA); Defense, Dept of (DOD); SENATE; Executive Office of the President (EOP); Labor, Dept of (DOL); Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Food & Drug Administration (FDA); Office of Management & Budget (OMB)

Copyright/Patent/Trademark CPT

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. S. 1948: A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents. H.R. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent settlements: 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

Contacted: Defense, Dept of (DOD); Centers For Medicare and Medicaid Services (CMS); Labor, Dept of (DOL); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); SENATE; Health Resources & Services Administration (HRSA); Office of Management & Budget (OMB); Executive Office of the President (EOP); Food & Drug Administration (FDA); Natl Economic Council (NEC)

Bills named: S. 1681 (115th), S. 1948 (115th), H.R. 4117 (115th), S. 1390 (115th), S. 124 (115th)

Health Issues HCR

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) 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 TRICARE pharmacy pilot program Confirmation of Alex Azar HR 4710 - 340B PAUSE ActHR 4297 - Protecting Seniors Through Immunization Act of 2017H.J.Res. 123 - Making further continuing appropriations for fiscal year 2018, and for other purposes.Graham-Cassidy Health Care Bill (S. Amdt. 1030 to HR 1628, the American Health Care Act of 2017)HR 4297/S. 2103 - Protecting Seniors Through Immunization Act of 2017Monograph Reform House and Senate Continuing Resolution IPAB Legislation-House 340B Tax Reform

Contacted: Office of Management & Budget (OMB); Health Resources & Services Administration (HRSA); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Executive Office of the President (EOP); Patent & Trademark Office (PTO); Natl Economic Council (NEC); Food & Drug Administration (FDA); Labor, Dept of (DOL); Defense, Dept of (DOD); HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 2026 (115th), H.R. 2871 (115th), H.R. 1480 (115th), H.R. 4297 (115th), S. 456 (115th), H.R. 1776 (115th), S. 92 (115th), S. 469 (115th), H.R. 1 (115th), H.R. 749 (115th), H.R. 2025 (115th), H.R. 1628 (115th), S. 974 (115th), S. 771 (115th), H.R. 2851 (115th), S. 64 (115th), H.R. 1245 (115th), S. 892 (115th), S. 1131 (115th), H.R. 4710 (115th), S. 2103 (115th), S. 204 (115th), H.R. 2051 (115th), H.R. 1231 (115th), S. 297 (115th), H.R. 1108 (115th), H.R. 2212 (115th), H.R. 878 (115th)

Medicare/Medicaid MMM

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.R.394 Restoring Access to Medication Act of 2017 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 HR 3922 - Community Health and Medical Professionals Improve Our Nation Act of 2017-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) HR 4392-Repeal of Medicare HOPPS Rule-340B

Contacted: SENATE; Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP); Defense, Dept of (DOD); Food & Drug Administration (FDA); Labor, Dept of (DOL); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Office of Management & Budget (OMB); Health Resources & Services Administration (HRSA); Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO)

Bills named: S.J.Res. 17 (115th), S. 41 (115th), H.R. 1316 (115th), H.R. 4392 (115th), S.J.Res. 16 (115th), S. 637 (115th), S. 260 (115th), H.J.Res. 51 (115th), S. 348 (115th), S. 251 (115th), S. 1688 (115th), S. 870 (115th), H.R. 3245 (115th), H.R. 3921 (115th), S. 1827 (115th), H.R. 849 (115th), S. 1348 (115th), H.R. 394 (115th), H.R. 242 (115th), H.R. 3922 (115th)

Budget/Appropriations BUD

H.R.1370: Continuing Resolution through January 19, 2018 H.R. 2810: National Defense Authorization Act for Fiscal Year 2018 - Provisions related to Department of Defense, Tricare, and medical research issues H.J.Res 123: Continuing Resolution through December 22, 2017 H.R.2998: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018 S. 1519: National Defense Authorization Act for Fiscal Year 2018 - Provisions related to Department of Defense, Tricare, and medical research issues S.0000: Department of Defense (Chairmans Mark) - Making appropriations for the Department of Defense for the fiscal year ending September 30, 2018 S.0000: Department of Homeland Security (Chairmans Mark) - Making appropriations for the Department of Homeland Security for the fiscal year ending September 30, 2018, and for other purposes. HR4618 ACA Tax Legislation-OTC Tax

Contacted: HOUSE OF REPRESENTATIVES; Health Resources & Services Administration (HRSA); Executive Office of the President (EOP); Office of Management & Budget (OMB); SENATE; Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); Defense, Dept of (DOD); Labor, Dept of (DOL); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Natl Economic Council (NEC)

Bills named: S.0000 (115th), S. 1519 (115th), H.R. 4618 (115th), H.R. 2998 (115th), H.R. 1370 (115th), H.R. 2810 (115th), H.J.Res. 123 (115th)