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

Health Issues HCR

Better Care Reconciliation Act of 2017 - Provisions related to repeal of the Affordable Care Act (ACA) and changes to Medicaid (discussion draft) 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. 934: FDA Reauthorization Act of 2017 - Provisions related to user fee program 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 S. 3477 (from the 114th Congress), Protecting Seniors Through Immunization Act of 2016- HR 1628, American Health Care Act- HR 1628, Better Care Reconciliation Act of 2017- HR 2810, National Defense Authorization Act- HR 2430, the FDA Reauthorization Act of 2017- S. 934, the FDA Reauthorization Act of 2017- HR 244, Consolidated Appropriations Act of FY 2017Issues:Drug ImportationMedicare Non-interferenceTaxesBiosecurityHIV OTC Monograph Reform HR 2430/S 934 - FDA Reauthorization Act of 2017HR 1628 - American Health Care Act, Provisions related to reimbursement of OTC drugs under flexible and health savings accounts 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. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs 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. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programs H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Provisions related to amending the Controlled Substances Act to give DEA greater authority to schedule certain synthetic drugs H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Biologics User Fee Act (BsUFA) reauthorization 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 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 Interim Final Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AA89 (82 Fed. Reg. 14332 (March 20, 2017)) Orphan Drug Act policy issues 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 Nomination and Confirmation of Scott Gottlieb as FDA Commissioner

Contacted: Commerce, Dept of (DOC); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; SENATE; White House Office; Executive Office of the President (EOP); Food & Drug Administration (FDA); Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS)

Bills named: H.R. 1480 (115th), S. 297 (115th), H.R. 2810 (115th), H.R. 244 (115th), H.R. 1703 (115th), H.R. 2871 (115th), H.R. 2026 (115th), H.R. 878 (115th), H.R. 749 (115th), S. 934 (115th), S. 3477 (115th), H.R. 2025 (115th), S. 1131 (115th), S. 64 (115th), H.R. 2430 (115th), S. 974 (115th), H.R. 1108 (115th), S. 456 (115th), S. 204 (115th), H.R. 1245 (115th), H.R. 2851 (115th), H.R. 2212 (115th), S. 469 (115th), H.R. 1776 (115th), S. 92 (115th), H.R. 2051 (115th), S. 771 (115th), H.R. 1231 (115th), H.R. 1628 (115th)

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

Contacted: Office of Management & Budget (OMB); Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); SENATE; White House Office; Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR)

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 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: U.S. Trade Representative (USTR); White House Office; HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); SENATE; Commerce, Dept of (DOC); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); Executive Office of the President (EOP)

Bills named: S. 1390 (115th), S. 124 (115th)

Medicare/Medicaid MMM

Better Care Reconciliation Act of 2017 - Provisions related to repeal of the Affordable Care Act (ACA) and changes to Medicaid (discussion draft) 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 H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation HR 394/S 85 - Restoring Access to Medication Act of 2017Drug importation340B Program H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 1316: Prescription Drug Transparency Act - Provisions related to transparency of payment methodologies 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 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 Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues

Contacted: Executive Office of the President (EOP); U.S. Trade Representative (USTR); Commerce, Dept of (DOC); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); SENATE; White House Office; Food & Drug Administration (FDA)

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

Budget/Appropriations BUD

H.R. 244: Consolidated Appropriations Act, 2017 H.R. __: Making appropriations for Agriculture, Rural Development, Food and Drug Administration and Related Agencies programs for the fiscal year ending September 30, 2018, and for other purposes Budget of the United States Government, Fiscal Year 2018 - A New Foundation for American Greatness - Provisions related to non-defense program funding including FDA and NIH and repeal of the Independent Payment Advisory Board (IPAB) FY18 House and Senate Labor HHS Appropriations FY18 DoD House and Senate Appropriations HR 1620 American Health Care Act of 2012 repeal/replace Prescription Drug User Fee Act Monograph legislation IPAB repeal

Contacted: Executive Office of the President (EOP); SENATE; U.S. Trade Representative (USTR); Office of Management & Budget (OMB); Commerce, Dept of (DOC); White House Office; Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES

Bills named: H.R. 244 (115th), H.R. 1620 (115th)