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

Trade (domestic/foreign) TRD

Trade Agreements and related policy issues Biopharmaceutical innovation policy issues International market access and intellectual property policy issues China intellectual property and market access policy issues Canada intellectual property and market access policy issues

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

Copyright/Patent/Trademark CPT

S. 124: Preserve Access to Affordable Generics Act - Provisions related to 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: Executive Office of the President (EOP); Food & Drug Administration (FDA); White House Office; Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); U.S. Trade Representative (USTR); SENATE; Centers For Medicare and Medicaid Services (CMS); Commerce, Dept of (DOC)

Bills named: 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 HR 394/S 85 - Restoring Access to Medication Act of 2017Monograph Reform legislation H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals H.R. 820: Childhood Cancer STAR Act - Provisions related to expanded access and other policy issues 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 HR 1271 - DXM Abuse Prevention Act of 2017 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 Repeal of the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148) and related policy issues including the pharmaceutical fee Prescription Drug User Fee Act (PDUFA) reauthorization 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 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 Food and Drug Administration Final Rule on Intended Use (82 Fed. Reg. 2193 (Jan. 9, 2017)) Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Biomarker policy issues Drug compounding policy issues Clinical trial policy issues Cancer drug vial size policy issues Antibiotic development policy issues Nomination and Confirmation of Tom Price as HHS Secretary Nomination and Confirmation of Scott Gottlieb as FDA Commissioner

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

Bills named: S. 92 (115th), S. 771 (115th), H.R. 1776 (115th), H.R. 1480 (115th), H.R. 1628 (115th), H.R. 1231 (115th), H.R. 1108 (115th), H.R. 749 (115th), H.R. 1271 (115th), S. 64 (115th), H.R. 1245 (115th), H.R. 878 (115th), H.R. 394 (115th), S. 204 (115th), S. 297 (115th), S. 469 (115th), H.R. 820 (115th), S. 456 (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 Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs (no bill number at time of filing) 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. 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 Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation 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 reformulations policy issues Prescription drug abuse policy issues

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

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

Budget/Appropriations BUD

S.Con.Res 3: Budget Resolution - Provisions related to the biopharmaceutical industry including importation and non-interference Continuing Resolution - Provisions related to HHS, FDA, and NIH funding and other issues FY2018 Presidents Budget - Provisions related to HHS, FDA, and NIH funding and other issues Senate and House budget process S.Con.Res.3 - FY17 Budget ResolutionImportationMedicare Part D Non-Interference FY 2018 Budget/AppropriationsPrescription Drug User Fee Agreement ReauthorizationDrug PricingMedicare Non-interferenceTax Reform AHCAFY 17 continuing resolutionFY18 House and Senate Labor HHS appropriationsSenate Budget amendment on importationIPAB repeal

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

Bills named: S.Con.Res. 3 (115th)