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 S 2312 - HELP ActNAFTATrade/Tariff Issues

Contacted: Food & Drug Administration (FDA); SENATE; Office of Management & Budget (OMB); Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); Congressional Budget Office (CBO)

Copyright/Patent/Trademark CPT

S. 2601: BIG Data for IP Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

Contacted: Patent & Trademark Office (PTO); Executive Office of the President (EOP); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); SENATE; Centers For Medicare and Medicaid Services (CMS); Congressional Budget Office (CBO)

Bills named: S. 2601 (115th)

Health Issues HCR

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report 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. 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. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program HR 4993 Vaccine Access Improvement Act HR 4297/S 2103 Protecting Seniors Through Immunization Act H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - To require improved packaging and disposal methods with respect to certain drugs H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste HR 6378/S 2852 Pandemic and All Hazards Preparedness Act reauthorization HR 6294 REVAMP Act 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. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1327: SITSA Act - Provisions related to controlled substances S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues 340B drug discount program 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 of FDA policy TRICARE pharmacy pilot program Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Pandemic and All-Hazards Preparedness Act, provisions related to emerging infectious diseases and antimicrobial resistance. HR 6 - SUPPORT for Patients and Communities Act HR 5687 - SOUND Disposal and Packaging ActHR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform ActHR 394/S 85 - Restoring Access to Medication Act of 2017 HR 6199 - To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses. HR 6157 - FY19 Defense Appropriations ActS 3159 - FY19 Defense Appropriations ActS 3158 - FY19 Labor-HHS-Education Appropriations ActHouse Draft - FY19 Labor-HHS-Education Appropriations ActPatient Access in Medicaid program340B Discount Drug ProgramHR 4710 - 340B PAUSE ActHR 5598 - 340B Optimization Act HR 5958 - Phair Pricing Act of 2018

Contacted: Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; SENATE; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Patent & Trademark Office (PTO); Executive Office of the President (EOP); Congressional Budget Office (CBO); Office of Management & Budget (OMB)

Bills named: S. 1327 (115th), S. 2453 (115th), H.R. 6378 (115th), H.R. 4993 (115th), H.R. 5687 (115th), S. 92 (115th), H.R. 6 (115th), H.R. 1245 (115th), H.R. 6294 (115th), H.R. 5958 (115th), H.R. 4297 (115th), H.R. 878 (115th), S. 469 (115th), H.R. 4710 (115th), H.R. 2851 (115th), H.R. 6199 (115th), H.R. 5311 (115th), H.R. 5598 (115th), H.R. 2212 (115th), H.R. 6142 (115th), S. 64 (115th), S. 974 (115th), S. 2312 (115th), H.R. 1480 (115th), H.R. 449 (115th), H.R. 6157 (115th)

Medicare/Medicaid MMM

Part D doughnut holeHouse and Senate Labor HHS Subcommittee appropriations House and Senate DoD Subcommittee appropriations H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation Part D policy issues including non-interference and rebates policy issues Drug cost and pricing policy issues Transparency policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues

Contacted: Patent & Trademark Office (PTO); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Congressional Budget Office (CBO); Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS); SENATE; Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB)

Bills named: H.R. 242 (115th), S. 41 (115th)

Budget/Appropriations BUD

H.R. 5515: National Defense Authorization Act for Fiscal Year 2019 H.R. __: Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes S. 2987: John S. McCain National Defense Authorization Act for Fiscal Year 2019

Contacted: SENATE; Patent & Trademark Office (PTO); Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Congressional Budget Office (CBO)

Bills named: S. 2987 (115th), H.R. 5515 (115th)