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

Health Issues HCR

H.R. 748, CARES Act H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R.1730, Cancer Drug Parity Act of 2019 H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S1872/HR5076, Protecting Seniors Through Immunization Act H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavi-rus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6457: Disaster and Emergency Pricing Abuse Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6472: COVID-19 Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing HR6711, Medical Supply Transparency and Delivery Act, DPA impact on Rx manufacturers H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7269: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes - Provisions related to FDA provisional approval pathways H.R. 7288: To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development related to COVID-19, and for other purposes - Provisions related to prescription drug research and development and transparency H.R. 7296: To require any COVID-19 drug developed in whole or in part with Federal support to be affordable and accessible by prohibiting monopolies and price gouging, and for other purposes - Provisions related to prescription drug pricing and transparency S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S3780, HOME Act S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways Transparency policy issues S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers H.R. 7288: Taxpayer Research and Coronavirus Knowledge (TRACK) Act of 2020 - Provisions related to database of federal biomedical investment information for COVID-19 H.R. 7296: Make Medicines Affordable by Preventing Pandemic Pricegouging (MMAPPP) Act of 2020 Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors FDA modernization policy issues PDUFA policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients CARES ACT-Monograph Reform Support for Arthritis Caucus

Contacted: Patent & Trademark Office (PTO); 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)

Bills named: S. 1437 (116th), H.R. 6260 (116th), H.R. 6450 (116th), S. 3545 (116th), S. 3439 (116th), H.R. 6222 (116th), H.R. 5668 (116th), S. 2304 (116th), H.R. 7296 (116th), H.R. 1730 (116th), H.R. 5239 (116th), H.R. 748 (116th), H.R. 6472 (116th), S. 3932 (116th), H.R. 7288 (116th), S. 3166 (116th), H.R. 6457 (116th), S. 3872 (116th), S. 658 (116th), S. 2723 (116th), S. 3432 (116th), S. 1532 (116th), H.R. 6390 (116th), H.R. 6231 (116th), H.R. 4100 (116th), H.R. 6711 (116th), S. 4010 (116th), S. 3162 (116th), S. 2161 (116th), H.R. 6258 (116th), S. 1384 (116th), H.R. 6019 (116th), H.R. 6080 (116th), H.R. 965 (116th), S. 61 (116th), H.R. 7269 (116th), S. 73 (116th), H.R. 6410 (116th), S. 1391 (116th), S. 1712 (116th), H.R. 5076 (116th), H.R. 985 (116th), H.R. 6906 (116th), S. 3384 (116th)

Trade (domestic/foreign) TRD

H.R. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 5430: United States-Mexico-Canada Agreement Implementation Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues H.R. 6049: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety H.R. 6379: SAVE Act of 2020 - Supply chain issues H.R. 6393: Strengthening America's Supply Chain and National Security Act - Provisions related to prescription drug supply chains H.R. 6431: Made in America Emergency Preparedness Act - Provisions related to prescription drug supply chains H.R. 6482: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains H.R. 6670: Prescription for American Drug Independence Act of 2020 - Provisions related to prescription drug supply chains H.R. 6690: Bring Entrepreneurial Advancements To Consumers Here In North America Act - Provisions related to prescription drug supply chains and manufacturing tax incentives H.R. 6731: Securing America's Pharmaceutical Supply Chain Act - Provisions related to prescription drug supply chains H.R. 6879: Buy American Medical Supply Chain Act of 2020 - Provisions related to prescription drug and medical device supply chains H.R. 6885: Safe and Secure Medicine Supply for Hardworking Americans Act of 2020 - Provisions related prescription drug supply chains H.R. 6930: MADE in America Act of 2020 - Provisions related prescription drug supply chains and manufacturing tax incentives S. 3343: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety S. 3478: To establish a commission to assess, evaluate, and address the dependence of the United States on medications, devices, and medical equipment from foreign countries - Provisions related to prescription drug supply chains and drug safety S. 3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes - Provisions related to prescription drug supply chains and drug safety S. 3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes - Provisions related to prescription drug supply chains and drug safety S. 3635: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains S. 3781: PART Act - Reporting provisions S. 3942: A bill to establish the position of Chief Pharmaceutical and Medical Supply Chain Negotiator in the Office of the United States Trade Representative, to be responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, to advance domestic production of life-saving medicines, and to secure the United States medical supply chain to eliminate reliance on foreign governments, and for other purposes - Provisions related to prescription drug supply chains S. 3945: A bill to amend the Internal Revenue Code of 1986 to provide incentives for relocating manufacturing of pharmaceuticals and medical supplies and devices to the United States - Provisions related to prescription drug supply chains and manufacturing tax incentives Trade Agreements including USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues

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

Bills named: S. 3635 (116th), H.R. 6879 (116th), S. 3478 (116th), S. 3781 (116th), S. 3538 (116th), H.R. 2209 (116th), H.R. 6049 (116th), H.R. 6670 (116th), H.R. 5430 (116th), H.R. 6885 (116th), S. 3343 (116th), H.R. 6431 (116th), H.R. 6379 (116th), H.R. 6930 (116th), H.R. 6393 (116th), H.R. 6731 (116th), S. 3537 (116th), H.R. 6690 (116th), H.R. 4710 (116th), H.R. 6482 (116th), S. 3942 (116th), S. 3945 (116th)

Copyright/Patent/Trademark CPT

H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks S. 2814: Patents for Humanity Program Improvement Act - Provisions related to certificates S. 3449: Trademark Modernization Act of 2020 - Provisions related to trademarks S. 3630: Facilitating Innovation to Fight Coronavirus Act - Provisions on patent terms Biopharmaceutical innovation and patent policy issues Trademark legislative proposals Bayh-Dole march-in rights policy issues

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

Bills named: H.R. 3666 (116th), S. 3630 (116th), H.R. 987 (116th), H.R. 2700 (116th), S. 3449 (116th), H.R. 6196 (116th), S. 2814 (116th)

Medicare/Medicaid MMM

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 1425: Patient Protection and Affordable Care Enhancement Act - Provisions related to affordability fund S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 2650: Medicare Prescription Drug Savings and Choice Act of 2019 - Provisions related to Part D and prescription drug pricing S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions 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 CMS Healthy Adult Opportunity (HAO) initiative and related policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-F) CMS Proposed Rule: Medicaid Program; Establishing Minimum Standardds in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)

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

Bills named: S. 1895 (116th), S. 2543 (116th), H.R. 19 (116th), H.R. 3 (116th), S. 3457 (116th), S. 3129 (116th), S. 2650 (116th), H.R. 1425 (116th)

Budget/Appropriations BUD

H.R. 6395: National Defense Authorization Act for Fiscal Year 2021 H.R. 6800: The Heroes Act - Provisions related to supplemental appropriations and federal health programs S. 4049: National Defense Authorization Act for Fiscal Year 2021 CARES Act, Pub. L. 116-136 S3548, CARES Act, issues relevant to biopharmaceutical companies. Labor-HHS appropriations H.R. 2500, National Defense Authorization Act for Fiscal Year 2020, Provisions related to supply chain CARES ACT-Monograph Reform HSA/FSA reimbursement of OTCs CDC Funding FY22

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

Bills named: H.R. 6395 (116th), S. 4049 (116th), H.R. 2500 (116th), H.R. 6800 (116th)