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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025.
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
Sen. Con. Res 11 amendments relevant to the biopharmaceutical industry including Medicare Part D H. Con. Res. 27 amendments relevant to the biopharmaceutical industry including Medicare Part D H.R 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestrationProvisions related to drug reimbursement, Part D, and biopharmaceutical research No bill # assigned2016 Agriculture Appropriations Bill Provisions related to compounding and e-labeling No bill # assignedThe Presidents FY 2016 Budget Provisions related to prescription drug reimbursement and data exclusivity. No bill # assignedFY 2016 Budget Resolution/Budget Control ActProvisions related to spending caps No bill # assignedBudget Control Act Provisions related to drug reimbursement, Part D, and biopharmaceutical research
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2015 · third_quarter · Q3
Sen. Con. Res 11 amendments relevant to the biopharmaceutical industry including Medicare Part D H. Con. Res. 27 amendments relevant to the biopharmaceutical industry including Medicare Part D H.R 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestrationProvisions related to drug reimbursement, Part D, and biopharmaceutical research No bill # assigned2016 Agriculture Appropriations Bill Provisions related to compounding and e-labeling No bill # assignedThe Presidents FY 2016 Budget Provisions related to prescription drug reimbursement and data exclusivity. No bill # assignedFY 2016 Budget Resolution/Budget Control ActProvisions related to spending caps No bill # assignedBudget Control Act Provisions related to drug reimbursement, Part D, and biopharmaceutical research
Source: Senate LDA
Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025.
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
Sen. Con. Res 11 amendments relevant to the biopharmaceutical industry including Medicare Part D H. Con. Res. 27 amendments relevant to the biopharmaceutical industry including Medicare Part D H.R 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestrationProvisions related to drug reimbursement, Part D, and biopharmaceutical research No bill # assigned2016 Agriculture Appropriations Bill Provisions related to compounding and e-labeling No bill # assignedThe Presidents FY 2016 Budget Provisions related to prescription drug reimbursement and data exclusivity. No bill # assignedFY 2016 Budget Resolution/Budget Control ActProvisions related to spending caps No bill # assignedBudget Control Act Provisions related to drug reimbursement, Part D, and biopharmaceutical research
Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025.
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
Sen. Con. Res 11 - amendments relevant to the biopharmaceutical industry including Medicare Part D H. Con. Res. 27 - amendments relevant to the biopharmaceutical industry including Medicare Part D
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
Sen. Con. Res 11 amendments relevant to the biopharmaceutical industry including Medicare Part D H. Con. Res. 27 amendments relevant to the biopharmaceutical industry including Medicare Part D H.R 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestrationProvisions related to drug reimbursement, Part D, and biopharmaceutical research No bill # assigned2016 Agriculture Appropriations Bill Provisions related to compounding and e-labeling No bill # assignedThe Presidents FY 2016 Budget Provisions related to prescription drug reimbursement and data exclusivity. No bill # assignedFY 2016 Budget Resolution/Budget Control ActProvisions related to spending caps No bill # assignedBudget Control Act Provisions related to drug reimbursement, Part D, and biopharmaceutical research
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
Sen. Con. Res 11 amendments relevant to the biopharmaceutical industry including Medicare Part D H. Con. Res. 27 amendments relevant to the biopharmaceutical industry including Medicare Part D H.R 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestrationProvisions related to drug reimbursement, Part D, and biopharmaceutical research No bill # assigned2016 Agriculture Appropriations Bill Provisions related to compounding and e-labeling No bill # assignedThe Presidents FY 2016 Budget Provisions related to prescription drug reimbursement and data exclusivity. No bill # assignedFY 2016 Budget Resolution/Budget Control ActProvisions related to spending caps No bill # assignedBudget Control Act Provisions related to drug reimbursement, Part D, and biopharmaceutical research
Protecting Seniors' Access to Medicare Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
Protecting Seniors' Access to Medicare Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues
Protecting Seniors' Access to Medicare Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions related to SGR reform H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act S. 31 - Medicare Prescription Drug Price Negotiation Act of 2015, provisions related to Part D issues S. 141 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board S. 648 - Medicare Formulary Improvement Act, provisions related to Medicare Part D No bill # assigned - proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - issues related to better use of medicines and comprehensive medication management No bill # assigned - vaccine access and coverage issues
PATIENT Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
PATIENT Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2045H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 Provisions related to demand letters H.R. 1353 PATIENT Act of 2015 Provisions related to extension of marketing exclusivity H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to extension of marketing exclusivity S. 1421S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to exclusivity S. 1137 PATENT Act Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office S. 926 Grace Period Restoration Act of 2015 Provisions related to grace period and patent law S. 632 STRONG Patents Act of 2015 Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9Innovation Actprovisions related to patent litigation reform S. 131Fair and Immediate Release of Generic Drugs Actprovisions related to patent settlements S. 632STRONG Patents Act of 2015provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedBiologics data protection issues No bill # assignedIntellectual property issues Additional data exclusivity request that was part of 21st Century Cures submission
SGR Repeal and Medicare Provider Payment Modernization Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
SGR Repeal and Medicare Provider Payment Modernization Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues
SGR Repeal and Medicare Provider Payment Modernization Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions related to SGR reform H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act S. 31 - Medicare Prescription Drug Price Negotiation Act of 2015, provisions related to Part D issues S. 141 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board S. 648 - Medicare Formulary Improvement Act, provisions related to Medicare Part D No bill # assigned - proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - issues related to better use of medicines and comprehensive medication management No bill # assigned - vaccine access and coverage issues
Family Health Care Flexibility Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1547 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 836 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122 - Safe and Affordable Drugs from Canada Act, provisions related to drug importation S. 185 - PATH Act, provisions related to antibiotics and drug approval S. 320 - Medical Innovation Act of 2015, provisions related to NIH funding and covered manufacturer supplemental fees No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use, issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products No bill # assigned - Antibiotic Development to Advance Patient Treatment Actprovisions related to antibiotics and drug approval
Family Health Care Flexibility Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
Family Health Care Flexibility Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
Targeting Rogue and Opaque Letters Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues
Preservation of Access for Seniors in Medicare Advantage Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
Preservation of Access for Seniors in Medicare Advantage Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues
Antibiotic Development to Advance Patient Treatment Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
Antibiotic Development to Advance Patient Treatment Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
Strengthening Public Health Emergency Response Act of 2016
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
Combination Drug Development Incentive Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Secure and Protect Americans' Data Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
Secure and Protect Americans' Data Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues
Secure and Protect Americans' Data Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions related to SGR reform H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act S. 31 - Medicare Prescription Drug Price Negotiation Act of 2015, provisions related to Part D issues S. 141 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board S. 648 - Medicare Formulary Improvement Act, provisions related to Medicare Part D No bill # assigned - proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - issues related to better use of medicines and comprehensive medication management No bill # assigned - vaccine access and coverage issues
21st Century Cures Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
21st Century Cures Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
Improving Regulatory Transparency for New Medical Therapies Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Vaccine Access, Certainty, and Innovation Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
Vaccine Access, Certainty, and Innovation Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
American Research and Competitiveness Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 880 - American Research and Competitiveness Act of 2015, provisions related making permanent the research and development (R&D) tax credit No bill # assigned - Tax reform policy issues, issues related to corporate tax reform
American Research and Competitiveness Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
American Research and Competitiveness Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
H.R. 9 - Innovation Act, provisions related to patent litigation reform S. 131 - Fair and Immediate Release of Generic Drugs Act, provisions related to patent settlements S. 632 - STRONG Patents Act of 2015, provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues, additional data exclusivity request that was part of 21st Century Cures submission
Andrea Sloan CURE Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
Andrea Sloan CURE Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2045H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 Provisions related to demand letters H.R. 1353 PATIENT Act of 2015 Provisions related to extension of marketing exclusivity H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to extension of marketing exclusivity S. 1421S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to exclusivity S. 1137 PATENT Act Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office S. 926 Grace Period Restoration Act of 2015 Provisions related to grace period and patent law S. 632 STRONG Patents Act of 2015 Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9Innovation Actprovisions related to patent litigation reform S. 131Fair and Immediate Release of Generic Drugs Actprovisions related to patent settlements S. 632STRONG Patents Act of 2015provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedBiologics data protection issues No bill # assignedIntellectual property issues Additional data exclusivity request that was part of 21st Century Cures submission
Medicare Drug Savings Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
Medicare Drug Savings Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
H.R. 2045H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 Provisions related to demand letters H.R. 1353 PATIENT Act of 2015 Provisions related to extension of marketing exclusivity H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to extension of marketing exclusivity S. 1421S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to exclusivity S. 1137 PATENT Act Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office S. 926 Grace Period Restoration Act of 2015 Provisions related to grace period and patent law S. 632 STRONG Patents Act of 2015 Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9Innovation Actprovisions related to patent litigation reform S. 131Fair and Immediate Release of Generic Drugs Actprovisions related to patent settlements S. 632STRONG Patents Act of 2015provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedBiologics data protection issues No bill # assignedIntellectual property issues Additional data exclusivity request that was part of 21st Century Cures submission
Safe and Affordable Drugs from Canada Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1547 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 836 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122 - Safe and Affordable Drugs from Canada Act, provisions related to drug importation S. 185 - PATH Act, provisions related to antibiotics and drug approval S. 320 - Medical Innovation Act of 2015, provisions related to NIH funding and covered manufacturer supplemental fees No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use, issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products No bill # assigned - Antibiotic Development to Advance Patient Treatment Actprovisions related to antibiotics and drug approval
FAIR Generics Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
FAIR Generics Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 9 - Innovation Act, provisions related to patent litigation reform S. 131 - Fair and Immediate Release of Generic Drugs Act, provisions related to patent settlements S. 632 - STRONG Patents Act of 2015, provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues, additional data exclusivity request that was part of 21st Century Cures submission
Protecting Seniors' Access to Medicare Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
Protecting Seniors' Access to Medicare Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues
Protecting Seniors' Access to Medicare Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions related to SGR reform H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act S. 31 - Medicare Prescription Drug Price Negotiation Act of 2015, provisions related to Part D issues S. 141 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board S. 648 - Medicare Formulary Improvement Act, provisions related to Medicare Part D No bill # assigned - proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - issues related to better use of medicines and comprehensive medication management No bill # assigned - vaccine access and coverage issues
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
H.R. 1547 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 836 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122 - Safe and Affordable Drugs from Canada Act, provisions related to drug importation S. 185 - PATH Act, provisions related to antibiotics and drug approval S. 320 - Medical Innovation Act of 2015, provisions related to NIH funding and covered manufacturer supplemental fees No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use, issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products No bill # assigned - Antibiotic Development to Advance Patient Treatment Actprovisions related to antibiotics and drug approval
Preserve Access to Affordable Generics Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Prescription Drug Affordability Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Advancing Targeted Therapies for Rare Diseases Act of 2016
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Promoting Life-Saving New Therapies for Neonates Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Medical Countermeasure Innovation Act of 2016
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
Medicare Prescription Drug Price Negotiation Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
Medicare Prescription Drug Price Negotiation Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues
Medicare Prescription Drug Price Negotiation Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions related to SGR reform H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act S. 31 - Medicare Prescription Drug Price Negotiation Act of 2015, provisions related to Part D issues S. 141 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board S. 648 - Medicare Formulary Improvement Act, provisions related to Medicare Part D No bill # assigned - proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - issues related to better use of medicines and comprehensive medication management No bill # assigned - vaccine access and coverage issues
Medical Innovation Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1547 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 836 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122 - Safe and Affordable Drugs from Canada Act, provisions related to drug importation S. 185 - PATH Act, provisions related to antibiotics and drug approval S. 320 - Medical Innovation Act of 2015, provisions related to NIH funding and covered manufacturer supplemental fees No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use, issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products No bill # assigned - Antibiotic Development to Advance Patient Treatment Actprovisions related to antibiotics and drug approval
Improving Regulatory Transparency for New Medical Therapies Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
STRONG Patents Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
STRONG Patents Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 9 - Innovation Act, provisions related to patent litigation reform S. 131 - Fair and Immediate Release of Generic Drugs Act, provisions related to patent settlements S. 632 - STRONG Patents Act of 2015, provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues, additional data exclusivity request that was part of 21st Century Cures submission
STRONG Patents Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2045H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 Provisions related to demand letters H.R. 1353 PATIENT Act of 2015 Provisions related to extension of marketing exclusivity H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to extension of marketing exclusivity S. 1421S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to exclusivity S. 1137 PATENT Act Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office S. 926 Grace Period Restoration Act of 2015 Provisions related to grace period and patent law S. 632 STRONG Patents Act of 2015 Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9Innovation Actprovisions related to patent litigation reform S. 131Fair and Immediate Release of Generic Drugs Actprovisions related to patent settlements S. 632STRONG Patents Act of 2015provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedBiologics data protection issues No bill # assignedIntellectual property issues Additional data exclusivity request that was part of 21st Century Cures submission
Medicare Formulary Improvement Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions related to SGR reform H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act S. 31 - Medicare Prescription Drug Price Negotiation Act of 2015, provisions related to Part D issues S. 141 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board S. 648 - Medicare Formulary Improvement Act, provisions related to Medicare Part D No bill # assigned - proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - issues related to better use of medicines and comprehensive medication management No bill # assigned - vaccine access and coverage issues
Family Health Care Flexibility Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1547 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 836 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122 - Safe and Affordable Drugs from Canada Act, provisions related to drug importation S. 185 - PATH Act, provisions related to antibiotics and drug approval S. 320 - Medical Innovation Act of 2015, provisions related to NIH funding and covered manufacturer supplemental fees No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use, issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products No bill # assigned - Antibiotic Development to Advance Patient Treatment Actprovisions related to antibiotics and drug approval
Grace Period Restoration Act of 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2045H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 Provisions related to demand letters H.R. 1353 PATIENT Act of 2015 Provisions related to extension of marketing exclusivity H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to extension of marketing exclusivity S. 1421S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to exclusivity S. 1137 PATENT Act Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office S. 926 Grace Period Restoration Act of 2015 Provisions related to grace period and patent law S. 632 STRONG Patents Act of 2015 Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9Innovation Actprovisions related to patent litigation reform S. 131Fair and Immediate Release of Generic Drugs Actprovisions related to patent settlements S. 632STRONG Patents Act of 2015provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedBiologics data protection issues No bill # assignedIntellectual property issues Additional data exclusivity request that was part of 21st Century Cures submission
Dr. Rita Hocog Inos Territorial Fellowship Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
Preserving Access to Orphan Drugs Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
Preserving Access to Orphan Drugs Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
Preserve Access to Affordable Generics Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
Continuing Appropriations Resolution, 2015
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 4800 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2015; provisions relating to FDA regulation and funding, sequestration, drug importation No bill # assigned - Labor, Health and Human Services, Education and Related Agencies Appropriations Act of 2014; provisions related to ADAP, BARDA and Section 317 H.J. Res 124 - Continuing Appropritions Resolution
Medication Therapy Management Empowerment Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014; provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs; Provisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine ActNo bill # assigned - Vaccine access and coverage issues
Medication Therapy Management Empowerment Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits ProgramsProvisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues
National Diabetes Clinical Care Commission Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1074- National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products
National Diabetes Clinical Care Commission Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1074 - National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act S. 2917 - Adding Ebola to the FDA Priority Review Voucher Program Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products
Medicare Prescription Drug Price Negotiation Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits ProgramsProvisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues
Medicare Prescription Drug Price Negotiation Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014; provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs; Provisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine ActNo bill # assigned - Vaccine access and coverage issues
Family Health Care Flexibility Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1074- National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products
Family Health Care Flexibility Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1074 - National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act S. 2917 - Adding Ebola to the FDA Priority Review Voucher Program Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products
Newborn Screening Saves Lives Reauthorization Act of 2014
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1074- National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products
Newborn Screening Saves Lives Reauthorization Act of 2014
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1074 - National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act S. 2917 - Adding Ebola to the FDA Priority Review Voucher Program Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products
Medicare Drug Savings Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits ProgramsProvisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues
Medicare Drug Savings Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014; provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs; Provisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine ActNo bill # assigned - Vaccine access and coverage issues
PATENT Jobs Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013; provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013; Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
PATENT Jobs Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
Manufacturing Innovation in America Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013; provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013; Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
Patent Litigation and Innovation Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013; provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013; Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
Patent Litigation and Innovation Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013; provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013; Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits ProgramsProvisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014; provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs; Provisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine ActNo bill # assigned - Vaccine access and coverage issues
Part D Beneficiary Appeals Fairness Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits ProgramsProvisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues
Part D Beneficiary Appeals Fairness Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014; provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs; Provisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine ActNo bill # assigned - Vaccine access and coverage issues
MODDERN Cures Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013; provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013; Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
MODDERN Cures Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
H.R. 880American Research and Competitiveness Act of 2015A bill to modify and make permanent the research and development (R&D) tax credit
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 S. 2055 - the Medical Countermeasure Innovation Act of 2015
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2015 · second_quarter · Q2
Sen. Con. Res 11 amendments relevant to the biopharmaceutical industry including Medicare Part D H. Con. Res. 27 amendments relevant to the biopharmaceutical industry including Medicare Part D H.R 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestrationProvisions related to drug reimbursement, Part D, and biopharmaceutical research No bill # assigned2016 Agriculture Appropriations Bill Provisions related to compounding and e-labeling No bill # assignedThe Presidents FY 2016 Budget Provisions related to prescription drug reimbursement and data exclusivity. No bill # assignedFY 2016 Budget Resolution/Budget Control ActProvisions related to spending caps No bill # assignedBudget Control Act Provisions related to drug reimbursement, Part D, and biopharmaceutical research
H.R. 880American Research and Competitiveness Act of 2015A bill to modify and make permanent the research and development (R&D) tax credit No bill # assignedTax reform policy issuesprovisions related to corporate tax reform
H.R. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program S. 1083 Medicare Drug Savings Act of 2015 S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assignedIssues related to better use of medicines and comprehensive medication management No bill # assignedVaccine access and coverage issues
H.R. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program H.R. 909(CURE) Act Provisions related to expanded access H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress) H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation S. 185PATH Act provisions related to antibiotics and drug approval S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned21st Century Cures Initiative and related policy issues No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway No bill # assignedFDA accelerated approval policy issues No bill # assignedComparative effectiveness policy issues No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedPharmaceutical supply chain security issues No bill # assigned340B policy issue No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act No bill # assignedSupport for COPD national action plan No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
H.R. 2045H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 Provisions related to demand letters H.R. 1353 PATIENT Act of 2015 Provisions related to extension of marketing exclusivity H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to extension of marketing exclusivity S. 1421S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to exclusivity S. 1137 PATENT Act Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office S. 926 Grace Period Restoration Act of 2015 Provisions related to grace period and patent law S. 632 STRONG Patents Act of 2015 Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9Innovation Actprovisions related to patent litigation reform S. 131Fair and Immediate Release of Generic Drugs Actprovisions related to patent settlements S. 632STRONG Patents Act of 2015provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedBiologics data protection issues No bill # assignedIntellectual property issues Additional data exclusivity request that was part of 21st Century Cures submission
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2015 · first_quarter · Q1
H.R. 1547 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 836 - Family Health Care Flexibility Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 122 - Safe and Affordable Drugs from Canada Act, provisions related to drug importation S. 185 - PATH Act, provisions related to antibiotics and drug approval S. 320 - Medical Innovation Act of 2015, provisions related to NIH funding and covered manufacturer supplemental fees No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use, issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products No bill # assigned - Antibiotic Development to Advance Patient Treatment Actprovisions related to antibiotics and drug approval
H.R. 9 - Innovation Act, provisions related to patent litigation reform S. 131 - Fair and Immediate Release of Generic Drugs Act, provisions related to patent settlements S. 632 - STRONG Patents Act of 2015, provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues, additional data exclusivity request that was part of 21st Century Cures submission
Sen. Con. Res 11 - amendments relevant to the biopharmaceutical industry including Medicare Part D H. Con. Res. 27 - amendments relevant to the biopharmaceutical industry including Medicare Part D
H.R. 880 - American Research and Competitiveness Act of 2015, provisions related making permanent the research and development (R&D) tax credit No bill # assigned - Tax reform policy issues, issues related to corporate tax reform
H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions related to SGR reform H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act S. 31 - Medicare Prescription Drug Price Negotiation Act of 2015, provisions related to Part D issues S. 141 - Protecting Seniors' Access to Medicare Act of 2015, provisions related to the Independent Payment Advisory Board S. 648 - Medicare Formulary Improvement Act, provisions related to Medicare Part D No bill # assigned - proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - issues related to better use of medicines and comprehensive medication management No bill # assigned - vaccine access and coverage issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2014 · fourth_quarter · Q4
H.R. 3830 - Bipartisan Congressional Trade Priorities Act of 2014; provisions related to trade agreeemnts S. 1900 - Bipartisan Congressional Trade Priorities Act of 2014; provisions related to trade agreeemnts No bill # assigned - Trans-Pacific Strategic Economic Partnership Agreement (TPP); provisions related to intellectual property, market access and public health issues No bill # assigned - Transatlantic Trade and Investment Partnership (TTIP); provisions related to market access intellectual property, regulatory harmonization and other issues No bill # assigned - International market access and intellectual property issues No bill # assigned - Canada IP and market access issues
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014; provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs; Provisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine ActNo bill # assigned - Vaccine access and coverage issues
H.R. 1074 - National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act S. 2917 - Adding Ebola to the FDA Priority Review Voucher Program Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products
H.R. 83 - Making consolidated appropriations for the fiscal year ending September 30, 2015, and for other purposes; provisions related to FDA regulation and funding, sequestration, drug importation, ADAP, BARDA and Section 317 H.R. 4800 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2015; provisions relating to FDA regulation and funding, sequestration, drug importation No bill # assigned - Labor, Health and Human Services, Education and Related Agencies Appropriations Act of 2014; provisions related to ADAP, BARDA and Section 317
H.R. 4438 - A bill to modify and make permanent the research and development (R&D) tax credit H.R. 5771 - Tax Increase Prevention Act of 2014; provisions related to extension of the research and development tax credit S. 2786 - Corporate Inverters Earnings Stripping Reform Act of 2014; provisions related to Internal Revenue Code section 163(j) No bill # assigned - Tax reform policy issues; provisions related to corporate tax reform and research and development tax credit
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2014 · third_quarter · Q3
H.R. 1074- National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products
H.R. 4438 - A bill to modify and make permanent the research and development (R&D) tax credit S. 2786 - Corporate Inverters Earnings Stripping Reform Act of 2014; provisions related to Internal Revenue Code section 163(j) No bill # assigned - Tax reform policy issues; provisions related to corporate tax reform and research and development tax credit
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D H.R. 1024 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues H.R. 1102 - Medicare Prescription Drug Price Negotiation Act of 2013; Provisions related to Part D issues and non-interference H.R. 1588 - Medicare Drug Savings Act of 2013; provisions related to Part D issues H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013; Provisions related to SGR reform H.R. 2827 - To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D; provisions related to Medicare Part D Drug Tier Formularies H.R. 3890 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease H.R 4160 - Keep the Promise to Seniors Act of 2014; provisions related to Part D H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 4302 - Protecting Access to Medicare Act of 2014 - provisions related to the biopharmaceutical industry S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013; provisions related to Part D issues S. 351 - Protecting Seniors' Access to Medicare Act of 2013; provisions related to the Independent Payment Advisory Board S. 408 - Medicare Prescription Drug Savings and Choice Act of 2013; provisions related to Medicare Part D S. 557 - Medication Therapy Empowerment Act of 2013; provisions related to Part D issues S. 740 - Medicare Drug Savings Act of 2013; provisions related to Part D issues S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013; Provisions related to reforming Medicare physician payments S. 1932 - Better Care, Lower Cost Act; Provisions related to Part D, value-based insurance design, and chronic disease S. 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014; Provisions related to SGR reform S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014; Provisions related to SGR reform No bill # assigned - Contract Year 2015 Policy and Technical Cganges to the Medicare Advantage and the Medicare Prescription Drug Benefits ProgramsProvisions related to Part D No bill # assigned - Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy No bill # assigned - Issues related to better use of medicines and comprehensive medication management No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act No bill # assigned - Vaccine access and coverage issues
H.R. 4800 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2015; provisions relating to FDA regulation and funding, sequestration, drug importation No bill # assigned - Labor, Health and Human Services, Education and Related Agencies Appropriations Act of 2014; provisions related to ADAP, BARDA and Section 317 H.J. Res 124 - Continuing Appropritions Resolution
H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013; provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013; Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission
H.R. 6726 - U.S. Job Creation and Manufacturing Competitiveness Act of 2013 - provisions related to the emporary duty suspension for preparations, such as tablets or chewing gum, intended to assist smokers to stop smoking (provided for in subheading 2106.90.99)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)