Loading…
How to read the money
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.
Prescription drug pricing issues, Access to generic medicines Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Implementation of Generics Drug User Fee Amendments (GDUFA), The FDA Reauthorization Act of 2017, Insulins, Complex Generics Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for Biosimilars
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
2018 · third_quarter · Q3
Trade issues related to generic medicines
Tariff issues related to generic medicines
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office
Source: Senate LDA
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars
Prescription drug pricing issues, Access to generic medicines Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Implementation of Generics Drug User Fee Amendments (GDUFA), The FDA Reauthorization Act of 2017, Insulins, Complex Generics Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for Biosimilars
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Client: VIATRIS INC · Firm: VIATRIS INC.
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Client: VIATRIS INC · Firm: VIATRIS INC.
Prescription drug pricing issues, Access to generic medicines Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Implementation of Generics Drug User Fee Amendments (GDUFA), The FDA Reauthorization Act of 2017, Insulins, Complex Generics Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for Biosimilars
An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018.
Client: VIATRIS INC · Firm: VIATRIS INC.
H.R. 1: Tax Cuts and Jobs Act (proposals affecting corporate tax)
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments(GDUFA) - House and Senate Re-authorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs S.637 -C THRU Act - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments (GDUFA) - House and Senate Reauthorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
Prescription drug pricing issues, Issues related to epinephrine auto-injectors pricing, Access to generic medicines Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Implementation of Biologics Price Competition and Innovation Act (BPCIA) for Insulins, Complex Generics Medicare Part D coverage gap for biosimilars, Medicare Part B reimbursement for biosimilars
Prescription drug pricing issues, Issues related to epinephrine auto-injectors pricing, Access to generic medicines Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Implementation of Biologics Price Competition and Innovation Act (BPCIA) for Insulins, Complex Generics Medicare Part D coverage gap for biosimilars, Medicare Part B reimbursement for biosimilars
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments(GDUFA) - House and Senate Re-authorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs S.637 -C THRU Act - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments (GDUFA) - House and Senate Reauthorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs S.637 -C THRU Act - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments (GDUFA) - House and Senate Reauthorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments(GDUFA) - House and Senate Re-authorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
Issues related to epinephrine auto-injectors pricing Prescription drug pricing issues, Generic Drugs Drug Supply Chain Security Act implementation of pharmaceutical distribution REMS program, S. 3056 CREATES Act, H.R. 2841 FAST Generics Act Biologics Price Competition and Innovation Act (BPCIA) Generic and Biosimilar user fee program re-authorization
Issues related to epinephrine auto-injectors pricing Prescription drug pricing issues, Generic Drugs Drug Supply Chain Security Act implementation of pharmaceutical distribution REMS program, S. 3056 CREATES Act, H.R. 2841 FAST Generics Act Biologics Price Competition and Innovation Act (BPCIA) Generic and Biosimilar user fee program re-authorization
Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017
Client: VIATRIS INC · Firm: VIATRIS INC.
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs S.637 -C THRU Act - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments (GDUFA) - House and Senate Reauthorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Client: VIATRIS INC · Firm: VIATRIS INC.
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments(GDUFA) - House and Senate Re-authorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Client: VIATRIS INC · Firm: VIATRIS INC.
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs S.637 -C THRU Act - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments (GDUFA) - House and Senate Reauthorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Client: VIATRIS INC · Firm: VIATRIS INC.
Prescription drug pricing issues, Issues related to epinephrine auto-injectors pricing, Access to generic medicines Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Implementation of Biologics Price Competition and Innovation Act (BPCIA) for Insulins, Complex Generics Medicare Part D coverage gap for biosimilars, Medicare Part B reimbursement for biosimilars
Issues related to implementation of the Generic Drug User Fee Agreement (GDUFA), FDA funding Medicaid Generic Drug Rebate, HR. 1314 - Bipartisan Budget Act of 2015, S. 1364- Medicaid Generic Drug Price Fairness Act of 2015
Medicaid Generic Drug Rebate, Bipartisan Budget Act of 2015, H.R. 1314
Medicaid Generic Drug Rebate, Bipartisan Budget Act of 2015, H.R. 1314
Medicaid Generic Drug Rebate, Bipartisan Budget Act of 2015, H.R. 1314
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act
Senate Health, Education, Labor and Pensions Committee's Innovation for Healthier Americans initiative Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act, Senate REMS proposed legislation S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; S. 2658 Federal Aviation Administration Reauthorization Act of 2016 S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Senate Health, Education, Labor and Pensions Committee's Innovation for Healthier Americans initiative Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act, Senate REMS proposed legislation S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; S. 2658 Federal Aviation Administration Reauthorization Act of 2016 S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to implementation of the Generic Drug User Fee Agreement (GDUFA), FDA funding Medicaid Generic Drug Rebate, HR. 1314 - Bipartisan Budget Act of 2015, S. 1364- Medicaid Generic Drug Price Fairness Act of 2015
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Senate Health, Education, Labor and Pensions Committee's Innovation for Healthier Americans initiative Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act, Senate REMS proposed legislation S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; S. 2658 Federal Aviation Administration Reauthorization Act of 2016 S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Senate Health, Education, Labor and Pensions Committee's Innovation for Healthier Americans initiative Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act, Senate REMS proposed legislation S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; S. 2658 Federal Aviation Administration Reauthorization Act of 2016 S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Federal Aviation Administration Reauthorization Act of 2016
Client: VIATRIS INC · Firm: VIATRIS INC.
Senate Health, Education, Labor and Pensions Committee's Innovation for Healthier Americans initiative Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act, Senate REMS proposed legislation S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; S. 2658 Federal Aviation Administration Reauthorization Act of 2016 S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act
Addiction Prevention and Responsible Opioid Practices Act
Client: VIATRIS INC · Firm: VIATRIS INC.
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Addiction Prevention and Responsible Opioid Practices Act
Client: VIATRIS INC · Firm: VIATRIS INC.
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Addiction Prevention and Responsible Opioid Practices Act
Client: VIATRIS INC · Firm: VIATRIS INC.
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: VIATRIS INC · Firm: VIATRIS INC.
PEPFAR, President's Emergency Plan for AIDS Relief funding, Global Fund funding, Generic Drug, Biosimilar User Fees, FY 2016 Budget, FY2016 House and Senate Appropriations (HR 3049, S 1800, HR 3020, S 1695, HR 2772, S 1725) FDA Safety Over Sequestration Act, HR 1078
Biosimilar Naming, Issues related to implementation of the Generic Drug User Fee Agreement, generic drug pricing Medicaid Generic Drug Rebate, Bipartisan Budget Act of 2015, H.R. 1314
Department of State, Foreign Operations, and Related Programs Appropriations Act, 2016
Client: VIATRIS INC · Firm: VIATRIS INC.
PEPFAR, President's Emergency Plan for AIDS Relief funding, Global Fund funding, Generic Drug, Biosimilar User Fees, FY 2016 Budget, FY2016 House and Senate Appropriations (HR 3049, S 1800, HR 3020, S 1695, HR 2772, S 1725) FDA Safety Over Sequestration Act, HR 1078
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Generic drug pricing issues, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act, Innovation for Healthier American Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
Biosimilar Naming, Issues related to implementation of the Generic Drug User Fee Agreement, generic drug pricing Issues related to Senate HELP Innovation Initiative Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: VIATRIS INC · Firm: VIATRIS INC.
PEPFAR, President's Emergency Plan for AIDS Relief funding, Global Fund funding, Generic Drug, Biosimilar User Fees, FY 2016 Budget, FY2016 House and Senate Appropriations (HR 3049, S 1800, HR 3020, S 1695, HR 2772, S 1725) FDA Safety Over Sequestration Act, HR 1078
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: VIATRIS INC · Firm: VIATRIS INC.
PEPFAR, President's Emergency Plan for AIDS Relief funding, Global Fund funding, Generic Drug, Biosimilar User Fees, FY 2016 Budget, FY2016 House and Senate Appropriations (HR 3049, S 1800, HR 3020, S 1695, HR 2772, S 1725) FDA Safety Over Sequestration Act, HR 1078
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Generic drug pricing issues, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act, Innovation for Healthier American Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 2019 Preserve Access to Affordable Generics Act Access for Generics to Inter Partes Review (IPR)
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 2019 Preserve Access to Affordable Generics Act Access for Generics to Inter Partes Review (IPR)
Patent Reform, H.R. 9 Innovation Act, S. 632 The STRONG Act
Patent Reform, H.R. 9 Innovation Act, S. 632 The STRONG Act Access for Generics to Inter Partes Review (IPR)
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 1137, the Patent Act, S. 2019 Preserve Access to Affordable Generics Act
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 1137, the Patent Act, S. 2019 Preserve Access to Affordable Generics Act
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: VIATRIS INC · Firm: VIATRIS INC.
PEPFAR, President's Emergency Plan for AIDS Relief funding, Global Fund funding, Generic Drug, Biosimilar User Fees, FY 2016 Budget, FY2016 House and Senate Appropriations (HR 3049, S 1800, HR 3020, S 1695, HR 2772, S 1725) FDA Safety Over Sequestration Act, HR 1078
Department of State, Foreign Operations, and Related Programs Appropriations Act, 2016
Client: VIATRIS INC · Firm: VIATRIS INC.
PEPFAR, President's Emergency Plan for AIDS Relief funding, Global Fund funding, Generic Drug, Biosimilar User Fees, FY 2016 Budget, FY2016 House and Senate Appropriations (HR 3049, S 1800, HR 3020, S 1695, HR 2772, S 1725) FDA Safety Over Sequestration Act, HR 1078
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: VIATRIS INC · Firm: VIATRIS INC.
PEPFAR, President's Emergency Plan for AIDS Relief funding, Global Fund funding, Generic Drug, Biosimilar User Fees, FY 2016 Budget, FY2016 House and Senate Appropriations (HR 3049, S 1800, HR 3020, S 1695, HR 2772, S 1725) FDA Safety Over Sequestration Act, HR 1078
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
Biosimilar Naming, Issues related to implementation of the Generic Drug User Fee Agreement, generic drug pricing Issues related to Senate HELP Innovation Initiative Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 2019 Preserve Access to Affordable Generics Act Access for Generics to Inter Partes Review (IPR)
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 1137, the Patent Act, S. 2019 Preserve Access to Affordable Generics Act
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 2019 Preserve Access to Affordable Generics Act Access for Generics to Inter Partes Review (IPR)
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 1137, the Patent Act, S. 2019 Preserve Access to Affordable Generics Act
Patent Reform, H.R. 9 Innovation Act, S. 632 The STRONG Act Access for Generics to Inter Partes Review (IPR)
Patent Reform, H.R. 9 Innovation Act, S. 632 The STRONG Act
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 2019 Preserve Access to Affordable Generics Act Access for Generics to Inter Partes Review (IPR)
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 2019 Preserve Access to Affordable Generics Act Access for Generics to Inter Partes Review (IPR)
Food and Drug Administration Safety Over Sequestration Act of 2013
Client: VIATRIS INC · Firm: VIATRIS INC.
Pharmaceutical Distribution Supply Chain Security; Electronic distribution of prescribing information; H.R. 3204, the Drug Quality and Security Act; Compounding; Generic Labeling; Biosimilars; H.R. 486, the Stop Tampering of Prescription Pills (STOPP) Act; S. 214, the Preserve Access to Affordable Generics; S. 504, the Fair and Immediate Release of Generic Drugs Act; H.R. 2725, the FDA Safety Over Sequestration Act of 2013; S. 621, the Safe Prescribing Act of 2013Risk Evaluation Mitigation Strategies; H.R. 460, Patients' Access to Treatments Act of 2013; implementation of the Generic Drug User Fee Act
Pharmaceutical Distribution Supply Chain Security; Electronic distribution of prescribing information; H.R. 3204, the Drug Quality and Security Act; Compounding; Generic Labeling; Biosimilars; H.R. 486, the Stop Tampering of Prescription Pills (STOPP) Act; S. 214, the Preserve Access to Affordable Generics; S. 504, the Fair and Immediate Release of Generic Drugs Act; H.R. 2725, the FDA Safety Over Sequestration Act of 2013; S. 621, the Safe Prescribing Act of 2013Risk Evaluation Mitigation Strategies; H.R. 460, Patients' Access to Treatments Act of 2013; implementation of the Generic Drug User Fee Act
FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics; Implementation of Biosimilars in the Affordable Care Act (ACA), Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act; H.R. 4437, The Generic Drug Pricing Transparency Act, Generic drug pricing issues, Medicare Part D program and Generic Drugs; H.R. 5657, the Fair Access for Safe and Timely Generics Act of 2014 (FAST Generics Act) PEPFAR program supply chain management
Federal policy regarding Public Law 113-54, the Drug Quality and Security Act; FDA proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including BiologicalProducts," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics; Implementations of Biosimilars in the Affordable Care Act (ACA), Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act; The Generic Drug Pricing Transparency Act, H.R. 4437; Risk Evaluation Mitigation Strategies, Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing
Federal policy regarding Public Law 113-54, the Drug Quality and Security Act; FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics; Implementation of Biosimilars in the Affordable Care Act (ACA), Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act; The Generic Drug Pricing Transparency Act, H.R. 4437; Risk Evaluation Mitigation Strategies, Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; The Fair Access for Safe and Timely (FAST) Generics Act. PEPFAR program supply chain management
2018 · second_quarter · Q2
Trade issues related to generic medicines
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs, Hatch-Waxman Integrity Act of 2018, Patent Settlements
Tariff issues related to generic medicines
Medicaid Rebate provision of the Bipartisan Budget Act of 2015
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office
2018 · first_quarter · Q1
Prescription drug pricing issues, Access to generic medicines Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Implementation of Generics Drug User Fee Amendments (GDUFA), The FDA Reauthorization Act of 2017, Insulins, Complex Generics Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for Biosimilars
PEPFAR and Global Fund federal appropriations Medicaid Rebate provision of the Bipartisan Budget Act of 2015 (CPI Penalty)
Issues related to Inter Partes Review (IPR) process, Patent Settlements
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · fourth_quarter · Q4
H.R. 1: Tax Cuts and Jobs Act (proposals affecting corporate tax)
Prescription drug pricing issues, Issues related to epinephrine auto-injectors pricing, Access to generic medicines Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Implementation of Biologics Price Competition and Innovation Act (BPCIA) for Insulins, Complex Generics Medicare Part D coverage gap for biosimilars, Medicare Part B reimbursement for biosimilars
PEPFAR and Global Fund federal appropriations Medicaid Rebate provision of the Bipartisan Budget Act of 2015 (CPI Penalty)
Issues related to Inter Partes Review (IPR)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Q3
- Access for Generics to Inter Partes Review (IPR)
- PEPFAR and Global Fund federal appropriations - Medicaid Rebate provision of the Bipartisan Budget Act of 2015 (CPI Penalty)
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments(GDUFA) - House and Senate Re-authorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
- Tax reform proposals
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Q2
- Corporate tax reform proposals including proposed border adjustment tax
- PEPFAR and Global Fund federal appropriations - Medicaid Rebate provision of the Bpartisan Budget Act of 2015
- Issues related to epinephrine auto-injectors pricing - Prescription drug pricing issues, Generic Drugs S.637 -C THRU Act - Drug Supply Chain Security Act implementation of pharmaceutical distribution - Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 - Implementation of Generic Drug User Fee Amendments (GDUFA) - House and Senate Reauthorization Act of 2017, H.R. 2430, Collins/Franken Amendment, Improving Access to Generic Drugs - Biologics Price Competition and Innovation Act (BPCIA), Medicare reimbursement for biosimilars
2017 · first_quarter · Q1
Issues related to epinephrine auto-injectors pricing Prescription drug pricing issues, Generic Drugs Drug Supply Chain Security Act implementation of pharmaceutical distribution REMS program, S. 3056 CREATES Act, H.R. 2841 FAST Generics Act Biologics Price Competition and Innovation Act (BPCIA) Generic and Biosimilar user fee program re-authorization
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · 4A
Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Program Support Center, SENATE
2016 · fourth_quarter · Q4
Issues related to epinephrine auto-injectors pricing Prescription drug pricing, Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Program Support Center, SENATE
2016 · second_quarter · 2A
Trans Pacific Partnership(TPP), TTIP (trans-atlantic trade and investment partnership agreement); General trade issues
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
2016 · third_quarter · Q3
Trans Pacific Partnership(TPP), TTIP (trans-atlantic trade and investment partnership agreement); General trade issues
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
2016 · second_quarter · Q2
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Trans Pacific Partnership(TPP), TTIP (trans-atlantic trade and investment partnership agreement); General trade issues
2016 · first_quarter · Q1
Patent reform proposals, use of inter partes review (IPR) challenges of pharmaceutical and biotechnology patents
Trans Pacific Partnership(TPP), Intellectual property provisions related to pharmaceuticals
Issues related to implementation of the Generic Drug User Fee Agreement (GDUFA), FDA funding Medicaid Generic Drug Rebate, HR. 1314 - Bipartisan Budget Act of 2015, S. 1364- Medicaid Generic Drug Price Fairness Act of 2015
2015 · third_quarter · 3A
Trans Pacific Partnership(TPP), General trade issues
Corporate Tax Reform, Proposals to reform domestic and international tax structures
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
2015 · fourth_quarter · Q4
Biosimilar Naming, Issues related to implementation of the Generic Drug User Fee Agreement, generic drug pricing Issues related to Senate HELP Innovation Initiative Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector
Biosimilar Naming, Issues related to implementation of the Generic Drug User Fee Agreement, generic drug pricing Medicaid Generic Drug Rebate, Bipartisan Budget Act of 2015, H.R. 1314
2015 · third_quarter · Q3
Trans Pacific Partnership(TPP), General trade issues
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA)
Corporate Tax Reform, Proposals to reform domestic and international tax structures
2015 · second_quarter · Q2
FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Generic drug pricing issues, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act, Innovation for Healthier American Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
Patent Reform, H.R. 9 Innovation Act, S. 632 The STRONG Act Access for Generics to Inter Partes Review (IPR)
2015 · first_quarter · Q1
Trans Pacific Partnership (TPP), Trade Promotion Authority (TPA), General trade issues
Patent Reform, H.R. 9 Innovation Act, S. 632 The STRONG Act
FDA proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0919-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics Implementations of Biosimilars in the Affordable Care Act (ACA), Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Generic drug pricing issues, Medicare Part D program and Generic Drugs House Energy & Commerce Committee 21st Century Cures Discussion document, Senate Report "Innovation for Healthier Americans" Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, FAST Generics Act
2014 · fourth_quarter · Q4
President's Emergency Plan for AIDS Relief funding, Global Fund funding, FY 2015 Budget, FY2015 House and Senate Appropriations, Generic Drug User Fees
General trade issues, Trans Pacific Partnership
FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics; Implementation of Biosimilars in the Affordable Care Act (ACA), Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act; H.R. 4437, The Generic Drug Pricing Transparency Act, Generic drug pricing issues, Medicare Part D program and Generic Drugs; H.R. 5657, the Fair Access for Safe and Timely Generics Act of 2014 (FAST Generics Act) PEPFAR program supply chain management
2014 · third_quarter · Q3
Federal policy regarding Public Law 113-54, the Drug Quality and Security Act; FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics; Implementation of Biosimilars in the Affordable Care Act (ACA), Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act; The Generic Drug Pricing Transparency Act, H.R. 4437; Risk Evaluation Mitigation Strategies, Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; The Fair Access for Safe and Timely (FAST) Generics Act. PEPFAR program supply chain management
Tax Reform, Tax Extenders, Corporate tax; Administrations Tax Reform and 2015 Budget Proposals; Senate and House Committee Tax Reform Proposals; Proposals to reform domestic and international tax structures
2014 · second_quarter · Q2
Federal policy regarding Public Law 113-54, the Drug Quality and Security Act; FDA proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including BiologicalProducts," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics; Implementations of Biosimilars in the Affordable Care Act (ACA), Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act; The Generic Drug Pricing Transparency Act, H.R. 4437; Risk Evaluation Mitigation Strategies, Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing
General Trade Issues, TPP
2014 · first_quarter · Q1
Global Health Appropriations, President's Emergency Plan for AIDS Relief funding, Global Fund funding, FY2014 Budget, FY 2015 Budget, FY2015 Appropriations, Funding for FDA, Funding for the Office of Generic Drugs, Generic Drug User Fees, Biosimilar User Fees
Pharmaceutical Distribution Supply Chain Security; Electronic distribution of prescribing information; H.R. 3204, the Drug Quality and Security Act; Compounding; Generic Labeling; Biosimilars; H.R. 486, the Stop Tampering of Prescription Pills (STOPP) Act; S. 214, the Preserve Access to Affordable Generics; S. 504, the Fair and Immediate Release of Generic Drugs Act; H.R. 2725, the FDA Safety Over Sequestration Act of 2013; S. 621, the Safe Prescribing Act of 2013Risk Evaluation Mitigation Strategies; H.R. 460, Patients' Access to Treatments Act of 2013; implementation of the Generic Drug User Fee Act
2013 · second_quarter · 2A
Global Health Appropriations, Presidents Emergency Plan for AIDS Relief, the Global Fund, FY 2014 Budget, FY 2013 Budget, Funding for FDA, Funding for the Office of Generic Drugs, FY14 Presidential Budget Request
Pharmaceutical Distribution Supply Chain Security, Electronic distribution of prescribing information, H.R. 2094, the School Access to Emergency Epinephrine Act, S.214, Preserve Access to Affordable Generics Act, S.504, Fair and Immediate Release of Generic Drugs ActH.R.460 - Patients' Access to Treatments Act of 2013, Generic Drug User Fees, Biosimilar User Fees, Compounding, S. 959: Pharmaceutical Compounding Quality and Accountability Act, H.R. 1919: Safeguarding Americas Pharmaceuticals Act of 2013, S.957, the Drug Supply Chain Security Act, Global HIV/AIDS programs
2013 · fourth_quarter · Q4
Patent Settlements
Pharmaceutical Distribution Supply Chain Security; Electronic distribution of prescribing information; H.R. 3204, the Drug Quality and Security Act; Compounding; H.R. 2094 and S. 1503, the School Access to Emergency Epinephrine Act; Biosimilars; H.R. 486, the Stop Tampering of Prescription Pills (STOPP) Act; S. 214, the Preserve Access to Affordable GenericsS. 504, Fair and Immediate Release of Generic Drugs Act; H.R. 1285, S. 621, the Safe Prescribing Act of 2013; H.R. 460, Patients' Access to Treatments Act of 2013; H.R. 2725, the FDA Safety Over Sequestration Act 2013; S. 1545, the PEPFAR Stewardship and Oversight Act; Generic Labeling
2013 · third_quarter · Q3
Patent Settlements
Global Health Appropriations, President's Emergency Plan for AIDS Relief funding, Global Fund funding, FY2014 Budget, FY2013 Budget, Funding for FDA, Funding for the Office of Generic Drugs, Generic Drug User Fees, Biosimilar User Fees
Pharmaceutical Distribution Supply Chain Security; Electronic distribution of prescribing information; H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013; S. 959, Pharmaceutical Quality, Security, and Affordability Act; H.R. 3204, Drug Quality and Security Act; Compounding; H.R. 2094 and S. 1503, the School Access to Emergency Epinephrine Act; Biosimilars; H.R. 486, the Stop Tampering of Prescription Pills (STOPP) Act; S. 214, Preserve Access to Affordable Generics ActS. 504, Fair and Immediate Release of Generic Drugs Act; H.R. 1285, S. 621, the Safe Prescribing Act of 2013; H.R. 460, Patients' Access to Treatments Act of 2013; H.R. 2725, the FDA Safety Over Sequestration Act 2013
2013 · second_quarter · Q2
Global Health Appropriations, Presidents Emergency Plan for AIDS Relief, the Global Fund, FY 2014 Budget, FY 2013 Budget, Funding for FDA, Funding for the Office of Generic Drugs, FY14 Presidential Budget Request
Pharmaceutical Distribution Supply Chain Security, Electronic distribution of prescribing information, H.R. 2094, the School Access to Emergency Epinephrine Act, S.214, Preserve Access to Affordable Generics Act, S.504, Fair and Immediate Release of Generic Drugs ActH.R.460 - Patients' Access to Treatments Act of 2013, Generic Drug User Fees, Biosimilar User Fees, Compounding, S. 959: Pharmaceutical Compounding Quality and Accountability Act, H.R. 1919: Safeguarding Americas Pharmaceuticals Act of 2013, S.957, the Drug Supply Chain Security Act, Global HIV/AIDS programs
2013 · first_quarter · Q1
Patent Settlements
Global Health Appropriations, Presidents Emergency Plan for AIDS Relief, the Global Fund; Pharmaceutical Distribution Supply Chain Security; Electronic distribution of prescribing information; School Access to Emergency Epinephrine; Biosimilars; H.R. 8 The American Taxpayer Relief Act; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.214 - Preserve Access to Affordable Generics ActS.504 - Fair and Immediate Release of Generic Drugs Act H.R.933 - Consolidated and Further Continuing Appropriations Act, 2013 S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients' Access to Treatments Act of 2013 S.CON.RES.8 - An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2014, revising the appropriate budgetary levels for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023. FY 2014 Budget, FY 2013 Budget, Generic Drug User Fees, Biosimilar User Fees, Funding for FDA, Funding for the Office of Generic Drugs, FY13 Presidential Budget Request
2012 · fourth_quarter · Q4
Patent settlements
H.R. 3627/S. 1884, School Access to Emergency Epinephrine Act; S. 3187, Food and Drug Administration Safety and Innovation Act (FDASIA), Title 3, Generic Drug User Fee Amendment (GDUFA), Title 4, Fees Relating to Biosimilar Biological Products; Pharmaceutical Distribution Supply Chain; HIV/AIDS; Patent Settlements; Biosimilars; Electronic Distribution of Labeling of Prescription Drugs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Medicaid Generic Drug Rebate, Bipartisan Budget Act of 2015, H.R. 1314
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, U.S. Trade Representative (USTR), White House Office
Medicaid Generic Drug Rebate, Bipartisan Budget Act of 2015, H.R. 1314
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, U.S. Trade Representative (USTR), White House Office
Medicaid Generic Drug Rebate, Bipartisan Budget Act of 2015, H.R. 1314
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, U.S. Trade Representative (USTR), White House Office
Senate Health, Education, Labor and Pensions Committee's Innovation for Healthier Americans initiative Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act, Senate REMS proposed legislation S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; S. 2658 Federal Aviation Administration Reauthorization Act of 2016 S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), White House Office
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA)
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 2019 Preserve Access to Affordable Generics Act Access for Generics to Inter Partes Review (IPR)
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), White House Office
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 1137, the Patent Act, S. 2019 Preserve Access to Affordable Generics Act
Issues related to Trans Pacific Partnership(TPP), General trade issues
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), White House Office
Biosimilar Naming, Implementation of FDASIA and Generic Drug User Fee Act (GDUFA) Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector Issues related to the antitrust review of Teva Pharmaceuticals Industries, Ltd. offer to acquire Mylan N.V.
Patent Reform, H.R. 9 Innovation Act, S. 632 STRONG Patents Act, S. 2019 Preserve Access to Affordable Generics Act Access for Generics to Inter Partes Review (IPR)
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), White House Office
Trans Pacific Partnership (TPP), Trade Promotion Authority (TPA), General trade issues
PEPFAR, President's Emergency Plan for AIDS Relief funding, Global Fund funding, Generic Drug, Biosimilar User Fees, FY 2016 Budget, FY2016 House and Senate Appropriations (HR 3049, S 1800, HR 3020, S 1695, HR 2772, S 1725) FDA Safety Over Sequestration Act, HR 1078
Corporate Tax Reform, Proposals to reform domestic and international tax structures
Filing targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), White House Office
Corporate Tax Reform, Administration's Tax Reform and 2016 Budget Proposals; Proposals to reform domestic and international tax structures
PEPFAR, President's Emergency Plan for AIDS Relief funding, Global Fund funding, Generic Drug, Biosimilar User Fees, FY 2016 Budget, FY 2016 House and Senate Appropriations, FDA Safety Over Sequestration Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Patent Reform
Corporate Tax Reform, Tax Extenders, Administrations Tax Reform and 2015 Budget Proposals; Proposals to reform domestic and international tax structures, Tax Treatment of Patent Infringement Litigation costs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Global Health Appropriations, President's Emergency Plan for AIDS Relief funding, Global Fund funding, FY 2015 Budget, FY2015 House and Senate Appropriations, Funding for FDA, Funding for the Office of Generic Drugs, Generic Drug User Fees
Patent Settlements, Patent Reform
General trade issues, TPP
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office
Patent Settlements, Patent Reform, S. 1720 Patent Transparency and Improvments Act of 2013, Patent Abuse Reduction Act
Global Health Appropriations, President's Emergency Plan for AIDS Relief funding, Global Fund funding; FY 2015 Budget, FY 2015 House and Senate Appropriations, Funding for FDA, Funding for the Office of Generic Drug, Generice Drug User Fees
Tax Reform, Tax Extenders, Corporate Tax
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Patent Settlements, Patent Reform
Tax Reform, Tax Extenders
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
Patent Settlements
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Global Health Appropriations, President's Emergency Plan for AIDS Relief funding, Global Fund funding, FY2014 Budget, FY14 Appropriations, FY2013 Budget, Funding for FDA, Funding for the Office of Generic Drugs, Generic Drug User Fees, Biosimilar User Fees
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Patent Settlements
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE