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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.
Protecting Consumer Access to Generic Drugs Act of 2019
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. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
2019 · fourth_quarter · Q4
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements
Medicaid Rebate provision of the Bipartisan Budget Act of 2015
Source: Senate LDA
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Protecting Consumer Access to Generic Drugs Act of 2019
Client: VIATRIS INC · Firm: VIATRIS INC.
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Protecting Consumer Access to Generic Drugs Act of 2019
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. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 CY2020 CMS Call Letter
Further Extension of Continuing Appropriations Act, 2021
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. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Further Extension of Continuing Appropriations Act, 2021
Client: VIATRIS INC · Firm: VIATRIS INC.
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Further Extension of Continuing Appropriations Act, 2021
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. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 CY2020 CMS Call Letter
Preserve Access to Affordable Generics and Biosimilars Act
Client: VIATRIS INC · Firm: VIATRIS INC.
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes.
Client: VIATRIS INC · Firm: VIATRIS INC.
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 CY2020 CMS Call Letter
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 CY2020 CMS Call Letter
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 CY2020 CMS Call Letter
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs, Section 101 Reform of the Patent Act S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019, S.1416 - Affordable Prescriptions for Patients Act of 2019, Patent Settlements
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs, S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019, Patent Settlements
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs, Section 101 Reform of the Patent Act S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019, S.1416 - Affordable Prescriptions for Patients Act of 2019, Patent Settlements
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
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. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 CY2020 CMS Call Letter
A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
Client: VIATRIS INC · Firm: VIATRIS INC.
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
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. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
Client: VIATRIS INC · Firm: VIATRIS INC.
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs, Section 101 Reform of the Patent Act S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019, S.1416 - Affordable Prescriptions for Patients Act of 2019, Patent Settlements
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs, S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019, Patent Settlements
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements
Preserve Access to Affordable Generics and Biosimilars Act
Client: VIATRIS INC · Firm: VIATRIS INC.
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
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
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
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
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
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
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.
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
- 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 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 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 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, 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
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
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
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
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
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
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.
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
Trade issues related to generic medicines
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
2019 · third_quarter · Q3
Medicaid Rebate provision of the Bipartisan Budget Act of 2015
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugsRisk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Trade issues related to generic medicines
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
2019 · second_quarter · Q2
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars S. 1416, Affordable Prescriptions for Patients Act Senate HELP Committee Lower Health Care Costs Act of 2019 FY 2020 House/Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs, Section 101 Reform of the Patent Act S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019, S.1416 - Affordable Prescriptions for Patients Act of 2019, Patent Settlements
Trade issues related to generic medicines
Medicaid Rebate provision of the Bipartisan Budget Act of 2015
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
2019 · first_quarter · Q1
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs, S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019, Patent Settlements
Trade issues related to generic medicines
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - The Purple Book Continuity Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 CY2020 CMS Call Letter
Tariff issues related to generic medicines
Medicaid Rebate provision of the Bipartisan Budget Act of 2015
Filing targets: Centers For Medicare and Medicaid Services (CMS), 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, U.S. Trade Representative (USTR), White House Office
2018 · fourth_quarter · Q4
Trade issues related to generic medicines
Medicaid Rebate provision of the Bipartisan Budget Act of 2015
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
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: 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
2018 · third_quarter · Q3
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
Medicaid Rebate provision of the Bipartisan Budget Act of 2015
Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs, Hatch-Waxman Integrity Act of 2018, Patent Settlements
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
2017 · second_quarter · Q2
- 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
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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 · third_quarter · Q3
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
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
2012 · first_quarter · Q1
User Fees; Drug Shortages; Patent Settlements; Food, Drug, and Cosmetic Act (FDCA); Globalizing the FDA; Serialization; Access to epinephrine auto-injectors in an emergency; Issues relating to HIV/AIDS, funding for Antiretrovirals (ARVs), PEPFAR, Global Fund; Issues relating to biosimilars; Issues relating to the generic drug industry; Issues relating to Average Manufacturer Price (AMP)
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
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
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