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Reported covered position: Dep. Assistant Sec. for Legislation, HHS; Staff, Senate HELP Committee; Staff, Senator Bill Frist
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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.
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. S.1414: Expedited Access to Biosimilars Act. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. Medicare Conditions of Participation. H.R.1: One Big Beautiful Bill Act as it relates to Delinking in Medicare Part D, Medicaid Spread Pricing, PBM transparency, and NADAC Reporting.
To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm:
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2025 · second_quarter · Q2
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
Source: Senate LDA
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: A bill to provide for increased transparency in generic drug applications. H.R.1396: To amend the Internal Revenue Code of 1986 to establish the generic drugs and biosimilars production credit, and for other purposes. Drug Shortages. Biosimilar Interchangeability. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. E-Labeling.
PILLS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: A bill to provide for increased transparency in generic drug applications. H.R.1396: To amend the Internal Revenue Code of 1986 to establish the generic drugs and biosimilars production credit, and for other purposes. Drug Shortages. Biosimilar Interchangeability. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. E-Labeling.
PILLS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: A bill to provide for increased transparency in generic drug applications. H.R.1396: To amend the Internal Revenue Code of 1986 to establish the generic drugs and biosimilars production credit, and for other purposes. Drug Shortages. Biosimilar Interchangeability. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. E-Labeling.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
RAPID Reserve Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
Prescription Information Modernization Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
EB–5 Regional Center Program Advisory Committee Authorization Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
Increasing Transparency in Generic Drug Applications Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
Increasing Transparency in Generic Drug Applications Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: A bill to provide for increased transparency in generic drug applications. H.R.1396: To amend the Internal Revenue Code of 1986 to establish the generic drugs and biosimilars production credit, and for other purposes. Drug Shortages. Biosimilar Interchangeability. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. E-Labeling.
Expedited Access to Biosimilars Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. S.1414: Expedited Access to Biosimilars Act. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. Medicare Conditions of Participation. H.R.1: One Big Beautiful Bill Act as it relates to Delinking in Medicare Part D, Medicaid Spread Pricing, PBM transparency, and NADAC Reporting.
MAPS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
PILLS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
Biosimilar Red Tape Elimination Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
Prescription Information Modernization Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
RAPID Reserve Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.
End Drug Shortages Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
American Relief Act, 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
Increasing Access to Biosimilars Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty. Inflation Reduction Act (Pub.L.117-169).
Increasing Access to Biosimilars Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicaid Generics Penalty.
Increasing Access to Biosimilars Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. Medicare Reimbursement for Biosimilars. H.R.1352: Increasing Access to Biosimilars Act of 2023. Medicaid Rebate Penalty.
Increasing Access to Biosimilars Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty.
Increasing Access to Biosimilars Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty.
Prescription Information Modernization Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
Prescription Information Modernization Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Prescription Information Modernization Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Prescription Information Modernization Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
National Defense Authorization Act for Fiscal Year 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
National Defense Authorization Act for Fiscal Year 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
National Defense Authorization Act for Fiscal Year 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
National Defense Authorization Act for Fiscal Year 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
Protecting Patients Against PBM Abuses Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
Protecting Patients Against PBM Abuses Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
Protecting Patients Against PBM Abuses Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
Protecting Patients Against PBM Abuses Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Protecting Patients Against PBM Abuses Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Drug Shortage Prevention Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
PATIENT Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
PATIENT Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicaid Generics Penalty.
Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty.
Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. Medicare Reimbursement for Biosimilars. H.R.1352: Increasing Access to Biosimilars Act of 2023. Medicaid Rebate Penalty.
Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty. Inflation Reduction Act (Pub.L.117-169).
Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty.
PILLS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
PILLS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
PILLS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
To address patent thickets.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
To address patent thickets.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
To address patent thickets.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Restoring America’s Leadership in Innovation Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Restoring America’s Leadership in Innovation Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Affordable Prescriptions for Patients Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Affordable Prescriptions for Patients Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Affordable Prescriptions for Patients Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
RESTORE Patent Rights Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
RESTORE Patent Rights Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Patent Eligibility Restoration Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Patent Eligibility Restoration Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Patent Eligibility Restoration Act of 2024
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Expanding Access to Low-Cost Generics Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Expanding Access to Low-Cost Generics Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
Preserve Access to Affordable Generics and Biosimilars Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Preserve Access to Affordable Generics and Biosimilars Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Preserve Access to Affordable Generics and Biosimilars Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Affordable Prescriptions for Patients Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Affordable Prescriptions for Patients Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Affordable Prescriptions for Patients Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Pharmaceutical Supply Chain Risk Assessment Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
Pharmaceutical Supply Chain Risk Assessment Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
Ensuring Access to Lower-Cost Medicines for Seniors Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. Medicare Reimbursement for Biosimilars. H.R.1352: Increasing Access to Biosimilars Act of 2023. Medicaid Rebate Penalty.
Ensuring Access to Lower-Cost Medicines for Seniors Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicaid Generics Penalty.
Ensuring Access to Lower-Cost Medicines for Seniors Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Ensuring Access to Lower-Cost Medicines for Seniors Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty.
Ensuring Access to Lower-Cost Medicines for Seniors Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty. Inflation Reduction Act (Pub.L.117-169).
Ensuring Access to Lower-Cost Medicines for Seniors Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty.
Ensuring Access to Lower-Cost Medicines for Seniors Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Patent Eligibility Restoration Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Patent Eligibility Restoration Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Patent Eligibility Restoration Act of 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Medicare Part D Reform. S.1414: Expedited Access to Biosimilars Act. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. Medicare Conditions of Participation. H.R.1: One Big Beautiful Bill Act as it relates to Delinking in Medicare Part D, Medicaid Spread Pricing, PBM transparency, and NADAC Reporting.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2025 · first_quarter · Q1
Prescription Drug Costs. H.R.1843 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: A bill to provide for increased transparency in generic drug applications. H.R.1396: To amend the Internal Revenue Code of 1986 to establish the generic drugs and biosimilars production credit, and for other purposes. Drug Shortages. Biosimilar Interchangeability. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. E-Labeling.
Medicare Part D Reform. H.R._/S._: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R._/S._: Increasing Access to Biosimilars Act. Medicaid Rebate Penalty.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR), White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2024 · third_quarter · 3A
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty.
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2024 · fourth_quarter · Q4
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicaid Generics Penalty.
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2024 · third_quarter · Q3
Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2024 · second_quarter · Q2
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty. Inflation Reduction Act (Pub.L.117-169).
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Natl Drug Control Policy (NDCP), SENATE, White House Office
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2024 · first_quarter · Q1
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. Medicare Reimbursement for Biosimilars. H.R.1352: Increasing Access to Biosimilars Act of 2023. Medicaid Rebate Penalty.
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2023 · fourth_quarter · Q4
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. Medicare Reimbursement for Biosimilars. H.R.1352: Increasing Access to Biosimilars Act of 2023 Medicaid Rebate Penalty. Inflation Reduction Act (IRA) Implementation. Guthrie Bill Eliminating Medicaid Generics Penalty.
Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Labeling of Generic Drugs and Biosimilars. H.R.4134/S.2886: Updated Drug Labeling for Patient Safety Act. Hickenlooper Safe Harbor for Skinny Labeling. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. S.2510: RAPID Reserve Act. Drug Shortages. Stop Drug Shortages Act of 2023. H.R.405: Essential Medicines Strategic Stockpile Act of 2023. S.2305: Biosimilar Red Tape Eliminations Act. FDA Inspections. Process issues regarding third-party contract to assess drug quality. Inflation Reduction Act (IRA) Implementation. H.R.3561: PATIENT Act of 2023. H.R.3793: Ensuring Access to Lifesaving Drugs Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2023 · third_quarter · Q3
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Rebates and Pharmacy Benefit Managers (PBMs). Medicare Price Negotiation. Medicare Advantage Proposed Rule. Inflation Reduction Act (IRA) Implementation.
Prescription Drug Costs. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. S.1128: Ensuring Access to Generic Medications Act. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.4692/S.574: Increasing Prescription Drug Competition Act. H.R.1790: Biologics Competition Act of 2023. Labeling of Generic Drugs and Biosimilars. H.R.4134/S.2886: Updated Drug Labeling for Patient Safety Act Hickenlooper Safe Harbor for Skinny Labeling. S.775: Increasing Transparency in Generic Drug Applications Act. S.2510: RAPID Reserve Act. Drug Shortages. END Drug Shortages Act of 2023. Stop Drug Shortages Act. H.R.3008/S.2362: Drug Shortage Prevention Act of 2023. H.R. 3810: Drug Origin Transparency Act of 2023. Stockpile of Generic Drugs. Same Strength Requirement for Biosimilars. Biosimilar Red Tape Eliminations Act. Expediting Competitive Biosimilar Competition. FDA Inspections. Shaheen-Cassidy Citizen Petition Legislation. Guthrie Priority Review Voucher. Inflation Reduction Act (IRA) Implementation. H.R.3561: PATIENT Act of 2023. Trusted Partners in Medical Supply Chains. S.2364: MAPS Act. Dunn DeLauro Valisure and Department of Defense Agreement. H.R.3793: Ensuring Access to Lifesaving Drugs Act of 2023. H.R.167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2023 · second_quarter · Q2
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Rebates and Pharmacy Benefit Managers (PBMs). Medicare Price Negotiation. Medicare Advantage Proposed Rule. Inflation Reduction Act (IRA) Implementation.
Prescription Drug Costs. Drug Pricing. Civil Monetary Penalties. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. S.1128: Ensuring Access to Generic Medications Act. S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. S.574: Increasing Prescription Drug Competition Act. Crenshaw Interchangeability and Bioequivalence Common Rating. H.R.1790: Biologics Competition Act of 2023. Labeling of Generic Drugs and Biosimilars. Hickenlooper Safe Harbor for Skinny Labeling. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. S.775: Increasing Transparency in Generic Drug Applications Act. Incentivize Domestic Manufacturing. Drug Shortages. Stockpile of Generic Drugs. GAO Report on Generic Drug Framework. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. Same Strength Requirement for Biosimilars. Biosimilar Red Tape Eliminations Act. Expediting Competitive Biosimilar Competition. Crenshaw Competitive Biosimilar Therapy Bill. FDA Inspections. Shaheen-Sanders Inspections. Energy & Commerce Factory Inspection Legislation. FDA-PTO Collaboration. FDA Catalyst Decision. FDA Proposal on Combination Products. Shaheen-Cassidy Citizen Petition Legislation. Buy American Proposals. Inflation Reduction Act (IRA) Implementation. HELP Committee Briefing. H.R.3561: PATIENT Act of 2023. Trusted Partners in Medical Supply Chains.
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2023 · first_quarter · Q1
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Rebates and Pharmacy Benefit Managers (PBMs). Medicare Price Negotiation. Medicare Advantage Proposed Rule. Inflation Reduction Act (IRA) Implementation.
Prescription Drug Costs. Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. Labeling of Generic Drugs and Biosimilars. Section 505(j)(10) Labeling [Legislation not yet introduced]. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. Incentivize Domestic Manufacturing. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. FDA Inspections. Energy & Commerce Factory Inspection Legislation. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. Shaheen-Cassidy Citizen Petition Legislation. 506I Marketing Status Updates. Buy American Proposals. Issues Related to COVID-19. Inflation Reduction Act (IRA) Implementation.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2022 · fourth_quarter · Q4
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
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2022 · third_quarter · Q3
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
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2022 · second_quarter · Q2
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
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2022 · first_quarter · Q1
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
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2021 · fourth_quarter · Q4
General Trade Issues. Drug Supply Chain. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. US-India Trade Discussions. TRIPS Waivers. Enhanced Access to Affordable Medicines Act. Shipping Delays.
Prescription Drug Costs. Drug Pricing. Biden Executive Order on Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. Carter Bill on Section 505(j)(10) Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Legislation to incentivize domestic manufacturing. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. H.R.2565: FDA Modernization Act of 2021 as it relates to alternative testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes. FDA Inspections. FDA-PTO Collaboration. Buy American Proposals. Issues Related to COVID-19. H.R.2910: Veterans Health Care Freedom Act. H.R.5376: Build Back Better Act.
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2021 · third_quarter · Q3
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846:Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Shared Savings Program. H.R.2869/S.1427: Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act.
General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. US-India Trade Discussions. TRIPS Waivers.
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2021 · second_quarter · Q2
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846:Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Shared Savings Program. H.R.2869/S.1427 - Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act.
Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. FDA Inspections. FDA and Future Public Health Emergencies. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021.
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2021 · first_quarter · Q1
General Trade Issues. Drug Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-UK Trade Agreement. US-India Trade Discussions. US-European Trade Discussions. US-China Trade Discussions. TRIPS Waivers.
FDA Funding. Budget Reconciliation.
Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Orange Book. Drug Shortages. S.917: Short on Competition Act. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Buy American Proposals. Issues Related to COVID-19. Secretary Azar Importation Plan.
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2020 · fourth_quarter · Q4
General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. Pharmaceutical Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. Carter Supply Chain Legislation. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-China Trade Discussions.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: 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. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.
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2020 · third_quarter · Q3
FDA Funding. S. Rept. 116-236: National Defense Authorization Act for Fiscal Year 2021. Public Law 115-141: Consolidated Appropriations Act of 2018.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: 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. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.
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2020 · second_quarter · Q2
General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.6049/S.3343: Medical Supply Chain Security Act. H.R.6393/S.3538: Strengthening Americas Supply Chain and National Security Act. S. ___More Accurate Supply Chain Information. Air Transport of Pharmaceuticals. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. Secretary Azar Importation Plan.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: 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. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.
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2020 · first_quarter · Q1
FDA Funding. H.R.1865: Further Consolidated Appropriations Act, 2020. Section 605 of H.R.1865: Further Consolidated Appropriations Act, 2020. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
General Trade Issues. Biologic Exclusivity. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. H.R.6049/S.3343: Medical Supply Chain Security Act. S. ___Strengthening Americas Supply Chain and National Security Act. S. ___More Accurate Supply Chain Information. H.R.___LOSS Act. Air Transport of Pharmaceuticals. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. U.S.-China Phase 1 Trade Deal. Secretary Azar Importation Plan.
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2019 · fourth_quarter · Q4
FDA Funding. H.R.1865: Further Consolidated Appropriations Act, 2020. Section 605 of H.R.1865: Further Consolidated Appropriations Act, 2020. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Shared Savings Program. S.1895: Lower Health Care Costs Act.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. H.R.5381: International Pharmaceutical Transparency Act of 2019. Drug Compounding. Drug Shortages. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. FDA Citizen Petitions. H.R.2387: STOP GAMES Act of 2019. H.R.1506: FAIR Generics Act. H.R.4913: 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. S.475: RxCAP Act of 2019. 180-Day Exclusivity. H.R.2455/S.1169: Ensuring Timely Access to Generics Act of 2019. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.2376: Prescription Pricing for the People Act of 2019. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. S.1805: Better Tools for Healthy Living Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA).
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2019 · third_quarter · Q3
FDA Funding. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. Drug Compounding. Drug Shortages. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Proposed Anti-Kickback Statute (AKS) Rebates. FDA Citizen Petitions. Suitability Petitions. S.660: Efficiency and Transparency in Petitions Act. H.R.2387: STOP GAMES Act of 2019. H.R.985: FAST Generics Act of 2019. H.R.1506: FAIR Generics Act. H.R.2455/S.1169: Ensuring Timely Access to Generics Act of 2019. H.R.1503: Orange Book Transparency Act of 2019. H.R.1520: Purple Book Continuity Act of 2019. Drug Pricing. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.2374/S.1224: Stop STALLING Act. H.R.2376: Prescription Pricing for the People Act of 2019. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.1093/S.378: Stop Price Gouging Act. H.R.3: Lower Drug Costs Now Act of 2019. S.474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019. S.440: Preserving Access to Cost Effective Drugs (PACED) Act. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Orphan Drug Exclusivity. Biologic Exclusivity. H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Public Law 115-52: FDA Reauthorization Act of 2017.
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2019 · second_quarter · Q2
FDA Funding. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
Inter Partes Review (IPR) Process. H.R.990/S.344: Hatch-Waxman Integrity Act of 2019. Patent Settlements. Patent Abuse. Section 101 of the Patent Act. New Chemical Entity Exclusivity (NCE). REMEDY Act (Bill number not yet assigned). S.440: Preserving Access to Cost Effective Drugs (PACED) Act. H.R.2375: Preserve Access to Affordable Generics and Biosimilars Act.
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.448/S.99: Medicare Drug Price Negotiation Act. H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019. S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019. H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019. S.1895: Lower Health Care Costs Act.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2019 · first_quarter · Q1
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.448/S.99: Medicare Drug Price Negotiation Act. H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019. S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019. H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Drug Shortages. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.985: FAST Generics Act of 2019. H.R.1506: FAIR Generics Act. H.R.1503: Orange Book Transparency Act of 2019. H.R.1520: Purple Book Continuity Act of 2019. S.61: Safe and Affordable Drugs from Canada Act of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. H.R.447/S.97: Affordable and Safe Prescription Drug Importation Act. S.124: Freedom to Compete Act. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.1093/S. 378: Stop Price Gouging Act. S.474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019. S.475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act of 2019. S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019. S.440: Preserving Access to Cost Effective Drugs (PACED) Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Public Law 115-52: FDA Reauthorization Act of 2017.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2018 · fourth_quarter · Q4
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Drug Shortages. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. S.3792: Preserve Access to Affordable Generics and Biosimilars Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Pharmaceutical Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. H.R.7348/S.3775: Affordable Drug Manufacturing Act of 2018. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. S.3680: Low Drug Prices Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. H.R.6: SUPPORT for Patients and Communities Act.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2018 · third_quarter · 3A
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2018 · second_quarter · 2A
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program.
FDA Funding. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2018 · first_quarter · 1A
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2018 · third_quarter · Q3
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2018 · second_quarter · Q2
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2018 · first_quarter · Q1
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program.
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · fourth_quarter · Q4
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program.
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · third_quarter · Q3
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · first_quarter · RA
*Please see the current quarterly report for full details of specific lobbying issues.
*Please see the current quarterly report for full details of specific lobbying issues.
*Please see the current quarterly report for full details of specific lobbying issues.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · second_quarter · Q2
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Rebates and Pharmacy Benefit Managers (PBMs). H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Price Negotiation. H.R.5260: Reduced Costs and Continued Cures Act. Medicare Shared Savings Program. H.R.2869/S.1427: Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815: BIOSIM Act. Implementation of the Inflation Reduction Act. H.R.6485/S.3495: Inflation Prevention Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Rebates and Pharmacy Benefit Managers (PBMs). H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Price Negotiation. H.R.5260: Reduced Costs and Continued Cures Act. Medicare Shared Savings Program. H.R.2869/S.1427: Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Price Negotiation. H.R.5260: Reduced Costs and Continued Cures Act. Medicare Shared Savings Program. H.R.2869/S.1427: Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act.
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. US-India Trade Discussions. US-UK Intellectual Property Policies. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R. 4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Shipping Delays. US-India Trade Discussions. China Patent Listing. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927: MADE in America Act.
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Price Negotiation. H.R.5260: Reduced Costs and Continued Cures Act. Medicare Shared Savings Program. H.R.2869/S.1427: Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
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), SENATE, U.S. Trade Representative (USTR), White House Office
Prescription Drug Costs. Drug Pricing. Biden Executive Order on Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Carter Bill on Section 505(j)(10) Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Legislation to incentivize domestic manufacturing. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. H.R.5388/S.2740: PREPARE Act. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Biosimilars Misinformation. FDA Inspections. FDA and Future Public Health Emergencies. FDA-PTO Collaboration. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-India Trade Discussions. TRIPS Waivers.
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)
Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Shared Savings Program. Most Favored Nation Interim Final Rule.
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), SENATE, U.S. Trade Representative (USTR)
FDA Funding. H.R.133: Consolidated Appropriations Act, 2021.
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Shared Savings Program.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: 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. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.
General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. Pharmaceutical Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. Carter Supply Chain Legislation. S.4175: Pharmaceutical Supply Chain Defense and Enhancement Act. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. Secretary Azar Importation Plan.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
FDA Funding. H.R.1865: Further Consolidated Appropriations Act, 2020. S.4049: National Defense Authorization Act for Fiscal Year 2021. Public Law 115-141: Consolidated Appropriations Act of 2018.
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: 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. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: 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. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: 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. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.
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), SENATE, U.S. Trade Representative (USTR)
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), SENATE, U.S. Trade Representative (USTR)
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.448/S.99: Medicare Drug Price Negotiation Act. H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019. S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019. H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019. S.1895: Lower Health Care Costs Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Drug Shortages. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Proposed Anti-Kickback Statute (AKS) Rebates. FDA Citizen Petitions. H.R.985: FAST Generics Act of 2019. H.R.1506: FAIR Generics Act. H.R.1503: Orange Book Transparency Act of 2019. H.R.1520: Purple Book Continuity Act of 2019. S.61: Safe and Affordable Drugs from Canada Act of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. S.1224: Stop STALLING Act. H.R.447/S.97: Affordable and Safe Prescription Drug Importation Act. S.124: Freedom to Compete Act. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.1093/S. 378: Stop Price Gouging Act. S.474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019. S.475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act of 2019. S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019. S.440: Preserving Access to Cost Effective Drugs (PACED) Act. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. Biologic Exclusivity. H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs Act. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Public Law 115-52: FDA Reauthorization Act of 2017.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Inter Partes Review (IPR) Process. H.R.990/S.344: Hatch-Waxman Integrity Act of 2019. Patent Settlements. Patent Abuse. S.440: Preserving Access to Cost Effective Drugs (PACED) Act.
FDA Funding. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
FDA Funding. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
FDA Funding. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program.
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Inter Partes Review (IPR) Process. Hatch-Waxman Integrity Act. Patent Settlements. S.1390: STRONGER Patents Act of 2017. S.2514: PACED Act.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
General Trade Issues. Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. North American Free Trade Agreement (NAFTA). China Tariffs.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program.
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
FDA Funding. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
General Trade Issues. Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. North American Free Trade Agreement (NAFTA). China Tariffs.
Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program.
FDA Funding. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.
Inter Partes Review (IPR) Process. Hatch-Waxman Integrity Act. Patent Settlements. S.1390: STRONGER Patents Act of 2017. S.2514: PACED Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
*Please see the current quarterly report for full details of specific lobbying issues.
*Please see the current quarterly report for full details of specific lobbying issues.
*Please see the current quarterly report for full details of specific lobbying issues.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program.
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)