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Reported covered position: Covered Positions Continued: Policy Coordinator-House Energy & Commerce Committee Energy Subcommittee (Rep. Fred Upton); Policy Coordinator-House Energy & Commerce Committee Energy (Rep. Fred Upton); Sr. LA/LA-Rep. Fred Upton; LA-Rep. Joe Schwarz
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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.
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. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
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
2026 · third_quarter · Q3
General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Source: Senate LDA
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms 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.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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms 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.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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
Patent Eligibility Restoration Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Patent Eligibility Restoration Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Patent Eligibility Restoration Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
ETHIC Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
ETHIC Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
ETHIC Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
Interagency Patent Coordination and Improvement Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
Biosimilar Red Tape Elimination Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
Restoring America’s Leadership in Innovation Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
Restoring America’s Leadership in Innovation Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Restoring America’s Leadership in Innovation Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Skinny Labels, Big Savings Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Skinny Labels, Big Savings Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
Skinny Labels, Big Savings Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Consolidated Appropriations Act, 2026
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
Consolidated Appropriations Act, 2026
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
CLEAR LABELS 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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
CLEAR LABELS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
CLEAR LABELS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
CLEAR LABELS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
Drug Origin Transparency Act of 2026
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
Expedited Access to Biosimilars 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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
Affordable Prescriptions for Patients Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Affordable Prescriptions for Patients Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
Affordable Prescriptions for Patients Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Preserve Access to Affordable Generics and Biosimilars Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Preserve Access to Affordable Generics and Biosimilars Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Preserve Access to Affordable Generics and Biosimilars Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
Interagency Patent Coordination and Improvement Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
Expedited Access to Biosimilars 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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
Expedited Access to Biosimilars Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
Expedited Access to Biosimilars 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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
Patent Eligibility Restoration Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
Patent Eligibility Restoration Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Patent Eligibility Restoration Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
Biosimilar Red Tape Elimination Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
ETHIC Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
ETHIC Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
ETHIC Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Medication Affordability and Patent Integrity Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
BIOSECURE 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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
BIOSECURE 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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
BIOSECURE Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
CLEAR LABELS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
CLEAR LABELS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
CLEAR LABELS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
CLEAR LABELS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
CLEAR LABELS 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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
CLEAR LABELS 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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
SAFE 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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
Skinny Labels, Big Savings Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Skinny Labels, Big Savings Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Skinny Labels, Big Savings Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
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: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469 - BIOSECURE Act of 2025. Quotas on Controlled Substances.
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: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars Act.
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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars 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.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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars 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.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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469 - BIOSECURE Act of 2025. Quotas on Controlled Substances.
Patent Eligibility Restoration Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025.
Patent Eligibility Restoration Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
PREVAIL Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025.
ETHIC Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025.
ETHIC Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars Act.
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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469 - BIOSECURE Act of 2025. Quotas on Controlled Substances.
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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars Act.
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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469 - BIOSECURE Act of 2025. Quotas on Controlled Substances.
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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars Act.
Interagency Patent Coordination and Improvement Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement 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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars Act.
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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469 - BIOSECURE Act of 2025. Quotas on Controlled Substances.
Restoring America’s Leadership in Innovation Act of 2025
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
Skinny Labels, Big Savings Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
Drug Competition Enhancement Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025.
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. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.
Medicare Part D Reform. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. CMS RFC on Domestic Manufacturing. CMS Final Rule on Bona Fide Service Fees. HCPCS Codes. Tiering. PBM Bid Transparency.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), 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
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 · second_quarter · Q2
FDA Funding.
General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Medicare Part D Reform. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. Medicare Conditions of Participation. CMS RFC on Domestic Manufacturing. CMS Final Rule on Bona Fide Service Fees. HCPCS Codes. Tiering. PBM Bid Transparency.
Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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 (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 · first_quarter · Q1
Medicare Part D Reform. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. Medicare Conditions of Participation. CMS RFC on Domestic Manufacturing. PBM Bid Transparency.
General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
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. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA 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), Patent & Trademark Office (PTO), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2025 · fourth_quarter · Q4
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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469 - BIOSECURE Act of 2025. Quotas on Controlled Substances.
Medicare Part D Reform. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. Medicare Conditions of Participation.
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).
General Trade Issues. Drug Supply Chain. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement.
FDA Funding.
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. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2025 · third_quarter · Q3
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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). 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.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars Act.
Medicare Part D Reform. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. Medicare Conditions of Participation.
H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025.
General Trade Issues. Drug Supply Chain. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars.
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), Justice, Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office