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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2026 · first_quarter · Q1
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) S. 1637: MVP Act Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule
Source: Senate LDA
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
RESTORE Patent Rights Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Patent Eligibility Restoration Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
PREVAIL Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
ETHIC Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Military Construction and Veterans Affairs, Agriculture, and Legislative Branch Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Rescissions Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Department of Homeland Security Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Interagency Patent Coordination and Improvement Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
USTRx Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) H.R. 4780: USTRx Act Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Tariff policy issues Most Favored Nation (MFN) policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US-UK Framework Agreement
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Consolidated Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Stopping Pharma’s Ripoffs and Drug Savings For All Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Drug Competition Enhancement Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Affordable Prescriptions for Patients Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
National Defense Authorization Act for Fiscal Year 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Stop STALLING Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Preserve Access to Affordable Generics and Biosimilars Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Interagency Patent Coordination and Improvement Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Patent Eligibility Restoration Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
PREVAIL Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
ETHIC Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
National Defense Authorization Act for Fiscal Year 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) H.R. 4780: USTRx Act Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Tariff policy issues Most Favored Nation (MFN) policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US-UK Framework Agreement
National Defense Authorization Act for Fiscal Year 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
REMEDY Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Medication Affordability and Patent Integrity Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Skinny Labels, Big Savings Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
RESTORE Patent Rights Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
Lower Energy Costs Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
CCU Parity Act of 2023
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
CBO Show Your Work Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
To provide for a limitation on availability of funds for Related Agencies, John F. Kennedy Center for the Performing Arts, Capital Repair and Restoration for fiscal year 2024.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
To amend the National Voter Registration Act of 1993 to require States to submit a report to the Election Assistance Commission that includes information with respect to the voter list maintenance activities of the State, and for other purposes.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Medicare Access to Rural Anesthesiology Act of 2023
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Foster and Homeless Youth Food Security Act of 2023
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Enhancing Intelligence Collection on Foreign Drug Traffickers Act of 2024
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Servicemember Healthcare Freedom Act of 2024
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Dual Loyalty Disclosure Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
National Weather Service Communications Improvement Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Improving Whole Health for Veterans with Chronic Conditions Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Middle Class Borrower Protection Act of 2023
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Fair Calculations in Civil Damages Act of 2023
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Travel Trailer and Camper Tax Parity Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Federal Price Gouging Prevention Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
National Landslide Preparedness Act Reauthorization Act of 2024
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Biosimilars Access and Affordability Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
Safe Step Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
International Port Security Enforcement Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
TASK Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
ATC SOAR Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
No CORRUPTION Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
For the People Act of 2021
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) S. 1637: MVP Act Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule
Hizballah Money Laundering Prevention Act of 2021
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) S. 1637: MVP Act Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule
Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 H.R. 3838: Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026 S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No: 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 Government funding policy issues
Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 Government funding policy issues
Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 Government funding policy issues
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 H.R. 3838: Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026 S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No: 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 Government funding policy issues
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1302: Increasing Transparency in Generic Drug Applications Act S. 1414: Expedited Acccess to Biosimilars Act S. 1784: MAPS Act S. 2780: Medication Affordability and Patent Integrity Act S. 1954: Biosimilar Red Tape Elimination Act H.R. 1: One Big Beautiful Bill Act H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act H.R. 4132: Prescription Information Modernization Act of 2025 H.R. 8574: 340B ACCESS Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First
Mikaela Naylon Give Kids a Chance Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1302: Increasing Transparency in Generic Drug Applications Act S. 1414: Expedited Acccess to Biosimilars Act S. 1784: MAPS Act S. 2780: Medication Affordability and Patent Integrity Act S. 1954: Biosimilar Red Tape Elimination Act H.R. 1: One Big Beautiful Bill Act H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act H.R. 4132: Prescription Information Modernization Act of 2025 H.R. 8574: 340B ACCESS Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First
Mikaela Naylon Give Kids a Chance Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 652: Protecting Patients from Deceptive Drug Ads Act S. 705: Innovation in Pediatric Drugs Act of 2025 S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Pandemic preparedness policy issues Artificial intelligence policy issues
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1302: Increasing Transparency in Generic Drug Applications Act S. 1414: Expedited Acccess to Biosimilars Act S. 1784: MAPS Act S. 2780: Medication Affordability and Patent Integrity Act S. 1954: Biosimilar Red Tape Elimination Act H.R. 1: One Big Beautiful Bill Act H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act H.R. 4132: Prescription Information Modernization Act of 2025 H.R. 8574: 340B ACCESS Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 652: Protecting Patients from Deceptive Drug Ads Act S. 705: Innovation in Pediatric Drugs Act of 2025 S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Pandemic preparedness policy issues Artificial intelligence policy issues
RESTORE Patent Rights Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
RESTORE Patent Rights Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
RESTORE Patent Rights Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
RESTORE Patent Rights Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
DRUG Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1302: Increasing Transparency in Generic Drug Applications Act S. 1414: Expedited Acccess to Biosimilars Act S. 1784: MAPS Act S. 2780: Medication Affordability and Patent Integrity Act S. 1954: Biosimilar Red Tape Elimination Act H.R. 1: One Big Beautiful Bill Act H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act H.R. 4132: Prescription Information Modernization Act of 2025 H.R. 8574: 340B ACCESS Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First
DRUG Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 652: Protecting Patients from Deceptive Drug Ads Act S. 705: Innovation in Pediatric Drugs Act of 2025 S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Pandemic preparedness policy issues Artificial intelligence policy issues
Patent Eligibility Restoration Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
Patent Eligibility Restoration Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
Patent Eligibility Restoration Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
PREVAIL Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
PREVAIL Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
PREVAIL Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
ETHIC Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
ETHIC Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
ETHIC Act
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 H.R. 3838: Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026 S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No: 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 Government funding policy issues
Military Construction and Veterans Affairs, Agriculture, and Legislative Branch Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026
Military Construction and Veterans Affairs, Agriculture, and Legislative Branch Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 Government funding policy issues
Military Construction and Veterans Affairs, Agriculture, and Legislative Branch Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 H.R. 3838: Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026 S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No: 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 Government funding policy issues
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 H.R. 3838: Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026 S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No: 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 Government funding policy issues
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 Government funding policy issues
Prescription Information Modernization Act of 2025
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1302: Increasing Transparency in Generic Drug Applications Act S. 1414: Expedited Acccess to Biosimilars Act S. 1784: MAPS Act S. 2780: Medication Affordability and Patent Integrity Act S. 1954: Biosimilar Red Tape Elimination Act H.R. 1: One Big Beautiful Bill Act H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act H.R. 4132: Prescription Information Modernization Act of 2025 H.R. 8574: 340B ACCESS Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First
Department of Homeland Security Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026
Department of Homeland Security Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 Government funding policy issues
Department of Homeland Security Appropriations Act, 2026
Client: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · Firm: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 H.R. 3838: Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026 S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No: 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 Government funding policy issues
S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) H.R. 4780: USTRx Act Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Tariff policy issues Most Favored Nation (MFN) policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US-UK Framework Agreement
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues SECURE Rx Act of 2026 (draft) User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4: Rescissions Act of 2025 (Public Law No. 119-28) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 6938: Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations Act, 2026 (Public Law No. 119-74) S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Public Law No. 119-37) S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No. 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 H.R. 7148: Consolidated Appropriations Act, 2026 (Public Law 119-75) Inflation Reduction Act of 2022 (Public Law No. 117-169) implementation policy issues Government funding policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2025 · fourth_quarter · Q4
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 H.R. 3838: Streamlining Procurement for Effective Execution and Delivery and National Defense Authorization Act for Fiscal Year 2026 S. 1071: National Defense Authorization Act for Fiscal Year 2026 (Public Law No: 119-60) S. 2296: National Defense Authorization Act for Fiscal Year 2026 Government funding policy issues
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 2710: Open Payments Expansion Act S. 3345: PBM Price Transparency and Accountability Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Mikaela Naylon Give Kids a Chance Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) S. 1637: MVP Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2025 · third_quarter · Q3
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. 5342: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. 2354: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 Government funding policy issues
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Tariff policy issues Most Favored Nation (MFN) policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1414: Expedited Acccess to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 2821: FDA Modernization Act 3.0 H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues MAHA Commission Report - Make Our Children Healthy Again Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Compounding policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B rebate pilot program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues S. 5459: Biosimilars Access and Affordability Act (118th Congress) Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements
H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 4299: Protecting Patient Access to Cancer and Complex Therapies Act S. 1637: MVP Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2025 · second_quarter · Q2
H.R. 1: One Big Beautiful Bill Act H.R. 3944: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026 H.R. 4121: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H. Res. 566: Providing for consideration of the Senate amendment to the bill (H.R. 1) to provide for reconciliation pursuant to title II of H. Con. Res. 14 H.R. 4213: Department of Homeland Security Appropriations Act, 2026 S. 2256: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 H.R. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 S. __: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 H.R. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026 S. __: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2026
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1302: Increasing Transparency in Generic Drug Applications Act S. 1414: Expedited Acccess to Biosimilars Act S. 1784: MAPS Act S. 2780: Medication Affordability and Patent Integrity Act S. 1954: Biosimilar Red Tape Elimination Act H.R. 1: One Big Beautiful Bill Act H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act H.R. 4132: Prescription Information Modernization Act of 2025 H.R. 8574: 340B ACCESS Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First
H.R. 1: One Big Beautiful Bill Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Insulin policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2025 · first_quarter · Q1
S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues
S. 652: Protecting Patients from Deceptive Drug Ads Act S. 705: Innovation in Pediatric Drugs Act of 2025 S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Pandemic preparedness policy issues Artificial intelligence policy issues
H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Insulin policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), President of the U.S., SENATE
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2024 · fourth_quarter · Q4
H.R. 10445: Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 H.R. 10515: American Relief Act, 2025 H.R. 10545: American Relief Act, 2025 H.R. 4368: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 5894: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 FY 2025 President's Budget Request H.R. 9027: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 S. 4690: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 H.R. 9029: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 S. 4942: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 H.R. 9026: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 S. 4795: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180) H.R. 8070: Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025 S. 4638: National Defense Authorization Act for Fiscal Year 2025
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2024 · third_quarter · Q3
H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act H.R. 8261: Preserving Telehealth, Hospital, and Ambulance Access Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY 2026 and Maximum Fair Prices policy issues CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P) Medicaid Drug Rebate Program Final rule (CMS-2434-F)
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2024 · second_quarter · Q2
H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues H.R. 6986: To address patent thickets. - Provisions related to patents S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act S. 3569: Improving Efficiency to Increase Competition Act S. 3583: A bill to address patent thickets. - Provisions related to patents Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues AI patent policy issues
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2024 · first_quarter · Q1
H.R. 4368: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 5894: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 H.R. 2670: National Defense Authorization Act for Fiscal Year 2024 (P.L. 118-31) S. 2226: National Defense Authorization Act for Fiscal Year 2024 S. 2131: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 FY 2025 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180)
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues
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2023 · fourth_quarter · Q4
H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 447: MMEDS Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 3858: No Free TRIPS Act S. 845: Short on Competition Act S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
H.R. 4368: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 5893: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2024 H.R. 5894: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 H.R. 2670: National Defense Authorization Act for Fiscal Year 2024 S. 2226: National Defense Authorization Act for Fiscal Year 2024 S. 2131: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. 2321: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2024 S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 FY 2024 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180)
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2019 · second_quarter · 2A
H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - Provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products H.R. 2020: STEER Act - Provisions related to encapsulating & tableting machine registration H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2584: To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings - Provisions related to CBO scoring of preventive health savings H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: To amend title XI of the Social Security Act to require that direct-to-consumer television advertisements for prescription drugs and biological products include the list price of such drugs and products, and for other purposes - Provisions related to direct-to-consumer prescription drug advertising H.R. 3379: Price Relief, Innovation, and Competition for Essential Drugs or PRICED Act - Provisions related to exclusivity H.R. 3408: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3415: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes - Provisions related to FDA over-the-counter drug approvals S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 989: STEER Act - Provisions related to encapsulating & tableting machine registration S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
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2019 · second_quarter · Q2
H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug patent issues H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3199: Terminating the Extension of Rights Misappropriated Act of 2019 - Provisions related to prescription drug patents S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues
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2019 · first_quarter · Q1
Trade Agreements including NAFTA, USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues
H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency and reporting H.R. 1839: Medicaid Services Investment and Accountability Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 801: To amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP (RIN 0936-AA10) Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Services Fees (RIN 0936-AA08)
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2018 · fourth_quarter · Q4
H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 - Drug pricing H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. 7217: Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act or IMPROVE Act S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues False Claims Act policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Changes to the Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)
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2018 · third_quarter · Q3
H.R. 5515: National Defense Authorization Act for Fiscal Year 2019 - Provisions related to prescription drugs in TRICARE H.R. 5961: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 6157: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 - Provisions related to prescription drugs, defense research, and opioids S. 2976: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs S. 2987: John S. McCain National Defense Authorization Act for Fiscal Year 2019 - Provisions related to prescription drugs in TRICARE S. 3158: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 S. 3159: Department of Defense Appropriations Act, 2019 - Provisions related to prescription drugs, defense medical research, and opioids
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2018 · second_quarter · Q2
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3528: Every Prescription Conveyed Securely Act - e-Prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5151: To amend the Public Health Service Act to reauthorize a grant program improving treatment for pregnant and postpartum women H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. 5477: Rural DOCS Act - To provide for a demonstration project to increase substance use provider capacity under the Medicaid program H.R. 5580: STOP Fentanyl Deaths Act of 2018 - To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5676: Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 - To authorize the suspension of payments by Medicare prescription drug plans and MA-PD plans pending investigations of credible allegations of fraud by pharmacies H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5711: Improving Access to Mental Health Services Act - To allow National Health Service Corps members to provide obligated service as behavioral and mental health professionals at schools, other community-based settings, or patient homes H.R. 5723: Expanding Oversight of Opioid Prescribing and Payment Act of 2018 - To require the Medicare Payment Advisory Commission to report on opioid payment, adverse incentives, and data under the Medicare program H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5774: Combating Opioid Abuse for Care in Hospitals Act of 2018 - Provisions related to opioids H.R. 5775: Providing Reliable Options for Patients and Educational Resources Act of 2018 - To require Medicare Advantage plans and part D prescription drug plans to include information on the risks associated with opioids, coverage of certain nonopioid treatments used to treat pain, and on the safe disposal of prescription drugs H.R. 5796: Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment (REACH OUT) Act of 2018 - To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program H.R. 6110: Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018' H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2312: HELP Act - Provisions related to 340B program S. 2406: ACE Research Act - Research initiatives of the NIH S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 2842: Opioid Addiction Recovery Fraud Prevention Act of 2018 - Provisions related to opioid treatment programs or products S. __: Drug Accepted Use Labeling Act of 2018 - Provisions related to labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Opioids shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
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2018 · first_quarter · Q1
H.R. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent Settlements H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services. S. 1948: A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents S. 2514: PACED Act - Provisions related to sovereign immunity and patents S. 2601: BIG Data for IP Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
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2017 · fourth_quarter · Q4
H.R.1370: Continuing Resolution through January 19, 2018 H.R. 2810: National Defense Authorization Act for Fiscal Year 2018 - Provisions related to Department of Defense, Tricare, and medical research issues H.J.Res 123: Continuing Resolution through December 22, 2017 H.R. 2998: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018 S. 1519: National Defense Authorization Act for Fiscal Year 2018 - Provisions related to Department of Defense, Tricare, and medical research issues S.0000: Department of Defense (Chairmans Mark) - Making appropriations for the Department of Defense for the fiscal year ending September 30, 2018 S.0000: Department of Homeland Security (Chairmans Mark) - Making appropriations for the Department of Homeland Security for the fiscal year ending September 30, 2018, and for other purposes
S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services. S. 1948: A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents H.R. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent settlements Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues
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2017 · third_quarter · Q3
S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 934: FDA Reauthorization Act of 2017 - Provisions related to user fee program S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programs H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Provisions related to amending the Controlled Substances Act H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Proposed Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AB11 (82 Fed. Reg. 39553 (August 21, 2017)) Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Tax reform policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues TRICARE pharmacy pilot program
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2017 · second_quarter · Q2
H.R. 244: Consolidated Appropriations Act, 2017 H.R. __: Making appropriations for Agriculture, Rural Development, Food and Drug Administration and Related Agencies programs for the fiscal year ending September 30, 2018, and for other purposes Budget of the United States Government, Fiscal Year 2018 - A New Foundation for American Greatness - Provisions related to non-defense program funding including FDA and NIH and repeal of the Independent Payment Advisory Board (IPAB)
Better Care Reconciliation Act of 2017 - Provisions related to repeal of the Affordable Care Act (ACA) and changes to Medicaid (discussion draft) S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 934: FDA Reauthorization Act of 2017 - Provisions related to user fee program S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programs H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Provisions related to amending the Controlled Substances Act to give DEA greater authority to schedule certain synthetic drugs H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Biologics User Fee Act (BsUFA) reauthorization Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Interim Final Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AA89 (82 Fed. Reg. 14332 (March 20, 2017)) Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues Nomination and Confirmation of Scott Gottlieb as FDA Commissioner
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2017 · first_quarter · Q1
S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs (no bill number at time of filing) H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and reformulations policy issues Prescription drug abuse policy issues
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2016 · fourth_quarter · Q4
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 9: Innovation Act - Provisions related to patent litigation reform Provisions related to exclusivity Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole Act march-in rights policy issues
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2010 · fourth_quarter · Q4
H.R. 3082, Continuing Appropriations Amendments, 2011: FDA funding, comparative effectiveness funding, importation policy rider, Biomedical Advanced Research and Development Authority (BARDA), trade and intellectual property restrictions, patent settlements
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 628, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 4954, To amend title 35, United States Code, to provide recourse under the patent law for persons who suffer competitive injury as a result of false markings: false patent marking H.R. 5980, Bring Jobs Back to America: Strategic Manufacturing & Job Repatriation Act: publication of patent applications and the economy H.R. 6352, Patent Lawsuit Reform Act of 2010: false patent marking H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: patent pilot program S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 1315, Drug Price Competition Act of 2009: 180-day exclusivity issues S. 3677, Financial Services and General Government Appropriations Act, 2011: patent settlements International intellectual property policy issues Biopharmaceutical innovation policy issues
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2010 · third_quarter · Q3
H.RES. 1493, Providing for budget enforcement for fiscal year 2011: budget provisions S. 3606, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2011: FDA funding
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 3677, Financial Services and General Government Appropriations Act, 2011: patent settlements International intellectual property issues
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2010 · second_quarter · Q2
H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: Medicaid rebate issues H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4899, Supplemental Appropriations Act, 2010: Medicaid rebate issues
H.R. 4899, Supplemental Appropriations Act, 2010: Provisions relating to the Strategic National Stockpile and disclosure of certain information by DOD contractors FY 2011 Agriculture, FDA, and Rural Development Appropriations Bill: FDA funding
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2010 · first_quarter · Q1
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
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2009 · fourth_quarter · Q4
H.R. 2892, Department of Homeland Security Appropriations Act, 2010: importation H.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding S. 1298, Department of Homeland Security Appropriations Act, 2010: importation S. 1406, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding H.R. 3288, Consolidated Appropriations Act: comparative effectiveness, NIH funding, pandemic funding
H.R. 3590, Patient Protection and Affordable Care Act: Part D coverage gap discounts, Part D rebates, Part D issues generally, Medicare payment issues, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: Part D coverage gap, Part D rebates, Part D issues generally, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform issues generally S. 1796, Americas Healthy Future Act of 2009: Part D coverage gap discounts, Part D issues generally, Medicare payment issues, Medicaid rebate issues, comparative effectiveness, health reform fee, health reform issues generally
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2009 · third_quarter · Q3
H.R. 2847, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010: trade infringement H.R. 2892, Department of Homeland Security Appropriations Act, 2010: importation H.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding H.R. 3293, Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2010, and for other purposes: comparative effectiveness, NIH funding, pandemic funding S. 1298, Department of Homeland Security Appropriations Act, 2010: importation S. 1406, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues (drug pricing program for covered entities) H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3200, Americas Affordable Health Choices Act: regulatory approval pathway for follow-on biologics, 340B program issues, comparative effectiveness S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow on biologics, 340B program issues Americas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: comparative effectiveness
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2009 · second_quarter · Q2
H.R. 1, American Recovery and Reinvestment Act of 2009: comparative effectiveness H.R. 444, 340B Program Improvement and Integrity Act: issues related to 340B program (drug pricing program for covered entities) H.R. 759, Food and Drug Administration Globalization Act of 2009: import safety H.R. 1256, Family Smoking Prevention and Tobacco Control Act: importation H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness House Tri-Committee Health Reform Discussion Draft S. 1, American Recovery and Reinvestment Act of 2009: comparative effectiveness S. 350, American Recovery and Reinvestment Act of 2009: comparative effectiveness S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 717, 21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act: reimbursement and clinical trial issues S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 882, Drug and Device Accountability Act of 2009: import safety S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. __, Affordable Health Choices Act: health reform, regulatory approval pathway for follow on biologics, 340B program issues Confirmation of Kathleen Sebelius for Department of Health and Human Services Secretary Confirmation of Margaret Hamburg for Commissioner of Food and Drugs
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2009 · first_quarter · Q1
H.R. 1, American Recovery and Reinvestment Act of 2009: health care provisions including comparative effectiveness research, health information technology, and privacy issues H.R. 1105, Omnibus Appropriations Act, 2009: budget for FDA and HHS S. 1, American Recovery and Reinvestment Act of 2009: health care provisions including comparative effectiveness, health information technology, and privacy issues S. 336, American Recovery and Reinvestment Act of 2009: health care provisions including comparative effectiveness, health information technology, and privacy issues S.Con.Res.13, 2010 Budget Resolution: health care related provisions H.Con.Res. 85, 2010 Budget Resolution: health care related provisions
H.R. 628, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: establishing a pilot program for district court judges concerning patent litigation H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act, House: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: establishing a pilot program for district court judges concerning patent litigation S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 560, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
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2008 · fourth_quarter · Q4
H.R. 7322, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2009: Restrictions relating to enforcement of trade agreements by the Office of the United States Trade Representative (USTR) S. 3182, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2009: Restrictions relating to enforcement of trade agreements by the Office of the United States Trade Representative (USTR) S. 3230, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2009: HHS budget, importation, comparative effectiveness, and Part D benefit issues S. 3289, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2009: FDA budget and importation issues
H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: Direct-to-consumer drug advertising H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs
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2008 · third_quarter · Q3
H.R. 1902, Protecting Consumer Access to Generic Drugs Act of 2007: patent settlements H.R. 1908, Patent Reform Act of 2007: patent issues H.R. 4279, Prioritizing Resources and Organization for Intellectual Property Act of 2007: enforcement S. 316, Preserve Access to Affordable Generics Act: patent settlements S. 522, Intellectual Property Rights Enforcement Act: anti-counterfeiting and enforcement S. 1145, Patent Reform Act of 2007: patent issues S.2317, Intellectual Property Enforcement Act of 2007: enforcement S.3325, Prioritizing Resources and Organization for Intellectual Property Act of 2008: enforcement S.3600, Patent Reform Act of 2008: patent reform and related issues International intellectual property issues
H.2638, Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009: prescription drug importation H.6947, Department of Homeland Security Appropriations Act, 2009 - Making appropriations for the Department of Homeland Security for the fiscal year ending September 30, 2009, and for other purposes: prescription drug importation S.3181, Department of Homeland Security Appropriations Act, 2009: prescription drug importation S.3182, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2009: Office of the United States Trade Representative (USTR) and related issues S.3230, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2009: HHS budget, importation, comparative effectiveness, and Part D benefit issues S.3289, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2009: FDA budget and importation issues
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2008 · second_quarter · Q2
H.Con.Res. 312, Budget Resolution FY 2009: FDA, HHS and CMS budget issues, importation, non-interference S.Con.Res. 70, Budget Resolution FY 2009: FDA, HHS and CMS budget issues, importation, non-interference S. 3181, Making appropriations for the Department of Homeland Security for the fiscal year ending September 30, 2009, and for other purposes: importation FY'09 Agriculture Appropriations which could include FDA budget and importation issues (no bill introduced during reporting period) FY'09 Labor HHS Appropriations which could include HHS budget, importation, comparative effectiveness, and Part D benefit issues (no bill introduced during reporting period)
H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6378, Strengthening of FDA Integrity Act of 2008: debarment S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues Food and Drug Administration Amendments Act (FDAAA) technical amendments (no bill introduced during reporting period) Pharmaceuticals in the environment issues Direct to Consumer (DTC) advertising issues Federal preemption issues
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2008 · first_quarter · Q1
H.Con.Res. 312, Budget Resolution FY 2009: FDA, HHS and CMS budget issues, importation, non-interference S.Con.Res. 70, Budget Resolution FY 2009: FDA, HHS and CMS budget issues, importation, non-interference Preparation for FY 2009 Agriculture Appropriations including FDA budget and importation issues (no bill introduced yet) Preparation for FY 2009 Labor HHS Appropriations including HHS budget, importation, comparative effectiveness, and Medicare Part D issues (no bill introduced yet) Preparation for FY 2009 Department of Homeland Security Appropriations including importation issues (no bill introduced yet)
H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007: Medicaid rebate H.R. 3162, Children's Health and Medicare Protection Act of 2007: Medicaid rebate H.R. 5605, Physician Payments Sunshine Act of 2008: transparency issues S. 558, Mental Health Parity Act of 2007: health insurance issues S. 2029, Physician Payments Sunshine Act of 2007: transparency issues S. 2041, False Claims Act Correction Act of 2007: liability issues Medicaid Program; Prescription Drugs; Final Rule, 72 Fed. Reg 39142 (July 17, 2007) (AMP Rule): Medicaid Preparation for 2008 Medicare/Medicaid bill including comparative effectiveness, issues related to the federal upper limit for Medicaid pharmacy reimbursement, Medicaid rebate, e-prescribing and Part D data disclosure issues (no bill introduced yet)
African Growth and Opportunity Act Developed Country Market Access Issues Columbia Free Trade Agreement Korea Free Trade Agreement
HR 4, Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit S. 3, Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit
S. Con Res 21, Senate Budget Resolution, FDA & Medicare Issues H. Con Res 99, House Budget Resolution, FDA & Medicare Issues
Peru Free Trade Agreement Korea Free Trade Agreement Latin America Free Trade Agreement African Growth and Opportunity Act Developed Country Market Access Issues Latin America Free Trade Agreement Panama Free Trade Agreement
S. 1145, Patent Reform Act of 2007, patent issues HR 1908, Patent Reform Act of 2007, patent issues S. 316, Preserve Access to Affordable Generics Act, patent settlements International Intellectual Property Issues
S. 1082, Food and Drug Administration Revitalizaton Act of 2007 (Importation, Follow-on Biologics, Patent settlements, Drug Safety and PDUFA) HR. 2900, Food and Drug Administration Amendments Act of 2007 (Drug Safety and PDUFA) S. 1693, Wired for Health Care Quality Act of 2007
HR Con Res 376, House Budget Act, FDA appropriations S Con Res 83, Senate Budge Act, FDA appropriations HR 429, Budget Reconciliation Act, FDA approriations
S 3582, Preserve Access to Affordable Generics Act, patent issues HR 2795, Patent Reform Act of 2005, patent issues HR 5416, pilot program on patent cases S 2300, Lower Priced Drugs Act, patent issues S 3818, Patent Reform Act of 2006, patent issues
World Trade Orgranization issues Russia WTO Accession Korean Free Trade Agreement, intellectual property issues Peru Free Trade Agreement, intellectual property issues Columbia Free Trade Agreement, intellectual property issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
H.R. 133: MERIT Act H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 8261: Preserving Telehealth, Hospital, and Ambulance Access Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Final rule (CMS-2434-F)
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 3430: Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 S. 5021: 340B PATIENTS Act of 2024 S. 5040: Protecting Patients from Deceptive Drugs Online Act S. 5459: Biosimilars Access and Affordability Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Pandemic preparedness policy issues Artificial intelligence policy issues
H.R. 3334: STOP CCP Act H.R. 4307: Medical Supply Chain Resiliency Act H.R. 8333: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2024 S. 2115: Medical Supply Chain Resiliency Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6986: To address patent thickets. - Provisions related to patents S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act S. 3583: A bill to address patent thickets. - Provisions related to patents S. 4878: REMEDY Act S. 5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues AI patent policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 5021: 340B PATIENTS Act of 2024 BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Pandemic preparedness policy issues Artificial intelligence policy issues Cybersecurity policy issues
H.R. 4307: Medical Supply Chain Resiliency Act H.R. 7085: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2024 S. 2115: Medical Supply Chain Resiliency Act S. 3558: Prohibiting Foreign Access to American Genetic Information Act of 2024 Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues H.R. 6986: To address patent thickets. - Provisions related to patents S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act S. 3569: Improving Efficiency to Increase Competition Act S. 3583: A bill to address patent thickets. - Provisions related to patents Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues AI patent policy issues
H.R. 4368: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 5894: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 S. 2226: National Defense Authorization Act for Fiscal Year 2024 S. 2131: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 FY 2025 President's Budget Request H.R. 9027: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 S. 4690: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 H.R. 9029: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 S. 4942: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 H.R. 9026: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 S. 4795: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180) H.R. 8070: Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025 S. 4638: National Defense Authorization Act for Fiscal Year 2025
Filing targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of
H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 1691: Ensuring Patient Access to Critical Breakthrough Products Act of 2023 H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act H.R. 8261: Preserving Telehealth, Hospital, and Ambulance Access Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues
H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 7085: BIOSECURE Act S. 1956: Invent Here, Make Here Act of 2023 S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
H.R. 4368: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 5894: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 H.R. 2670: National Defense Authorization Act for Fiscal Year 2024 (P.L. 118-31) S. 2226: National Defense Authorization Act for Fiscal Year 2024 S. 2131: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. 2624: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 FY 2025 President's Budget Request H.R.___: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 S.____: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 H.R.___: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 S.____: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 H.R.___: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 S.____: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (P.L. 117-180) H.R. 8070: Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025 S. 4638: National Defense Authorization Act for Fiscal Year 2025
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act S. 1450: Cutting Medicare Prescription Drugs in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] ___ IPAY 2026 and Solicitation of Comments CMS Medicare Drug Price Negotiation Revised Guidance CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)
H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues H.R. 6986: To address patent thickets - Provisions related to patents S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act S. 3583: A bill to address patent thickets - Provisions related to patents Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues AI patent policy issues
H.R. 405: Essential Medicines Strategic Stockpile Act of 2023 H.R. 4307: Medical Supply Chain Resiliency Act H.R. 3858: No Free TRIPS Act H.R. 7085: BIOSECURE Act S. 845: Short on Competition Act S. 1834: No Free TRIPS Act S. 2115: Medical Supply Chain Resiliency Act S. 3558: BIOSECURE Act Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3134: Emergency Access to Insulin Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act of 2023 H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues Artificial intelligence policy issues
H.R. 133: MERIT Act H.R. 485: Protecting Health Care for All Patients Act of 2023 - To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs H.R. 2666: Medicaid VBPs for Patients Act or MVP Act H.R. 3421: Medicare for All Act S. 1491: Pharmacy and Medically Underserved Areas Enhancement Act S. 1450: Cutting Medicare Prescription Drug Prices in Half Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Insulin policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMMI Cell and Gene Therapy Access Model Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] IPAY 2026 and Solicitation of Comments CMS Medicare Drug Price Negotiation Revised Guidance CMS Guidance on Medicare Part B and D Inflation Rebates Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)
H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6684: Improving Efficiency to Increase Competition Act - Patent-related policy issues S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
H.R. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues Trade Agreements including NAFTA, USMCA and related policy issues US-China trade policy issues including regulatory data protection for biologics Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues
H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)
H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug patent issues H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3199: Terminating the Extension of Rights Misappropriated Act of 2019 - Provisions related to prescription drug patents S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues
H.R. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 2500: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs H.R. 2740: Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs H.R. 3055: Making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes - FDA provisions related to prescription drugs H.R. 3164: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs H. Res. 436: Providing for further consideration of the bill (H.R. 2740) making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes H. Res. 4455: Providing for consideration of the bill (H.R. 3055) making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes; relating to consideration of the bill (H.R. 2740) making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes; and providing for proceedings during the period from June 28, 2019, through July 8, 2019 S. 1215: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs S. 1790: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs Presidents FY 2020 Budget Request - Medicare and Medicaid provisions and other issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
H.R. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 2500: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs H.R. 2740: Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs H.R. 3055: Making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes - FDA provisions related to prescription drugs H.R. 3164: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs H. Res. 436: Providing for further consideration of the bill (H.R. 2740) making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes H. Res. 4455: Providing for consideration of the bill (H.R. 3055) making appropriations for the Departments of Commerce and Justice, Science, and Related Agencies for the fiscal year ending September 30, 2020, and for other purposes; relating to consideration of the bill (H.R. 2740) making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes; and providing for proceedings during the period from June 28, 2019, through July 8, 2019 S. 1215: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs S. 1790: National Defense Authorization Act for Fiscal Year 2020 - DoD provisions related to prescription drugs Presidents FY 2020 Budget Request - Medicare and Medicaid provisions and other issues
H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)
H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - Provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products H.R. 2020: STEER Act - Provisions related to encapsulating & tableting machine registration H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2584: To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings - Provisions related to CBO scoring of preventive health savings H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: To amend title XI of the Social Security Act to require that direct-to-consumer television advertisements for prescription drugs and biological products include the list price of such drugs and products, and for other purposes - Provisions related to direct-to-consumer prescription drug advertising H.R. 3379: Price Relief, Innovation, and Competition for Essential Drugs or PRICED Act - Provisions related to exclusivity H.R. 3408: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3415: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes - Provisions related to FDA over-the-counter drug approvals S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 989: STEER Act - Provisions related to encapsulating & tableting machine registration S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
H.R. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues Trade Agreements including NAFTA, USMCA and related policy issues US-China trade policy issues including regulatory data protection for biologics Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
H.R. 21: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H.R. 265: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs House H.R. 648: Consolidated Appropriations Act, 2019 - FDA provisions related to prescription drugs H. J. Res. 31: Consolidated Appropriations Act, 2019 - FDA funding H. Res. 293: Providing for budget enforcement for fiscal year 2020 S. Con. Res. 12: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2020 and setting forth the appropriate budgetary levels for fiscal years 2021 through 2024 - Provisions related to prescription drugs Presidents FY 2020 Budget Request - Provisions related to prescription drugs FY 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations FY 2020 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations
H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1323: Rural Hospital Frontier Fairness Act - Provisions related to the 340B drug pricing program H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R. 2069: To amend title XI of the Social Security Act to provide for drug manufacturer price transparency H.R. 2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act - Price transparency S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 418: FDA Accountability for Public Safety Act - Provisions related to FDA drug approvals S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals S. 474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: To amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. __: Transparent Drug Pricing Act - Provisions related to transparency and drug pricing S. __: Patient Affordability Value and Efficiency Act - To amend titles XI, XVIII, and XIX of the Social Security Act to promote value-based arrangements Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing and patents H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act of 2019 - Provisions related to patent listings H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to 180 day exclusivity and patent litigation H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologics patent listings H.R. 2011: To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009 S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing and patents S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug exclusivity periods and pricing S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
H.R. 5961: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs S. 2976: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs
H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms H.R. 7251: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 3738: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Trade Agreements including NAFTA, USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms H.R. 5887: BIG Data for IP Act - Provisions related to fee-setting authority H.R. 6758: SUCCESS Act - Provisions related to fee authority and study S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 974 Amendment: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms S. 3416: USPTO FEES Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 3635: Local Coverage Determination Clarification Act of 2018 H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. __: To amend title XIX of the Social Security Act to provide the Medicare Payment Advisory Commission with access to certain drug rebate information S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions S. 3000: Patient Advocacy Transparency Act - Social Security Act amendments Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder records H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 - Provisions related to substance use disorder information H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to loan repayment program H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3428: Lessening Addiction by Enhancing Labeling Opiods Act of 2018 S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
Trade Agreements including NAFTA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 974 Amendment: Hatch-Waxman Integrity Act of 2018 - Provisions related to inter partes review process S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms S. 2601: BIG Data for IP Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to drug rescheduling H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication-assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. __: FDA and International Mail - Provisions related to chemical importation H.R. __: FDA Long-term Efficacy - Provisions related to post-approval studies H.R. __: FDA Misuse/Abuse - Provisions related to misuse/abuse in approval decisions H.R. __: FDA Packaging and Disposal - Provisions related to drug packaging H.R. __: Tableting and Encapsulating Machine Regulation Act of 2018 - Provisions related to manufacturing equipment H.R. __: The Special Registration for Telemedicine Clarification Act of 2018 - Provisions related to telemedicine H.R. __: The Improving Access to Remote Behavioral Health Treatment Act of 2018 - Provisions related to telemedicine H.R. __: A Bill to Improve Fentanyl Testing and Surveillance - Provisions related to synthetic opioid detection grants H.R. __: A Bill to Enhance and Improve State-run Prescription Drug Monitoring Programs - Provisions related to evidence-based overdose prevention grants and other funding H.R. __: A Bill to Support the Peer Support Specialist Workforce - Provisions related to national youth recovery grants and other funding H.R. __: FDA Accelerated Approval and Breakthrough Therapy Status - Provisions related to expedited treatment for non-opioid medicines H.R. __: FDA Opioid Sparing - Provisions related to alternative models for data collection S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2456: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. __: Access to Increased Drug Disposal Act of 2018 - Provisions related to grants for disposal Biopharmaceutical innovation policy issues Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues National All Schedules Prescription Electronic Reporting Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Clinical trial policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Confirmation of Alex Azar Opioids shortages policy issues
H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors Access to Medicare Act - Provisions related to repeal of the IPAB H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.R. 3922: CHAMPIONING HEALTHY KIDS Act - CHIP and CHC reauthorization H.J.Res. 51: Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Patient Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program S.J.Res. 16: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S.J.Res. 17: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)
H.R. 195: Making further continuing appropriation for the fiscal year ending September 30, 2018, and for other purposes. H.R. 1625: Consolidated Appropriations Act, 2018 H.R. 1892: Bipartisan Budget Act of 2018
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Administration, Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE
S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 3245: Medicare Civil and Criminal Penalties Update Act - Civil and criminal penalty provisions H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.R. 3922: Championing Healthy Kids Act - CHIP and CHC reauthorization H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4192-P)
S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 892: Opioid Addiction Prevention Act of 2017 - Scheduling issues S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing H.R. 1: Tax Cuts and Jobs Act - An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (Public Law 115-97) H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Scheduling issues H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 4710: 340B Protecting Access for the Underserved and Safety-Net Entities Act or PAUSE Act - 340B program Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (Public Law No. 114-145) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues Confirmation of Alex Azar TRICARE pharmacy pilot program
Filing targets: Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE
H.R. 601: Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 - Provisions related to Puerto Rico and other issues H.R. 2810: National Defense Authorization Act for Fiscal Year 2018 - Provisions related to Department of Defense, Tricare, and medical research issues H.R. 3219: Make America Secure Appropriations Act, 2018 - Provisions related to FDA, HHS, Medicare and Medicaid issues H.R. 3268: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018 - Provisions related to FDA issues H.R. 3354 (Make America Secure and Prosperous Act): Interior and Environment, Agriculture and Rural Development, Commerce, Justice, Science, Financial Services and General Government, Homeland Security, Labor, Health and Human Services, Education, State and Foreign Operations, Transportation, Housing and Urban Development, Defense, Military Construction and Veterans Affairs, Legislative Branch, and Energy and Water Development Appropriations Act, 2018 - Omnibus package of all 12 bills H.R. 3358: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018 - Provisions related to NIH, HHS, Medicare and Medicaid issues S. 1519: National Defense Authorization Act for Fiscal Year 2018 - Provisions related to Department of Defense, Tricare, and medical research issues S. 1557: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018 S. 1603: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018 - FDA related issues S.1662: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2018 S. 1771: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018 - Provisions related to NIH, HHS, Medicare and Medicaid issues H.Con.Res. 71: FY18 Budget Resolution - Provisions related to FDA, Medicare, Medicaid and other issues S.Con.Res. __: FY 18 Budget Resolution - Provisions related to FDA, Medicare, Medicaid and other issues
S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services. Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues Venue in patent cases policy issues
S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program H.R. __: Stark Law Modernization Act of 2017 - Provisions related to Stark and Anti-Kickback policy issues H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 3245: Medicare Civil and Criminal Penalties Update Act - Civil and criminal penalty provisions H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Proposed Rule; Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (CMS-1678-P) (July 13, 2017) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018
Filing targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, White House Office
Better Care Reconciliation Act of 2017 - Provisions related to repeal of the Affordable Care Act (ACA) and changes to Medicaid (discussion draft) S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Payment Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition cost of prescription drugs H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.J.Res. 51 - Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 16 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to the IPAB repeal S.J.Res. 17 - A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899A of the Social Security Act - Provisions related to IPAB repeal Department of Health and Human Services (HHS) drug policy issues and regulatory barriers to value based care Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues
S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceedings at the PTO Bayh-Dole march-in rights policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 820: Childhood Cancer STAR Act - Provisions related to expanded access and other policy issues H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing Repeal of the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148) and related policy issues including the pharmaceutical manufacturer fee Prescription Drug User Fee Act (PDUFA) reauthorization Biologics User Fee Act (BsUFA) reauthorization Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Interim Final Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AA89 (82 Fed. Reg. 14332 (March 20, 2017)) Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Final Rule on Intended Use (82 Fed. Reg. 2193 (Jan. 9, 2017)) Biologics Price Competition and Innovation Act (BPCIA) policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Biomarker policy issues Drug compounding policy issues Clinical trial policy issues Cancer drug vial size policy issues Antibiotic development policy issues Nomination and Confirmation of Tom Price as HHS Secretary Nomination and Confirmation of Scott Gottlieb as FDA Commissioner
S.Con.Res 3: Budget Resolution - Provisions related to the biopharmaceutical industry including importation and non-interference Continuing Resolution - Provisions related to HHS, FDA, and NIH funding and other issues FY2018 Presidents Budget - Provisions related to HHS, FDA, and NIH funding and other issues Senate and House budget process
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
S. 2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry S. 3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry H.R. 5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry H.R. 5926: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry Senate and House budget process Continuing Resolution Budget Reconciliation
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4994: Medicare and Medicaid Extenders Act of 2010: exclusion issues H.R. 6130 Strengthening Medicare Anti-Fraud Measures Act of 2010: exclusion issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
H.R. 422, Heart Disease Education, Analysis Research, and Treatment for Women Act: R&D tax credit provisions H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1032, Heart Disease Education, Analysis Research, and Treatment for Women Act: clinical trial data reporting issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, drug labeling, access to clinical trials, health reform fee, Independent Payment Advisory Board (IPAB) and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B program and average manufacturer price (AMP) issues H.R. 4489, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program and health reform fee issues H.R. 5710, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010: controlled substance monitoring H.R. 5809, Safe Drug Disposal Act of 2010: disposal of controlled substances S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1203, Grow Research Opportunities With Taxcredits' Help Act: R&D tax credit provisions S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues S. 3397, Secure and Responsible Drug Disposal Act of 2010: disposal of controlled substances General FDA advocacy
H.R. 1586, FAA Air Transportation Modernization and Safety Improvements: AMP issues H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, Part D coverage gap discounts, Part D issues generally, Medicare payment issues including the Independent Payment Advisory Board (IPAB), and Medicaid issues H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: average manufacturer price (AMP) issues H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee, and other health reform implementation issues generally H.R. 4899, Supplemental Appropriations Act, 2010: AMP issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), 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), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 444, 340B Program Improvement and Integrity Act: 340B drug pricing program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B drug pricing program issues, drug labeling, access to clinical trials, and other health reform implementation issues H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: 340B drug pricing program and average manufacturer price (AMP) issues H.R. 4489, Federal Employees Health Benefits Plan (FEHBP) Prescription Drug Integrity, Transparency, and Cost Savings Act: transparency of drug pricing H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B drug pricing program issues H.R. 4899, Supplemental Appropriations Act, 2010: average manufacturer price (AMP) issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: 340B program issues, importation, and other health reform implementation issues User fee issues
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 4213, American Jobs and Closing Tax Loopholes Act of 2010: patent term restoration filing deadlines and tax issues H.R. 4899, Supplemental Appropriations Act, 2010: patent settlements H.R. 5322, Patent and Trademark Office Funding Stabilization Act of 2010: Patent and Trademark Office Funding S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws International intellectual property issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, and health reform issues generally H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation Health and environment issues User fee issues
H.R. 3590, Patient Protection and Affordable Care Act: Part D coverage gap discounts, Part D rebates, Part D issues generally, Medicare payment issues, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform fee and health reform issues generally H.R. 3962, Affordable Health Care for America Act: Part D coverage gap, Part D rebates, Part D issues generally, Medicaid rebate issues, transparency issues, comparative effectiveness, and health reform issues generally H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee and health reform issues generally
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions S. 515, Patent Reform Act of 2009: reforms of the patent laws S. 610, Patent Reform Act of 2009: reforms of the patent laws S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics H.R. 1859, Independent Drug Education and Outreach Act of 2009: academic detailing H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation [S.A. 2793], health reform issues generally H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, health reform issues generally S. 422, The Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: new drug application requirements S. 488, Access to Cancer Clinical Trials Act of 2009, access to clinical trials S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 767, Independent Drug Education and Outreach Act of 2009: academic detailing S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development S. 1142, Informed Health Care Decision Making Act: drug labeling S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation S. 1796, Americas Healthy Future Act of 2009: comparative effectiveness, importation, health reform issues generally
Filing targets: Agency for Healthcare Research & Quality (AHRQ), 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issues H.R. 3200, Americas Affordable Health Choices Act: Medicaid rebate issues, Part D issues, health reform issues S. 301, Physician Payments Sunshine Act of 2009: transparency issues S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009: Medicare payment issues S. 1380, Medicare Payment Advisory Commission Reform Act of 2009: Medicare payment issues Americas Healthy Future Act of 2009 Chairmans Mark Senate Finance Committee: Medicaid rebate issues, Part D issues, health reform issues Senate Finance Committee options papers
Filing targets: Agency for Healthcare Research & Quality (AHRQ), 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), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 2346, Supplemental Appropriations Act, 2009: pandemic flu funding H.R. 2847, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010: trade infringement H.R. 2892, Department of Homeland Security Appropriations Act, 2010: importation H.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010: importation, FDA funding S. 1298, Department of Homeland Security Appropriations Act, 2010: importation H.Con.Res. 85, 2010 Budget Resolution: health care reform funding provisions S.Con.Res.13, 2010 Budget Resolution: health care reform funding provisions Labor - Health and Human Services - Education Appropriations for Fiscal Year 2010: comparative effectiveness, NIH funding, pandemic flu funding
H.R. 1260, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements S. 299, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges: establishing a pilot program for district court judges concerning patent litigation S. 369, Preserve Access to Affordable Generics Act: patent settlements S. 515, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation S. 610, Patent Reform Act of 2009: patent reform issues including obtaining a patent, post-grant review, and patent litigation S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics International intellectual property issues
H.R. 2, Childrens Health Insurance Program Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate, 340B H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issues H.R. 904, Medicaid Prescription Drug Rebate Equalization Act of 2009: managed care organization (MCO) rebate H.R. 1788, False Claims Act Correction Act of 2009: liability issues S. 275, Childrens Health Insurance Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate S. 301, Physician Payments Sunshine Act of 2009: transparency issues S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 458, False Claims Act Clarification Act of 2009: liability issues S. 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009: Medicare payment issues Health care reform issues Senate Finance Committee options papers
Filing targets: Agency for Healthcare Research & Quality (AHRQ), 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), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
H.R. 1, American Recovery and Reinvestment Act of 2009: Medicaid rebate H.R. 2, Childrens Health Insurance Program Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate, 340B H.R. 684, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 1, American Recovery and Reinvestment Act of 2009: Medicaid rebate S. 275, Childrens Health Insurance Reauthorization Act of 2009: SCHIP reauthorization, Medicaid rebate S. 301, Physician Payments Sunshine Act of 2009: transparency issues S. 330, Medicare Prescription Drug Savings and Choice Act: Part D issues S. 350, American Recovery and Reinvestment Act of 2009: Medicaid rebate S. 458, False Claims Clarification Act of 2009: liability issues
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues H.R. 759, Food and Drug Administration Globalization Act of 2009: import safety H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics H.R. 1548, Pathway for Biosimilars Act, House: regulatory approval pathway for follow-on biologics S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation S. 717, 21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act: reimbursement and clinical trial issues S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics S. 3409, Drug and Device Accountability Act of 2008: import safety Health care reform issues Confirmation of Department of Health and Human Services Secretary
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
H.R. 4, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues H.R. 758, Price Disclosure Regarding Treatment of Breast Cancer: transparency H.R. 2184, Enhanced Health Care Value for All Act of 2007: comparative effectiveness H.R. 3162, Children's Health and Medicare Protection Act of 2007: Medicaid rebate H.R. 4854, False Claims Act Correction Act of 2007: liability issues H.R. 5605, Physician Payments Sunshine Act of 2008: transparency issues H.R. 6684, Medicare Prescription Drug Cost Equalization Act: Part D issues H.R. 6752, The Independent Drug Education and Outreach Act of 2008: direct to physician marketing S. 3, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues S. 2029, Physician Payments Sunshine Act of 2007: transparency issues S. 2041, False Claims Act Correction Act of 2007: liability issues S. 3118, Preserving Access to Medicare Act of 2008: electronic prescribing, Part D data disclosure, and other issues S. 3396, The Independent Drug Education and Outreach Act of 2008: direct to physician marketing S. 3408, Comparative Effectiveness Research Act of 2008: comparative effectiveness
H.R. 1902, Protecting Consumer Access to Generic Drugs Act of 2007: patent settlements H.R. 1908, Patent Reform Act of 2007: patent system reform and related issues such as obtaining/opposing patents and remedies H.R. 4279, Prioritizing Resources and Organization for Intellectual Property Act of 2007: enforcement S. 316, Preserve Access to Affordable Generics Act: patent settlements S. 522, Intellectual Property Rights Enforcement Act: anti-counterfeiting and enforcement S. 1145, Patent Reform Act of 2007: patent system reform and related issues such as obtaining/opposing patents and remedies S. 2317, Intellectual Property Enforcement Act of 2007: enforcement S. 3325, Prioritizing Resources and Organization for Intellectual Property Act of 2008: enforcement S. 3464, International Intellectual Property Protection and Enforcement Act of 2008: enforcement S. 3600, Patent Reform Act of 2008: patent system reform and related issues such as obtaining/opposing patents and remedies International intellectual property issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), 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), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
H.R. 4, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues H.R. 758, Price Disclosure Regarding Treatment of Breast Cancer: transparency H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007: Medicaid rebate H.R. 2184, Enhanced Health Care Value for All Act of 2007: comparative effectiveness H.R. 3162, Children's Health and Medicare Protection Act of 2007: Medicaid rebate H.R. 4854, False Claims Act Correction Act of 2007: liability issues H.R. 5605, Physician Payments Sunshine Act of 2008: transparency issues H.R. 5683, The Government Accountability Office Act: disclosure of data H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008: comparative effectiveness, federal upper limit for Medicaid pharmacy reimbursement, electronic prescribing, Part D data disclosure, and other issues H.R. 6388 The Government Accountability Office Improvement Act of 2008: disclosure of data H.R. 6684, Medicare Prescription Drug Cost Equalization Act: Part D issues H.R. 6752, The Independent Drug Education and Outreach Act of 2008: direct to physician marketing S. 3, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues S. 558, Mental Health Parity Act of 2007: health insurance issues S. 2029, Physician Payments Sunshine Act of 2007: transparency issues S. 2041, False Claims Act Correction Act of 2007: liability issues S.3101, Medicare Improvements for Patients and Providers Act of 2008: comparative effectiveness, federal upper limit for Medicaid pharmacy reimbursement, electronic prescribing, Part D data disclosure, and other issues S. 3118, Preserving Access to Medicare Act of 2008: electronic prescribing, Part D data disclosure, and other issues S. 3396, The Independent Drug Education and Outreach Act of 2008: direct to physician marketing S. 3408, Comparative Effectiveness Research Act of 2008: comparative effectiveness
H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1014, Heart Disease Education, Analysis Research, and Treatment for Women Act: reporting and analysis of patient data H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5683, The Government Accountability Office Act: disclosure of data H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: direct-to-consumer drug advertising H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008: on-line pharmacy issues H.R. 6378, Strengthening of FDA Integrity Act of 2008: debarment H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6388 The Government Accountability Office Improvement Act of 2008: disclosure of data H.R. 6432, Animal Drug User Fee Amendments of 2008: technical corrections to FDAAA H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs
Filing targets: Agency for Healthcare Research & Quality (AHRQ), 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), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007: Medicaid rebate H.R. 3162, Children's Health and Medicare Protection Act of 2007: Medicaid rebate H.R. 4854, False Claims Act Correction Act of 2007: liability issues H.R. 5605, Physician Payments Sunshine Act of 2008: transparency issues H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008: comparative effectiveness, federal upper limit for Medicaid pharmacy reimbursement, electronic prescribing, Part D data disclosure, and other issues S. 558, Mental Health Parity Act of 2007: health insurance issues S. 2029, Physician Payments Sunshine Act of 2007: transparency issues S. 2041, False Claims Act Correction Act of 2007: liability issues S. 3101, Medicare Improvements for Patients and Providers Act of 2008: comparative effectiveness, federal upper limit for Medicaid pharmacy reimbursement, electronic prescribing, Part D data disclosure, and other issues S. 3118, Preserving Access to Medicare Act of 2008: electronic prescribing, Part D data disclosure, and other issues Medicaid Program; Prescription Drugs; Final Rule, 72 Fed. Reg 39142 (July 17, 2007) (AMP Rule): Medicaid
H.R. 1902, Protecting Consumer Access to Generic Drugs Act of 2007: patent settlements H.R. 1908, Patent Reform Act of 2007: patent issues H.R. 4279, Prioritizing Resources and Organization for Intellectual Property Act of 2007: enforcement S. 316, Preserve Access to Affordable Generics Act: patent settlements S. 522, Intellectual Property Rights Enforcement Act: anti-counterfeiting and enforcement S. 1145, Patent Reform Act of 2007: patent issues S. 2317, Intellectual Property Enforcement Act of 2007: enforcement Senate reauthorization of the Federal Trade Commission (no bill introduced during reporting period) International intellectual property issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
H.R. 1902, Protecting Consumer Access to Generic Drugs Act of 2007: patent settlements H.R. 1908, Patent Reform Act of 2007: patent issues S. 1145, Patent Reform Act of 2007: patent issues S. 316, Preserve Access to Affordable Generics Act: patent settlements Preparation for Senate reauthorization of the Federal Trade Commission (no bill introduced yet) International intellectual property issues
H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health care and technology S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: access and public health Measures to mitigate BSE risks related to non-ambulatory cattle Pharmaceuticals in the environment issues Anti-counterfeiting issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), 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), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
S. 1145, Patent Reform Act of 2007, patent issues HR 1908, Patent Reform Act of 2007, patent issues S. 316, Preserve Access to Affordable Generics Act, patent settlements International Intellectual Property Issues
HR. 2900, Food and Drug Administration Amendments Act of 2007 (Drug Safety and PDUFA) S. 1693, Wired for Health Care Quality Act of 2007 H.R. 3610, Food and Drug Import Safety Act of 2007 (Importation) H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
S. Con Res 21, Senate Budget Resolution, FDA & Medicare Issues H. Con Res 99, House Budget Resolution, FDA & Medicare Issues
HR 4 Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit S. 3 Medicare Prescription Drug Price Negotiation Act of 2007, Part D Benefit
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
S 3678, Pandemic and All Hazards Preparedness Act HR 5533, Biodefense and Pandemic Vaccine and Drug Development Act of 2006
HR 5970, Estate Tax and Extention of Tax Relief Act of 2006
S 1955, Health Care Modernization and Affordability Act, small business health plans HR 4157, Health Technology Promotion Act of 2006, health information technology HR 4939, Emergency Supplemental Appropriations Act, pandemic flu issues S 2766 Department of Defense Reauthorization Act, Tricare HR 5122, Department of Defense Reauthorization Act, Tricare HR 5441, Homeland Security Appropriations, Importation HR 5384, Agriculture Appropriations, Importation
Executive Branch Medicare reimbursement issues
Filing targets: Agency for Healthcare Research & Quality (AHRQ), 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 Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)