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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.
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
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 · third_quarter · Q3
H.R. 1: One Big Beautiful Bill Act (Public Law 119-21) H.R. 4299: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 10628: Biosimilars Access and Affordability Act S. 5571: Biosimilars Access and Affordability Act Inflation Reduction Act of 2022 (Public Law 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
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 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
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
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 Government funding policy issues
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
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
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
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
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
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
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 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
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. 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
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. 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
ORPHAN Cures 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
ORPHAN Cures 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
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 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
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. 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
Increasing Transparency in Generic Drug Applications 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
Expedited Access to Biosimilars 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
MAPS 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
Biosimilar Red Tape Elimination 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
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
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
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. 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
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. 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
FDA Modernization Act 3.0
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
Protecting Patients from Deceptive Drug Ads 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
Protecting Patients from Deceptive Drug Ads 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
Innovation in Pediatric Drugs Act of 2025
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
EPIC Act of 2025
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
EPIC 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
Bipartisan Health Care 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
Bipartisan Health Care 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
Give Kids a Chance Act of 2025
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
Give Kids a Chance 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
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. 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
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 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
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. 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
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 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
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. 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
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 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
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 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
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. 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
Young Americans Financial Literacy 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 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
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 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
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. 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
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 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
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. 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
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. 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
340B ACCESS 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
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. 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
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 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
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 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
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. 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
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 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
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. 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
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 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
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. 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
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 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
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. 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
Chesapeake Bay Conservation Acceleration 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. 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
Medication Affordability and Patent Integrity 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
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. 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
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. 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
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 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
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. 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
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 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
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. 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
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. 1387: National Biotechnology Initiative 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. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act S. 3794: SAFE Drugs Act of 2026 S. 4189: INSULIN Act of 2026 S. 5043: Secure Drug Supply Chain Act of 2026 S. 5244: SUSTAIN 340B Act H.R. 1: One Big Beautiful Bill Act (Public Law 119-21) H.R. 946: ORPHAN Cures 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. 3521: Clinical Trial Modernization Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 6509: SAFE Drugs Act of 2025 H.R. 6610: Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT H.R. 8269: CLEAR LABELS Act H.R. 9599: SECURE 340B Act H.R. 9661: Expedited Access to Biosimilars Act 340B Drug Pricing Integrity and Affordability for Patients Act (draft) SECURE Act of 2026 (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law 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 Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Peptides/counterfeiting policy issues Controlled substances policy issues Generics/devices policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B Rebate Model Pilot Program 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
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), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2026 · second_quarter · Q2
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. 1387: National Biotechnology Initiative 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. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act H.R. 1: One Big Beautiful Bill Act (Public Law 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. 3521: Clinical Trial Modernization Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 6610: Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT H.R. 8269: CLEAR LABELS Act H.R. 9661: Expedited Access to Biosimilars Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) 340B Drug Pricing Integrity and Affordability for Patients Act (draft) SECURE Act of 2026 (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (Public Law 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 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 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
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), SENATE, Treasury, Dept of
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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
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
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
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
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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. 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
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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
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2025 · first_quarter · Q1
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
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2024 · fourth_quarter · Q4
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
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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. 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)
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2024 · first_quarter · Q1
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)
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
2023 · fourth_quarter · Q4
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)
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
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2023 · third_quarter · Q3
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. 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. 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. 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. 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. 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. 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 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. 5539: ORPHAN Cures 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. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 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. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs 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. 2840: Bipartisan Primary Care and Health Workforce Act 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
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2023 · second_quarter · Q2
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. 5376: 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)
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2023 · first_quarter · Q1
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 1790: Biologics Competition Act of 2023 - Directs 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. 4390: Protect 340B Act - Provisions related to 340B Program H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 7032: Increasing Transparency in Generic Drug Application Act - Requires the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why) 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 - Directs 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. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Provisions related to drug pricing S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act 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 Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing 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 Defense Production Act policy issues
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2022 · fourth_quarter · Q4
Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022) CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products 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 Pharmacy Benefit Manager reform and 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 Notice of Benefit and Payment Parameters (NBPP)
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2022 · third_quarter · Q3
H.R. 2471: Consolidated Appropriations Act, 2022 (P.L. 117-103) H.R. 3932: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 8256: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2023 H.R. 8295: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 S. 2076: PASTEUR Act of 2021- To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 FY 2023 Presidents Budget Request
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2022 · second_quarter · Q2
CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 Department of Health and Human Services (HHS) drug policy issues and regulatory 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 Rebate policy issues Insulin policy issues VA drug 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 Medicare prescription drug payments cards and related policy issues Part B Discarded Units Refund policy issues Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements
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2022 · first_quarter · Q1
H.R. 1319: American Rescue Plan Act of 2021 - Public Law 117-2 H.R. 2471: Consolidated Appropriations Act, 2022 - Public Law 117-103 H.R. 4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R. 4350: National Defense Authorization Act for Fiscal Year 2022 H.R. 4356: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022 H.R. 5376: Build Back Better Act S. 2599: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022 S. 2792: National Defense Authorization Act for Fiscal Year 2022 S. 3062: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2022 CARES Act, Pub. L. 116-136 FY 2023 Presidents Budget Request
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2021 · fourth_quarter · Q4
H.R. 1319: American Rescue Plan Act of 2021 H.R. 4350: National Defense Authorization Act for Fiscal Year 2022 H.R. 5376: Build Back Better Act S. 2792: National Defense Authorization Act for Fiscal Year 2022 S. Con. Res. 14: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031 CARES Act, Pub. L. 116-136 FY 2022 Presidents Budget
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5416: Give Kids a Chance Act - To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing Department of Health and Human Services (HHS) drug policy issues and regulatory 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 Inflation penalty policy issues VA drug 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 Medicare prescription drug payments cards and related policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements
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2021 · third_quarter · Q3
H.R. 5: Equality Act H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2347: Strengthening the Vaccines for Children Program Act of 2021 - Provisions related to COVID-19 vaccines H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2623: Camerons Law - Provisions related to orphan drugs H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4418: SPIKE Act - Provisions related to prescription drug pricing transparency H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5416: To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 917: Short on Competition Act - Provisions related to FDA policy and prescription drug pricing S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2814: Vital Medication Affordability Act - Provisions related to 340B drug discount program S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program 21st Century Cures 2.0 (discussion draft) American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Executive Order 14036, Promoting Competitition in the American Economy (July 9, 2021) Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14005, Ensuring the Future Is Made in All of America by All of Americas Workers (January 25, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13987, Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security (January 20, 2021) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
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2021 · second_quarter · Q2
H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 796: Coverage for COVID-19 Treatment Act of 2021 - Provisions related to COVID-19 treatments H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 2078: Social and Economic Equity Promotion Act - CBO analyses H.R. 2366: STOP Fentanyl Act of 2021 H.R. 2484: Lowest Price for Patients Act - Provisions related to prescription drug pricing and transparency H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3932: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to antimicrobial resistance policy issues S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1523: Drug Price Transparency Act of 2021 - Provisions related to prescription drug pricing transparency S. 1524: Health Care PRICE Transparency Act - Provisions related to prescription drug pricing transparency S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to antimicrobial resistance policy issues 21st Century Cures 2.0 (discussion draft) American Jobs Plan American Families Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Prescription drug take back and secure disposal policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity 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 Drug shortages policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favord Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
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2021 · first_quarter · Q1
H.R. 3: Lower Drug Costs Now Act of 2019 [116th Congress] H.R. 19: Lower Costs, More Cures Act of 2019 [116th Congress] H.R. 1167: Advancing Enrollment and Reducing Drug Costs Act of 2021 - Provisions related to Part D H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: To establish an improved Medicare for All national health insurance program - Provisions related to Part D and non-interference H.R. 2010: To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Provisions related to Part D and non-interference H.R. 2071: To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - Provisions related to Part D and non-interference H.R. 2139: To amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes - Provisions related to Part D and non-interference H.R. 2170: To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid - Provisions related to COVID-19 vaccines S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: A bill to amend XVIII of the Social Security Act to allow the Secretary of Health and Human Services to negotiate fair prescription drug prices under part D of the Medicare program - Provisions related to Part D and non-interference S. 983: A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Provisions related to Part D and non-interference Department of Health and Human Services (HHS) drug policy issues and regulatory 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 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 Medicare prescription drug payments cards and related policy issues Tenncare III 1115 Medicaid Demonstration - Closed formulary policy issues Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements Final Rule; Fraud and Abuse; 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 Service Fees
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2020 · fourth_quarter · Q4
H.R. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 6049: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety H.R. 6393: Strengthening America's Supply Chain and National Security Act - Provisions related to prescription drug supply chains H.R. 6482: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains H.R. 6690: Bring Entrepreneurial Advancements To Consumers Here In North America Act - Provisions related to prescription drug supply chains and manufacturing tax incentives H.R. 6731: Securing America's Pharmaceutical Supply Chain Act - Provisions related to prescription drug supply chains H.R. 6879: Buy American Medical Supply Chain Act of 2020 - Provisions related to prescription drug and medical device supply chains H.R. 6930: MADE in America Act of 2020 - Provisions related prescription drug supply chains and manufacturing tax incentives H.R. 8508: COVID-19 Vaccine Distribution and Production Act - Provisions related to prescription drug supply chains H.R. 8943: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19, to elevate the Director of the Defense Logistics Agency as the head of the COVID-19 Joint Acquisition Task Force, to require the Director of the Defense Logistics Agency to establish a system for States and localities to access covered items during a covered emergency, and for other purposes - Provisions related to prescription drug supply chains H.R. 8987: To amend the Public Health Service Act to incentivize the manufacture of certain medicines in the United States and to enhance the security of the United States pharmaceutical supply chain, and for other purposes - Provisions related to prescription drug manufacturing and supply chains H.R. 8905: To amend the Federal Food, Drug, and Cosmetic Act to reduce the threat of counterfeit drugs to the pharmaceutical supply chain, and to make the pharmaceutical supply chain more robust, while ensuring the authenticity, content, purity, and manufacturing location and batch number of drugs (including COVID-19 therapeutics and vaccines) and allowing patient verification of authenticity, and for other purposes - Provisions related to prescription drug manufacturing and supply chains H.R. 8921: To direct the Secretary of Health and Human Services to reimburse qualified health care providers for the costs of purchasing, leasing, installing, and operating qualified equipment for cold storage of COVID-19 vaccines - Provisions related to prescription drug manufacturing and supply chains S. 3343: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety S. 3635: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains S. 3942: A bill to establish the position of Chief Pharmaceutical and Medical Supply Chain Negotiator in the Office of the United States Trade Representative, to be responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, to advance domestic production of life-saving medicines, and to secure the United States medical supply chain to eliminate reliance on foreign governments, and for other purposes - Provisions related to prescription drug supply chains S. 4175: Pharmaceutical Supply Chain Defense and Enhancement Act - Provisions related to pharmaceutical supply chains and manufacturing S. 4194: National Institute of Manufacturing Act - Provisions related to domestic manufacturing Trade Agreements including USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain and China Task Force policy issues
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2020 · third_quarter · Q3
H.R. 6395: National Defense Authorization Act for Fiscal Year 2021 H.R. 6800: The Heroes Act - Provisions related to supplemental appropriations and federal health programs H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 H.R. 8406: The Heroes Act - Provisions related to supplemental appropriations and federal health programs S. 4049: National Defense Authorization Act for Fiscal Year 2021 S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4381: Coronavirus Assistance for American Families Act CARES Act, Pub. L. 116-136
H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency H.R. 7647: To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - Provisions related to accumulator adjustment programs H.R. 7676: Health Care PRICE Transparency Act - Provisions related to hospital & insurer price transparency H.R. 7838: To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes - Provisions related to the 340B drug discount program H.R. 7942: Public Health Emergency COBRA Extension Act - Provisions related to health insurance coverage S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4439: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Executive Order 13937, Access to Affordable Life-saving Medications (July 24, 2020) Proposed Rule; Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
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2020 · second_quarter · Q2
H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 1425: Patient Protection and Affordable Care Enhancement Act - Provisions related to affordability fund S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 2650: Medicare Prescription Drug Savings and Choice Act of 2019 - Provisions related to Part D and prescription drug pricing S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access 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 ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-F) CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)
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2020 · first_quarter · Q1
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. 748: CARES Act - Provisions related to Part B, Part D, vaccines, transparency, and transportation H.R. 1158: Consolidated Appropriations Act, 2020 - Provisions related to prescription drugs, Medicare funding, and other provisions H.R. 1865: Consolidated Appropriations Act, 2020 - Provisions related to prescription drugs, Medicare funding, and other provisions H.R. 2401: American Cures Act - Provisions related to biomedical research funding 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. 2745: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2020 - VA provisions related to prescription drugs H.R. 2922: Respond NOW Act - Provisions related to funding to address opioid crisis H.R. 2968: Department of Defense Appropriations Act, 2020 - DoD 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.R. 4378: Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 - Provisions related to Medicare funding H.R. 6074: Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - Provisions related to biomedical research and prescription drug pricing H.R. 6201: Families First Coronavirus Response Act - Provisions related to Medicare funding H.R. 6373: To increase the amount available under the Defense Production Act of 1950 to respond to the coronavirus epidemic, and for other purposes - Provisions related to the Defense Production Act and medical devices H.R. 6379: Take Responsibility for Workers and Families Act - Provisions related to supplemental appropriations and federal health programs H. Res. 28: Providing for consideration of the bill (H.R. 264) making appropriations for financial services and general government for the fiscal year ending September 30, 2019, and for other purposes; providing for consideration of the bill (H.R. 265) making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2019, and for other purposes; providing for consideration of the bill (H.R. 266) making appropriations for the Department of the Interior, environment, and related agencies for the fiscal year ending September 30, 2019, and for other purposes; providing for consideration of the bill (H.R. 267) making appropriations for the Department of Transportation, and Housing and Urban Development, and related agencies for the fiscal year ending September 30, 2019, and for other purposes; and waiving a requirement of clause 6(a) of rule XIII with respect to consideration of certain resolutions reported from the Committee on Rules. H. Res. 293: Providing for budget enforcement for fiscal year 2020 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. 1250: American Cures Act - Provisions related to biomedical research funding S. 2474: Department of Defense Appropriations Act, 2020 - DoD provisions related to prescription drugs S. 2522: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 - FDA provisions related to prescription drugs S. 3161: National Biomedical Research Act - Provisions related to federal biomedical research funding S. 3370: Coronavirus Vaccine Act - Provisions related to NIH funding S. 3548: CARES Act - Provisions related to supplemental appropriations and federal health programs S. ___: 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
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2019 · fourth_quarter · Q4
H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions 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. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights 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. 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. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models H.R. 3925: Reducing Barriers to Substance Use Treatment Act - Provisions related to prior authorization requirements H.R. 4178: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates H.R. 4455: BIOSIM Act - Provisions related to biosimilar approval and reimbursement H.R. 4619: Pharmaceutical Rebates for Excessive Pricing Above Inflation Act - Provisions related to Part D and manufacturer rebates H.R. 4628: Better Tools to Lower Costs Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4649: Capping Drug Costs for Seniors Act of 2019 - Provisions related to Part D and patient cost-sharing H.R. 4650: Medicare Dental Act of 2019 - Provisions related to Medicare coverage of dental procedures H.R. 4655: Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4663: Freedom from Price Gouging Act - Provisions related to Part B and manufacturer rebates H.R. 4669: Maximizing Drug Coverage for Low-Income Seniors Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4913: Ensuring Access to Lower-Cost Medicines for Seniors Act - Provisions related to Part D prescription drug plans and formularies H.R. 5039: Life-Sustaining Prescription Drug Price Relief Act of 2019 - Provisions related to Part D, prescription drug negotiation, reference pricing and other provisions H.R. 5057: Pass-Through Technical Corrections Act - Provisions related to Medicare prescription drug pass-through payment status H.R. 5242: Opioid Settlement Accountability Act - Provisions related to Medicaid and opioid litigation related funds H.R. 5364: End Price Gouging for Insulin Act - Provisions related to prescription drug international reference pricing S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification 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. 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. 709: Prescription Drug Pricing Dashboard Act - Provisions related to prescription drug pricing transparency S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other 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 Policy issues related to patient medication information Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tennessee Section 1115 Medicaid waiver 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) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, 84 Fed. Reg. 55694 (10/17/19)
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2019 · third_quarter · Q3
H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions 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. 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. 3523: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models 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. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation 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. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions related to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lowering 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. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates S. 2081: Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 - Provisions related to prescription drug pricing and manufacturer rebates S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other 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 Policy issues related to patient medication information 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)
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2019 · second_quarter · 2A
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)
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2019 · second_quarter · Q2
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)
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2019 · first_quarter · Q1
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. 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)
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
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)
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2018 · first_quarter · Q1
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
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2017 · fourth_quarter · Q4
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)
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
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
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2017 · second_quarter · Q2
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
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
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
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2016 · fourth_quarter · Q4
Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule (CMS-1654-P) - Expansion of Medicare Diabetes Prevention Program Model S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Prescription drug abuse policy issues Center for Medicare and Medicaid Innovation (CMMI) transparency and other policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference policy issues
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2016 · second_quarter · 2A
S. 2806: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry S. 2943: National Defense Authorization Act for Fiscal Year 2017 - Provisions related to Department of Defense (DOD) authority to deny or limit coverage of medicines based on a government determination of value; TRICARE 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. 4974: Military Construction and Veterans Affairs 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. ___: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry Presidents FY2017 Budget - Issues related to the biopharmaceutical industry Senate and House budget process
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2016 · third_quarter · Q3
Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model Medicaid and Childrens Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Final rule [CMS-2390-F] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Prescription drug abuse policy issues Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference policy issues
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2016 · second_quarter · Q2
S. 2806: Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry S. 2943: National Defense Authorization Act for Fiscal Year 2017 - Provisions related to Department of Defense (DOD) authority to deny or limit coverage of medicines based on a government determination of value; TRICARE 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. 4974: Military Construction and Veterans Affairs 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. ___: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017 - Issues related to the biopharmaceutical industry Presidents FY2017 Budget - Issues related to the biopharmaceutical industry Senate and House budget process
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2016 · first_quarter · Q1
Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 8, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues Chronic Care Working Group - Medicare policy affecting drugs
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2015 · fourth_quarter · Q4
H.R. 1314: Bipartisan Budget Act of 2015 - Provisions in this general budget bill related to the pharmaceutical industry H.R. 2029: Consolidated Appropriations Act, 2016 - Provisions in this general appropriations bill related to the pharmaceutical industry
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 3819: Surface Transportation Extension Act of 2015 - Medicare related offsets to the biopharmaceutical industry H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Proposed rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Chronic Care Working Group - Medicare policy affecting drugs
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2015 · third_quarter · Q3
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 3244: Providing Innovative Care for Complex Cases Demonstration Act of 2015 - Provisions relating to changes to the Part D benefit Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Final Rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare Part D rebates issues Drug cost and pricing issues Medication adherence policy issues Alternative payment models policy issues
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA via PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2015 · second_quarter · Q2
S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing 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
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
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
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
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
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. 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. 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)
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. 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 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)
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, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program 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. 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. 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 Benefit Manager Accountability 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. 3281: Transparent PRICE 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. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 (117th Congress) H.R. 7653: Modern Authentication of Pharmaceuticals Act of 2022 (117th Congress) S. 6: Biosimilar Red Tape Elimination Act (117th Congress) 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. 1128: Ensuring Access to Generic Medications 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. 1114: Expanding Access to Low-Cost Generics Act 2023 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. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act (117th Congress) 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 Mental health policy issues High deductible health plans/HSA policy issues Supply chain 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 Defense Production Act policy issues Cybersecurity policy issues Anticounterfeiting policy issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
H.R. 485: Protecting Health Care for All Patients Act of 2023 - Prohibits all federal health care programs from using prices that are based on quality-adjusted life years to determine relevant thresholds for coverage, reimbursements, or incentive programs H.R. 830: Help Ensure Lower Patient Copays Act or the HELP Copays Act - Requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs National coverage determination 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 Rebate policy issues Insulin policy issues Pharmacy Benefit Manager reform and policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues Medicaid rebates and waiver policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] IPAY 2026 and Solicitation of Comments CMS Guidance on Medicare Part B and D Inflation Rebates
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act S. 4293: Pharmacy Benefit Manager Transparency Act of 2022 S. 2416: NOVEL Act of 2021 - Provisions related to medical products 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 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 Notice of Benefit and Payment Parameters (NBPP)
H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing 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 Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Filing targets: 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
H.R. 5: Equality Act H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Projects Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization 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 Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2179: Affordable Insulin for the COVID-19 Emergency Act - Provisions related to Part D and insulin H.R. 4417: Capping Drug Costs for Seniors Act of 2021 - Provisions related to Part D and prescription drug pricing H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5623: The Insulin Cost Reduction Act - Provisions related to prescription drug pricing and Medicaid H.R. 6833: Affordable Insulin Now Act S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing S. 3700: Affordable Insulin Now Act CMS National Coverage Determination (NCD) covering Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimers disease through coverage with evidence development (CED) Department of Health and Human Services (HHS) drug policy issues and regulatory 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 Insulin 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 Medicare prescription drug payments cards and related policy issues
H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - To amend the Public Health Service Act to improve the diversity of participants in research on Alzheimers disease, and for other purposes S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Nomination of Robert Califf to FDA Commissioner Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS)
H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5463: Drug Pricing Transparency and Accountability Act - To increase reporting requirements and transparency requirements in the 340B Drug Pricing Program, and for other purposes S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 1287: REFUND Act of 2021 - Provisions related to Part B and vial sizes S. 1773: Prescription Drug Pricing Dashboard Act - Provisions related to Medicare, Medicaid and prescription drug pricing transparency S. 1898: Affordable Medications Act - Provisions related to prescription drug pricing, Part D, non-interference, Part B, and intellectual property S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing S. 2815: Seniors Saving on Insulin Act - Provisions related to Part D and insulin pricing Department of Health and Human Services (HHS) drug policy issues and regulatory 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 VA drug 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 Medicare prescription drug payments cards and related policy issues Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Final Rule; Fraud and Abuse; 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 Service Fees
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 1167: Advancing Enrollment and Reducing Drug Costs Act of 2021 - Provisions related to Part D H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 2868: Protecting Access to Affordable Medicines Act of 2021 - Provisions related to Medicaid and prescription drug pricing and rebates S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1123: PING Act - Provisions related to Part D and non-interference S. 1323: End Price Gouging for Medications Act - Provisions related to Medicare, Medicaid and prescription drug pricing S. 2164: A bill to provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, and for other purposes Department of Health and Human Services (HHS) drug policy issues and regulatory 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 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 Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Fraud and Abuse; 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 Service Fees
H.R. 1319: American Rescue Plan Act of 2021 CARES Act, Pub. L. 116-136 FY2022 Presidents Budget FY2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act FY2022 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act FY2022 Commerce, Justice, Science, and Related Agencies Appropriations Act Senate infrastructure bills (no bill numbers)
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 Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)
H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 387: Vaccinate More Americans Act of 2021 - Provisions related to COVID-19 vaccines H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to drug pricing and COVID-19 vaccines and treatments H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1391: Taxpayer Research and Coronavirus Knowledge Act of 2021 - Provisions related to COVID-19 health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2078: Social and Economic Equity Promotion Act - CBO analyses H.R. 2181: To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals - Provisions related to prescription drug importation H.R. 2347: To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes - Provisions related to COVID-19 vaccines S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions - Provisions related to citizen petitions S. 670: To amend the Federal Food, Drug, and Cosmetic Act to accelerate development of therapies across the spectrum of rare diseases and conditions and facilitate patient access to such therapies, and for other purposes - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 898: A bill to require reporting regarding certain drug price increases, and for other purposes - Provisions related to prescription drug pricing transparency S. 917: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages S. 920: To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals - Provisions related to prescription drug importation HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation policy issues Expanded access policy issues Supply chain policy issues Real world evidence policy issues Regenerative medicine policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favored Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of HHS Secretary Xavier Becerra Nominaton of USTR Katherine Tai Nomination of HHS Assistant Secretary Rachel Levine Nomination of OMB Deputy Director Shalanda Young Nomination of CMS Administrator Chiquita Brooks-LaSure
H.R. 1319: American Rescue Plan Act of 2021 CARES Act, Pub. L. 116-136
Filing targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
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. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency H.R. 7647: To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - Provisions related to accumulator adjustment programs H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development 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. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1224: Stop STALLING Act - Provisions related to citizen petitions 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. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers S. 4427: SAVE Act - Provisions related to the FDA drug approval process S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatory recall authority policy issues Pharmaceutical supply chain policy issues COVID-19 policy issues Final Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26)
H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 8624: Protecting Access to Innovation During COVID-19 Act - Provisions related to Medicare and prescription drug pricing H.R. 8702: Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 - Provisions related to Part B and physician reimbursement S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4199: Prescription Drug Pricing Reduction Act of 2020 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4274: Legalizing Drug Discounts for Seniors Act of 2020 - Provisions related to Part D and manufacturer rebates 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 Medicare prescription drug payments cards and related issues Medicare Part B policy issues relating to ASP reporting, payment for drugs with non-covered versions, and drug wastage rebates AMP cap policy issues Vial size policy issues Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (RIN 0938-AT98) Final Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (RIN 0938-AT82) Final Rule: Transparency in Coverage (RIN 0938-AU04) Interim Final Rule with comment period: Most Favored Nation (MFN) Model (RIN 0938-AT91) Final Rule: Fraud and Abuse; 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 Service Fees (RIN 0936-AA08)
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), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 1425: Patient Protection and Affordable Care Enhancement Act - Provisions related to affordability fund S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4199: Prescription Drug Pricing Reduction Act of 2020 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 4274: Legalizing Drug Discounts for Seniors Act of 2020 - Provisions related to Part D and manufacturer rebates 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 ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-F) CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)
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), Justice, Dept of (DOJ), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
Filing targets: Centers For Disease Control & Prevention (CDC), 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), Homeland Security, Dept of (DHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
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), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
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), Natl Economic Council (NEC), 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. 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 (FAIR) of 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. 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 Drugs 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 / More Efficient Tools to Realize Information for Consumers Act - 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. 2401: American Cures Act - Provisions related to pharmaceutical research and development H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding 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: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions 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. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes 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: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing 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 S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan 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 Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues 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), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), President of the U.S., SENATE, U.S. Trade Representative (USTR)
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)
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. 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)
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. 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. 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)
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
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. 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)
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. 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. 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
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
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)
Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model H.R. 5273: Helping Hospitals Improve Patient Care Act of 2016 - Provisions related to exemption of hospitals that had off-site facilities under development Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Final rule [CMS-2390-F] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference policy issues
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. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers 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. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA 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. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: 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 H.R. 6: 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. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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 - 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. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse 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. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) 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 ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 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) negotiation and 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 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)
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), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
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. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers 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. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 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. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids 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 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
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), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
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. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers 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. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA 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. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: 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 H.R. 6: 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. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research 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 - 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. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse 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. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) 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 ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 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) negotiation and 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 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)
Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model H.R. 5273: Helping Hospitals Improve Patient Care Act of 2016 - Provisions related to exemption of hospitals that had off-site facilities under development Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Final rule [CMS-2390-F] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference 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), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.
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. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review 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. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients 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. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program H.R. 2841: Fair Access for Safe and Timely 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. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act 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 ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act issues including the Charitable Donation Exemption Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to 340B program 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 issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy policy issues Prescription drug abuse policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
H.R. 1078: Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestration H.R. 1735: National Defense Authorization Act for Fiscal Year 2016 - Provisions related to Tricare prescription reimbursement in this bill, which authorizes FY2016 appropriations and sets forth policies for Department of Defense (DOD) programs and activities FY 2016 Labor, Health and Human Services, and Education Appropriations Bill - Provisions related to drug reimbursement, Part D, and biopharmaceutical research FY 2016 Agriculture Appropriations Bill - Provisions related to compounding and e-labeling The Presidents FY 2016 Budget - Provisions related to prescription drug reimbursement and data exclusivity FY 2016 Budget Resolution - Provisions related to biopharmaceutical policy issues Budget Control Act - Provisions related to sequestration
Filing targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)