Lobbying Filing Details

Activity 1

Antibiotic Use in Livestock ---H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter Climate Change ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Foreign Agricultural Biotechnology Laws and Regulations ---H.R.5790/S.2992: Prioritizing Offensive Agricultural Disputes and Enforcement Act ---China Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---South Korea Living Modified Organisms Funding for the USDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulation for Gene Edited Products ---Labeling Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) ---EPA Regulatory Approach to Gene Editing ---FDA Proposed guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Synthetic Biotech USDA/APHIS Agricultural Biotechnology Regulations --- H.R.1472/S.802: Plant Biostimulant Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---Regulatory Treatment of Gene Edited Products

Lobbyists (9)

• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• ELISABETH FOX
• AMBER MANKO
• NANCY TRAVIS
• EMILY MICHAEL
• JOHN TORRES
• MS. REBECCA AIKEN HACKETT

Government Entities (7)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• Natl Security Council (NSC)
• U.S. Trade Representative (USTR)
• ... and 2 more

Activity 2

Antibiotic Use in Livestock --- H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulation for Gene Edited Products ---Labeling Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0

Lobbyists (7)

• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• AMBER MANKO
• EMILY MICHAEL
• JOHN TORRES
• MS. REBECCA AIKEN HACKETT

Government Entities (2)

• SENATE
• HOUSE OF REPRESENTATIVES

Activity 3

Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

Lobbyists (11)

• PHYLLIS ARTHUR
• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• MS. EMILY WHEELER
• ELISABETH FOX
• AMBER MANKO
• EMILY MICHAEL
• MS. ELIZABETH CARTIER ESHAM
• JOHN TORRES
• MS. REBECCA AIKEN HACKETT

Government Entities (4)

• SENATE
• HOUSE OF REPRESENTATIVES
• Natl Security Council (NSC)
• Food & Drug Administration (FDA)

Activity 4

Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---S.2452/H.R.5134: Biomanufacturing and Jobs Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Investment Tax Credit ---Production Tax Credit

Lobbyists (4)

• NICK SHIPLEY
• ELISABETH FOX
• JOHN TORRES
• MS. REBECCA AIKEN HACKETT

Government Entities (2)

• SENATE
• HOUSE OF REPRESENTATIVES

Activity 5

Antitrust Legislation Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---Reasonable Pricing Clause ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights Compulsory Licensing ---28 USC 1498 Government Use of Patents ---Prescription Drug Price Relief Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Data Privacy Issues ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity in Patenting ---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Intellectual Property Enforcement ---TRIPS Waiver Patent Reform ---H.R.3535: Advancing Americas Interest Act ---H.R.4575: Prohibiting Adversarial Patents Act (PAPA) ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.2140: Patent Eligibility Restoration Act (PERA) ---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---S.4417: Patent Trial and Appeal Board Reform Act of 2022 ---Patent Litigation Reform Patenting of Biological Inventions ---S.2140: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization ---PTO Examination Guidelines United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Intergovernmental Committee on IP and Genetic Resources World Trade Organization (WTO) ---13th Ministerial Conference ---TRIPS Waiver

Lobbyists (12)

• HANSJORG SAUER
• PHYLLIS ARTHUR
• DAVID LACHMANN
• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• AMBER MANKO
• NANCY TRAVIS
• JUSTIN PINE
• EMILY MICHAEL
• JOHN TORRES
• MS. REBECCA AIKEN HACKETT

Government Entities (10)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• Natl Security Council (NSC)
• U.S. Trade Representative (USTR)
• ... and 5 more

Activity 6

Biofuels (Non-Funding) ---H.R.5235: Farms to Fuselage Act ---H.R.6271/S.3637: Farm to Fly Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2024 Appropriations ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Lobbyists (5)

• NICK SHIPLEY
• KRISTIN MURPHY
• ELISABETH FOX
• JOHN TORRES
• MS. REBECCA AIKEN HACKETT

Government Entities (2)

• SENATE
• HOUSE OF REPRESENTATIVES

Activity 7

Antibiotic Use in Livestock ---H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulation for Gene Edited Products ---Labeling Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0

Lobbyists (7)

• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• AMBER MANKO
• EMILY MICHAEL
• JOHN TORRES
• MS. REBECCA AIKEN HACKETT

Government Entities (2)

• SENATE
• HOUSE OF REPRESENTATIVES

Activity 8

Biofuels (Non-Funding) ---H.R.5235: Farms to Fuselage Act ---H.R.6271/S.3637: Farm to Fly Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2024 Appropriations ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Lobbyists (5)

• NICK SHIPLEY
• KRISTIN MURPHY
• ELISABETH FOX
• JOHN TORRES
• MS. REBECCA AIKEN HACKETT

Government Entities (2)

• SENATE
• HOUSE OF REPRESENTATIVES

Activity 9

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement Coronavirus (COVID-19) Pandemic ---COVID-19 Lessons Learned ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Implementation of Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Lobbyists (15)

• HANSJORG SAUER
• PHYLLIS ARTHUR
• DAVID LACHMANN
• JOHN MURPHY
• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• MS. EMILY WHEELER
• ELISABETH FOX
• AMBER MANKO
• NANCY TRAVIS
• JUSTIN PINE
• EMILY MICHAEL
• MS. ELIZABETH CARTIER ESHAM
• MS. REBECCA AIKEN HACKETT

Government Entities (10)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• Natl Security Council (NSC)
• Office of Science & Technology Policy (OSTP)
• ... and 5 more

Activity 10

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)

Lobbyists (9)

• PHYLLIS ARTHUR
• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• MS. EMILY WHEELER
• ELISABETH FOX
• AMBER MANKO
• EMILY MICHAEL
• MS. REBECCA AIKEN HACKETT

Government Entities (4)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• Natl Security Council (NSC)

Activity 11

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Coronavirus (COVID-19) Pandemic ---FY 2024 Appropriations ---FY 2025 Appropriations ---R&D Funding for Medical Countermeasures Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act

Lobbyists (9)

• PHYLLIS ARTHUR
• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• MS. EMILY WHEELER
• ELISABETH FOX
• AMBER MANKO
• EMILY MICHAEL
• MS. REBECCA AIKEN HACKETT

Government Entities (5)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• Natl Security Council (NSC)
• Health & Human Services, Dept of (HHS)

Activity 12

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Coronavirus (COVID-19) Pandemic ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2630/S.652: SAFE STEP Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Lobbyists (11)

• HANSJORG SAUER
• PHYLLIS ARTHUR
• JOHN MURPHY
• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• ELISABETH FOX
• AMBER MANKO
• JUSTIN PINE
• EMILY MICHAEL
• MS. REBECCA AIKEN HACKETT

Government Entities (4)

• SENATE
• HOUSE OF REPRESENTATIVES
• Health & Human Services, Dept of (HHS)
• Centers For Medicare and Medicaid Services (CMS)

Activity 13

Banking Policy Impacting Emerging Companies Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---S.866: American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Market Liquidity Proposals ---Public Float Threshold Update ---SEC Small Business Forum Reform of SEC Regulation D ---Accredited Investor Certification Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program ---Reauthorization of SBIR and STTR

Lobbyists (9)

• DAVID LACHMANN
• CAMERON ARTERTON
• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• ELISABETH FOX
• AMBER MANKO
• EMILY MICHAEL
• MS. REBECCA AIKEN HACKETT

Government Entities (2)

• SENATE
• HOUSE OF REPRESENTATIVES

Activity 14

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---S.866: American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds Coronavirus (COVID-19) Pandemic Orphan Drug Issues Qualified Small Business Stock (QSBS) Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.7024: Tax Relief for American Families and Workers Act of 2024 ---S.866: American Innovation and Jobs Act ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Lobbyists (11)

• PHYLLIS ARTHUR
• DAVID LACHMANN
• CAMERON ARTERTON
• KATHLEEN CALLANAN
• NICK SHIPLEY
• KRISTIN MURPHY
• ELISABETH FOX
• AMBER MANKO
• EMILY MICHAEL
• JOHN TORRES
• MS. REBECCA AIKEN HACKETT

Government Entities (3)

• SENATE
• HOUSE OF REPRESENTATIVES
• Treasury, Dept of