Global Fairness in Drug Pricing Act

H.R. 1 - One Big Beautiful Bill Act - Rep. Arrington, Jodey - Medicaid eligibility and state financing, Marketplace coverage and enrollment, Health Savings Account expansion, Pharmacy Benefit Manager financing and regulation H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM reporting requirements for MA/Part D plans H.R. 1117 - Responsibility in Drug Advertising Act - Rep. DeLauro, Rosa - Direct-to-consumer ads H.R. 1244 - Reducing Drug Prices for Seniors Act - Rep. Davis, Donald - Coinsurance for Part D drugs H.R. 2214 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 2450 - Prescription Drug Transparency and Affordability Act - Rep. McDonald Rivet, Kristen - PBM transparency H.R. 3493 - Global Fairness in Drug Pricing Act - Rep. Khanna, Ro - Prescription drug international reference pricing H.R. 3546 - Prescription Drug Price Relief Act - Rep. Khanna, Ro - Prescription drug patent reform H.R. 3775 - Fair Prescription Drug Prices for Americans Act - Rep. Van Drew, Jefferson - Prescription drug and biological product international reference pricing H.R. 3789 - DTC Act - Rep. Taylor, David - Direct-to-consumer prescription advertising transparency H.R. 4139 - Cutting Copays Act - Rep. McGarvey, Morgan - Medicare cost-sharing for generic drugs H.R. 4231 - Treat and Reduce Obesity Act - Rep. Kelly, Mike - Medicare coverage of obesity drugs H.R. 4317 - PBM Reform Act - Rep. Carter, Earl L. Buddy - PBM contracting requirements and transparency H.R. 4605 - End Prescription Drug Ads Now Act - Rep. Nadler, Jerrold - Ban on DTC drug ads H.R. 4623 - Plain Prescription Prices Act - Rep. Williams, Nikema - Transparency requirements for DTC drug ads H.R. 5094 - Protect Patients from Costly Care Act - Rep. Pappas, Chris - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program H.R. 5197 - Protect Beneficiaries from Middlemen Act - Rep. Malliotakis, Nicole - Medicare cost-sharing limit for drugs S. 229 - DTC Act - Sen. Durbin, Richard - Drug advertising requirements S. 483 - Responsibility in Drug Advertising Act - Sen. King, Angus - Drug advertising requirements S. 526 - Pharmacy Benefit Manage Transparency - Sen. Grassley, Chuck - PBM reporting requirements S. 529 - Capping Prescription Costs Act - Sen. Warnock, Raphael - Drug copay caps S. 652 - Protecting Patients from Deceptive Drugs Ads Act - Sen. Durbin, Richard - Drug advertising requirements S. 882 - Patients Before Middlemen Act - Sen. Blackburn, Marsha - PBM reforms S. 891 - Bipartisan Health Care Act - Sen. Wyden, Ron - PBM reforms and transparency S. 1040 - Drug Competition Enhanced Act - Sen. Cornyn, John - Drug patent reform S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen. Hawley, Josh - Prescription drug international reference pricing S. 1753 - End Price Gouging for Medications Act - Sen. Merkley, Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval S. 1973 - Treat and Reduce Obesity Act - Sen. Cassidy, Bill - Medicare coverage for obesity drugs S. 2345 - Short on Competition Act - Sen. Klobuchar, Amy - Expedited approval for generic drugs S. 2447 - Repealing the Trump Sick Tax Act - Sen. Welch, Peter - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program S. 2620 - REMEDY Act - Sen. Durbin, Richard - Expedited approvals for certain drug approvals Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; coverage of weight loss drugs; high priced drugs; patent reforms; Pharmacy Benefit Managers; PBM related issues; and copay coupons.

Client expense: $4,230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institute of Health FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---Creating Hope Reauthorization Act ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---PPRV ---Prescription Drug User Fee Act (PDUFA) VII Implementation ---Project Bioshield ---Reauthorization of PAHPA ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Section 317 Immunization Program HR 5256 Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act). ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues ---BIOSECURE Act ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act ---Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---MCM PRV Program Reauthorization --- National Defense Authorization Act 2026 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilar Copay ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Preserve Access to Affordable Generics and Biosimilars Act ---Reimbursement Cell & Gene Therapy Data Privacy ---American Privacy Rights Act ---BIOSECURE Act ---Clinical Trial Data in China Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---H.R. 3521, Clinical Trial Modernization Act Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---A bill to address patent thickets ---A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Medication Affordability and Patient Integrity Act ---Patent Thickets ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R. 1492 Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672 Maintaining Investments and New Innovation (MINI) Act ---S.2082 Stronger Patents Act ---Access to Innovative Treatments Act ---Affordable Prescriptions for Patients Act ---Biosimilar Red Tape Elimination Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---DRUG Act ---Ensuring Timely Access to Generics ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) ---Increasing Transparency in Generic Drug Application ---Interagency Patent Coordination and Improvement Act ---Lowering Drug Costs for American Families Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Medicare Drug Price Negotiation Act ---Medicare Negotiation and Competitive Licensing Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation ---National Coverage Determination ---Patient Cost-Sharing and Implementation ---PBM Reform ---Pharmacy Benefit Manager Transparency Act ---Prescription Drug Price Relief Act ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Protecting Patient Access to Cancer and Therapies ---Strengthening Innovation in Medicare and Medicaid Act ---HR 1 One Big Beautiful Bill Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---BIOSECURE Act ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes. Generic Drug Entry ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Drug Rebate Program Rule ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Pharmacy Benefit Manager Transparency Act of 2025 ---The Medicaid VBPs for Patients (MVP) Act ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 National Security ---BIOSECURE Act ---Clinical Trial Data in China ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Opioid Crisis ---SUPPORT Act Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---H.R.1262: Give Kids a Chance Act ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Innovation in Pediatric Drugs Act of 2023 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Medical Countermeasures PRV Reauthorization ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---HR 3493 Global Fairness in Drug Pricing Act ---CMMI Authority ---HELP Copays Act ---National Coverage Determination ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Mandating Exclusive Review of Individual Treatments (MERIT) Act Vaccines and Infectious Diseases ---Adult Immunization ---Antimicrobial Resistance (General) ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence ---HR 3701 Family Vaccine Protection Act

H.R. 1476 / S. 694, Preserving Life-Saving Access to Specialty Medicines in America Act (PLASMA Act), legislation to provide rebate phase-in for plasma-derived therapies under the Medicare Part D program H.R. 1143, Medicare IVIG Access Enhancement Act of 2025 H.R. 2343 , John W. Walsh Alpha-1 Home Infusion Act of 2025 H.R. 2172, Preserving Patient Access to Home Infusion Act S. 1818 / H.R.3546, Prescription Drug Price Relief Act of 2025 S.1587 / H.R.3375, Fair Prescription Drug Prices for Americans Act S.1753, End Price Gouging for Medications Act H.R. 3493, Global Fairness in Drug Pricing Act Issues related to the implementation of P.L. 117-169, The Inflation Reduction Act; drug price negotiations, Part D rebate

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1 - One Big Beautiful Bill Act - Rep. Arrington, Jodey - Medicaid eligibility and state financing, Marketplace coverage and enrollment, Health Savings Account expansion, Pharmacy Benefit Manager financing and regulation H.R. 44 - 340B Access Act - Rep. Bergman, Jack - 340B participation expansion H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM reporting requirements for MA/Part D plans. H.R. 1117 - Responsibility in Drug Advertising Act - Rep. DeLauro, Rosa - Direct-to-consumer ads H.R. 1244 - Reducing Drug Prices for Seniors Act - Rep. Davis, Donald - Coinsurance for Part D drugs H.R. 2214 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 2450 - Prescription Drug Transparency and Affordability Act - Rep. McDonald Rivet, Kristen - PBM transparency H.R. 3493 - Global Fairness in Drug Pricing Act - Rep. Khanna, Ro - Prescription drug international reference pricing H.R. 3546 - Prescription Drug Price Relief Act - Rep. Khanna, Ro - Prescription drug patent reform H.R. 3775 - Fair Prescription Drug Prices for Americans Act - Rep. Van Drew, Jefferson - Prescription drug and biological product international reference pricing H.R. 3789 - DTC Act - Rep. Taylor, David - Direct-to-consumer prescription advertising transparency S. 229 - DTC Act - Sen. Durbin, Richard - Drug advertising requirements S. 483 - Responsibility in Drug Advertising Act - Sen. King, Angus - Drug advertising requirements S. 526 - Pharmacy Benefit Manage Transparency - Sen. Grassley, Chuck - PBM reporting requirements S. 529 - Capping Prescription Costs Act - Sen. Warnock, Raphael - Drug copay caps S. 652 - Protecting Patients from Deceptive Drugs Ads Act - Sen. Durbin, Richard - Drug advertising requirements S. 882 - Patients Before Middlemen Act - Sen. Blackburn, Marsha - PBM reforms S. 891 - Bipartisan Health Care Act - Sen. Wyden, Ron - PBM reforms and transparency S. 1040 - Drug Competition Enhanced Act - Sen. Cornyn, John - Drug patent reform S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen. Hawley, Josh - Prescription drug international reference pricing S. 1753 - End Price Gouging for Medications Act - Sen. Merkley, Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; coverage of weight loss drugs; high priced drugs; patent reforms; Pharmacy Benefit Managers; PBM related issues; and copay coupons.

FY 2026 Appropriations for Specific Issues ---Drug Pricing ---Antimicrobial Resistance (General) --- Vaccines and Infectious Diseases --- Alternative Funding Programs --- Pandemic Preparedness - R&D Funding for Medical Countermeasures 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight --- PROTECT 340B Act --- SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement ---Biosimilars Red Tape Elimination Act Cell & Gene Therapy --- H.R.1672 - Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---Promising Pathway Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounded Medicines Drug Patenting ---Interagency Patent Coordination and Improvement Act ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---Restrictions on Intellectual Property Rights ---Patent Thickets Drug Pricing ---H.R.946: ORPHAN Cures Act --- H.R. 1492 Ensuring Pathways to Innovative Cures (EPIC) Act --- H.R.1672 Maintaining Investments and New Innovation (MINI) Act ---Interagency Patent Coordination and Improvement Act of 2025 ---PBM Reform ---Prescription Pricing for the People Act ---Pharmacy Benefit Manager Transparency Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act ---Most Favored Nation Foreign Drug Data Protection Laws ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Medicaid ---Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Most Favored Nation ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---S. 946 ORPHAN Cures Act ---Give Kids A Chance Act ---Pediatric Priority Review Voucher Program Reauthorization ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness --- Drug Supply Chain Management --- House GOP RFI on Supply Chain --- Monoclonal Antibody Coverage and Utilization --- Restrictions on Intellectual Property Rights --- Supply Chain Issues --- WHO Pandemic Preparedness Accord --- Medical Countermeasure Priority Review Voucher Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products --- HR 3375 Fair Prescription Drug Prices for Americans Act --- HR 3493 Global Fairness in Drug Pricing Act --- S.1587 Fair Prescription Drug Prices for Americans Act --- S.1818 Prescription Drug Price Relief Act ---HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act ---Countermeasures Injury Compensation Program ---Vaccine Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institute of Health ---BARDA FY 2026 Appropriations for Specific Issues --- Alternative Funding Programs --- Antimicrobial Resistance (General) --- Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --- CICP --- Creating Hope Reauthorization Act --- Drug Pricing --- Funding for Strategic National Stockpile --- Funding for Women's Health Research --- Implementation of the Inflation Reduction Act (IRA) --- Influenza Planning & Response --- MCM PRV Reauthorization --- Pandemic Preparedness - R&D Funding for Medical Countermeasures --- PPRV --- Prescription Drug User Fee Act (PDUFA) VII Implementation --- Project Bioshield --- Reauthorization of PAHPA --- Vaccines and Infectious Diseases --- Vaccine Injury Compensation Program --- Section 317 Immunization Program 340B Drug Discount Program --- 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues ---Bio COMPETES (Draft) ---Biodefense ---BIOSECURE Act ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act ---Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---MCM PRV Program Reauthorization --- NDAA --- Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) --- Risky Research Review Act --- Tropical Disease Priority Review Voucher (PRV) Program --- VICP Loopholes --- WHO Pandemic Preparedness Accord Biosimilars ---Bio COMPETES (Draft) ---Biosimilar Copay ---Biosimilar Red Tape Elimination Act ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Preserve Access to Affordable Generics and Biosimilars Act ---Reimbursement Cell & Gene Therapy --- H.R.1672 Maintaining Investments and New Innovation (MINI) Act Climate Change Data Privacy ---American Privacy Rights Act ---Bio COMPETES (Draft) ---BIOSECURE Act ---Clinical Trial Data in China ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on 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 ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA ---FDA Reform Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounding & Counterfeit Medicines Drug Patenting ---A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Medication Affordability and Patient Integrity Act ---Patent Thickets ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Restrictions on Intellectual Property Rights ---Stop STALLING Act Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R. 1492 Ensuring Pathways to Innovative Cures (EPIC) Act --- H.R.1672 Maintaining Investments and New Innovation (MINI) Act --- S.2082 Stronger Patents Act --- Access to Innovative Treatments Act --- Affordable Prescriptions for Patients Act --- Biosimilar Red Tape Elimination Act --- CMMI Authority --- COVID-19 Pricing-Related Provisions --- DRUG Act --- Ensuring Timely Access to Generics --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Inflation Reduction Act (IRA) --- Increasing Transparency in Generic Drug Application --- Interagency Patent Coordination and Improvement Act --- Lowering Drug Costs for American Families Act --- Mandating Exclusive Review of Individual Treatments (MERIT) Act --- Medicare Drug Price Negotiation Act --- Medicare Negotiation and Competitive Licensing Act --- Modernizing and Ensuring PBM Accountability (MEPA) Act --- Most Favored Nation --- National Coverage Determination --- Patient Cost-Sharing and Implementation --- PBM Reform --- Pharmacy Benefit Manager Transparency Act --- Prescription Drug Price Relief Act --- Prescription Pricing for the People Act --- Preserve Access to Affordable Generics and Biosimilars Act --- Protecting Patient Access to Cancer and Therapies --- Stop STALLING Act --- Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---Bio COMPETES (Draft) ---BIOSECURE Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Generic Drug Entry --- Stop STALLING Act Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design --- Modernizing and Ensuring PBM Accountability (MEPA) Act ---Pharmacy Benefit Manager Transparency Act of 2025 ---Pricing and Rebates --- The Medicaid VBPs for Patients (MVP) Act ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 National Security ---American Privacy Rights Act ---BIOSECURE Act ---Clinical Trial Data in China --- Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics ---SUPPORT Act Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---H.R.1262: Give Kids a Chance Act ---S. 946 ORPHAN Cures Act ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Innovation in Pediatric Drugs Act of 2023 ---Pediatric Priority Review Voucher Program ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Rare Disease Pilot Program Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain --- Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Medical Countermeasures PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---Project Bio Shield ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Reimbursement and Coverage of Innovative Products --- HR 3375 Fair Prescription Drug Prices for Americans Act --- HR 3493 Global Fairness in Drug Pricing Act --- S.1587 Fair Prescription Drug Prices for Americans Act --- S.1818 Prescription Drug Price Relief Act ---CMMI Authority --- End Price Gauging for Medications Act ---HELP Copays Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Lower Costs, More Transparency Act ---Lowering Drug Costs for American Families Act --- Mandating Exclusive Review of Individual Treatments (MERIT) Act --- Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing --- Prescription Drug Price Relief Act ---Protected Classes --- SAFE STEP Act --- SMART Prices Act --- Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations --- The Medicaid VBPs for Patients (MVP) Act ---Value-based Contracting and Communications --- Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases --- Access to Innovative Treatments Act ---Adult Immunization --- Antimicrobial Resistance (General) ---CICP - General --- Countermeasure Injury Compensation Fund Amendment Act --- Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act --- Let Injured Americans Be Legally Empowered (LIABLE) Act --- Maternal Immunization ---MCM Manufacturing & Capacity --- MCM R&D Incentives --- Monoclonal Antibody Coverage and Utilization --- National Coverage Determination --- SAFE STEP Act --- Vaccine Access Improvement Act --- Vaccine and Antimicrobial Resistance Product Development and Incentives --- Vaccine Injury Compensation Modernization Act --- Vaccine Injury Compensation Program --- Vaccine Quality Measure --- Vaccine Safety --- Vaccine Safety Net and Vaccine Infrastructure --- Value of Vaccines and Vaccine Confidence --- VICP CICP (Discussion Draft) ---HR 3701 Family Vaccine Protection Act

H.R. 1476 / S. 694, Preserving Life-Saving Access to Specialty Medicines in America Act (PLASMA Act), legislation to provide rebate phase-in for plasma-derived therapies under the Medicare Part D program H.R. 1143, Medicare IVIG Access Enhancement Act of 2025 H.R. 2343 , John W. Walsh Alpha-1 Home Infusion Act of 2025 H.R. 2172, Preserving Patient Access to Home Infusion Act S. 1818 / H.R.3546, Prescription Drug Price Relief Act of 2025 S.1587 / H.R.3375, Fair Prescription Drug Prices for Americans Act S.1753, End Price Gouging for Medications Act H.R. 3493, Global Fairness in Drug Pricing Act

Client expense: $390,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE