ORPHAN Cures Act

Issues related to Most Favored Nation (MFN) drug pricing proposal; Issues related to Senate Finance Dear Colleague process; H.R. 946/S. 1862, ORPHAN Cures Act; S. 3019, No Big Blockbuster Bailouts Act (NOBBBA)

Client expense: Not reported · Firm income: $50,000

Issues related to Medicaid Drug Rebate program rule. Public Law 119-21: One Big Beautiful Bill Act, as it relates to H.R.946 - ORPHAN Cures Act. Issues related to drug pricing including potential legislation to impose Most Favored Nation pricing in Medicare. CMS Guard demonstration project".

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES

- H.R. 1539, Medical Device Electronic Labeling Act, regarding all provisions - H.R. 929/S. 266, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, regarding all provisions - H.R. 946 ORPHAN Cures Act, regarding all provisions - S.864, HELP Copays Act, regarding all provisions - H.R. 2214, Delinking Revenue from Unfair Gouging (DRUG) Act, regarding all provisions - H.R. 1492/S. 832, Ensuring Pathways to Innovative Cures (EPIC) Act, regarding all provisions - S. 1954/ H.R. 5526 Biosimilar Red Tape Elimination Act, regarding all provisions - H.R.2527, Early Detection of Vision Impairments for Children Act of 2025, regarding all provisions - PL117-169 The Inflation Reduction Act, regarding all provisions related to drug pricing and implementation - H.R.5343/S. 1717, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, regarding all provisions - H.R.4282, Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act, regarding all provisions - S.1399 / H.R. 6197, the Health Tech Investment Act, regarding all provisions - H.R. 3521, the Clinical Trial Modernization Act, regarding all provisions - H.R. 3006 / S.1776, the Medicare Beneficiary Co-Pay Fairness Act, regarding all provisions - H.R. 3514, the Improving Seniors Timely Access to Care Act of 2025, regarding all provisions - H.R. 6549, the VA Contracting and Procurement Act, regarding all provisions - H.R. 5509 / S. 2903, Safe Step Act, regarding all provisions - H.R. 5256, 340B ACCESS Act, regarding all provisions - H.R. 7391, Community Health Center Drug Pricing Protection Act, regarding all provisions - H.R. 3953 / S. 1874 Title VIII Nursing Workforce Reauthorization Act, regarding all provisions Issues related to - direct to consumer advertising - clinical trial modernization - biosimilars - cardiovascular health - 340B and 340B Rebate Pilot - Heart Recovery Awareness Day & H.Res. 1301, designating February 20th Heart Recovery Awareness Day - MFN - Foreign Reference Pricing - CMS Outpatient Prospective Payment System rule - peripheral artery disease (PAD) - PBM and Insurer Reforms

Client expense: $2,220,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

FDA regulation of CBD FDA Rare Disease PPRV program/reauthorization Issues related to the regulation of cannabis and CBD, research and development of cannabis-derived therapies Most Favored Nation drug pricing Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act HR 946: Orphan Cures Act Legislation Related to the Repeal or Reform of Orphan Cures Section 232 Tariffs

Client expense: $550,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. H.R.10571, Surge to Save Newborns Act. H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Support of reauthorization of priority review voucher program. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Most-Favored Nation and International Reference Pricing proposals. PDUFA/regulatory review process.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3521/ S 4440 Clinical Trial Modernization Act HR 946/S 1862 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act Discuss Vaccine concerns Cell Therapy Broad discussion on drug pricing CMMI GENEROUS Demo FDA modernization policy 340B policy Demo for CMMI regarding copay caps Policies related to international reference pricing for pharmaceuticals Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues and policies related to 340B Rebate Model Pilot Program for IRA compliance Issues related to most-favored nations drug pricing proposals Issues related to implementation and/or expansion of the Inflation Reduction Act (IRA) Issues related to the price and manufacture of inhaled medicines Issues related to next generation propellant and PFAS Issues related to vaccine access and vaccine R&D, including ACIP recommendations Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials clinical trial modernization act

Client expense: $810,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office

Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027

Client expense: $840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 946 / S. 1862, Orphan Cures Act implementation H. Res. 1331, Expressing support for "Hidradenitis Suppurativa Awareness Week" Issues related to Medicaid rebates Issues related to implementation of the Inflation Reduction Act Issues related to the 340B Drug Pricing Program Issues related to drug cost and pricing Education around access to innovative therapies in dermatology

Client expense: $380,000 · Firm income: Not reported

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

Education about chronic kidney disease and Medicare screening guidelines Issues related to Medicare Part D redesign Issues related to prescription drug pricing and value Issues regarding implementation of the Inflation Reduction Act, including H.R. 1492/S.832 - EPIC Act of 2025; H.R. 946/S. 1862, the Optimizing Research Progress Hope and New (ORPHAN) Cures Act Issues related to the Treat and Reduce Obesity Act The Access to Prescription Digital Therapeutic Act Issues related to Most Favored Nation Proposals Education about cancer and Medicare screening coverage, including H.R. 842/S. 339, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

Client expense: $1,020,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of the Inflation Reduction Act, P.L. 117-169, including potential changes to the structure of and reimbursement for Medicare Part D. H.R. 946 - Orphan Cures Act H.R. 1492 / S. 832 - Ensuring Pathways to Innovative Cures (EPIC) Act Issues related to drug pricing

Client expense: $940,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Issues relating to drug cost and pricing policy, no current bill. Pharmacy Benefit Manager legislation related to patient access to therapies and affordability Education and discussions regarding pharmaceutical issues related to supply chain, no specific bill. H.R.1492/S.832, EPIC Act, equalizes the negotation period between small-molecule and biologic candidates under the Drig Price Negotiation laws H.R.946, ORPHAN CURES Act

Client expense: $880,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues around drug pricing. Public Law 119-21: One Big Beautiful Bill Act, as it relates to H.R.946 - Orphan Cures Act.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES

Discussions regarding H.R.946, the ORPHAN Cures Act Discussions related to H.R.2319, the Women and Lung Cancer Research and Preventative Services Act Discussions regarding H.R.4299,the Protecting Patient Access to Cancer and Complex Therapies Act Issues related to most-favored-nation and other foreign reference drug pricing policy Issues related to the Food and Drug Administration Issues regarding 340B program Issues related to utilization management of medications

Client expense: $370,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 946 and S. 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act); related provisions in H.R.1, One Big Beautiful Bill Act; Most Favored Nation and international reference pricing proposals

Client expense: $100,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to rare disease and orphan drugs. Policies related to international reference pricing for pharmaceuticals. Pharmaceutical supply chain manufacturing. Pharmaceutical pricing negotiations. H.R.3521/S.4440: Clinical Trials Modernization Act. H.R.5509/S.2903: Safe Step Act. H.R.946/S.1862: Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act.

Client expense: Not reported · Firm income: $80,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Direct to Consumer Advertising. 340B Drug Discount Program - Program Implementation & Oversight. Accelerated Approval. Breast Cancer Research. Supply Chain Integrity and Traceability. PBM Reform. Coverage of Accelerated Approval Products. Drug Benefit Design. Orphan Drug Issues. S. 1682/H.R.946: ORPHAN Cures Act. Reimbursement and Coverage of Innovative Products. Lower Costs, More Transparency Act. Lower Costs, More Cures Act. Patient Cost-Sharing. Step Therapy. Value-based Contracting and Communications. User fee policy issues. Pharmacy Benefit Manager reform and policy issues. Drug cost and pricing policy issues. Drug importation policy issues. Competition policy issues. Drug shortages policy issues. IRA price negotiation expansion policy issues. Rare Pediatric Disease Priority Review Voucher program policies. SUSTAIN RFI/discussion draft. Most Favored Nation (MFN) policy. Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients. Utilization management policies.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

P.L.119-21 (H.R. 1): One Big Beautiful Bill Act. H.R.946: Orphan CURES Act. S.864: HELP Copays Act; all provisions. S.1862: Orphan CURES Act; all provisions. Executive Order 14216: Expanding Access to In Vitro Fertilization. Executive Order 14297: Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. Pharmacy Benefit Manager (PBM) policy issues. Healthcare supply chain policy issues. Drug pricing. General discussions related to caregiving support and awareness policy issues. Biopharmaceutical innovation.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pediatric Review Reauthorization. H.R.946/S.1862: ORPHAN Cures Act. H.R.1672: Maintaining Investments in New Innovation (MINI) Act. H.R.1262/S.932: Give Kids a Chance Act of 2025.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General Medicare and Medicaid Issues. H.R.1672: Maintaining Investments in New Innovation (MINI) Act. H.R.946/S.1862: ORPHAN Cures Act. Pediatric Review Reauthorization.

Client expense: Not reported · Firm income: $50,000

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues pertaining to the implementation of the Inflation Reduction Act of 2022 - H.R. 6166, Lowering Drug Costs for American Families Act Issues pertaining to CMS Coverage of APS in LTC Issues pertaining to Medicares Six Protected Classes policy Medicare Part D Smoothing Benefit - FY 2026 and FY2027 Labor-HHS Appropriations Orphan drug exclusion in the Inflation Reduction Act - H.R. 946 & S. 1862, ORPHAN Cures Act Small molecule discrepancy in the Inflation Reduction Act - H.R. 1492 & S. 832, The EPIC Act Issues pertaining to the Most Favored Nation drug price setting policy - H.R. 7837, Most Favored Patient Act of 2026 Issues pertaining to migraine screening for women in Medicare - FY 2026 and FY2027 Labor-HHS Appropriations Issues pertaining to prior authorization - HR 3514, Improving Seniors Timely Access to Care Act

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 119-21 (H.R. 1): One Big Beautiful Bill Act; provisions related to Title VII, Subtitle B H.R. 946: Orphan CURES Act; all provisions H.R. 2214: DRUG Act; all provisions H.R. 4317: PBM Reform Act of 2025; all provisions H.R. 6703: Lower Health Care Premiums for All Americans Act; provisions related to Pharmacy Benefit Management (PBM) S. 864: HELP Copays Act; all provisions S. 882: Patients Before Middlemen Act; all provisions S. 891: Bipartisan Health Care Act; provisions related to Titles I, II, VIII, and IX S. 1862: Orphan CURES Act; all provisions S. 3345: PBM Price Transparency and Accountability Act; all provisions Executive Order: Expanding Access to In Vitro Fertilization; all provisions of the order Executive Order: Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients; all provisions of the order General discussions related to Pharmacy Benefit Manager (PBM) policy issues General discussions related to Healthcare supply chain policy issues General discussions related to Drug cost and pricing policy issues General discussions related to caregiving support and awareness policy issues

Client expense: $700,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Most-Favored Nation and International Reference Pricing proposals. PDUFA/regulatory review process.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. Legislation regarding newborn screening. H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Support of reauthorization of priority review voucher program. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to drug cost and pricing policy, no current bill. Pharmacy Benefit Manager legislation related to patient access to therapies. H.R.4317, PBM Reform Act of 2025 S.3345, PBM Price Transparency and Accountability Act H.R.6837, to amend the Emloyee Retirement Income Security Act of 1974 to ensure PBMs are considered fiduciaries Education and discussions regarding pharmaceutical issues related to supply chain, no specific bill. H.R.1492/S.832, EPIC Act, equalizes the negotation period between small-molecule and biologic candidates under the Drig Price Negotiation laws H.R.946, ORPHAN CURES Act

Client expense: $1,060,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Draft, the Expedited Access to Biosimilars Act (no bill number) - Rep. Langworthy, Nick - Biosimilar approval requirements 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 H.R. 5526 - Biosimilar Red Tape Elimination Act - Rep. Pfluger, Austin - Biosimilars approval procedures H.R. 6255 - Affordable Insulin Now Act - Rep. Craig, Angie - require cost-sharing for certain insulin products H.R. 7837 - Most Favored Patient Act - Rep. Meuser, Daniel - MFN demonstration H.R. 8779 - PBM Act - Rep. Harshbarger, Diana - PBM ownership requirements 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 Manager Transparency Act of 2025 - 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 S. 2658 - Medication Affordability and Patient Integrity Act - Sen. Hassan, Margaret - FDA and USPTO coordination S. 3014 - Ensuring Timely Access to Generics Act - Sen. Shaheen, Jeanne - Generic drug approval S. 4332 - Medication Competition Act - Sen. Hassan, Maggie - Pharmaceutical exclusivity periods S. 4355 - Drug Deal Disclosure Act - Sen. Wyden, Ron - Federal MFN agreement transparency S. 4509 - PBM Act - Sen. Warren, Elizabeth - PBM ownership requirements Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; cost-sharing and coverage of weight loss drugs/GLP-1s; high priced drugs; patent reforms; generic approval; Pharmacy Benefit Managers; PBM-related issues; step therapy; copay caps; insulin costs; and copay coupons.

Client expense: $3,010,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare and Medicaid Issues. H.R.1672 - Maintaining Investments in New Innovation Act. H.R.946 - ORPHAN Cures Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA regulation of CBD FDA Rare Disease PPRV program/reauthorization Issues related to the regulation of cannabis and CBD, research and development of cannabis-derived therapies Most Favored Nation drug pricing Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act HR 946: Orphan Cures Act Legislation Related to the Repeal or Reform of Orphan Cures Section 232 Tariffs

Client expense: $490,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

- H.R. 1539, Medical Device Electronic Labeling Act, regarding all provisions - H.R. 929/S. 266, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, regarding all provisions - H.R. 946 ORPHAN Cures Act, regarding all provisions - S.864, HELP Copays Act, regarding all provisions - H.R. 2214, Delinking Revenue from Unfair Gouging (DRUG) Act, regarding all provisions - H.R. 1492/S. 832, Ensuring Pathways to Innovative Cures (EPIC) Act - S. 1954/ H.R. 5526 Biosimilar Red Tape Elimination Act, regarding all provisions - H.R.2527, Early Detection of Vision Impairments for Children Act of 2025, regarding all provisions - PL117-169 The Inflation Reduction Act, regarding all provisions related to drug pricing and implementation - H.R.5343/S. 1717, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, regarding all provisions - H.R.4282, Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 4299, Protecting Patient Access to Cancer and Complex Therapies Act, regarding all provisions - S.1399 / H.R. 6197, the Health Tech Investment Act, regarding all provisions - H.R. 3521, the Clinical Trial Modernization Act, regarding all provisions - H.R. 3006 / S.1776, the Medicare Beneficiary Co-Pay Fairness Act, regarding all provisions - H.R. 3514, the Improving Seniors Timely Access to Care Act of 2025, regarding all provisions - H.R. 6549, the VA Contracting and Procurement Act, regarding all provisions - H.R. 5509 / S. 2903, Safe Step Act, regarding all provisions - H.R. 5256, 340B ACCESS Act, regarding all provisions - H.R. 7391, Community Health Center Drug Pricing Protection Act, regarding all provisions Issues related to - direct to consumer advertising - clinical trial modernization - biosimilars - cardiovascular health - 340B and 340B Rebate Pilot - Heart Recovery Awareness Day & H.Res. 1301, designating February 20th Heart Recovery Awareness Day - obesity treatments - MFN - Foreign Reference Pricing - CMS Outpatient Prospective Payment System rule - peripheral artery disease (PAD) - PBM and Insurer Reforms

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Issues related to Medicaid Drug Rebate program rule. Public Law 119-21: One Big Beautiful Bill Act, as it relates to H.R.946 - ORPHAN Cures Act. Issues related to drug pricing.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES

Transitional coverage for innovative medical devices (Ensuring Patient Access to Critical Breakthrough Products Act). Public Law 119-21: One Big Beautiful Bill Act, as it relates to H.R.946 - Orphan Cures Act. Implementation of the Inflation Reduction Act. Education around NIH funding Issues around drug pricing.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES

Issues around drug pricing. Public Law 119-21: One Big Beautiful Bill Act, as it relates to H.R.946 - Orphan Cures Act. Education about 340b program.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Education about chronic kidney disease and Medicare screening guidelines Issues related to Medicare Part D redesign Issues related to prescription drug pricing and value Issues regarding implementation of the Inflation Reduction Act, including H.R. 1492/S.832 - EPIC Act of 2025; H.R. 946/S. 1862, the Optimizing Research Progress Hope and New (ORPHAN) Cures Act Issues related to the Treat and Reduce Obesity Act The Access to Prescription Digital Therapeutic Act Issues related to Most Favored Nation Proposals Education about cancer and Medicare screening coverage, including H.R. 842/S. 339, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

Client expense: $710,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Issues related to Most Favored Nation (MFN) drug pricing proposal; Issues related to implementation of the Inflation Reduction Act of 2022; Issues related to Senate Finance Dear Colleague process; H.R. 946/S. 1862, ORPHAN Cures Act

Client expense: Not reported · Firm income: $50,000

H.R. 946 / S. 1862, Orphan Cures Act implementation H. Res. 1331, Expressing support for "Hidradenitis Suppurativa Awareness Week" S. 2658, Medication Affordability and Patent Integrity Act Issues related to Medicaid rebates Issues related to implementation of the Inflation Reduction Act Issues related to the 340B Drug Pricing Program Issues related to drug cost and pricing Education around access to innovative therapies in dermatology

Client expense: $750,000 · Firm income: Not reported

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

Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027

Client expense: $1,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act

Client expense: $610,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo FDA modernization policy Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) BIOSECURE Act implementation Issues related to the Medicare title in the One Big Beautiful Bill Act Issues related to the IRA definition of a drug for purposes of price negotiation selection Duplicate discounts as required by IRA Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues related to 340B Rebate Model Pilot Program for IRA compliance Issues related to the US manufacturing of pharmaceuticals Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals

Client expense: $1,680,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

SB 864 - HELP Copays Act HR 946 - Orphan Cures Act SB 832/ HR 1492 - EPIC Act HR 1520 - Charlotte Woodward Organ Transplant Discrimination Prevention Act HR 3514 - Improving Seniors Timely Access to Care Act of 2025 SB 2426 - Equitable Community Access to Pharmacist Services Act H.R. 3826/ S.B. 1925 - Expanding Access to Diabetes Self-Management Training Act of 2025 SB 1140 - Health ACCESS Act Health Accelerating Consumers Care by Expediting Self-Scheduling Act H.R. 5256 - 340B ACCESS Act 340B Affording Care for Communities and Ensuring a Strong Safety-net Act SB 1973 - Treat and Reduce Obesity Act of 2025 SB 2761/ H.R. 5269 - Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act. SB 932 - Give Kids a Chance Act of 2025 SB 339- Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act H.R. 4317- PBM Reform Act of 2025 Pharmacy Benefit Manager Reform Act of 2025 H.R. 1244 - Reducing Drug Prices for Seniors Act H.R. 8270 - Every Dollar Counts Acr of 2026 H.R. 9599 - SECURE 340B Act

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of the Inflation Reduction Act, P.L. 117-169, including potential changes to the structure of and reimbursement for Medicare Part D. H.R. 946 - Orphan Cures Act H.R. 1492 / S. 832 - Ensuring Pathways to Innovative Cures (EPIC) Act Issues related to drug pricing

Client expense: $940,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

HR 946 and S. 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act); related provisions in H.R.1, One Big Beautiful Bill Act; Most Favored Nation and international reference pricing proposals

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussions regarding H.R.946, the ORPHAN Cures Act Discussions related to H.R.2319, the Women and Lung Cancer Research and Preventative Services Act Discussions related to the Protecting Patient Access to Cancer and Complex Therapies Act reintroduction Issues related to most-favored-nation and other foreign reference drug pricing policy Issues related to the Food and Drug Administration Issues regarding 340B program

Client expense: $380,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act; Issues related to H.R. 1672 - Maintaining Investments in New Innovation Act; Issues related to Medicare and Medicaid drug pricing.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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. 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 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. 3521: Clinical Trial Modernization Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act HR 5509, Safe Step Act, Provisions related step therapy protocols 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. 7391, the Community Health Center Drug Pricing Protection Act H.R. 7953: FAIR ACT H.R. 8269: CLEAR LABELS 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 (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 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 S. 891, Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S.4784, An original bill to authorize appropriations for fiscal year 2027 for military activities of the Department of Defense, for military construction, and for defense activities of the Department of Energy, to prescribe military personnel strengths for such fiscal year, and for other purposes, Provisions related to the pharmaceutical industry. Smucker's VICP bill Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Vaccine policy issues

Client expense: $890,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

Issues pertaining to the implementation of the Inflation Reduction Act of 2022 - H.R. 6166, Lowering Drug Costs for American Families Act Issues pertaining to CMS Coverage of APS in LTC Issues pertaining to Medicares Six Protected Classes policy Medicare Part D Smoothing Benefit - FY 2026 and FY2027 Labor-HHS Appropriations Orphan drug exclusion in the Inflation Reduction Act - H.R. 946 & S. 1862, ORPHAN Cures Act Small molecule discrepancy in the Inflation Reduction Act - H.R. 1492 & S. 832, The EPIC Act Issues pertaining to the Most Favored Nation drug price setting policy - H.R. 7837, Most Favored Patient Act of 2026 Issues pertaining to migraine screening for women in Medicare - FY 2026 and FY2027 Labor-HHS Appropriations Issues pertaining to prior authorization - HR 3514, Improving Seniors Timely Access to Care Act

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE