ORPHAN Cures Act

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

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

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

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

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

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

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

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

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: $820,000 · 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

Issues related to implementation of drug pricing and reimbursement for prescription drugs in the Inflation Reduction Act of 2022 (PL 117-169); Issues related to the implementation of the American Relief Act of 2025 (PL 118-158); Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act; Issues related to the One Big Beautiful Bill Act (PL 119-21).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CMMI GENEROUS Demo Medicare Part B ASP compliance 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 direct-to-consumer drug delivery policy options 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 next generation propellant and PFAS Issues related to the US manufacturing of pharmaceuticals Issues related to the price and manufacture of inhaled medicines Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to vaccine access and vaccine R&D Issues related to FDA Orange Book patent listings 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 General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to ACIP recommendations Policies related to international reference pricing for pharmaceuticals Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act HR 6166, the Lowering Drug Costs for American Families Act

Client expense: $2,280,000 · Firm income: Not reported

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

H.R. 946 / S. 1862, Orphan Cures Act implementation H.R. 1262 Give Kids a Chance 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: $480,000 · Firm income: Not reported

Government targets: 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: $1,165,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), 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: $200,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D and Part B Pricing Reform; Issues related to Medicaid Rebates; Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D and Part B Pricing Reform; Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D and Part B Pricing Reform; Issues related to the Medicaid Pricing reform; Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act.

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

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

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 340B Drug Discount Program - H.R. 5256, 340B ACCESS Act; H.R.4581 & S. 2372, 340B PATIENTS Act of 2025 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 Pharmacy Benefit Managers - S.3345, PBM Price Transparency and Accountability Act; H.R.4317, PBM Reform Act of 2025 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

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

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: $610,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), 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: $670,000 · 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

Value of prescription drugs and patient access Issues related to Medicare Parts B & D P.L. 119-21 H.R. 946/S. 1862, ORPHAN Cures Act H.R. 2483, SUPPORT for Patients and Communities Reauthorization Act of 2025/Public Law No: 119-44 Promoting U.S. competitiveness while ensuring U.S. leadership role in developing medicines

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

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: $580,000 · Firm income: Not reported

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

RNA interference scientific advancements and rare diseases; differentiation of genetically-targeted therapies; H.R. 1672, Maintaining Investments in New Innovation Act; H.R. 946/S. 1862, ORPHAN Cures Act; P.L. 119-21; U.S. Competitiveness

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

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 Institutes 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 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---PPRV ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of PAHPA ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.6166: Lowering Drug Costs for American Families 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 (Non-Funding) ---BIOSECURE Act ---House GOP RFI on Supply Chain ---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) ---State Strategic Stockpile Act ---Synthetic Nucleic Acid Synthesis Screening ---VICP Loopholes ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilar Red Tape Elimination Act ---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 Clinical Trial Data in China Data Privacy ---BIOSECURE Act ---Clinical Trial Data in China Drug Evaluation and Review ---FDA Hiring Flexibility ---PDUFA VIII Negotiations ---Promising Pathway Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Contract Manufacturing Ecosystem in the United States ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---A bill to address patent thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biologics Competition Act ---Biosimilar Red Tape Elimination Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---DRUG Act ---Ensuring Access to Generic Medications 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) of 2022 ---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 Drug Pricing Proposals ---National Coverage Determination ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---BIOSECURE Act Generic Drug Entry ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---The Medicaid VBPs for Patients (MVP) Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 National Security ---BIOSECURE Act ---Clinical Trial Data in China ---Most Favored Nation Pricing Opioid Crisis ---SUPPORT Act Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Lower Costs, More Transparency Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Protected Classes ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---Access to Innovative Treatments Act ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---PASTEUR ACT ---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

Client expense: $1,510,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, SENATE, White House Office

FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Pilot Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---Bio COMPETES (Draft) Drug Evaluation and Review ---FDA Hiring Flexibility Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Pricing ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Vaccine Access ---Vaccines for Children Program ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics ---SUPPORT Act Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Program Reauthorization Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---Medicare Part B Physician-Administered Products ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Client expense: $1,510,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE

FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act ---Cameron's Law Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---Expensing of R&D Expenditures ---Tax Incentives for Contract Manufacturing Ecosystem Vaccines and Infectious Disease ---Countermeasure Injury Compensation Fund Amendment Act ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act

Client expense: $1,510,000 · Firm income: Not reported

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

Issues related to drug pricing and implementation of the Inflation Reduction Act. H.R. 946/S. 1862, ORPHAN Cures Act. H.R. 1492, the Ensuring Pathways to Innovative Cures Act. Issues related to pharmacy benefit management reforms. Issues related to Most Favored Nation drug pricing.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, White House Office

H.R. 946/S. 1862, Orphan Cures Act implementation H.R. 1262 Give Kids a Chance Act Issues related to Medicaid rebates Issues related to Medicaid coverage of new drugs 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: $530,000 · Firm income: Not reported

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

Issues related to Medicare Part D and Part B Pricing Reform; Issues related to Medicaid Rebates; Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D and Part B Pricing Reform; Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to the 340B Drug Discount Program - H.R. 5256, 340B ACCESS Act; H.R.4581 & S. 2372, 340B PATIENTS Act of 2025 Issues pertaining to the implementation of the Inflation Reduction Act of 2022 Issues pertaining to Pharmacy Benefit Managers - S.3345, PBM Price Transparency and Accountability Act; H.R.4317, PBM Reform Act of 2025 Issues pertaining to CMS Coverage of APS in LTC Issues pertaining to Medicares Six Protected Classes policy Medicare Part D Smoothing Benefit - FY 2026 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 Issues pertaining to migraine screening for women in Medicare - FY 2026 Labor-HHS Appropriations

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D and Part B Pricing Reform; Issues related to the Medicaid Pricing reform; Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act.

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability 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 use of AI in R&D and manufacturing

Client expense: $670,000 · Firm income: Not reported

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

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