CLEAR LABELS Act

Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.

Client expense: Not reported · Firm income: $340,000

Monitor and engage on legislative and administrative action related to health care policy. Monitor and engage on legislative and administrative action related to womens health issues. Monitor and engage on legislative and administrative action related to regulation of over-the-counter medicines. Monitor and engage on legislative and administrative action related to dietary supplements, including FDA regulation of ingredients. Monitor and engage on legislative and administrative action related to servicing of medical device equipment. Monitor and engage on legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor and engage on legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor and engage on legislative and administrative action related to 340B drug discount program. Monitor and engage on legislative and administrative action related to drug supply chain issues, including pharmacy benefit manager (PBM) reform. Monitor and engage on legislative and administrative action related to copay assistance. Monitor and engage on legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor and engage on legislative and administrative action related to access to treatments for kidney disease patients. Monitor and engage on legislative and administrative action related to Make America Healthy Again (MAHA). Monitor and engage on legislative and administrative action related to generally recognized as safe (GRAS) rules for food additives. Monitor and engage on legislative and administrative action related to FDA regulation of cell and gene therapies. Monitor and engage on legislative and administrative action related to Parkinsons disease. Monitor and engage on legislative and administrative action related to federal investment in biotech development and manufacturing. H.R. 5509, Safe Step Act. H.R. 6118, Support and Defend Our Military Personnel and Their Families Act. H.R. 7366, Dietary Supplement Regulatory Uniformity Act. H.R. 8933, Dietary Supplements Access Act. H.R. 9090, Advancing Menopause Care and Mid-Life Womens Health Act. S. 2903, Safe Step Act. S. 3122, Better Food Disclosure Act of 2025. S. 3677, Dietary Supplement Listing Act of 2026. S. 3788, CLEAR Labels Act. S. 4503, Advancing Menopause Care and Mid-Life Womens Health Act. S. 4587, Dietary Supplements Access Act. S. 5260, Stroke Act.

Client expense: $1,710,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

H.R. 2484 Seniors Access to Critical Medications Act H.R. 2853 Combating Organized Retail Crime Act H.R. 3164 Ensuring Community Access to Pharmacist Services Act H.R. 4317 PBM Reform Act S. 526 Pharmacy Benefit Manager (PBM) Transparency Act S. 527 Prescription Pricing for the People Act S. 882 Patients Before Middlemen (PBM) Act S. 927 Protecting Pharmacies in Medicaid Act S. 1404 Combating Organized Retail Crime Act S. 2426 Equitable Community Access to Pharmacist Services Act S. 3345 PBM Price Transparency and Accountability Act H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act H.R. 6575 CommonGround for Affordable Health Care Act H.R. 6501 Bipartisan Health Insurance Affordability Act H.R. 5256 340B ACCESS Act H.R. 4581 340B PATIENTS Act S. 2372 340B PATIENTS Act H.R. 6400 Rx ACCESS Act S. 4106 Rx ACCESS Act S. 3788 CLEAR LABELS Act S. 4509 Patients Before Monopolies Act H.R. 8779 Patients Before Monopolies Act S. 3822 Break Up Big Medicine Act H.R. 8800 National Defense Authorization Act S. 4784 National Defense Authorization Act S. 3097 Health Information Privacy Reform Act

Client expense: $480,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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 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

Paper industry issues; General business issues; H.R.8646 - FY 2027 Agriculture; Rural Development FDA and Related Agencies Appropriations Act, 2027; S.3788 - CLEAR LABELS Act.

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

Government targets: SENATE

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 5316, the Drug Shortage Compounding Patient Access Act of 2025; S. 3794 / H.R. 6509, The Safe Drugs Act; S. 3788/ H.R. 8269 The Clear Labels Act

Client expense: $190,000 · Firm income: Not reported

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

Issues related to implementation of the OTC Drug Monograph User Fee Program reauthorization and non-prescription drug status, including Section 304 of H.R. 9393; issues related to consumer health care products supply chain; related FY27 appropriations report language, including Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646) and Financial Services and General Government Appropriations Act, 2027 (H.R. 8495); State of Men's Health Act (H.R. 7602, S. 5113); GRAS reform; CLEAR LABELS Act (S. 3788, H.R. 8269).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biosimilars; Generic drugs; Issues around country of origin labeling; Supply Chain; S.2658 - Medication Affordability and Patent Integrity Act; S.3014 - Ensuring Timely Access to Generics Act; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act; S.43 - Skinny Labels, Big Savings Act; Tariffs; General Business Issues.

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

Government targets: SENATE

H.R.3164, Ensuring Community Access to Pharmacist Services Act, Entirety PBM Reform related issues Public Law 119-75, Consolidated Appropriations Act, 2026, Division B - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026, Implementation of PBM Reform S.882, Patients Before Middlemen Act, Entirety S.3788, CLEAR LABELS Act, Entirety

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.

Client expense: $770,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR), White House Office

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.

Client expense: $770,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, White House Office

S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act, 2026 S.2491 - SAFE Sunscreen Standards Act H.R.6868 - ACCESS Through OTC Innovation Act S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches (SMART OTC Act) H.R.6868 - To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to apply the least burdensome appropriate means for supporting certain administrative order requests with respect to over-the-counter monograph drugs, and for other purposes. S.3122 - Better FDA Act of 2025 H.R.7366 - Dietary Supplement Regulatory Uniformity Act S.3788 - CLEAR LABELS Act - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule H.R. 10336 - Dietary Supplement Innovation Act

Client expense: Not reported · Firm income: $146,407

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

Work on drug shortage issues affecting outpatient and inpatient settings. Also work on drug visibility supply chain issues including S. 3788, "the CLEAR Labels Act."

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (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.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---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 Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies 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.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures 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 ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) 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 ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Client expense: $2,360,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, White House Office

General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.

Client expense: $870,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.

Client expense: $870,000 · Firm income: Not reported

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

Monitor and engage on legislative and administrative action related to health care policy. Monitor and engage on legislative and administrative action related to womens health issues. Monitor and engage on legislative and administrative action related to regulation of over-the-counter medicines. Monitor and engage on legislative and administrative action related to dietary supplements, including FDA regulation of ingredients. Monitor and engage on legislative and administrative action related to servicing of medical device equipment. Monitor and engage on legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor and engage on legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor and engage on legislative and administrative action related to 340B drug discount program. Monitor and engage on legislative and administrative action related to drug supply chain issues, including pharmacy benefit manager (PBM) reform. Monitor and engage on legislative and administrative action related to copay assistance. Monitor and engage on legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor and engage on legislative and administrative action related to access to treatments for kidney patients. Monitor and engage on legislative and administrative action related to Make America Healthy Again (MAHA). Monitor and engage on legislative and administrative action related to generally recognized as safe (GRAS) rules for food additives. Monitor and engage on legislative and administrative action related to FDA regulation of cell and gene therapies. Monitor and engage on legislative and administrative action related to Parkinsons disease. Monitor and engage on legislative and administrative action related to federal investment in biotech development and manufacturing. H.R. 6118, Support and Defend Our Military Personnel and Their Families Act. H.R. 7366, Dietary Supplement Regulatory Uniformity Act. S. 3677, Dietary Supplement Listing Act of 2026. S. 3788, CLEAR Labels Act.

Client expense: $1,820,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

Issues related to pharmacy benefit management. Issues related to cardiovascular care. Issues related to drug pricing. Issues related to the drug supply chain. S. 3788, Clear Labels Act. S. 3014, Ensuring Timely Access to Generics Act of 2025; S. 1954, Biosimilar Red Tape Elimination Act; S. 2658, Medication Affordability and Patent Integrity Act.

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

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

S. 1784 - Mapping America's Pharmaceutical Supply (MAPS) Act; H.R. 4191: Provisions regarding supply chain security and resilience and drug shortages. S. 3788 - Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act (CLEAR LABELS) Act: Provisions regarding drug labeling.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1784, H.R. 4191 - Mapping America's Pharmaceutical Supply (MAPS) Act - Provisions regarding supply chain security and resilience and drug shortages. S. 3788 - Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act (CLEAR LABELS) Act: Provisions regarding drug labeling. Issues related to strengthening the resiliency of the U.S. medical supply chain.

Client expense: $120,000 · Firm income: Not reported

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

H.R. 4581 / S.2372, 340B PATIENTS Act, all provisions; H.R. 3178 / S. 1600, The Save Healthcare Workers Act, all provisions; H.R. 929 / S. 266, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions; H.R. 1585 / S. 709, Conrad State 30 and Physician Access Reauthorization Act, all provisions; S. 1874, Title VIII Nursing Workforce Reauthorization Act, all provisions; S. 2169, Rural Hospital Cybersecurity Enhancement Act, all provisions; H.R. 5283 / S. 2759, Healthcare Workforce Resilience Act, all provisions; S. 3315, Health Care Cybersecurity and Resiliency Act of 2025, all provisions; H.R. 5256, 340B Access Act, all provisions; S. 2355 / H.R. 5582, Patients Deserve Price Tags Act, all provisions; H.R. 7961, Physicians and the Healthcare Workforce Act, all provisions; S. 3435 / H.R. 6607, The Future Advancement of Academic Nursing, all provisions; S. 4637, Physician Workforce Optimization Act, all provisions; S.3788 / H.R. 8269, Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act, all provisions; DRAFT, Issues pertaining to post-market surveillance of devices; S.Res.230, A resolution supporting the goals and ideals of National Hospital Week, to be observed from May 11 through May 17, 2025, all provisions; DRAFT, Issues pertaining to medical debt; S. 4568 / H.R. 8691, Nursing is a Professional Degree Act, all provisions; S.J. Res 196, A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Education relating to "Reimagining and Improving Student Education-Federal Student Loan Program Final Regulations", all provisions; H.R. 6718, Professional Student Degree Act, all provisions; DRAFT, Lower Costs More Transparency Act of 2026, all provisions; DRAFT, To amend title XXVII of the Public Health Service Act to require hospitals to post prices on the walls, all provisions; DRAFT, To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to ensure health insurer accountability through publishing of overhead costs and claim payments, all provisions; DRAFT, To amend title XVIII of the Social Security Act and title XXVII of the Public Health Service Act to require the displaying of claim denial rates, all provisions; DRAFT, To amend title XI of the Social Security Act to require mandatory reporting with respect to certain health-related ownership information, all provisions; S. 1482, National Nursing Workforce Center, all provisions; S. 4027, Healthy Competition for Better Care Act, all provisions; H.R. 5629, To provide that the final rule of the Department of Health and Human Services titled Medications for the Treatment of Opioid Use Disorder, except for the portion of the final rule relating to accreditation of opioid treatment programs, shall have no force or effect; all provisions; H.R. 8726, the Protecting Authority and Restoring Tools Necessary for Enforcement by Regulatory States Act of 2026 PARTNERS Act, all provisions; S.3364, Fast Track Healthcare Apprenticeships Act, all provisions; S.4252, WIPP Economic Assistance Assurance Act of 2026, all provisions; H.R. 4470, Removing Burdens From Organ Donation Act, all provisions; U.S. Department of Health & Human Services / Office of the National Coordinator for Health Information Technology, Issue pertaining to standardized set of data elements intended to support nationwide, interoperable electronic data exchange to help ensure consistent health information exchange throughout a patient's health care journey; Health Resources & Services Administration (HRSA), Issue pertaining a revised version of a 340B rebate model pilot program; Health Resources & Services Administration (HRSA), Issue pertaining to Eli Lilly 340B program decisions; Federal Trade Commission & Department of Justice, Issues pertaining to the effectiveness of the Hart-Scott-Rodino (HSR) premerger notification form and implications for hospital field; Enhanced Premium Tax Credits, Extension of Enhanced Premium Tax Credits; Rural Health Care Access, Issues to protect access to rural health care; 340B Program, Issues pertaining to protecting 340B Program, including 340B Rebate Model Pilot Program; Maternal and Child Health, Access to maternal and child health care and addressing related workforce shortages, conditions of participation (COP); Behavioral Health, Issues related to expanding access to care and reducing regulatory barriers; Workforce, Issues pertaining to workforce development programs, supporting health care workforce and physician shortages, loan repayment programs for providers in rural and underserved areas, Graduate Medical Education program; Health Plan Accountability, Issues specific to prior authorization, patient access to care, adequate provider networks, inappropriate denials, reducing account receivables, prompt pay, white-bagging and brown-bagging policies; Health Care Resiliency & Preparedness, Issues pertaining to natural disasters, strengthen health care cybersecurity, cybersecurity workforce, and securing drug supply chains, hospital preparedness program, PAHPA reauthorization; Healthcare Price Transparency, Issues related to health care price transparency; Affordability, Issues and policy solutions pertaining to health care affordability and rising costs of health care; Tax-exempt status, Issues pertaining to not-for-profit hospitals' tax exempt status and tax-exempt private activity bonds; Immigration, Proposed H1-B Visa Program changes and impact to health care workforce; AI in Healthcare, Issues pertaining to the use of AI in healthcare; Professional Degree Program Changes, Issues pertaining to new student loan borrowing limits and professional degree programs changes; Drug Prices, Issues pertaining to lowering drug prices, securing drug supply chain, and transparency; Rural Health Transformation Fund, Issues pertaining to implementation of the Rural Health Transformation program.

Client expense: $4,470,000 · Firm income: Not reported

Government targets: Education, Dept of, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Justice, Dept of (DOJ), SENATE

H.R. 2484 Seniors Access to Critical Medications Act H.R. 2853 Combating Organized Retail Crime Act H.R. 3164 Ensuring Community Access to Pharmacist Services Act H.R. 4317 PBM Reform Act S. 526 Pharmacy Benefit Manager (PBM) Transparency Act S. 527 Prescription Pricing for the People Act S. 882 Patients Before Middlemen (PBM) Act S. 927 Protecting Pharmacies in Medicaid Act S. 1404 Combating Organized Retail Crime Act S. 2426 Equitable Community Access to Pharmacist Services Act S. 3345 PBM Price Transparency and Accountability Act H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act H.R. 6575 CommonGround for Affordable Health Care Act H.R. 6501 Bipartisan Health Insurance Affordability Act H.R. 5256 340B ACCESS Act H.R. 4581 340B PATIENTS Act S. 2372 340B PATIENTS Act H.R. 6400 Rx ACCESS Act S. 4106 Rx ACCESS Act S. 3788 CLEAR LABELS Act S. 4509 Patients Before Monopolies Act H.R. 8779 Patients Before Monopolies Act S. 3822 Break Up Big Medicine Act H.R. 8800 National Defense Authorization Act S. 4784 National Defense Authorization Act

Client expense: $290,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 5316, the Drug Shortage Compounding Patient Access Act of 2025; S. 3794 / H.R. 6509, The Safe Drugs Act; S. 3788/ H.R. 8269 The Clear Labels Act

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

Government targets: Food & Drug Administration (FDA), 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

H.R.7410 - American Made Medicine Act; Drug shortages; Generic drugs; Issues around country of origin labeling; S.4327 - Securing America's Drug Supply from Communist China Act; S.2658 - Medication Affordability and Patent Integrity Act; S.3014 - Ensuring Timely Access to Generics Act; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act; S.4784 - Fiscal Year 2027 National Defense Authorization Act; Supply chain.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2214, the Delinking Revenue from Unfair Gouging Act; H.R. 1968, the Full-Year Continuing Appropriations and Extensions Act, 2025; H.Con.Res 14/S. Con. Res. 7, Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034; H.R. 1, the One Big Beautiful Bill; Comments to FDA on "Re: Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances [Docket No. FDA-2025-N-0082]"; LHHS Report Language Request to Improve the Care and Treatment of Long-Term Care Residents with Neuropsychiatric Symptoms; Comments to OMB on "Re: Request for Information: Deregulation"; Comments to HHS/DOGE on government efficiency, fraud, waste and PBMs; Comments on "Executive Order 14297 of May 12, 2025 - Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients"; Comments to CDC on "RE: June 25-26 Advisory Committee on Immunization Practices Meeting"; H.R.5316, the Drug Shortage Compounding and Patient Access Act; H.R.5256, the 340B ACCESS Act; Comments to FDA on "RE: Docket No. FDA-2025-N-2589, Comments on the Risks and Benefits of Menopause Hormone Therapy"; H.Res. 805, Recognizing October 2025 as American Pharmacists Month in honor of the contribution of pharmacists to provide safe, accessible, affordable, and beneficial patient care services and products to all residents and protect the public health of our communities; S.3345, the PBM Price Transparency and Accountability Act; H.R. 6609, Pharmacists Fight Back in Medicare and Medicaid Act; H.R. 6610, Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act]; H.R. 6703, the Lower Health Care Premiums for All Americans Act; H.R.5133, the Patient's Right to Know Their Medication Act; H.R. 4409, the Fair Pharmacies for Federal Employees Act; S.3549/H.R.6837, the Fiduciary Accountability, Integrity and Reform (FAIR) Act; H.R.7148, the Consolidated Appropriations Act of 2026; Rural Health Transformation Program; Creation and Implementation of TrumpRx; Comments to FDA on RFI, "Re: Increasing Access to Nonprescription Drugs; Request for Information"; S.3822, Break up Big Medicine Act; Comments to FDA on RFT, "Re: [Docket No. FDA-2025-N-6743] - Scientific and Clinical Considerations for Testosterone Replacement Therapy (TRT) in Men with Hypogonadism"; Comments to DoL, HHS, and DoT regarding "Re: Transparency in Coverage Proposed Rule [CMS-9882-P]"; Pharmacy Shortage Areas in reference to USC-NCPA joint project Mapping Tool; H.R. 7895, the PBM Kickback Prohibition Act; Comments to FDA on their comment request "Re: Agency Information Collection Activities; Proposed Collection; Comment Request; Medication Guides for Prescription Drug Products [FDA-2025-N-6869]"; H.R.6509/S.3794, the SAFE Drug Act; H.R.5316, the Drug Shortage Compounding Patient Access Act; H.R.8779/S.4509, the Patients Before Monopolies Act; S.3788/H.R.8269, the CLEAR LABELS Act; S.1941, the Cure Hepatitis C Act of 2025;

Client expense: $270,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT)

H.R.3164, Ensuring Community Access to Pharmacist Services Act, Entirety PBM Reform related issues Public Law 119-75, Consolidated Appropriations Act, 2026, Division B - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026, Implementation of PBM Reform S.882, Patients Before Middlemen Act, Entirety S.3788, CLEAR LABELS Act, Entirety

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

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

S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act, 2026 S.2491 - SAFE Sunscreen Standards Act S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches (SMART OTC Act) H.R.6868 - To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to apply the least burdensome appropriate means for supporting certain administrative order requests with respect to over-the-counter monograph drugs, and for other purposes. S.3122 - Better FDA Act of 2025 H.R.7366 - Dietary Supplement Regulatory Uniformity Act S.3788 - CLEAR LABELS Act - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule - Dietary Supplement Drug Preclusion - legislation intended to clarify ingredients that can be used in dietary supplements.

Client expense: Not reported · Firm income: $199,750

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

Work on drug shortage issues affecting outpatient and inpatient settings. Also work on drug visibility supply chain issues including S. 3788, "the CLEAR Labels Act."

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1784 - Mapping America's Pharmaceutical Supply (MAPS) Act; H.R. 4191: Provisions regarding supply chain security and resilience and drug shortages. S. 3788 - Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act (CLEAR LABELS) Act: Provisions regarding drug labeling.

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.

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

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062: RAPID Reserve Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmacy benefit management. Issues related to cardiovascular care. Issues related to drug pricing. Issues related to the drug supply chain. S. 3788, Clear Labels Act.

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

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

Biosimilars Access and Affordability Act (S. 5459); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276/H.R. 3269); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); CLEAR Act (H.R.7140); Artificial Intelligence-Ready Data Act (S.4098); Preserve Access to Affordable Generics and Biosimilars Act (S. 1096); Drug Competition Enhancement Act (S.1040); America's Living Library Project Bill (S. 4023); Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); improvements to the National Childhood Vaccine Injury Act of 1986; Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act (S. 3788).

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

Government targets: SENATE

H.R. 4581 / S.2372, 340B PATIENTS Act, all provisions; H.R. 3178 / S. 1600, The Save Healthcare Workers Act, all provisions; H.R. 929 / S. 266, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions; H.R. 1585 / S. 709, Conrad State 30 and Physician Access Reauthorization Act, all provisions; S. 1874, Title VIII Nursing Workforce Reauthorization Act, all provisions; S. 2169, Rural, Hospital Cybersecurity Enhancement Act, all provisions; H.R. 5283 / S. 2759, Healthcare Workforce Resilience Act, all provisions; S. 3315, Health Care Cybersecurity and Resiliency Act of 2025, all provisions; H.R. 5256, 340B Access Act, all provisions; S. 1929, SEPSIS Act, all provisions; S. 2355 / H.R. 5582, Patients Deserve Price Tags Act, all provisions; H.R. 7961, Physicians and the Healthcare Workforce Act, all provisions; S. 3435 / H.R. 6607, The Future Advancement of Academic Nursing, all provisions; H.R. 5428, Medical Student Education Authorization Act of 2025, all provisions; H.R. 7920 / S. 4085, Take Back Our Hospitals Act, all provisions; S. 4208, A bill to establish a demonstration program to provide payments on eligible loans for individuals who are eligible for the National Health Service Corps Loan Repayment Program, all provisions; DRAFT, Conrad 30 Enhancement Bill, all provisions; DRAFT, Rural Maternity Bill, all provisions; S.3788, Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act, all provisions; S.3822, Break Up Big Medicine Act, all provisions; H.R.7727, Sustaining Rural Healthcare Act, all provisions; DRAFT, Preserving Patient Access Act, all provisions; H.R. 5629, Medications for the Treatment of Opioid Use Disorder (OUD), all provisions; S. 4141, Rural Hospital Revitalization Act of 2026, all provisions; H.R. 7478, Patient Debt Relief Act, all provisions; Federal Trade Commission, Issue pertaining to the remarks at the forge Mason Law Review 29th Annual Antitrust Symposium; Department of Health & Human Services / Office of the National Coordinator for Health IT, Issues pertaining to Health Data, Technology and Interoperability; Health Resources and Services Administration (HRSA), Comments pertaining to Eli Lilly and Company policy and impact to 340B hospitals; Health Resources and Services Administration (HRSA), Comments pertaining to Novo Nordisk policy and impact to 340B hospitals; Health Resources and Services Administration (HRSA), Comments pertaining to the request for information on a new 340B rebate model program; Department of Health & Human Services / Office of the National Coordinator for Health IT, Issues pertaining to diagnostic imaging interoperability; U.S. Department of Education, Issues pertaining to proposed rule implementing borrowing limits for federal student loans and impact on health care workforce; U.S. Department of Health & Human Services (HHS), Issues pertaining to accelerating the adoption and use of AI as part of clinical care; Enhanced Premium Tax Credits, Extension of Enhanced Premium Tax Credits; Rural Health Care Access, Issues to protect access to rural health care; 340B Program, Issues pertaining to protecting 340B Program, including 340B Rebate Model Pilot Program; Maternal and Child Health, Access to maternal and child health care and addressing related workforce shortages, conditions of participation (COP); Behavioral Health, Issues related to expanding access to care and reducing regulatory barriers; Workforce, Issues pertaining to workforce development programs, supporting health care workforce and physician shortages, definitions of professional degree programs and borrowing limits, loan repayment programs for providers in rural and underserved areas, Graduate Medical Education program; Health Plan Accountability, Issues specific to prior authorization, patient access to care, adequate provider networks, inappropriate denials, reducing account receivables, prompt pay, white-bagging and brown-bagging policies; Health Care Resiliency & Preparedness, Issues pertaining to natural disasters, strengthen health care cybersecurity, cybersecurity workforce, and securing drug supply chains, hospital preparedness program, PAHPA reauthorization, outstanding FEMA COVID payments to hospitals; Price Transparency, Issues related to hospital price transparency; Affordability, Issues pertaining to the cost of health care; Tax-exempt status, Issues pertaining to not-for-profit hospitals' tax exempt status and tax-exempt private activity bonds; Immigration, Proposed H1-B Visa Program changes and impact to health care workforce; AI in Healthcare, Issues pertaining to the use of AI in healthcare.

Client expense: $6,080,000 · Firm income: Not reported

Government targets: Education, Dept of, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

H.R. 7148 Consolidated Appropriations Act, 2026 H.R. 2484 Seniors Access to Critical Medications Act H.R. 2853 Combating Organized Retail Crime Act H.R. 3164 Ensuring Community Access to Pharmacist Services Act H.R. 4317 PBM Reform Act S. 526 Pharmacy Benefit Manager (PBM) Transparency Act S. 527 Prescription Pricing for the People Act S. 882 Patients Before Middlemen (PBM) Act S. 927 Protecting Pharmacies in Medicaid Act S. 1404 Combating Organized Retail Crime Act S. 2426 Equitable Community Access to Pharmacist Services Act S. 3345 PBM Price Transparency and Accountability Act H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act H.R. 6575 CommonGround for Affordable Health Care Act H.R. 6501 Bipartisan Health Insurance Affordability Act H.R. 5256 340B ACCESS Act H.R. 4581 340B PATIENTS Act S. 2372 340B PATIENTS Act H.R. 6400 Rx ACCESS Act S. 4106 Rx ACCESS Act S. 3788 CLEAR LABELS Act

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 5316, the Drug Shortage Compounding Patient Access Act of 2025; S. 3794 / H.R. 6509, The Safe Drugs Act; S. 3788, The Clear Labels Act

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

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

Supply Chain; Drug Shortages; Generic Drugs; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act;S.3510 - Biosimilar Inspection Modernization Act; API; Issues around Country of Origin labeling.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE