CLEAR LABELS Act

H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues

Client expense: $1,450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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

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

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

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.

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

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;

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