ORPHAN Cures Act

340B: Biologic/Small molecule drug negotiation eligibility within HR 7174/S.832 EPIC Act; CDC Type 1 Diabetes Awareness and Education within LHHS appropriations; Clinical Trial Diversity; Copay Accumulators; COPD Education and Awareness within LHHS appropriations; COPD Research Funding within LHHS appropriations; Delinking; Drug Price Negotiations - General; Drug Price Negotiations within Inflation Reduction Act; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; Issues related to HR 1 One Big Beautiful Bill; HR 830 (118th) HELP Copays Act; HR 2880: Protecting Patients Against PBM Abuses Act; HR 5143 (118th) Vaccines Access Improvement Act; HR 5376: Inflation Reduction Act; HRSA - Type 1 Diabetes Screening within LHHS appropriations; Influenza Vaccines; Insurance Design; Intellectual Property; International Reference Pricing; Most Favored Nation; Orphan Drug Negotiation within HR 5539/S 3131 Orphan Cures Act; Out of Pocket Cap; Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization; Pharmacy Benefit Managers (PBM) Reform; Rare Pediatric Priority Review Voucher Program Reauthorization within HR 7834; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 864 HELP Copays Act: S. 1339 (118th): PBM Reform Act; S. 1375: HELP Copays Act; S. 1542 (118th) DRUG Act; S. 2027: Prescription Information Modernization Act; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $1,100,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Center for Medicare and Medicaid Innovation (CMMI) policy issues. Drug Pricing. General Medicare and Medicaid Issues. Implementation of Inflation Reduction Act of 2022. H.R.1672 - Maintaining Investments in New Innovation Act. S.3131 / H.R.5539 - ORPHAN Cures Act. S.832/H.R.1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025.

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

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

Center for Medicare and Medicaid Innovation (CMMI) policy issues. Drug Pricing. General Medicare and Medicaid Issues. Implementation of Inflation Reduction Act of 2022. H.R.1672 - Maintaining Investments in New Innovation Act. S.3131 / H.R.5539 - ORPHAN Cures Act. S.832/H.R.1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025.

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

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

340B: Biologic/Small molecule drug negotiation eligibility within HR 7174; EPIC Act; CDC Type 1 Diabetes Awareness and Education within LHHS appropriations; Clinical Trial Diversity; Copay Accumulators; COPD Education and Awareness within LHHS appropriations; COPD Research Funding within LHHS appropriations; Delinking; Drug Price Negotiations within Inflation Reduction Act; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; issues related to HR 1 One Big Beautiful Bill; HR 1503: Prescription Information Modernization Act of 2023; HR 2880: Protecting Patients Against PBM Abuses Act; HR 5376: Inflation Reduction Act; HRSA - Type 1 Diabetes Screening within LHHS appropriations; Influenza Vaccines; Insurance Design; Intellectual Property; International Reference Pricing; Most Favored Nation; Orphan Drug Negotiation within HR 5539/S 3131 Orphan Cures Act; Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization; Pharmacy Benefit Managers (PBM) Reform; Rare Pediatric Priority Review Voucher Program Reauthorization within HR 7834; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 864 HELP Copays Act: S. 1339: PBM Reform Act; S. 1375 S. 1542: DRUG Act; S. 2027: Prescription Information Modernization Act; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $1,590,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B: Biologic/Small molecule drug negotiation eligibility within HR 7174; EPIC Act; CDC Type 1 Diabetes Awareness and Education within LHHS appropriations; Clinical Trial Diversity; Copay Accumulators; COPD Education and Awareness within LHHS appropriations; COPD Research Funding within LHHS appropriations; Delinking; Drug Price Negotiations within Inflation Reduction Act; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; issues related to HR 1 One Big Beautiful Bill; HR 1503: Prescription Information Modernization Act of 2023; HR 2880: Protecting Patients Against PBM Abuses Act; HR 5376: Inflation Reduction Act; HR 830: HELP Copays Act; HRSA - Type 1 Diabetes Screening within LHHS appropriations; Influenza Vaccines; Insurance Design; Intellectual Property; International Reference Pricing; Most Favored Nation; Orphan Drug Negotiation within HR 5539/S 3131 Orphan Cures Act; Out of Pocket Cap (OOP); Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization; Pharmacy Benefit Managers (PBM) Reform; Rare Pediatric Priority Review Voucher Program Reauthorization within HR 7834; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 864 HELP Copays Act: S. 1339: PBM Reform Act; S. 1375 S. 1542: DRUG Act; S. 2027: Prescription Information Modernization Act; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $1,050,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Center for Medicare and Medicaid Innovation (CMMI) policy issues. Drug Pricing. General Medicare and Medicaid Issues. Implementation of Inflation Reduction Act of 2022. H.R.1672 - Maintaining Investments in New Innovation Act. S.3131 / H.R.5539 - ORPHAN Cures Act. S.832 - EPIC Act of 2025.

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

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

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions) H.R. 3433, Give Kids a Chance Act of 2024 (generally, no specific provisions) H.R. 7623, Telehealth Modernization Act of 2024 (generally, no specific provisions) S. 2780, Medication Affordability and Patent Integrity Act (generally, no specific provisions) S. 4583, Creating Hope Reauthorization Act of 2024 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to healthcare, including drug pricing and Medicare Part D; Issues related to low-volume Diagnosis Related Groups (DRG); Issues related to orphan drug tax credit; Issues related to rare disease; Issues related to the Inflation Reduction Act of 2022 (PL 117-169); Issues related to H.R 5539/S. 3131 - the ORPHAN Cures Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare and Medicaid Issues. H.R.5547/S.476 - Maintaining Investments in New Innovation (MINI) Act. H.R.5539/S.3131 - ORPHAN Cures Act. Home infusion.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General health issues, including H.R. 5539/S. 3131, Optimizing Research Progress Hope And New Cures (ORPHAN Cures) Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to health care; H.R. 5539/S. 3131, 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), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of the Inflation Reduction Act, P.L. 117-169, including potential changes to the structure of and reimbursement for Medicare Part D. H.R. 5539 - Orphan Cures Act H.R. 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act.

Client expense: $830,000 · Firm income: Not reported

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

Support for H.R.5539 - Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation impacting products approved under the Accelerated Approval pathway. H.R.6790, New Era of Preventing End-Stage Kidney Disease Act. Policies regarding copay accumulators and impact on rare disease patients.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for H.R.5539 - Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. Legislation regarding newborn screening. H.R.6790, New Era of Preventing End-Stage Kidney Disease Act. Policies regarding copay accumulators and impact on rare disease patients. Support of reauthorization of priority review voucher program.

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

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

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 766: Dr. Michael C. Burgess Preventive Health Savings Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7024 Tax Relief for American Families and Workers Act of 2024 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: 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. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2477: Equitable Community Access to Pharmacist Services Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 3430: Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 S. 5021: 340B PATIENTS Act of 2024 S. 5040: Protecting Patients from Deceptive Drugs Online Act S. 5459: Biosimilars Access and Affordability Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Artificial intelligence policy issues Vaccine provisions of the Inflation Reduction Act Policy issues related to vaccines

Client expense: $920,000 · Firm income: Not reported

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

Issues related to drug pricing reform Changes to Public law 117-1769 Inflation Reduction Act Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 830/ S 1375 HELP Copays Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act R 2534 PROTECT 340B Act of 2023 HR 3561 the PATIENT Act S. 1542 DRUG Act S. 1967 PBM Act HR 3503 The NIH Clinical Trials Diversity Act Issues related to cardiovascular disease awareness and treatment Issues related to Federal Trade Commission FDA issues Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to 340B Issues related to pharmacy benefit managers Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S. 2407 Treat and Reduce Obesity Act S. 2305 Biosimilar Red Tape Elimination Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 652/ HR2630 SAFE Step Act S 2474/ HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 5539 Orphan Cures Act HR 5547 Maintaining Investments in New Innovation Act S 3558 BIOSECURE Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) S Res 566 Cholesterol Education Month 2024 HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act. HR 5376 Share the Savings With Seniors Act S 3430 Mental Health, Lower Cost Drugs and Extenders Package. BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities HR 8412 Clinical Trial Modernization Act S 5573 Skinny Labels, Big Savings Act HR 10515 American Relief Act

Client expense: $2,780,000 · Firm income: Not reported

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

Issues related to drug pricing reform Changes to Public law 117-1769 Inflation Reduction Act Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act HR 2534 PROTECT 340B act of 2023 HR 3561 the PATIENT act Issues related to cardiovascular disease awareness and treatment Issues related to ESRD Issues related to asthma and self-administered drug list Issues related to reimbursement for biologics/biosimilars Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S2407 Treat and Reduce Obesity Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 1542/HR 6283 DRUG Act S652 SAFE Step Act HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 S 2474/HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act HR 5547 Maintaining Investments in New Innovation Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act. HR 5376 Share the Savings With Seniors Act. S 3430 Mental Health, Lower Cost Drugs and Extenders Package HR 5539 Orphan Cures Act HR 10515 American Relief Act

Client expense: $2,780,000 · Firm income: Not reported

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

- S 1375/HR 830, "HELP Copays Act", regarding all provisions. - PL 117-169, "The Inflation Reduction Act", regarding provisions impacting drug pricing and implementation. - PL 113-5 "Pandemic All Hazards Preparedness Reauthorization", regarding all provisions. - S 1355/HR 2940, "PASTEUR Act", regarding all provisions. - HR 3723, "Medical Device Electronic Labeling Act", regarding all provisions. - HR 2748, "Contact Lens Prescription Verification Modernization Act", regarding all provisions. - HR 4261, "Amputation Reduction and Compassion Act", regarding all provisions. - S 3131/HR 5539, "ORPHAN Cures Act", regarding all provisions. - HR 5372, "Expanding Access to Seniors Access to Lower Cost Medicines Act of 2023", regarding all provisions. - S 2305, "The Biosimilar Red Tape Elimination Act", regarding all provisions. - HR 1352, "Increasing Access to Biosimilars Act of 2023", regarding all provisions. - HR 7174, "Ensuring Pathways to Innovative Cures (EPIC) Act", regarding all provisions - HR 8574, the "340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act", regarding all provisions - HR 7384, "Creating Hope Reauthorization Act", regarding all provisions - HR 7153/ S 3679 the "Dr. Lorna Breen Health Care Provider Protection Reauthorization Act", regarding all provisions Issues related to: - Obesity - Biosimilars - Health equity and diversity in clinical trials - Myopia - Ambulatory surgical services - Access to sterilization capacity for medical technologies - Peripheral artery disease - Cardiovascular health - Stroke care - FDA medical device shortage reporting requirements - Alternative funding programs - PBM practices - Health care workforce wellbeing - Medicaid Drug Rebate Program - the SUSTAIN 340B Act

Client expense: $1,520,000 · Firm income: Not reported

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

H.R. 5539/S. 3131, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act H.R.7085 BioSecure Act; Issues related to the BIOSECURE Act and US manufacturing of pharmaceuticals HR 3433/S 2897, Give Kids A Chance Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to the price and manufacture of inhaled medicines Issues related to the IRAs drug price negotiation program Issues related to importation of drugs Issues related to drug pricing Issues related to RSV monoclonal antibody manufacture and distribution Issues related to FDA proposed regulation of lab developed tests Issues related to pharmacy benefit managers (PBM) reform Issues related to FDA Orange Book patent listings Issues related to COVID vaccine access and reimbursement Issues related to COPD patient access through CMMI demonstration models General issues related to health equity in rare disease and clinical trials General issues related to rare disease and orphan drugs Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS AZ sustainability platform FDA modernization policy issues Reauthorization of the pediatric priority review voucher program

Client expense: $640,000 · Firm income: Not reported

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

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions) H.R. 3433, Give Kids a Chance Act of 2024 (generally, no specific provisions) H.R. 7623, Telehealth Modernization Act of 2024 (generally, no specific provisions) S. 2780, Medication Affordability and Patent Integrity Act (generally, no specific provisions) S. 4583, Creating Hope Reauthorization Act of 2024 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 5539 - ORPHAN Cures Act S 3131 - ORPHAN Cures Act 21st Century Cures

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: 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. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 3430: Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 S. 5021: 340B PATIENTS Act of 2024 S. 5040: Protecting Patients from Deceptive Drugs Online Act S. 5459: Biosimilars Access and Affordability Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Artificial intelligence policy issues

Client expense: $7,560,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Congressional Personalized Medicine Caucus Precision Medicine Answers for Kids Today Act and Medicaid Early Periodic Screening, Diagnostic and Treatment Benefit 21st Century Cures 2.1 Oversight of Laboratory Developed Tests H.R. 3876/S. 2323 Access to Genetic Counselor Services Act H.R. 5539/S. 3131 Optimizing Research Progress Hope And New (ORPHAN) Cures Act H.R. 5547/S.476 Maintaining Investments in New Innovation (MINI) Act H.R. 7174 Ensuring Pathways to Innovative Cures (EPIC) Act CMS Implementation of Medicare Drug Price Negotiation Program/ Medicare Drug Price Negotiation Program Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc (CMS-1807-P) FDA Center for Drug Evaluation and Research AI Council Priorities Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community

Client expense: $41,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S. 142, the Preserve Access to Affordable Generics and Biosimilars Act. S. 148, the Stop STALLING act. S. 150, the Affordable Prescriptions for Patients Act. H.R. 9070, the Affordable Prescriptions for Patients Act. S. 3131/H.R. 5539, the ORPHAN Cures Act. No bill number. Discussed prescription drug provisions of the Inflation Reduction Act. No bill number. Discussed pharmacy benefit manager reforms. No bill number. Discussed biologics, biosimilars, and interchangeability. No bill number. Discussed out-of-pocket caps for generic prescription drugs. No bill number. Discussed Medicare part D open enrollment. No bill number. Discussed prescription drug pricing reforms. No bill number. Discussed Medicare Two Dollar Drug List Model.

Client expense: $5,580,000 · Firm income: Not reported

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

H.R.7384, Creating Hope Reauthorization Act H.R.5539/S.3131, the ORPHAN Cures Act H.R.3433/S.2897, the Give Kids a Chance Act

Client expense: Not reported · Firm income: $160,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2860 - SAFER Banking Act HR 5539/ S. 3131 - Orphan Cures Act HR 8467 - Farm, Food, and National Security Act of 2024 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2025 Control status of Epidiolex Changes to Inflation Reduction Act Drug safety, prescription drug abuse, value of prescription drugs Issues related to the regulation of cannabis and CBD Research and development of cannabis-derived therapies

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.485, Protecting Health Care for All Patients Act H.R.5378, Lowering Costs, More Transparency Act H.R.6283/S.1542, DRUG Act H.R.1385/S.1424, DOC Access Act H.R.5608, ACCESS Act H.R.5539/S.3131, ORPHAN Cures Act H.R. 3433, Give Kids a Chance Act of 2024 H.R. 7623, Telehealth Modernization Act of 2024 S. 2780, Medication Affordability and Patent Integrity Act S. 4583, Creating Hope Reauthorization Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act S. 5021/HR. 7635 - 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 HR. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Drug Shortages Supply Chain Integrity and Traceability Drug Patenting PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2630/S. 652: SAFE STEP Act H.R. 5378: 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. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority 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 S. 2305: Biosimilar Red Tape Elimination Act IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies

Client expense: $720,000 · Firm income: Not reported

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

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---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 ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART) Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office