Give Kids a Chance Act of 2024

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

H.R. 7384/S. 4583, the Creating Hope Reauthorization Act of 2024 H.R. 4758/S. 2372, the Accelerating Kids Access to Care Act H.R. 3433, the Give Kids A Chance Act General discussions about ultra-rare disease drug development General discussions about regulatory reform, including scientific-focused drug development meetings H.R. 1092/S. 526, the BENEFIT Act General discussions about mitochondrial diseases H.R. 9979, the Scientific EXPERT Act of 2024 General discussions about ultra-rare diseases FDA Rare Disease Innovation Hub

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, TRICARE, and private insurance Issues regarding the annual Notice of Benefit and Payment Parameters for the Exchanges and private insurance Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce and related access issues. Issue regarding Medicaid supplemental payments and directed payments Issues related to Health Information Technology, interoperability, information blocking, and cybersecurity Issues regarding the importance of Medicaid to children, including military and veteran families  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program and funding Issues related to 340B Drug Pricing Program, prescription drug pricing, drug shortages, high-cost drugs/therapies and pharmaceutical supply chain, including H.R. 3290 Issues related to pediatric workforce, Medicare GME, the Pediatric Specialty Loan Repayment Program, and Title VII and VIII Issues regarding Organ Procurement and Transplantation Network Issues regarding site neutrality, facility fees, and price transparency in health care  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness Issues regarding food security and nutrition Issues regarding drugs and medical device shortages and high costs, including IV fluid shortages and infant formula Issues related to the regulation of laboratory-developed tests Issues regarding prescribing of drugs via telehealth Issues related to mental health services in schools Issues related to pediatric cancer and the Moonshot Issues regarding Artificial Intelligence (AI) Issues regarding oversight and implementation of EPSDT H.R. 2412 The Helping Kids Cope Act S.2372/HR. 4758 - Accelerating Kids Access to Care Act  H.R. 1397, Telehealth Improvement for Kids Essential Services (TIKES) Act H.R. 7623/ S. 3967, Telehealth Modernization Act Issues involving Site Neutral payment legislation, including H.R. 3281 and H.R. 3561 S. 3029/H.R. 6085 PREEMIE Reauthorization Act H.R. 2584/S.2768, Safety form Violence for Healthcare employees (Save) Act S. 1409, Kids Online Safety Act H.R. 6663/S. 3364, Kid PROOF Act of 2023 H.R. 6664 Innovation for Pediatric Drugs Act of 2023 H.R. 7808, the Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 7153/S. 3679 Dr. Lorna Breen Health Care Provider Protection Reauthorization Act S. 3757 Congenital Heart Futures Reauthorization Act of 2024 H.R. 6960 Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 3391 Gabriella Miller Kids First Research Act 2.0 H.R. 6963 Pediatric Cancer Drug Supply Act H.R. 3433/ S. 2897, Give Kids A Chance Act H.R. 7384, Creating Hope Reauthorization Act. H.R. 6664/S. 4905, Innovation in Pediatric Drugs Act

Client expense: $1,600,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE

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) 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

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

Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilar Red Tape Elimination Act (S.2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); 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; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.

Client expense: Not reported · Firm income: $200,000

Government targets: SENATE

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.4426, Promising Pathway Act 2.0 H.R.7384/S.4583, the Creating Hope Reauthorization Act of 2024 H.R.4758/S.2372, Accelerating Kids Access to Care Act H.R.3433, the Give Kids a Chance Act H.R. 10545, American Relief Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 over-the-counter consumer care products. Monitor and engage on legislative and administrative action related to dietary supplements. 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 FDA monograph reform and user fees. 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 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 long-acting reversable contraception usage. 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 broader insurance coverage of supplemental imaging procedures for women with dense breast tissue. Monitor and engage on legislative and administrative action related to phenylephrine. Monitor and engage on legislative and administrative action related to e-labeling. Monitor and engage on legislative and administrative action related to DEA-determined pseudoephedrine quotas. H.R. 3086, Find It Early Act. H.R. 3433, Give Kids a Chance Act of 2023. H.R. 7384, A bill to amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of HHS to issue priority review vouchers to encourage treatments for rare pediatric diseases. H.R. 10545, American Relief Act, 2025, including pharmacy benefit manager reform. S. 4583, Creating Hope Reauthorization Act of 2024.

Client expense: $2,010,000 · 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)

FY 25 Congressional appropriations: -Increase funding for Health Resources and Services Administration (HRSA) Organ Transplantation Program -Increase NIH funds, including proportional increase for NIDDK to support kidney research -Provide $25 million to KidneyX to continue development of an artificial kidney and other innovations innovative kidney therapeutics and technologies -Address the implementation of the retrospective trend adjustment in the CKCC model Legislation: Explore the establishment of an Officer of Kidney Health and Transplantation at HHS Clarifying HRSA's ability to use OPTN patient waitlist registration fees (HR3433/S Increase support for living donors including through the Honor Our Living Donors Act, The Living Organ Donor Tax Credit Act (H.R. 6171), and the Living Donor Protection Act (H.R. 2923/S. 1384) Increase patient choice and bolster the kidney health workforce by passing the Providing Relief and Stability for Medicare Patients Act of 2023 (H.R. 3674) and the Strengthening Medicare for Patients and Providers Act (HR 2474) Regulatory: Increase kidney health coordination, innovation, and reimbursement through ESRD PPS/QIP, PFS, and ESRD-QIP Measure Set Review Improve transparency and accountability in transplant system to maximize access to kidney transplant, including through the HRSA OPTN Modernization Initiative Establish a federal screening recommendation for kidney diseases

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

Issues related to gene therapy and rare diseases. H.R. 4758 - Accelerating Kids Access to Care Act, all provisions. H.R. 3433 - Give Kids a Chance Act of 2024, all provisions.

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues: Issues related to Medicaid rebates, H.R. 3433 The Give Kids a Chance Act

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues pertaining to finding treatments and cures for brain tumors, including funding at NIH, NCI, and DOD; H.R.9113 and S.4739, Bolstering Research and Innovation Now (BRAIN) Act; H.R.3433, Give Kids a Chance Act.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), 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

Issues related to Medicaid; Public Readiness and Emergency Preparedness Act (PREP). H.R.3433/S.2897, Give Kids a Chance Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Creating Hope Reauthorization Act of 2024 - H.R. 7384 Give Kids a Chance Act of 2024 - H.R. 3433 Creating Hope Reauthorization Act of 2024 - S. 4583 March-in/Bayh-Dole Act Orphan drug policies Scientific EXPERT Act of 2024 - H.R.9979 H.R.9979 - Scientific EXPERT Act of 2024 H.R.10545 - American Relief Act, 2025

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues impacting rare disease treatments, including rare disease research incentives; H.R. 7384/S. 4583 - Creating Hope Reauthorization Act of 2024; H.R. 3433 - Give Kids a Chance Act of 2024; American Relief Act of 2025 (PL 118-158).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Inflation Reduction Act of 2022; Issues Related to the Orphan Drug Tax Credit; Help Copays Act (HR 830 / S 1375); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); The Creating Hope Reauthorization Act (HR 7384 / S 4583) / HR 3433); BIOSECURE Act (HR 7085); The American Recovery Act (HR 10545).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Establishment of FDA Rare Disease Innovation Hub and related issues pertaining to rare disease therapy applications; reauthorization of the pediatric priority review voucher (H.R. 3433), Promising Pathways Act (S. 4426); Creating Hope Reauthorization Act of 2024 (S.4583).

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5547, Maintaining Investments in New Innovation (MINI) Act H.R.7174, Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 6094, Providing Realistic Opportunity To Equal and Comparable Treatment for (PROTECT) Rare Act H.R. 6664, Innovation in Pediatric Drugs Act H.R. 7384, Creating Hope Reauthorization Act H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act H.R.7024, Tax Relief for American Families and Workers Act of 2024 H.R.3433 / S.2897, Give Kids a Chance Act

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pandemic preparedness; Antimicrobial resistance; Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization; PASTEUR Act (H.R. 2940, S. 1355); Rare Pediatric Disease Priority Review Voucher reauthorization. (H.R. 3433, HR 7384, S. 4583)

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

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

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384, S. 4583 - Creating Hope Reauthorization Act; H.R. 7383, S. 1214 - RARE Act; H.R. 3433 - Give Kids a Chance Act of 2023; H.R. 6664 - Innovation in Pediatric Drugs Act of 2023; H.R. 9979 - Scientific External Process for Educated Review of Therapeutics (EXPERT) Act of 2024; H.R. 3433 - Give Kids a Chance Act

Client expense: $20,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3226 & S.1573, The PREEMIE Reauthorization Act H.R. 3838 & S.2415, Preventing Maternal Deaths Reauthorization Act of 2023 H.R. 4714 & S. 2345, The Pediatricians Accelerate Childhood Therapies (PACT) Act    H.R.7087 & S.3641, MOMS Who Serve Act SUSTAIN 340B Act - Senate discussion draft H.R 7635, 340B PATIENTS Act H.R. 8574, 340B Access Act H.R. 2439 & S. 1135, Ally's Act   H.R. 7542 & S. 3864, Stop CMV Act  H.R. 3433, Give Kids a Chance Act   H.R. 6664 & S.4905, Innovation in Pediatric Drug Act of 2023 H.R. 7379, Patient Matching and Transparency in Certified Health IT (MATCH IT) Act CHGME Reauthorization H. Res. 1581, Expressing support for the designation of Prematurity Awareness Month" Analysis of sickle cell disease legislation in anticipation of future advocacy/endorsement of legislation Prep for military health care legislation support Continuing Resolution (CR)/Year End Package - H.R.10545 - American Relief Act, 2025 - Advocated for inclusion of: - H.R. 3226 & S.1573, The PREEMIE Reauthorization Act - H.R. 3838 & S.2415, Preventing Maternal Deaths Reauthorization Act of 2023 - Telehealth extension provisions

Client expense: $178,004 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: Adoption of recommendations of the National Academy of Medicine report, The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention H.R. 766/S 114, Dr. Michael C. Burgess Preventive Health Savings Act H.R. 1147/S. 1957, Whole Milk for Healthy Kids Act of 2023 H.R. 1843/S.1001, Telehealth Expansion Act of 2023 H.R. 2411/S. 1150, National Nursing Workforce Centers Act of 2023 H.R. 2663/S. 1176, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 2713/S. 2418, Improving Care and Access to Nurses (I CAN) Act H.R. 2901, Food Labeling Modernization Act of 2023 H.R. 3073/S. 1452, Community Mental Wellness and Resilience Act of 2023 H.R 3226/S. 1573, PREEMIE Reauthorization Act of 2023 H.R. 3305/S. 1606, Black Maternal Health Momnibus Act H.R. 3331/S. 754, Improving Mental Health and Wellness in Schools Act H.R.3433, Give Kids a Chance Act H.R. 3633, Promoting Resources to Expand Vaccination, Education, and New Treatments for HPV Cancers (PREVENT HPV Cancers) Act of 2023 H.R. 4310/S. 2233, Youth Poisoning Protection Act H.R. 4581/S. 2231, Maternal and Child Health Stillbirth Prevention Act of 2023 H.R. 4758/S. 2372, Accelerating Kids Access to Care Act H.R. 4775, Helping Tobacco Users Quit Act H.R. 4892/S. 3921, Medicaid Bump Act H.R. 5012/S. 2647, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2023 H.R. 5378, Lower Costs, More Transparency Act H.R. 5541, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act H.R. 6122/S. 2853, Train More Nurses Act H.R. 6149/S. 1291, Protecting Kids on Social Media Act H.R. 6766/S. 3512, Transparency, Readability, Understandability, Truth, and Helpfulness (TRUTH) in Labeling Act H.R. 6960/S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 7002/S. 2815, Nurse Faculty Shortage Reduction Act of 2024 H.R. 7153/S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act H.R. 7224, To reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program. H.R. 7808, Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 8467, Farm, Food, and National Security Act of 2024 H.R. 8818, American Privacy Rights Act H.R. 9076, Protecting Americas Children by Strengthening Families Act H.R. 9425, Tobacco User Fee Modernization Act of 2024 H.R. 9774/S. 5194, Health Care Affordability Act of 2024 S. 397, Promoting Physical Activity for Americans Act S.644/H.R. 1359, Modernizing Opioid Treatment Access Act S. 1409/H.R. 7891, Kids Online Safety Act S. 1418/H.R. 7890, Children and Teens Online Privacy Protection Act S. 1840/H.R. 3916, Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act of 2023 S. 1884/H.R. 3713, Mental Health Services for Students Act of 2023 S. 2073, Kids Online Safety and Privacy Act S. 2840, Bipartisan Primary Care and Health Workforce Act S. 3085, Preventing Adverse Childhood Experiences (PACE) Act S. 3193/H.R. 5163, Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act S. 3393/H.R. 4531, SUPPORT for Patients and Communities Reauthorization Act S. 3770/H.R. 7266, Future Advancement of Academic Nursing (FAAN) Act S. 4041, Creating Access and Resources in Education (CARE) for Student Mental Health Act S. 4532/H.R. 8702, Improving Seniors Timely Access to Care Act S. 4745, Federal Food Administration Act

Client expense: Not reported · Firm income: $24,000

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

H.R. 7384/S. 4583, the Creating Hope Reauthorization Act of 2024 H.R. 4758/S. 2372, the Accelerating Kids Access to Care Act H.R. 3433, the Give Kids A Chance Act General discussions about ultra-rare disease drug development General discussions about regulatory reform, including scientific-focused drug development meetings H.R. 1092/S. 526, the BENEFIT Act General discussions about mitochondrial diseases

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1692 / S 8, the Health Care Affordability Act; HR 2630 / S 652, the Safe Step Act; HR 3433 / S 2897, the Give Kids a Chance Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 7383 / S 1214, the RARE Act; HR 8311 / S 4289, Medical Debt Cancellation Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; HR 2813, Self-Insurance Protection Act; HR 2868, the Association Health Plans; HR 2880, the Protecting Patients Against PBM Abuses Act; HR 3799, CHOICE Arrangement Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5609, the Advancing Health Savings Act; HR 5688, the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 7384, the Creating Hope Reauthorization Act; HR 8261, Preserving Telehealth, Hospital, and Ambulance Access Act; HR 8412, the Clinical Trial Modernization Act; HR 8574, the 340B ACCESS Act; HR 9129, Patient Debt Relief Act; S 113, the Prescription Pricing for the People Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; S 1967 the Patients Before Middlemen Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; HR 9774 / S 5194, the Health Care Affordability Act; Legislation to protect insurance purchasers interacting with insurance brokers; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Efforts to extend and make permanent the current enhanced Advance Premium Tax Credits; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; FDA draft guidance related to dose optimization studies in clinical trials

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

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

Implementation of the Inflation Reduction Act of 2022; Help Copays Act (HR 830 / S 1375); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); The Creating Hope Reauthorization Act (HR 7384 / S 4583) / HR 3433); BIOSECURE Act (HR 7085).

Client expense: $220,000 · 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. 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. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues 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. 1906: Promising Pathway Act - Approval pathway policy issues 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 (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 5021: The 340B PATIENTS Act of 2024 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 Health Equity Inflation Reduction Act of 2022 (P.L. 117-169), Implementation 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 Real world evidence 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 Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $1,540,000 · Firm income: Not reported

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

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act 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. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages 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 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 Value-Based Purchasing (VBP) Rule 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. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule 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. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications 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 COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues

Client expense: $740,000 · 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

Issues related to Medicaid; Public Readiness and Emergency Preparedness Act (PREP). H.R.3433/S.2897, Give Kids a Chance Act.

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

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

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 over-the-counter consumer care products. Monitor and engage on legislative and administrative action related to dietary supplements. 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 FDA monograph reform and user fees. 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 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 long-acting reversable contraception usage. 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 broader insurance coverage of supplemental imaging procedures for women with dense breast tissue. Monitor and engage on legislative and administrative action related to phenylephrine. Monitor and engage on legislative and administrative action related to e-labeling. Monitor and engage on legislative and administrative action related to DEA-determined pseudoephedrine quotas. H.R. 3086, Find It Early Act. H.R. 3433, Give Kids a Chance Act of 2023. H.R. 7384, A bill to amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of HHS to issue priority review vouchers to encourage treatments for rare pediatric diseases. S. 4583, Creating Hope Reauthorization Act of 2024.

Client expense: $2,080,000 · 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)

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

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, and private insurance Issues regarding the annual Notice of Benefit and Payment Parameters for the Exchanges and private insurance Issues regarding childrens and mothers health specifically continuous eligibility for children in Medicaid and CHIP, CHIP permanency Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce and related access issues. Issue regarding Medicaid supplemental payments and directed payments Issues related to Health Information Technology, interoperability, information blocking, and cybersecurity Issues regarding the importance of Medicaid to children, including military and veteran families  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program and funding Issues related to 340B Drug Pricing Program, prescription drug pricing, drug shortages, high-cost drugs/therapies and pharmaceutical supply chain, including H.R. 3290 Issues related to pediatric workforce, Medicare GME, the Pediatric Specialty Loan Repayment Program, and Title VII and VIII Issues regarding Organ Procurement and Transplantation Network Issues regarding site neutrality and price transparency in health care  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness Issues regarding food security and nutrition Issues regarding drugs and medical device shortages and high costs Issues related to the regulation of laboratory-developed tests Issues regarding prescribing of drugs via telehealth Issues related to mental health services in schools Issues related to pediatric cancer and the Moonshot Issues regarding Artificial Intelligence (AI) Issues regarding oversight and implementation of EPSDT H.R. 2412 The Helping Kids Cope Act S.2372/HR. 4758 - Accelerating Kids Access to Care Act  H.R. 1397, Telehealth Improvement for Kids Essential Services (TIKES) Act H.R. 7623/ S. 3967, Telehealth Modernization Act Issues involving Site Neutral payment legislation, including H.R. 3281 and H.R. 3561 S. 1774/H.R. 3761 the Assist Act H.R. 2584/S.2768, Safety form Violence for Healthcare employees (Save) Act S. 1409, Kids Online Safety Act H.R. 6663/S. 3364, Kid PROOF Act of 2023 H.R. 6664 Innovation for Pediatric Drugs Act of 2023 H.R. 7808, the Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 6960 Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 3391 Gabriella Miller Kids First Research Act 2.0 H.R. 6963 Pediatric Cancer Drug Supply Act H.R. 3433/ S. 2897, Give Kids A Chance Act H.R. 7384, Creating Hope Reauthorization Act. H.R. 6664/S. 4905, Innovation in Pediatric Drugs Act H.R: 4714: Pediatricians Accelerate Childhood Therapies Act of 2023 S. 0251 340B PATIENTS Act of 2024 H.R. 9577 Stabilization to Prevent (STOP) Suicide Act.

Client expense: $1,170,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE

Issues related to gene therapy and rare diseases. H.R. 4758 - Accelerating Kids Access to Care Act, all provisions. H.R. 3433 - Give Kids a Chance Act of 2024, all provisions.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B 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, SAFE 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 ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations 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 ---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. 2780 Medication Affordability & Patient Integrity Act ---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 ---FY 2025 Appropriations ---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/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 Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---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 ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.4351: Enhanced Access to Affordable Medicines Act ---H.R 6973: 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 Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---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 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) 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 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 7384, Creating Hope Reauthorization Act S.2372/H.R.4758, Accelerating Kids Access to Care Act H.R.6664, Innovation in Pediatric Drugs Act of 2023 H.R.5539/S.3131, the ORPHAN Cures Act H.R.1184/S.4071, the Helping Experts Accelerate Rare Treatments Act S.526/H.R.1092, the BENEFIT Act S.350/H.R.482, the Newborn Screening Saves Lives Reauthorization Act H.R.3433/S.2897, the Give Kids a Chance Act

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S.4426, Promising Pathway Act 2.0 H.R.7384/S.4583, the Creating Hope Reauthorization Act of 2024 H.R.4758/S.2372, Accelerating Kids Access to Care Act H.R.3433, the Give Kids a Chance Act H.R. 7623, Telehealth Modernization Act

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

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. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues 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. 1906: Promising Pathway Act - Approval pathway policy issues 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 (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 5021: 340B PATIENTS Act of 2024 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 Real world evidence 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 Cybersecurity policy issues

Client expense: $6,880,000 · Firm income: Not reported

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

Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); Biosimilar Red Tape Elimination Act (S.2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; REMEDY Act (S. 1209); Medication Affordability and Patent Integrity Act (S.2780); rare pediatric disease priority review vouchers; Stop STALLING Act (S. 148); Interagency Patent Coordination and Improvement Act of 2023 (S. 79); Preserve Access to Affordable Generics and Biosimilars Act (S. 142); Bayh-Dole; Biosecure Act (H.R. 7085, H.R. 8333, S. 3385); and The Federal Acquisition Security Council Improvement Act (discussion draft).

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

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

General issues pertaining to finding treatments and cures for brain tumors, including funding at NIH, NCI, and DOD; H.R.9113 and S.4739, Bolstering Research and Innovation Now (BRAIN) Act; H. Res. 1203 and S. Res. 735, Glioblastoma Awareness Day; H.R.3433, Give Kids a Chance Act.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Creating Hope Reauthorization Act of 2024 - H.R. 7384 Give Kids a Chance Act of 2024 - H.R. 3433 Creating Hope Reauthorization Act of 2024 - S. 4583 March-in/Bayh-Dole Act Orphan drug policies

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE