PASTEUR Act of 2021

H.R. 1, One Big Beautiful Bill, issues related to health care S. 1339, Pharmacy Benefit Manager Reform Act S. 2076, Pioneering Antimicrobial Subscriptions To End Upsurging Resistance (PASTEUR) Act of 2021 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; Cost and value of medicines; Vaccine issues; Package inserts and e-labeling Package inserts, labeling issues, and e-labeling authorization legislation; Pharmaceutical supply channel issues; Drug shortages issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; FY-2026 Budget and Appropriations Legislation; Budget reconciliation drug pricing provisions; Commerce Justice, Science, and related agencies appropriations legislation for 2026; Interior, Environment, and related agencies appropriations legislation for 2026; Intellectual property protection and trade issues; Animal Health Policy Issues; Animal Drug User Fee Act (ADUFA) & Funding for Electronic Animal Traceability; General pharmaceutical issues; Vaccine Injury Compensation Program (VICP); Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms; Food and Drug Administration issues; Public Health Issues; Most Favored Nation (MFN) drug pricing.

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

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

H.R. 1, One Big Beautiful Bill, issues related to health care H.R. 1244, Reducing Drug Prices for Seniors Act H.R. 1492, To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. H.R. 1503/S. 2916, Prescription Information Modernization Act of 2023 H.R. 1968, Full-Year Continuing Appropriations and Extensions Act, 2025 S. 1040, Drug Competition Enhancement Act S. 1339, Pharmacy Benefit Manager Reform Act S. 2076 Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; Prescription drug cost-sharing; Anti-microbial Resistance; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines issues; Vaccine misinformation; Measles, Mumps, and Rubella (MMR) immunizations; Package inserts and e-labeling Package inserts, labeling issues, and e-labeling authorization legislation; Pharmaceutical supply channel issues; Drug shortages issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; FY-2026 Budget and Appropriations Legislation; Commerce Justice, Science, and related agencies appropriations legislation for 2026; Interior, Environment, and related agencies appropriations legislation for 2026; Intellectual property protection and trade issues; WTO IP Waiver for COVID therapeutics; Animal Health; Animal Health Technology Issues; Animal Drug User Fee Act (ADUFA) & Funding for Electronic Animal Traceability; One Health Issues; General pharmaceutical issues; Vaccine Injury Compensation Program (VICP); Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms; Food and Drug Administration issues; Public Health Issues; Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients, (Docket No. 250411-0065).

Client expense: $4,980,000 · Firm income: Not reported

Government targets: Bureau of Industry and Security (BIS), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 1244, Reducing Drug Prices for Seniors Act H.R. 1492, To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. H.R. 1503/S. 2916, Prescription Information Modernization Act of 2023 H.R. 1968, Full-Year Continuing Appropriations and Extensions Act, 2025 S. 1040, Drug Competition Enhancement Act S. 1339, Pharmacy Benefit Manager Reform Act S. 2076 Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; Prescription drug cost-sharing; Anti-microbial Resistance; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines issues; Vaccine misinformation; Measles, Mumps, and Rubella (MMR) immunizations; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical supply channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; FY-2025 Budget and Appropriations Legislation; Intellectual property protection and trade issues; WTO IP Waiver for COVID therapeutics; Animal Health; Animal Health Technology Issues; Animal Health Policy Issues: Animal Drug User Fee Act (ADUFA) & Funding for Electronic Animal Traceability; One Health Issues; General pharmaceutical issues; Vaccine Injury Compensation Program (VICP); Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms; Food and Drug Administration issues; Public Health Issues.

Client expense: $2,600,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

COVID Supplemental Appropriation S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing FY2024 Defense Appropriations Issues related to the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) National Biodefense Strategy and Implementation Plan H.R.3746 Fiscal Responsibility Act of 2023 H.R.4421 Preparing for All Hazards and Pathogens Reauthorization Act

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program 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. 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. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefit Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2940/S. 1355: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications 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 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 HR 4223 - National AI Commission Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act H.R. 4882: Clinical Laboratory Price Transparency 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 HR 5027 - Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 H.R. 5142 - Vaccine Injury Compensation Modernization Act -- reform the vaccine injury compensation program H.R.5143 - Vaccine Access Improvement Act - reform the vaccine injury compensation program H.R. 5376: Share the Savings with Seniors Act HR 5378 - Lower Costs, More Transparency Act (PBM transparency provisions, Q1/Q2 provisions) 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. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1128: Ensuring Access to Generic Medications 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. 1909, The Pharmacy DIR Reform to Reduce Senior Drug Costs Act. HR 830 HELP Copays Act. S. 2076 PASTEUR Act of 2021. S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333 - Pandemic and All Hazards Preparedness Act reauthorization PBB S. 2474: Share the Savings with Seniors Act S 2965 - Modernizing and Ensuring PBM Accountability Act Inflation Reduction Act of 2022 (P.L. 117-169) 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 High deductible health plans/HSA policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues White Paper on AI in Healthcare Labor HHS Appropriations Modernizing and Ensuring PBM Accountability Post-TDAPA policies at CMS - seeking Congressional letter to CMS

Client expense: $1,030,000 · Firm income: Not reported

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

COVID Supplemental Appropriation S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing FY2024 Defense Appropriations Issues related to the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) National Biodefense Strategy and Implementation Plan H.R.3746 Fiscal Responsibility Act of 2023 H.R.4421 Preparing for All Hazards and Pathogens Reauthorization Act

Client expense: $230,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to antimicrobial resistance. H.R. 3932/S. 2076 - The PASTEUR Act of 2021. Consolidated Appropriations Act, 2023 (PL 117-328).

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

Government targets: SENATE

COVID Supplemental Appropriation S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing FY2024 Defense Appropriations Issues related to the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) National Biodefense Strategy and Implementation Plan H.R.3746 Fiscal Responsibility Act of 2023 H.R.4421 Preparing for All Hazards and Pathogens Reauthorization Act

Client expense: $230,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 382: Pandemic is Over Act - This bill terminates the COVID-19 public health emergency that was declared on January 31, 2020, on the date of the bill's enactment H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property PDUFA Riders provisions related to disclosure of trade secrets H.R. 4390: Protect 340B Act - Provision related to 340B Program H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 7032: Increasing Transparency in Generic Drug Application Act - This bill requires the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes. S. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Provisions related to drug pricing S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B Drug Pricing Program - drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act policy issues

Client expense: $1,700,000 · Firm income: Not reported

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

COVID Supplemental Appropriation FY2023 Defense Appropriations S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing H.R.8236 - Department of Defense Appropriations Act, 2023 H.R.6833 - Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 H.R.2617 - Consolidated Appropriations Act, 2023 FY2024 Defense Appropriations Issues related to the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) National Biodefense Strategy and Implementation Plan

Client expense: $230,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 1790: Biologics Competition Act of 2023 - Directs 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. 4390: Protect 340B Act - Provisions related to 340B Program H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 7032: Increasing Transparency in Generic Drug Application Act - Requires the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why) S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - Directs the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Provisions related to drug pricing S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act 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 Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act policy issues

Client expense: $7,990,000 · Firm income: Not reported

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

H.R. 1384, the Mainstreaming Addiction Treatment Act S.445, the Mainstreaming Addiction Treatment Act H.R. 2503, the Social Determinants Accelerator Act S. 3039, the Social Determinants Accelerator Act H.R. 3517, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 3932, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act S. 2076, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act HR 4040, Advancing Telehealth Beyond COVID-19 Act H.R. 4521, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act H.R. 6000, Cures 2.0 Act H.R. 6072, the Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act S. 509, the Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act H.R. 6087, the Improving Access to Workers Compensation for Injured Federal Workers Act H.R. 6883, Continuing Appropriations and Ukraine Supplemental Appropriations Act H.R.7008, Pre-approval Information Exchange Act H.R. 7353, the Telehealth Benefit Expansion for Workers Act H.R. 7503, Hospital Inpatient Services Modernization Act S. 3792, Hospital Inpatient Services Modernization Act H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act H.R. 7667, Food and Drug Amendments of 2022 H.R. 8152, American Data Privacy and Protection Act H.R. 8188, the Saving Access to Laboratory Services Act S. 4449, the Saving Access to Laboratory Services Act S. 3799, PREVENT Pandemics Act S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022

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

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

H.R. 1384, the Mainstreaming Addiction Treatment Act S.445, the Mainstreaming Addiction Treatment Act H.R. 2503, the Social Determinants Accelerator Act S. 3039, the Social Determinants Accelerator Act H.R. 3517, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act H.R. 3932, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act S. 2076, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act HR 4040, Advancing Telehealth Beyond COVID-19 Act H.R. 4521, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act H.R. 6000, Cures 2.0 Act H.R. 6072, the Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act S. 509, the Leveraging Integrated Networks in Communities (LINC) to Address Social Needs Act H.R. 6087, the Improving Access to Workers Compensation for Injured Federal Workers Act H.R. 6883, Continuing Appropriations and Ukraine Supplemental Appropriations Act H.R.7008, Pre-approval Information Exchange Act H.R. 7353, the Telehealth Benefit Expansion for Workers Act H.R. 7503, Hospital Inpatient Services Modernization Act S. 3792, Hospital Inpatient Services Modernization Act H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act H.R. 7667, Food and Drug Amendments of 2022 H.R. 8152, American Data Privacy and Protection Act H.R. 8188, the Saving Access to Laboratory Services Act S. 4449, the Saving Access to Laboratory Services Act S. 3799, PREVENT Pandemics Act S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022

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

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

Reproductive health, physician-patient relationship, and EMTALA issues H.R.1193-Cardiovascular Advances in Research and Opportunities Legacy Act H.R.1195-Workplace Violence Prevention for Health Care and Social Service Workers Act H.R.1205-Improving Mental Health Access from the Emergency Department Act of 2021 H.R.1260-Bipartisan Solution to Cyclical Violence Act of 2021 H.R.1324-Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 H.R.1364-Parity Enforcement Act of 2021 H.R.1384-Mainstreaming Addiction Treatment Act of 2021 H.R.1620-Violence Against Women Act Reauthorization Act of 2021 H.R.3650-Improving Access to Medicare Coverage Act of 2021 H.R.3932-Pioneering Antimicrobial Subscriptions to End Up Surging Resistance Act of 2021 H.R.4555-Oral Health Literacy and Awareness Act of 2021 H.R.5294-Meaningful Access to Federal Health Plan Claims Data Act of 2021 H.R.7666-Restoring Hope for Mental Health H.R.7850-Prevent BLEEDing Act of 2022 H.R.8163-Improving Trauma Systems and Emergency Care Act H.R.8597-Emergency Care Improvement Act H.Res.656-Supporting the designation of September 17, 2021, as National Physician Suicide Awareness Day to raise awareness of, and promote a national discussion about, physician suicide and to reduce the stigma of mental health issues S.445-Mainstreaming Addiction Treatment Act of 2021 S.467-Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 S.1133-Cardiovascular Advances in Research and Opportunities Legacy Act S.2048-Improving Access to Medicare Coverage Act of 2021 S.2076-Pioneering Antimicrobial Subscriptions to End Up Surging Resistance Act of 2021 S.2157-Improving Mental Health Access from the Emergency Department Act of 2021 S.2422-Bipartisan Solution to Cyclical Violence Act S.3566-Improving Trauma Systems and Emergency Care Act S. 4269-Prevent BLEEDing Act S.Res.364-Supporting the designation of September 17, 2021, as National Physician Suicide Awareness Day to raise awareness of, and promote a national discussion about, physician suicide and to reduce the stigma of mental health issues. S.Res.557-A resolution recognizing the week of March 20 through March 26, 2022, as National Poison Prevention Week and encouraging communities across the United States to raise awareness of the dangers of poisoning and promote poison prevention.

Client expense: $515,937 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Antimicrobial resistance research, infectious disease product R&D regulatory science, unnecessary regulatory burdens placed on medical research; laboratory developed tests; comparative effectiveness research; support for evidence-based decision making; point-of-care diagnostic tests; and organ transplant policies to allow HIV+ to HIV+ organ transplants, Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR Act-S. 2076/H.R. 3932), Verifying Accurate Leading Edge IVCT Development (S. 2209/HR. 4128), PREVENT Pandemics Act

Client expense: $166,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

Support the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (S. 2076 / H.R. 3932)

Client expense: Not reported · Firm income: $21,600

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies related to: APRN prescribing authority Development, testing and prescribing of pediatric pharmaceuticals Implementation of the Inflation Reduction Act (P.L. 117-169) provisions related to policies to lower prescription drug prices and improve vaccines for children H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 3932/S. 2076, Pioneering Antimicrobial Subscriptions to End Surging Resistance (PASTEUR) Act

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

Government targets: Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 869: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS S. 289: RESEARCH INVESTMENT TO SPARK THE ECONOMY (RISE) ACT OF 2021; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS S. 3799: PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING THE 2023 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR HHS AND RELATED AGENCIES, FDA AND RELATED AGENCIES, CDC AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 3932: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS H.R. 4040: ADVANCING TELEHEALTH BEYOND COVID-19 ACT OF 2022; ALL PROVISIONS H.R. 5030: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS H.R. 5566: FINDING ORPHAN-DISEASE REMEDIES WITH ANTIFUNGAL RESEARCH AND DEVELOPMENT (FORWARD) ACT OF 2021; ALL PROVISIONS H.R. 5801: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 6000: CURES 2.0 ACT; ALL PROVISIONS H.R. 9303: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2022; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 942: NO JUNK PLANS ACT; ALL PROVISIONS S. 2076: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2021; ALL PROVISIONS S. 2706: DIVERSIFYING INVESTIGATIONS VIA EQUITABLE RESEARCH STUDIES FOR EVERYONE (DIVERSE) TRIALS ACT; ALL PROVISIONS S. 3799: PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING ACE KIDS 2.0; ALL PROVISIONS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Healthcare Supply Chain - Highlighted the important role played by hospital group purchasing organizations in promoting resiliency and value in healthcare purchasing. Engaged to support policies to ensure greater transparency and mitigate or limit shortages of prescription drugs. Supported policies that would expedite critical cargo, including cargo necessary for medical care, during a public health emergency or disaster. Advocated for greater transparency in the health care supply chain for drugs and medical devices. Supported updating language related to the Unapproved Drugs Initiative, and incorporating the PASTUER Act (S.2076) and the PATCH Act (H.R. 7084) in omnibus legislation (H.R. 2617). Telehealth - Supported efforts to make telehealth flexibilities offered during COVID-19 Public Health Emergency permanent. Supported CONNECT for Health Act (H.R. 2617 S. 1512/H.R. 2903) and the Extending Telehealth Beyond COVID-19 Act (H.R. 4040). Encouraged reimbursement parity for certain telehealth services and support for audio-only telehealth services. Health Care Workforce - Urged passage of the Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708; S. 168); The Health Care Workforce Resilience Act (S. 1024/H.R. 2255). Urged administration to examine practices of health care staffing agencies and supported passage of the Travel Nursing Agency Transparency Study Act (S. 4352). Supported passage of the Safety from Violence for Healthcare Employees Act (H.R. 7961). Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act (S. 3799; H.R 2617) - monitored PREVENT Pandemics Act and supported inclusion of provisions to improve supply chain transparency, enhance cybersecurity of medical devices and extend shelf life of prescription drugs in omnibus legislation. 340B Drug Pricing Program - Urged HHS to enforce guidance that would allow 340B Covered Entities to utilize contract pharmacies. Social Determinants of Health and Health Equity - Shared insights and offered suggestions to CMS regarding health equity measurement, indices and data collection. Supported the Social Determinants Accelerator Act (H.R. 2503; S. 3039); The LINC to Address Social Needs Act (S. 509). Supported passage of Opioid Treatment Access Act (S. 3629/H.R. 6279). Supported passage of Drug Shortages Shelf Life Extension Act (S. 3493). Supported passage of the Biologics Competition Act (H.R. 8877).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, "To amend title XVIII of the Social Security Act to provide for the expansion of coverage of vaccines under part B of the Medicare program, and for other purposes", regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month, regarding all provisions - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act", regarding all provisions - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "Emergency Use Transparency Act", regarding all provisions - HR 3990/S 2047, "No PFAS in Cosmetics Act", regarding all provisions - HR 8299/S 4386, "To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.", regarding all provisions - HR 7667/S 4348, "Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act", regarding provisions on accelerated approval and diversity in clinical studies - HR 5801, "HELP Copays Act", regarding all provisions - HR 3173/S 3018 - "Improving Seniors Timely Access to Care Act of 2021", regarding all provisions - S 3799 - "PREVENT Pandemics Act", regarding all provisions - HR 3932/S 2076 - "PASTEUR Act of 2021", regarding all provisions - HR 5376 - "Inflation Reduction Act", regarding provisions on drug pricing and provisions related to revenue - HR 7559 - Prescription Information Modernization Act of 2022, regarding all provisions - HR 2617 - "Consolidated Appropriations Act, 2023", regarding provisions related to pharmaceuticals, medical devices, mental health, and tax - Issues related to Dengue - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation

Client expense: $2,270,000 · Firm income: Not reported

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

H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products HR 1978 - Protecting Seniors Through Immunization Act H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing, patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Issues related to HFC's Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)

Client expense: $860,000 · Firm income: Not reported

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

H.R. 2617: Consolidated Appropriations Act, 2023 (PL. 117-328) - various funding levels; FDA provisions H.R. 3932: PASTEUR Act of 2021- To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169), prescription drug provisions H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 8256: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2023 H.R. 8295: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 S. 2076: PASTEUR Act of 2021- To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 FY 2023 Presidents Budget Request National Coverage Determination (NCD) for Apretude (cabotegravir long-acting [CAB-LA] for Pre-Exposure Prophylaxis [PrEP]) PAHPA Reauthorization Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates

Client expense: $860,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

General education about policies impacting pharmaceutical development, approval and reimbursement; Drug safety and drug counterfeiting; Medicare Part D; Federal preemption for prescription drugs; drug importation; and drug shortages. Drug pricing proposals including H.R. 3. Medicare rebate reform, the 340B program, and proposals to impose "most favored nation" pricing on Medicare Part B and D. COVID-19 relief proposals. American Rescue Plan Act of 2021, P.L. 117-2, H.R. 1319. H.R.5376, "Inflation Reduction Act of 2022" (PL 117-169). H.R. 3. H.R. 19. HR 3927. S. 2082. Consolidated Appropriations Act, FY 23 (P.L. 117-328). PASTEUR Act H.R. 3932, S. 2076.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $6,610,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE

H.R. 2617: Consolidated Appropriations Act, 2023 (PL. 117-328) H.R. 3932: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 8256: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2023 H.R. 8295: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 S. 2076: PASTEUR Act of 2021 - To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 FY 2023 Presidents Budget Request

Client expense: $6,610,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to third party servicing of medical devices Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of COVID-19 diagnostic tests Issues related to the Valid Act of 2021 - H.R. 4128/S. 2209 Issues related to Health Equity Issues related to the PASTEUR Act of 2021 - S. 2076/HR 3932 Issues related to COVID-19 Clinical Testing & Testing Supplies Issues related to Public Health Emergency Preparedness Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to COVID-19 Clinical Testing and Testing Supplies Issues related to consumer and health data privacy Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to H.R. 7667, Food and Drug Amendments of 2022 Issues related to S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Issues related to S. 4386, A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. Issues related to S. 3799, PREVENT Pandemics Act Issues related to S. 3700 Prevent Pandemics Act Issues related to H.R. 2617 Consolidated Appropriations Act Issues related to H.R. 6833 Continuing Appropriations and Ukraine Supplemental Appropriations Act Issues related to S. 4349 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices. Issues related to H.R. 7676 Emerging Signals Modernization Act of 2022 Issues related to cyber security including H.R. 7084/S. 3983, PATCH Act and S. 4336 Strengthening Cybersecurity for Medical Devices Act

Client expense: $750,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Inflation Reduction Act of 2022 (PL 117-169) implementation - creating Medicare negotiation of drugs, creating a new inflation rebate under Medicare, limiting insulin copays to $35/month, capping Medicare Part D premium growth, expanding premium and co-pay assistance on prescription drugs for low-income individuals, and capping Medicare out of pocket costs at $2,000 per year, and preventing commercial spillover of maximum fair price into markets beyond Medicare; Consolidated Appropriations Act, 2023 (PL 117-328)- allowing new vaccines to be added to the Vaccine Injury Compensation Fund (VICF), preserving coverage and access to Part D products under EUA; Antibiotics/stewardship; Value of prescription drugs; S. 2076/H.R. 3932, PASTEUR Act of 2021; ACIP recommendations related to pneumococcal vaccines; S. 3700/H.R. 6833, Affordable Insulin Now Act; Issues related to reauthorization of FDA user fee bills (H.R.7667, Food and Drug Amendments of 2022; S. 4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDSLA Act of 2022)), including accelerated approval and reimportation; Issues related to the Public Health Emergency; Issues related to the White House Cancer Moonshot initiative; S. 2706/H.R. 5030, DIVERSE Trials Act; Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to the further development of antibiotics and antimicrobials for serious and unmet medical needs; Antibiotics/stewardship; S.2076/H.R.3932, PASTEUR Act of 2021; Value of prescription drugs; Issues related to Medicare Parts B and D; Issues related to Vaccine Injury Compensation Fund (VICF); Issues related to coverage of EUA products in Part D

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pandemic preparedness; Antimicrobial resistance; PASTEUR Act (H.R. 3932 and S. 2076)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

COVID Supplemental Appropriation FY2023 Defense Appropriations S.2076/H.R.3932 - PASTEUR Act of 2021 S.3799 - PREVENT Pandemics Act Issues related to the development of an antibody therapy for COVID-19 Issues related to antimicrobial resistance (AMR) and drug development Issues related to supply chain and biopharmaceutical manufacturing H.R.8236 - Department of Defense Appropriations Act, 2023 H.R.7667 - Food and Drug Amendments of 2022 S.4348 - Food and Drug Administration Safety and Landmark Advancements Act (FDASLA) of 2022 H.R.5585 - Advanced Research Projects Agency - Health (ARPA-H) Act S.3819 - Advanced Research Project Authority for Health (ARPA-H) Act H.R.6833 - Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 H.R.2617 - Consolidated Appropriations Act, 2023

Client expense: $210,000 · Firm income: Not reported

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

National Vaccine Injury Compensation Program issues; Consolidated Appropriations Act, 2023 (P.L. 117-328); PAHPA reauthorization; policy riders related to reauthorization of the FDA user fee agreements, PASTEUR Act of 2021 (S. 2076).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pandemic preparedness; Antimicrobial resistance; PASTEUR Act (H.R. 3932 and S. 2076)

Client expense: Not reported · Firm income: Not reported

FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348); Food and Drug Amendments of 2022 (H.R. 7667); Diverse and Equitable Participation in Clinical Trials Act (H.R. 6584); Advanced Research Project Agency-Health Act (H.R. 5585); America COMPETES Act of 2022 (H.R. 4521); Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Increasing Prescription Drug Competition Act (S. 4918); Consolidated Appropriations Act, 2023 (H.R. 2617); PASTEUR Act of 2021 (H.R. 3932/S. 2076); Biologics Competition Act of 2022 (H.R. 8877); Give Kids a Chance Act of 2022 (S. 4125/H.R. 6972); Orange Book listing issues; Bayh-Dole Act.

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

genomic sequencing and surveillance Tracking Pathogens Act (H.R.7152, S. 3534) Antimicrobial resistance (PASTEUR Act, S. 2076, STAAR Act, S. 3291) PREVENT Pandemics Act (S. 3799)

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

genomic sequencing and surveillance Tracking Pathogens Act (H.R.7152, S. 3534) Antimicrobial resistance (PASTEUR Act, S. 2076, STAAR Act, S. 3291) PREVENT Pandemics Act (S. 3799)

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Supporting Funding for the National Institutes of Health (NIH) research and the Food and Drug Administration that benefits people with cystic fibrosis. Tracking developments related to S.2076/H.R.3932, the PASTEUR Act, and incusion of the bill in the end-of-year omnibus. Highlighting the importance of FDA policies on patients with rare diseases.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Antibiotic research and development; S. 3799, PREVENT Pandemics Act; H.R. 3932/S. 2076, the PASTEUR Act.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1976 / S. 4204- "Medicare for All Act" - Single-payer healthcare systems. H.R. 2617 - Consolidated Appropriations Act, 2023 - Provisions related to health care H.R. 1227/ S.386 - "Medicare-X Choice Act of 2021" - Public Option Healthcare systems S. 2428 - False Claims Amendments Act of 2021 - False Claims Act Amendments H.R. 8201 - Promoting Health Care Quality Act of 2022 - Health care quality provisions under the Medicare program. S. 3799 - "PREVENT Pandemics Act" - pandemic preparedness H.R.3932/ S. 2076 - "PASTEUR Act of 2021" - addressing antimicrobial resistance (AMR) Support continued Congressional work on behavioral health

Client expense: $620,000 · Firm income: Not reported

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

H.R. 3932 / S. 2076, The PASTEUR Act and issues related to sepsis treatment and antibiotic stewardship.

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

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

Issues surrounding antimicrobial preparedness H.R.4127 - DISARM Act of 2021 H.R.3932/S.2076 - PASTEUR Act of 2021

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

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) 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 Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $3,740,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for the USDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

Client expense: $3,740,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA

Client expense: $3,740,000 · Firm income: Not reported

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

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Client expense: $3,740,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office