Vaccine Injury Compensation Modernization Act of 2021

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

Biofuels (Non-Funding) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft) ---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Reform of New Operating Loss Rules Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Orphan Drug Issues ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Tax Credit Qualified Small Business Stock (QSBS) ---Draft Legislation to modify and expand the Section 1202 exclusion for gain from QSBS ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit Research & Development Tax Credit Reforms ---H.R.1304/S.749: American Innovation and Jobs Act ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Expensing of R&D Expenditures ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---R&D Payroll Credit 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: HOUSE OF REPRESENTATIVES, SENATE

HR 550, Immunization Information Systems Modernization Act HR 2170/S 581, Helping Adults Protect Immunity (HAPI) Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act PREVENT Pandemics Act HR 2347/S 2691, Strengthening the Vaccines for Children Program Act Federal funding for Section 317 Immunization Programs, infectious disease and public health funding Student loan forgiveness for public health workforce HR 3655, Vaccine Injury Compensation Modernization Act FY23 Omnibus Spending bill

Client expense: Not reported · 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), Health Resources & Services Administration (HRSA), SENATE

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act; H.R. 6000, Cures 2.0 Act; H.R. 6519, Patients Right to Know Their Medication Act of 2022; Draft legislation, Pharmacy Price Transparency Protection Act; H.R. 7559, Prescription Information Modernization Act; Draft legislation, To ensure that private health insurers are able to provide appropriate oversight of entities providing pharmacy benefit manager services; Draft legislation, the PBM Transparency, Accountability, and Reform Act

Client expense: $320,000 · 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), Health Resources & Services Administration (HRSA), SENATE, White House Office

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) 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. 909/S. 484, Moms Matter Act H.R. 959/S. 346, Black Maternal Health Momnibus Act of 2021 H.R. 1620, Violence Against Women Act Reauthorization Act of 2021 H.R. 2347/S. 2691, Strengthening the Vaccines for Children Program Act of 2021 H.R. 3407/S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act H.R. 3655, Vaccine Injury Compensation Modernization Act of 2021 H.R. 4217/S. 2779, Taskforce Recommending Improvements for Unaddressed Mental Perinatal & Postpartum Health (TRIUMPH) for New Moms Act H.R. 5376, Inflation Reduction Act - provisions related to health equity and mental and behavioral health for patients and health care providers H.R. 5585, Advanced Research Projects Agency-Health (ARPA-H) Act H.R. 7236, Strengthen Kids Mental Health Now Act of 2022 H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022 H.R. 7780, Mental Health Matters Act H.R. 8296, Womens Health Protection Act of 2022 H.R. 8391, Continuity in Necessary Evaluative Crisis Treatment (CONNECT) Act of 2022 S. 104/H.R. 379, Improving Social Determinants of Health Act of 2021 S. 674, Public Health Infrastructure Saves Lives Act S. 3479/H.R. 8151, Building a Sustainable Workforce for Healthy Communities Act S. 3623, Violence Against Women Act Reauthorization Act of 2022 S. 4170, Mental Health Reform Reauthorization Act of 2022

Client expense: Not reported · Firm income: $26,600

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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. 66, Comprehensive Access to Robust Insurance Now Guaranteed for Kids (CARING for Kids) Act H.R. 482/S. 350, Newborn Screening Saves Lives Reauthorization Act of 2021 H.R. 485, Stronger Child Abuse Prevention and Treatment Act H.R. 550, Immunization Infrastructure Modernization Act of 2021 H.R. 909/S. 484, Moms Matter Act H.R. 959/S. 346, Black Maternal Health Momnibus Act of 2021 H.R. 1065/S. 1486, Pregnant Workers Fairness Act H.R. 1324/S/ 467, Effective Suicide Screening and Assessment in the Emergency Department Act of 2021 H.R. 1390, Childrens Health Insurance Program Pandemic Enhancement and Relief (CHIPPER) Act H.R. 1620, Violence Against Women Act Reauthorization Act of 2021 H.R. 1791, Childrens Health Insurance Program Permanency (CHIPP) Act H.R. 2094/S. 1301, Promoting Physical Activity for Americans Act H.R. 2347/S. 2691, Strengthening the Vaccines for Children Program Act of 2021 H.R. 3173/S. 3018, Improving Seniors Timely Access to Care Act of 2021 H.R. 3182, Safe Sleep for Babies Act of 2021 H.R. 3407/S. 411, Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act H.R. 3655, Vaccine Injury Compensation Modernization Act of 2021 H.R. 4217/S. 2779, Taskforce Recommending Improvements for Unaddressed Mental Perinatal & Postpartum Health (TRIUMPH) for New Moms Act H.R. 5376, Inflation Reduction Act - provisions related to health equity and mental and behavioral health for patients and health care providers H.R. 5487/S. 3972, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021 H.R. 5585, Advanced Research Projects Agency-Health (ARPA-H) Act H.R. 7076, Supporting Childrens Mental Health Care Access Act of 2022 H.R. 7236, Strengthen Kids Mental Health Now Act of 2022 H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022 H.R. 7780, Mental Health Matters Act H.R. 8296, Womens Health Protection Act of 2022 H.R. 8391, Continuity in Necessary Evaluative Crisis Treatment (CONNECT) Act of 2022 H.R. 8450, Healthy Meals, Healthy Kids Act S. 104/H.R. 379, Improving Social Determinants of Health Act of 2021 S. 248/H.R. 804, Family and Medical Insurance Leave (FAMILY) Act S. 499/H.R. 369, Improving Health Insurance Affordability Act of 2021 S. 674, Public Health Infrastructure Saves Lives Act S. 844/H.R. 3109, PHIT Act of 2021 S. 1259, Safe Cribs Act S. 1275/H.R. 2119, Family Violence Prevention and Services Improvement Act of 2021 S. 1658/H.R. 3110, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act S. 1675/H.R. 4387, Maternal Health Quality Improvement Act S. 2069/H.R. 4323, Excellence in Mental Health and Addiction Treatment Act S. 3479/H.R. 8151, Building a Sustainable Workforce for Healthy Communities Act S. 3623, Violence Against Women Act Reauthorization Act of 2022 S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) S. 4170, Mental Health Reform Reauthorization Act of 2022

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. 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.1978 - Protecting Seniors Through Immunization Act of 2021 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. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing 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. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing 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 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 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 S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act 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. 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. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 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. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) 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. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing 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 Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform 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 PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) 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 Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property

Client expense: $1,390,000 · Firm income: Not reported

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---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 ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---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 --- In-Home Administration of Part B Drugs ---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 ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations 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.729: Strength in Diversity Act of 2021 ---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.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 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---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.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment (Discussion Draft) ---Advanced Manufacturing ---Counterfeiting ---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 ---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 ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 Appropriations ---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.153: Protecting Consumer Access to Generic Drugs 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.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---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 ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---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 ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---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 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---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.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---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.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---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 ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---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.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: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)

Client expense: $3,220,000 · 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, White House Office

Biofuels (Non-Funding) ---H.R.5376: Inflation Reduction Act of 2022 ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act --- H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft) ---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft) ---Reform of New Operating Loss Rules Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Orphan Drug Issues ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Tax Credit Qualified Small Business Stock (QSBS) ---H.R.5376: Inflation Reduction Act of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.5376: Inflation Reduction Act of 2022 ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)

Client expense: $3,220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1280, George Floyd Justice in Policing Act. H.R. 3655, Vaccine Injury Compensation Modernization Act. H.R. 3962: Securing and Enabling Commerce Using Remote and Electronic Notarization Act of 2022. S. 1260, United States Innovation and Competition Act, with specific regard to provisions on supply chain liability for information sharing programs. H.R. 4777/ S. 2497, Nondebtor Release Prohibition Act. H.R. 27, Settlement Agreement Information Database Act of 2021. S. 3942, Disabled Jurors Nondiscrimination Act. H.R. 8736, GUARD VA Benefits Act. H.R. 8569 the Removal Adjustment Act of 2022. H.R. 2988 Whistleblower Protection Improvement Act. Draft legislation related to regulatory reforms and significant guidance. Draft legislation related to police misconduct reforms. Draft legislation on structured settlements. Draft legislation on SLAPP claims. Draft legislation on peremptory challenges to jurors. General lobbying with regard to qualified immunity reforms. General lobbying with regard to diversity of professional background for the federal judiciary. General lobbying with regard to federal judicial nominations, and with specific regard to Tiffany M. Cartwright, nominated for the United States District Court for the Western District of Washington; Rachel Bloomekatz nominated for the United States Court of Appeals for the Sixth Circuit; Judge Mia Perez nominated for the United States District Court for the Eastern District of Pennsylvania; Judge Matthew Garcia nominated for the United States District Court for the District of New Mexico; Judge Adrienne Nelson nominated for the United States District Court for the District of Oregon; Judge Jamal Whitehead nominated for the United States District Court for the Western District of Washington; Judge Araceli Martinez-Olguin nominated for the United States District Court for the Northern District of California; Judge Maria Araujo Kahn nominated for the United States Court of Appeals for the Second Circuit; Judge Myong Joun nominated for the United States District Court for the District of Massachusetts; Judge Frances Kay Behm nominated for the United States District Court for the Eastern District of Michigan; Judge Anne Nardacci nominated for the United States District Court for the Northern District of New York; Judge Sarah Merriam nominated to the United States Court of Appeals for the Second Circuit; Judge Jessica Clarke nominated for the United States District Court for the Southern District of New York; Judge Dale Ho nominated for the United States District Court for the Southern District of New York; Judge Nancy Abudu nominated for the United States Court of Appeals for the Eleventh Circuit; Judge William Pocan nominated for the United States District Court for the Eastern District of Wisconsin; Judge Arun Subramanian nominated for the United States District Court for the Southern District of New York. General lobbying on the Nomination of Kalpana Kotagal for Member of the Equal Employment Opportunity Commission. General lobbying with regard to nonconsensual third-party releases and stays in bankruptcy proceedings. General lobbying with regard to diversity jurisdiction and snap removal. General lobbying with regard to federal officer removal. General lobbying with regard to liability in voluntary government sharing programs. General lobbying with regard to litigation financing. General lobbying with regard to Johnson & Johnson and the Texas Two-Step. General lobbying with regard to Respondeat Superior and Monell claims against states and localities.

Client expense: $1,180,000 · Firm income: Not reported

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

H.R.3655 - Vaccine Injury Compensation Modernization Act of 2021. S.4348 - FDASLA Act of 2022 and H.R.7667 - Food and Drug Amendments of 2022.

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

Government targets: HOUSE OF REPRESENTATIVES

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act; H.R. 6000, Cures 2.0 Act; H.R. 6519, Patients Right to Know Their Medication Act of 2022; Draft legislation, Pharmacy Price Transparency Protection Act; H.R. 7559, Prescription Information Modernization Act; Draft legislation, To ensure that private health insurers are able to provide appropriate oversight of entities providing pharmacy benefit manager services

Client expense: $400,000 · 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), Health Resources & Services Administration (HRSA), SENATE, White House Office

HR 550, Immunization Information Systems Modernization Act HR 2170/S 581, Helping Adults Protect Immunity (HAPI) Act HR 1978/S 912, Protecting Seniors through Immunity Act HR 951/S 345, Maternal Vaccination Act PREVENT Pandemics Act HR 2347/S 2691, Strengthening the Vaccines for Children Program Act Federal funding for Section 317 Immunization Programs, infectious disease and public health funding Student loan forgiveness for public health workforce HR 3655, Vaccine Injury Compensation Modernization Act

Client expense: $10,000 · 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), Health Resources & Services Administration (HRSA), SENATE

H.R. 1280, George Floyd Justice in Policing Act. H.R. 3655, Vaccine Injury Compensation Modernization Act. S. 1260, United States Innovation and Competition Act, with specific regard to provisions on supply chain liability for information sharing programs. H.R. 4777/ S. 2497, Nondebtor Release Prohibition Act. H.R. 27, Settlement Agreement Information Database Act of 2021. S. 3942, Disabled Jurors Nondiscrimination Act. Draft legislation related to regulatory reforms and significant guidance. Draft legislation related to police misconduct reforms. Draft legislation on structured settlements. Draft legislation on SLAPP claims. Draft legislation on peremptory challenges to jurors. General lobbying with regard to qualified immunity reforms. General lobbying with regard to diversity of professional background for the federal judiciary. General lobbying with regard to federal judicial nominations, and with specific regard to Tiffany M. Cartwright, nominated for the United States District Court for the Western District of Washington; Rachel Bloomekatz nominated for the United States Circuit for the Sixth Circuit; Judge Elizabeth Hanes nominated for the United States District Court for the Eastern District of Virginia. General lobbying on the Nomination of Kalpana Kotagal for Member of the Equal Employment Opportunity Commission. General lobbying with regard to nonconsensual third-party releases and stays in bankruptcy proceedings. General lobbying with regard to diversity jurisdiction and snap removal. General lobbying with regard to federal officer removal. General lobbying with regard to the Solicitor General and ambassador positions. General lobbying with regard to liability in voluntary government sharing programs. General lobbying with regard to litigation financing. General lobbying with regard to Johnson & Johnson and the Texas Two-Step. General lobbying with regard to Respondeat Superior and Monell claims against states and localities.

Client expense: $1,010,000 · Firm income: Not reported

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

Biofuels (Non-Funding) ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7555: A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7556: A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---Build Back Better Act (Discussion Draft Senate) ---Reform of New Operating Loss Rules Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Orphan Drug Issues ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Tax Credit Qualified Small Business Stock (QSBS) ---H.R.5376: Build Back Better Act of 2021 ---Build Back Better Act (Discussion Draft Senate) Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.5376: Build Back Better Act of 2021 ------R&D Amortization ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---H.R.1304/S.749: American Innovation and R&D Competitiveness Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021

Client expense: $3,120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---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 ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Biosimilars ---H.R.7035: Biologics Market Transparency Act ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---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 ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Families First Coronavirus Response Act of 2020 ---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 ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---TRIPS IP Waiver Climate Change ---FY 2023 Appropriations 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.729: Strength in Diversity Act of 2021 ---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 ---H.R.7667: The Food and Drug Amendments of 2022 ---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.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.4472: Better Empowerment Now To Enhance Framework and Improve Treatments (BENEFIT) Act ---H.R.4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---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 ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---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 ---S.4351: Enhanced Access to Affordable Medicines Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---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.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---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.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Counterfeiting ---Drug Shortages ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: 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 ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---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.4418: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 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 ---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 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Build Back Better Act (Discussion Draft Senate) ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Rare Disease Pilot Program 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.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---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.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 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of Consolidated Appropriations Act for FY 2021 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Recovery of Routine Immunizations ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021

Client expense: $3,120,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act; H.R. 6000, Cures 2.0 Act; H.R. 6519, Patients Right to Know Their Medication Act of 2022; Draft legislation, Pharmacy Price Transparency Protection Act; H.R. 7559, Prescription Information Modernization Act; Draft legislation, To ensure that private health insurers are able to provide appropriate oversight of entities providing pharmacy benefit manager services

Client expense: $460,000 · 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), Health Resources & Services Administration (HRSA), SENATE, White House Office

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy ---Tropical Disease Priority Review (PRV) Program Biosimilars ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R. 7035: Biologics Market Transparency Act ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---BSUFA III Discussion Draft ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---In-Home Administration of Part B Drugs ---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 ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Draft Discussion) Diversity & Inclusion ---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 ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R. 4472: Better Empowerment Now To Enhance Framework and Improve Treatments Act ( BENEFIT Act) ---H.R. 4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R. 6963: Accelerated Approval Integrity Act ---H.R. 6996: Accelerating Approval for Patients Act ---H.R. 7008: The Pre-Approval Information Exchange Act ---S.1644 Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---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 Drug Manufacturing, Quality & Distribution ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---H.R. 3927: Manufacturing API, Drugs, & Excipients in America (MADE in America) Act ---H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies Act (INSPECTIONS Act) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: 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 ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---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.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Generic Drug Entry ---H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R. 5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R. 6888: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R. 1730: Speeding Therapy Access Today (STAT) Act ---Orphan Drug Act Reforms ---Tax Credit 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.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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.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.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021

Client expense: $3,170,000 · Firm income: Not reported

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

H.R. 1280, George Floyd Justice in Policing Act. H.R. 3655, Vaccine Injury Compensation Modernization Act. S. 1260, United States Innovation and Competition Act, with specific regard to provisions on supply chain liability for information sharing programs. H.R. 4777/ S. 2497, Nondebtor Release Prohibition Act. H.R. 27, Settlement Agreement Information Database Act of 2021. S. 3942, Disabled Jurors Nondiscrimination Act. Draft legislation related to regulatory reforms and significant guidance. Draft legislation related to police misconduct reforms. Draft legislation on structured settlements. General lobbying with regard to qualified immunity reforms. General lobbying with regard to diversity of professional background for the federal judiciary. General lobbying with regard to federal judicial nominations, and with specific regard to the following nominees: Judge William S. Pocan, nominated for the United States District Court of the Eastern District of Wisconsin; Tiffany M. Cartwright, nominated for the United States District Court for the Western District of Washington; and Judge Ketanji Brown Jackson, nominated for the United States Supreme Court. General lobbying with regard to nonconsensual third-party releases and stays in bankruptcy proceedings. General lobbying with regard to diversity jurisdiction and snap removal. General lobbying with regard to federal officer removal. General lobbying with regard to the Solicitor General and ambassador positions. General lobbying with regard to liability in voluntary government sharing programs. General lobbying with regard to litigation financing. General lobbying with regard to Johnson & Johnson and the Texas Two-Step.

Client expense: $1,070,000 · Firm income: Not reported

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

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act; H.R. 6000, Cures 2.0 Act; H.R. 6519, Patients Right to Know Their Medication Act of 2022; Draft legislation, Pharmacy Price Transparency Protection Act; Draft legislation, Prescription Information Modernization Act;

Client expense: $2,010,000 · 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), Health Resources & Services Administration (HRSA), SENATE, White House Office

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act

Client expense: $2,100,000 · 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), Health Resources & Services Administration (HRSA), SENATE, White House Office

H.R. 1280, George Floyd Justice in Policing Act. H.R. 3655, Vaccine Injury Compensation Modernization Act. S. 1260, United States Innovation and Competition Act, with specific regard to provisions on supply chain liability for information sharing programs. H.R. 4777/ S. 2497, Nondebtor Release Prohibition Act. Draft legislation related to regulatory reforms and significant guidance. Draft legislation related to police misconduct reforms. Draft legislation on structured settlements. General lobbying with regard to qualified immunity reforms. General lobbying with regard to diversity of professional background for the federal judiciary. General lobbying with regard to federal judicial nominations, and with specific regard to Margaret Strickland, nominated and confirmed for District of New Mexico; Charlotte Sweeney, nominated for District of Colorado; Shalina D. Kumar, nominated for Eastern District of Michigan; Jane M. Beckering, nominated for Western District of Michigan; David Herrera Urias, nominated for District of New Mexico; Tana Lin, nominated for Western District of Washington; Jennifer Sung, nominated for 9th Circuit Court of Appeals (OR). General lobbying with regard to federal judicial nominations, and with specific regard to Judge Julie Rubin, nominated for the United States District Court for the District of Maryland; Jessica G.L. Clarke, nominated for the United States District Court for the Southern District of New York; Judge William S. Pocan, nominated for the United States District Court of the Eastern District of Wisconsin. General lobbying with regard to nonconsensual third-party releases and stays in bankruptcy proceedings. General lobbying with regard to diversity jurisdiction and snap removal. General lobbying with regard to federal officer removal. General lobbying with regard to the Solicitor General and ambassador positions. General lobbying with regard to liability in voluntary government sharing programs. General lobbying with regard to litigation financing. General lobbying with regard to a board member position on the President's Intelligence Advisory Board.

Client expense: $1,180,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Federal Motor Carrier Safety Administration, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Highway Traffic Safety Administration (NHTSA), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy Biosimilars ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---In-Home Administration of Part B Drugs ---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 ---TRIPS IP Waiver Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity ---Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (Discussion Draft) Drug Evaluation and Review ---S.1644: Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Drug Manufacturing, Quality & Distribution ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---Drug Shortages ---Executive Order on Buy American ---Inspections ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: 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 ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---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.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Principles Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Generic Drug Entry ---H.R.2883: Stop Stalling Access to Affordable Medications Act Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit 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.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---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.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---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.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.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

Client expense: $3,370,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574 / H.R. 5632, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act; H.R. 6005, the Access to Birth Control Act

Client expense: $430,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Occupational Safety & Health Administration (OSHA), SENATE, Small Business Administration (SBA), Treasury, Dept of, White House Office

Issues related to broadband infrastructure and spectrum management H.R. 3684, Infrastructure Investment and Jobs Act H.R. 5378, Spectrum Innovation Act of 2021 H.R. 5376, Build Back Better Act H.R. 981, IoT Readiness Act of 2021 S. 553, Government Spectrum Valuation Act H.R. 2501, Spectrum Coordination Act S. 1365, Extending Tribal Broadband Priority Act of 2021 S. 1472, Improving Spectrum Coordination Act of 2021 H.R. 3655, Vaccine Injury Compensation Modernization Act of 2021 H.R. 5486, Simplifying Management, Reallocation, and Transfer of Spectrum Act (SMART Act)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to HR 3 "Lower Drug Costs Now Act of 2019"; issues related to drug pricing; issues related to Drug Pricing in H.R.5376 "Build Back Better Act"; issues related to influenza vaccines; issues related to RSV Access; issues related to routine immunization rates; general issues related to vaccines; issues related to 340B; issues related to insulin pricing; issues related to funding for Pandemic influenza; issues related to Bipartisan Infrastructure Package; issues related to HR 550 "Immunization Infrastructure Modernization Act"; issues related to HR 3655 "Vaccine Injury Compensation Modernization Act"; issues related to RX to OTC switch; issues related to S.1132 "EPI Act"; issues related to HR 19 "Lower Costs, More Cures Act of 2021"; issues related Counterfeits in S.936 "INFORM Consumers Act"; issues related to Counterfeits in S.1843 "SHOP SAFE Act"; issues related to Pandemic Preparedness; issues related to Cures 2.0; issues related to Platform Technologies; issues related to Medicare Sequestration; issues related to Reconciliation; and issues related to Intellectual Property.

Client expense: $1,310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1280, George Floyd Justice in Policing Act. H.R. 3655, Vaccine Injury Compensation Modernization Act. S. 1260, United States Innovation and Competition Act, with specific regard to provisions on supply chain liability for information sharing programs. H.R. 4777/ S. 2497, Nondebtor Release Prohibition Act. Draft legislation related to regulatory reforms and significant guidance. Draft legislation related to police misconduct reforms. General lobbying with regard to qualified immunity reforms. General lobbying with regard to diversity of professional background for the federal judiciary. General lobbying with regard to federal judicial nominations, and with specific regard to Margaret Strickland, nominated and confirmed for District of New Mexico; Charlotte Sweeney, nominated for District of Colorado; Shalina D. Kumar, nominated for Eastern District of Michigan; Jane M. Beckering, nominated for Western District of Michigan; David Herrera Urias, nominated for District of New Mexico; Tana Lin, nominated for Western District of Washington; Jennifer Sung, nominated for 9th Circuit Court of Appeals (OR). General lobbying with regard to nonconsensual third-party releases and stays in bankruptcy proceedings. General lobbying with regard to diversity jurisdiction and snap removal. General lobbying with regard to federal officer removal. General lobbying with regard to the Solicitor General and ambassador positions. General lobbying with regard to liability in voluntary government sharing programs.

Client expense: $1,240,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Motor Carrier Safety Administration, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Highway Traffic Safety Administration (NHTSA), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---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 ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---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.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 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 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit 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 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021

Client expense: $3,360,000 · Firm income: Not reported

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

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution; Pharmacist scope of practice, including authorities established by the Public Readiness and Emergency Preparedness (PREP) Act; H.R. 4390, the PROTECT 340B Act of 2021; S. 1574, the Long-Term Care Pharmacy Definition Act of 2021; Provider Relief Fund; Implementation of Pubic Law 113-54, the Drug Quality and Security Act;

Client expense: $420,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Occupational Safety & Health Administration (OSHA), SENATE, Small Business Administration (SBA), Treasury, Dept of, White House Office

Issues related to HR 3 "Lower Drug Costs Now Act of 2019"; issues related to drug pricing; issues related to influenza vaccines; issues related to RSV Access; issues related to routine immunization rates; issues related to HR 1319 "American Rescue Plan"; general issues related to trade; general issues related to AMP CAP; general issues related to vaccines; issues related to 340B; issues related to insulin pricing; issues related to funding for Pandemic influenza; issues related to Flu Infrastructure Funding; issues related to HR 1978 "Protecting Seniors Through Immunization Act"; issues related to HR 2170 "Helping Adults Protect Immunity Act"; issues related to HR 550 "Immunization Infrastructure Modernization Act"; issues related to HR 2437 "Strengthening the Vaccines for Children Act of 2021"; issues related to HR 3655 "Vaccine Injury Compensation Modernization Act"; issues related to vaccine authorized for emergency use under HR 3705; issues related to RX to OTC switch; issues related to S.1132 "EPI Act"; issues related to S.2164 "Lower Costs, More Cures Act of 2021; and issues related to HR 19 "Lower Costs, More Cures Act of 2021".

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; Rx reform; Prescription drugs; Prescription Drug Reform; H.R. 951 - Maternal Vaccination Act Sponsor: Rep. Terri Sewell (D-AL-07) H.R. 979 - Vaccine Fairness Act Sponsor: Rep. Angie Craig (D-MN-02) H.R. 1452 - To direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. Sponsor: Rep. Dan Crenshaw (R-TX-02) H.R. 1978 - Protecting Seniors Through Immunization Act of 2021 Sponsor: Rep. Annie Kuster (D-NH-02) H.R. 2347 - Strengthening the Vaccines for Children Program Act of 2021 Sponsor: Rep. Kim Schrier (D-WA-08) H.R. 3013 - COVID Vaccine Transportation Access Act Sponsor: Rep. Nanette Barragan (D-CA-44) H.R. 3655 - Vaccine Injury Compensation Modernization Act of 2021 Sponsor: Rep. Lloyd Doggett (D-TX-35) H.R. 3742 - Vaccine INFO Act Sponsor: Rep. Gus Bilirakis (R-FL-12) H.R. 3 - Lower Drug Costs Now Act Sponsor: Rep. Frank Pallone (D-NJ-06) H.R. 2831 - Prompt Approval of Safe Generic Drugs Act Sponsor: Rep. Nanette Barragan (D-CA-44)

Client expense: $124,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1280, George Floyd Justice in Policing Act. H.R. 3655, Vaccine Injury Compensation Modernization Act. S. 1260, United States Innovation and Competition Act, with specific regard to provisions on supply chain liability for information sharing programs. Draft legislation related to regulatory reforms and significant guidance. Draft legislation related to police misconduct reforms. General lobbying with regard to qualified immunity reforms. General lobbying with regard to diversity of professional background for the federal judiciary. General lobbying with regard to federal judicial nominations. General lobbying with regard to the nomination of Vanita Gupta as the United States Associate Attorney General. General lobbying with regard to the nomination of Kristen Clarke as head of the Department of Justice's Civil Rights Division. General lobbying with regard to nonconsensual third-party releases and stays in bankruptcy proceedings. General lobbying with regard to diversity jurisdiction and snap removal. General lobbying with regard to federal officer removal. General lobbying with regard to the Solicitor General and ambassador positions. General lobbying with regard to liability in voluntary government sharing programs.

Client expense: $963,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Federal Motor Carrier Safety Administration, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; Rx reform; Prescription drugs; Prescription Drug Reform; H.R. 550 - Immunization Infrastructure Modernization Act of 2021 Sponsor: Rep. Annie Kuster (D-NH-02) H.R. 3743 - Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act Sponsor: Rep. Richard Hudson (R-NC-08) H.R. 951 - Maternal Vaccination Act Sponsor: Rep. Terri Sewell (D-AL-07) H.R. 979 - Vaccine Fairness Act Sponsor: Rep. Angie Craig (D-MN-02) H.R. 1452 - To direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. Sponsor: Rep. Dan Crenshaw (R-TX-02) H.R. 1978 - Protecting Seniors Through Immunization Act of 2021 Sponsor: Rep. Annie Kuster (D-NH-02) H.R. 2347 - Strengthening the Vaccines for Children Program Act of 2021 Sponsor: Rep. Kim Schrier (D-WA-08) H.R. 3013 - COVID Vaccine Transportation Access Act Sponsor: Rep. Nanette Barragan (D-CA-44) H.R. 3655 - Vaccine Injury Compensation Modernization Act of 2021 Sponsor: Rep. Lloyd Doggett (D-TX-35) H.R. 3742 - Vaccine INFO Act Sponsor: Rep. Gus Bilirakis (R-FL-12) H.R. 3 - Lower Drug Costs Now Act Sponsor: Rep. Frank Pallone (D-NJ-06) H.R. 2831 - Prompt Approval of Safe Generic Drugs Act Sponsor: Rep. Nanette Barragan (D-CA-44)

Client expense: $1,650,000 · Firm income: Not reported

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

21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: 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. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---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 ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---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.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule 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 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021

Client expense: $3,500,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), 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

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; Rx Reform; Prescription Drugs; Prescription Drug Reform HR 3 (117th Congress), Elijah E. Cummings Lower Drug Costs Now Act, by Rep. Frank Pallone (D-NJ). Establishes a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees. HR 550 (117th Congress), Immunization Infrastructure Modernization Act of 2021, by Rep. Ann Kuster (D-NH). Amends the Public Health Service Act with respect to immunization system data modernization and expansion. HR 951 (117th Congress), Maternal Vaccination Act, by Rep. Terri Sewell (D-AL). Directs the Secretary of Health and Human Services to carry out a national campaign to increase awareness of the importance of maternal vaccinations for the health of pregnant and postpartum individuals and their children. HR 979 (117th Congress), Vaccine Fairness Act, by Rep. Angie Craig (D-MN). Directs the Secretary of Health and Human Services to submit to Congress a weekly report on COVID-19 vaccine distribution. HR 1452 (117th Congress), by Rep. Dan Crenshaw (R-TX). Directs the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines. HR 1978 (117th Congress), Protecting Seniors Through Immunization Act of 2021, by Rep. Ann Kuster (D-NH). Amends title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare Part D is consistent with the treatment of vaccines under Medicare Part B. HR 2347 (117th Congress), Strengthening the Vaccines for Children Program Act of 2021, by Rep. Kim Schrier (D- WA). Amends title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program. HR 2831 (117th Congress), Prompt Approval of Safe Generic Drugs Act, by Rep. Nanette Diaz Barragan (D-CA). Amends the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling. HR 3013 (117th Congress), COVID Vaccine Transportation Access Act, by Rep. Nanette Diaz Barragan (D-CA). Authorizes the Secretary of Health and Human Services to award grants for removing transportation barriers to accessing vaccines for SARS-CoV-2, including booster vaccines, for individuals from low-income communities, minority communities, or other communities in which transportation poses a barrier to health care access. HR 3655 (117th Congress), Vaccine Injury Compensation Modernization Act of 2021, by Rep. Lloyd Doggett (D-TX). Amends the Public Health Service Act to make updates to the Vaccine Injury Compensation Program. HR 3742 (117th Congress), Vaccine INFO Act, by Rep. Gus Bilirakis (R-FL). Requires the Secretary of Health and Human Services to issue revised regulations to require the dissemination of information on ACIP recommended immunizations to staff of nursing facilities. HR 3743 (117th Congress), Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act, by Rep. Richard Hudson (R-NC). Increases funding for the Reagan-Udall Foundation for the Food and Drug Administration and for the Foundation for the National Institutes of Health.

Client expense: Not reported · Firm income: Not reported

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

COVID-19 Testing; COVID-19 Vaccine Strategy and Treatment; Vaccine Rollout; Rx Reform; Prescription Drugs; Prescription Drug Reform HR 3 (117th Congress), Elijah E. Cummings Lower Drug Costs Now Act, by Rep. Frank Pallone (D-NJ). Establishes a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees. HR 550 (117th Congress), Immunization Infrastructure Modernization Act of 2021, by Rep. Ann Kuster (D-NH). Amends the Public Health Service Act with respect to immunization system data modernization and expansion. HR 951 (117th Congress), Maternal Vaccination Act, by Rep. Terri Sewell (D-AL). Directs the Secretary of Health and Human Services to carry out a national campaign to increase awareness of the importance of maternal vaccinations for the health of pregnant and postpartum individuals and their children. HR 979 (117th Congress), Vaccine Fairness Act, by Rep. Angie Craig (D-MN). Directs the Secretary of Health and Human Services to submit to Congress a weekly report on COVID-19 vaccine distribution. HR 1452 (117th Congress), by Rep. Dan Crenshaw (R-TX). Directs the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines. HR 1978 (117th Congress), Protecting Seniors Through Immunization Act of 2021, by Rep. Ann Kuster (D-NH). Amends title XVIII of the Social Security Act to provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare Part D is consistent with the treatment of vaccines under Medicare Part B. HR 2347 (117th Congress), Strengthening the Vaccines for Children Program Act of 2021, by Rep. Kim Schrier (D- WA). Amends title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program. HR 2831 (117th Congress), Prompt Approval of Safe Generic Drugs Act, by Rep. Nanette Diaz Barragan (D-CA). Amends the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling. HR 3013 (117th Congress), COVID Vaccine Transportation Access Act, by Rep. Nanette Diaz Barragan (D-CA). Authorizes the Secretary of Health and Human Services to award grants for removing transportation barriers to accessing vaccines for SARS-CoV-2, including booster vaccines, for individuals from low-income communities, minority communities, or other communities in which transportation poses a barrier to health care access. HR 3655 (117th Congress), Vaccine Injury Compensation Modernization Act of 2021, by Rep. Lloyd Doggett (D-TX). Amends the Public Health Service Act to make updates to the Vaccine Injury Compensation Program. HR 3742 (117th Congress), Vaccine INFO Act, by Rep. Gus Bilirakis (R-FL). Requires the Secretary of Health and Human Services to issue revised regulations to require the dissemination of information on ACIP recommended immunizations to staff of nursing facilities. HR 3743 (117th Congress), Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act, by Rep. Richard Hudson (R-NC). Increases funding for the Reagan-Udall Foundation for the Food and Drug Administration and for the Foundation for the National Institutes of Health.

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

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

S. 298 / H.R. 1829, the Pharmacy Benefit Manager Accountability Study Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 3656, the Vaccine Access Improvement Act of 2021; H.R. 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021; COVID vaccine distribution

Client expense: $370,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office