Food and Drug Amendments of 2022

Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---DISARM Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Implementation of USDA Discretion to Provide Support for Biofuel Producers in Consolidated Appropriations Act for FY 2021 Funding for Biorefineries ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for FDA ---FY 2024 Appropriations ---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 ---Food and Drug Administration Safety and Landmark Advancements Act ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---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 ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for the USDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

Client expense: $2,430,000 · Firm income: Not reported

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

H.R.7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R.1730/S.670, Speeding Therapy Access Today Act; H.R.7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R.6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes; H.R.2617, the Consolidated Appropriations Act, 2023.

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

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

Legislation regarding drug pricing, value, and reimbursement; H.R.3, Elijah Cummings Lower Drug Costs Now Act, and related Senate legislation; H.R.19, Lower Costs, More Cures Act of 2021; H.R.5376 - Build Back Better Act and Inflation Reduction Act - P.L. 117-169, issues related to drug policies and access to therapies for patients with rare diseases; H.R.1629, Fairness in Orphan Drug Exclusivity Act; H.R.7506, legislation to revolutionize education, diagnoses, and treatment of rare kidney diseases; H.R.7667, the Food and Drug Amendments of 2022 - provisions concerning accelerated approval, orphan drugs; S.4348, Food and Drug Administration Safety and Landmark Advancements Act of 2022 - provisions concerning accelerated approval, orphan drugs; H.R.6963, Accelerated Approval Integrity Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for post-approval studies for drugs approved using accelerated approval, and for other purposes; H.R.2617, the Consolidated Appropriations Act, 2023.

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

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

Paper product supply chain issues Prescription Drug Paper Inserts S.4348 FDASLA Act of 2022, H.R. 7667, Food and Drug Amendments of 2022 H.R. 8781, Ensuring Accurate Postal Rates FDA rider on paper inserts for prescription drugs in H.R. 2617, the Consolidated Appropriations Act (FY23 Omnibus)

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Natl Security Council (NSC), SENATE

Prescription drug pricing. H.R.6 - SUPPORT for Patients and Communities Act. Awareness of outcomes data and the need for training on all medication assisted treatment. H.R.7667/S.4348 - Prescription Drug User Fee Agreement Reauthorization. Implementation of Inflation Reduction Act of 2022.

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

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

Issues related to MDUFA implementation Issues related to H.R. 7667, Food and Drug Amendments of 2022 Issues related to S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act Issues relating to FDA Covid-19 Response Issues relating to the medical product supply chain Issues relating to S. 3799, PREVENT Pandemics Act Issues related to CURES 2.0 Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to the Valid Act of 2021 - H.R. 4128/S.2209 Issues related to cyber security including H.R. 7084/ S. 3983, PATCH Act

Client expense: $300,000 · Firm income: Not reported

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

Issues related to FDA and drug development, Accelerated Approval Pathway; H. R. 5375- Inflation Reduction Act of 2022, issues related to prescription drugs; H.R. 7667 and S.4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA Act), issues related to Prescription Drug User Fee Act (PDUFA)

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 5376, the Inflation Reduction Act H.R. 6000, the CURES 2.0 Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 innovation, supply chain. health disparities, raising awareness of Cystic Fibrosis, appropriation for the Department of Health and Human Services, PDUFA, Sunshine Act, orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies, drug pricing, transparency

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

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

H.R. 5376, the Inflation Reduction Act H.R. 6000, the CURES 2.0 Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 innovation, supply chain. health disparities, raising awareness of Cystic Fibrosis, appropriation for the Department of Health and Human Services, PDUFA, Sunshine Act, orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies, drug pricing, transparency

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

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

H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 innovation, Duchenne Muscular Dystrophy, platform technologies, non-interference, transparency, value based contracting, gene therapy

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376, the Inflation Reduction Act H.R. 6000, the CURES 2.0 Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act H.R.2617, Consolidated Appropriations Act, 2023 importation, supply chain integrity, 304b, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, drug pricing, insulin, international reference pricing, user fee reauthorization

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376, the Inflation Reduction Act H.R. 6000, the CURES 2.0 Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 prescription drug importation, import safety, supply chain integrity, innovation, 304B, transparency, importation, non-interference, user fee reauthorization

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 Medication affordability and access, general diabetes prevention, obesity

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

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

H.R. 5376, the Inflation Reduction Act H.R. 4521, America COMPETES Act S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 510K reform, imaging policy, medical device user fee reauthorization and all related policies, mobile medical apps, device regulation, Innovation, service, radiopharmaceuticals, coverage decisions, cybersecurity

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

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

H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 innovation, non-interference, 340B, Hepatitis C, HPV, Shingles, anti-microbial resistance, transparency, Pandemic All Hazards Preparedness Act reauthorization, drug pricing, anti-microbial resistance, transparency, vaccines

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376, the Inflation Reduction Act H.R. 4521, America COMPETES Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 non-interference, dormant therapies, drug shortages, prescription drug access and affordability, transparency, insulin policy, authorized generics, 340B

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 drug safety, prescription drug abuse, drug pricing

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 Pharmaceutical access and affordability, Ryan White, PEPFAR, 340B, HCV Screening, drug pricing and access, HIV, HCV, oncology, coronavirus therapeutics, FDA user fees

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

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

H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 drug pricing and access, transparency, covid, 340B, drug safety

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

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

H.R. 5376, the Inflation Reduction Act S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 companion diagnostics, testing, innovation, surprise billing implementation

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 prescription drug access and affordability, pricing, transparency, user fee reauthorization

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 drug safety, prescription drug importation, import safety, supply chain integrity, biosimilars, PDUFA and associated policies, patent settlements, accelerated approval, break through therapies, compounding, user fee reauthorization, innovation, transparency

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R. 5376, the Inflation Reduction Act H.R.2617, Consolidated Appropriations Act, 2023 prescription drug pricing, prescription drug access and affordability, pricing, transparency, user fees

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

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

H.R. 5376, the Inflation Reduction Act H.R. 4521, America COMPETES Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 FDA related issues, diagnostics, pandemic preparedness, health IT, opioid safety, anti-microbial resistance, hazardous drug safety, VA procurement, medical technology regulation, artificial intelligence, cybersecurity, privacy, medication safety & drug diversion, ESRD, coronavirus response, Operation Warp Speed, COVID-19 testing, user fees

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

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

S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 Drug coverage & reimbursement, vaccination, user fees, no specific bills, Import Safety, drug development policy, drug shortages, supply chain integrity, Innovation, reimportation, transparency, 340B, pay for delay

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R. 5376, the Inflation Reduction Act H.R.2617, Consolidated Appropriations Act, 2023 340B, Biosimilars, Orphan drugs, prescription drug access & reimbursement, FDA issues, transparency

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 opioids, childhood cancer, vaccination, Affordable Care Act, market stabilization, access and coverage, LDT regulation, smoking cessation, Prescription drug pricing and access, Vaping and e-cigarettes

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

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

H.R. 5376, the Inflation Reduction Act S. 4348, FDA Safety and Landmark Advancements Act H.R. 7667, Food and Drug Amendments of 2022 H.R.2617, Consolidated Appropriations Act, 2023 340B, non-interference, importation, Puerto Rico, transparency, prescription drug pricing and access, beneficiary access

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot

Client expense: $1,760,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to Health Care Trade and Supply Chain Security. Issues related to AI in Health Care. Issues related to Department of Health and Human Services Appropriations. Issues related to research and development tax policy. HR 1846, To amend the Public Health Service Act with respect to hospital infrastructure, all provisions. HR 4479 / S 2609, Facilitating Innovative Nuclear Diagnostics Act of 2021, all provisions. S 2107, Facilitating American-Built Semiconductors Act, all provisions. HR 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions. HR 5585, Advanced Research Projects Agency - Health Act, all provisions. S 3983 / HR 7084, PATCH Act of 2022, all provisions. HR 7667, Food and Drug Amendments of 2022, all provisions. HR 4521 / S 1260, United States Innovation and Competition Act of 2021, all provisions. S 2533 / HR 4794, Making Advances in Mammography and Medical Options for Veterans Act, all provisions. S 2102, Dr. Kate Hendricks Thomas SERVICE Act, all provisions. HR 4571, Supporting Expanded Review for Veterans In Combat Environments Act of 2021, all provisions. HR 2617, Consolidated Appropriations Act, 2023, provisions pertaining to health care cyber security, medical contrast and diagnostic radiopharmaceutical regulation, and HHS ASPR Hospital Preparedness Program appropriations. S 3799, PREVENT Pandemics Act, provisions pertaining medical device shortage reporting.

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

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

OTC switch process -- no bill number H.R. 6000 - 21st Century Cures 2.0 S.1435/HR 2873 - Affordable Prescriptions for Patients Act of 2021 H.R.4405 - Small Business FDA User Fee Adjustment Act of 2021 H.R. 7667 - Food and Drug Amendments of 2022 Dietary Supplement Reform -- no bill number Cosmetics Reform -- no bill number S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 Genus vs. FDA Circuit Court Lobby Activity

Client expense: $160,270 · Firm income: Not reported

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

VALID Act (HR 4128/S.2209); Issues related to proposals on reauthorization of the FDA drug and device user fee programs (S.4348/H.R.7667), (H.R. 6833); Issues related to data privacy and security House legislation (H.R. 8152).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 963/ S. 505, Forced Arbitration Injustice Repeal Act (FAIR). H.R. 2195, Protecting the Employment Rights of Service Members Act (PERSA). H.R. 2196, Justice for Servicemembers Act. H.R. 2812, Fairness in Nursing Home Arbitration Act. H.R. 3947, bill to prohibit forced arbitration in health insurance contracts. S. 1334, PFAS Accountability Act. H.R. 2467, PFAS Action Act of 2021. H.R. 5169 / S. 2694, Nursing Home Improvement and Accountability Act. H.R. 4445 / S. 2342, Ending Forced Arbitration of Sexual Assault and Sexual Harassment Act of 2021. H.R. 4350, National Defense Authorization Act, with specific regard to amendments on SCRA and USERRA forced arbitration, MCA claims, and cyber incident reporting. H.R.4128, VALID Act of 2021. H.R. 7667, Food and Drug Amendments of 2022, with specific regard to provisions on cosmetics. H.R. 7900, National Defense Authorization Act, with specific regard to amendments on SCRA and USERRA forced arbitration. HR 8227, SPEAK OUT Act. S. 4348, FDA Safety and Landmark Advancements Act. Draft legislation on prohibiting forced arbitration in age discrimination cases. Draft legislation on PFAS. Draft asbestos ban legislation. Draft generic drug labeling legislation. Draft cosmetics reform legislation. Draft dietary supplement legislation. General lobbying on ending the use of forced arbitration for consumers and workers. General lobbying with regard to forced arbitration in nursing homes. General lobbying with regard to COVID-19 liability. General lobbying on e-cigarettes safety and regulation. General lobbying on the FDA proposal regarding the testing of talc for asbestos. General lobbying on FIFRA preemption and Monsanto Company v. Hardeman preemption case. General lobbying on glyphosate safety. General lobbying on drug pricing.

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

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

S. 253, Cannabidiol and Marihuana Research Expansion Act, all provisions H.R. 6087, Improving Access to Workers Compensation for Injured Federal Workers Act of 2022, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5030, Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, all provisions H.R. 1384, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions S. 445, Mainstreaming Addiction Treatment (MAT) Act of 2021, all provisions H.R. 2067, Medication Access and Training Expansion (MATE) Act of 2021, all provisions S. 2235, Medication Access and Training Expansion (MATE) Act of 2021, all provisions H.R. 6072, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services S. 509, Leveraging Integrated Networks in Communities (LINC) To Address Social Needs Act of 2021, provisions relating to social determinants of health, impact on mental health and social services H.R. 379, Improving Social Determinants of Health Act of 2021, all provisions S. 104, Improving Social Determinants of Health Act of 2021, all provisions S. 3799, Prepare for and Respond to Existing Viruses, Emerging New Threats, and (PREVENT) Pandemics Act, all provisions H.R. 8, Bipartisan Background Checks Act of 2021, all provisions H.R. 1446, Enhanced Background Checks Act of 2021, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 2163, Safe Step Act, all provisions S. 464, Safe Step Act, all provisions H.R. 666, Anti-Racism in Public Health Act of 2021, all provisions S. 162, Anti-Racism in Public Health Act of 2021, all provisions H.R. 5248, Temporary Responders for Immediate Aid in Grave Emergencies (TRIAGE) Act of 2021, all provisions H.R. 6311, Comprehensive Addiction Resources Emergency Act of 2021, all provisions S. 3418, Comprehensive Addiction Resources Emergency Act of 2021, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 3735, Parity Implementation Assistance Act, all provisions H.R. 7232, 9-8-8 and Parity Assistance Act of 2022, all provisions H.R. 7116, 9-8-8 Implementation Act of 2022, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions S. 4090, Dietary Supplement Listing Act of 2022, all provisions S. 1675, Maternal Health Quality Improvement Act, all provisions H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act, all provisions S. 610, Dr. Lorna Breen Health Care Provider Protection Act, all provisions H.R. 3753, Parity Implementation Assistance Act, all provisions S. 1962, Parity Implementation Assistance Act, all provisions S. 3904, Healthcare Cybersecurity Act of 2022, all provisions H.R. 4128, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions S. 2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, all provisions H.R. 6000, Cures 2.0 Act, all provisions S. 2416, New Opportunities for Value that Extend Lives (NOVEL) Act of 2021, all provisions H.R. 8152, To provide consumers with foundational data privacy rights, create strong oversight mechanisms, and establish meaningful enforcement, all provisions H.R. 2377, Federal Extreme Risk Protection Order Act of 2022, all provisions H.R. 7910, Protecting Our Kids Act, all provisions S. 2938, Bipartisan Safer Communities Act, all provisions H.R. 7667, Food and Drug Amendments of 2022, all provisions H.R. 7666, Restoring Hope for Mental Health and Well-Being Act of 2022, all provisions H.R. 2503, Social Determinants Accelerator Act of 2021, all provisions S. 3039, Social Determinants Accelerator Act of 2021, all provisions H.R. 7192, Diagnostic Device Advisory Committee Act, all provisions H.R. 3085, Equity in Neuroscience and Alzheimers Clinical Trials (ENACT) Act of 2021, all provisions H.R. 5218, Collaborate in an Orderly and Cohesive Manner Act, all provisions H.R. 7845, NIH Clinical Trial Diversity Act of 2022, all provisions H.R. 708, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions S. 168, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions H.R. 4480, Telehealth Coverage and Payment Parity Act, all provisions H.R. 7573, Telehealth Extension and Evaluation Act, all provisions S. 3593, Telehealth Extension and Evaluation Act, all provisions H.R. 5541, Primary and Virtual Care Affordability Act, all provisions H.R. 1306, National Coronavirus Commission Act of 2021, all provisions S. 412, National Coronavirus Commission Act of 2021, all provisions H.R. 1843, COVID-19 Hate Crimes Act, all provisions S. 937, COVID-19 Hate Crimes Act, all provisions H.R. 3778, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions S. 1976, Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act, all provisions H.R. 6904, Patients Before Profits Act of 2022, all provisions H.R. 7053, Hospital Inpatient Services Modernization Act, all provisions S. 3792, Hospital Inpatient Services Modernization Act, all provisions H.R. 1364, Parity Enforcement Act of 2021, all provisions H.R. 5224, Preventing Overdoses and Saving Lives Act of 2021, all provisions H.R. 6279, Opioid Treatment Access Act of 2022, all provisions H.R. 7234, Summer Barrow Prevention, Treatment, and Recovery Act, all provisions H.R. 3352, Midwives for MOMS Act of 2021, all provisions H.R. 847, Promoting Digital Privacy Technologies Act, all provisions S. 224, Promoting Digital Privacy Technologies Act, all provisions H.R. 3771, South Asian Heart Health Awareness and Research Act of 2021, all provisions H.R. 7559, Prescription Information Modernization Act of 2022, all provisions H.R. 8289, Banning Misleading Drug Ads Act of 2022, all provisions H.R. 3614, Menstrual Equity For All Act of 2021, all provisions No Surprises Act/implementation Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act, all provisions 21st Century Cures Act/implementation Maternal mortality Maternal health and inequities/FY 2023 funding Prior Authorization AMA Recovery Plan for Americas Physicians/telehealth/prior authorization/physician burnout/scope Section 2527(b) of the U.S. Innovation and Competition Act (USICA)/Open Access Language Retired Physician Re-entry COVID-19 telehealth flexibilities COVID-19/Vaccine distribution/Vaccines in physician offices Physician burnout and suicide COVID-19/Health Equity/vaccines COVID-19 response/testing/misinformation/therapeutics/Paxlovid Public Health Emergency COVID-19 Health Equity/Men who have sex with men/3-month blood donation use deferral Health Equity/Federally qualified health centers and clinical trials Womens Reproductive Health Medication Abortion Access Diabetes Provider Relief Fund/COVID-19 Electronic Health Records (EHR) Certification Data Privacy Hunger, Nutrition, and Health Digital Health/AI/Digital Therapeutics Monkeypox/testing/vaccination

Client expense: $4,550,000 · 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), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), President of the U.S., SENATE, Vice President of the U.S., White House Office

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing Connected care and remote patient monitoring Supply chain legislative proposals S.4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (Title II, Rosen cybersecurity amendment adopted in Committee) H.R.7667 - Food and Drug Amendments of 2022 (Title II, Title VIII - Sec. 808) Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

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

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

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing FDA device approval- 510(k) and PMA processes Connected care and remote patient monitoring Supply chain legislative proposals S.4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (Title II, Rosen cybersecurity amendment adopted in Committee) H.R.7667 - Food and Drug Amendments of 2022 (Title II, Title VIII - Sec. 808) H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions H.R.6637 - Health Equity Accountability Act Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress H.R.5640 /S.3252 - Data Mapping to Save Moms Lives Act, in whole HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

Client expense: $870,000 · Firm income: Not reported

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

Issues related to access to medicines and other medical therapies, the development of new medical therapies, pharmaceutical supply chain and regulatory matters regarding the biopharmaceutical industry. Issues related to user fee reauthorization; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.8295/S.4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2023, Laboratory infrastructure; Mental Health initiatives H.R.4128/S.2209, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, generally S.4348, Food and Drug Administration Safety and Landmark Advancements Act, Lab Develop Testing issues Public Law 117-328, Consolidated Appropriations Act, FY2023, Laboratory infrastructure; Diagnostic Laboratory Testing issues Monitor the following: H.R.7667, Food and Drug Amendments Act, Lab Develop Testing issues Mental Health initiatives Center for Excellence in Improving Diagnosis legislation 340B generally P.L.117-2, American Rescue Plan Act of 2021, Hospital and healthcare funding eligibility related issues Surprise Billing Health Care Transparency Prescription Drug Cost Disproportionate Share Hospital (DSH) Coronavirus, Hospital and Healthcare Telehealth initiatives H.R.6000, CURES 2.0, Health services delivery; and Research and development issues ARPA-H Proposal Public Law 117-169, Inflation Reduction Act of 2022, Implementation issues

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Opposition to provision in FDA User Fee Reauthorization that bans certain medical devices. H.R. 7667 / S. 4348, Food and Drug Amendments of 2022 and provision in Consolidated Appropriations Act, 2023, H.R.2617.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms. -Food and Drug Amendments of 2022 (H.R. 7667) / PDUFA VII-- provisions related to accelerated approval program, clinical trial diversity, novel clinical trial design and modeling, improving accountability and transparency of the FDA.

Client expense: $25,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Value Based Payment legislation; Cures 2.0 legislation; CMS policies regarding Value Based legislation; FDA user fee legislation; H.R. 7667, Food and Drug Amendments of 2022; S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act.

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

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

Value Based Payment legislation; Cures 2.0 legislation; CMS policies regarding Value Based legislation; FDA user fee legislation; H.R. 7667, Food and Drug Amendments of 2022; S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act; H.R. 7389, the Medicaid VBPs for Patients (MVP) Act. Advocacy on issues related to regulation of, access to, and reimbursement for regenerative medicine products, and any other issues related to the Alliance for Regenerative Medicine specifically.

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

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