National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021

Practice Support/Grants to Practice S.3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act: Ambulatory Surgical Centers H.R.6205, Healthcare Workforce Resilience Act: physician workforce H.R.7591, National Patient Safety Board Act of 2024: patient safety S.1302, Resident Physician Shortage Reduction Act of 2023: residency positions S.665, Conrad State 30 and Physician Access Reauthorization Act: Foreign physician immigration status Medical liability H.Res. 734: Expressing support for the designation of October 1 as "National Latino and Latina Physician Day" S. 705, Specialty Physicians Advancing Rural Care (SPARC) Act: physician shortages in rural areas Public Law No. 113-5, Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA): preparedness for public health H.R. 467, HALT Act: scheduling of fentanyl-related substances H.R. 7259, Medical Controlled Substances Transportation Act of 2022: to enable physicians to more easily transport controlled substances safely and legally across state lines H.R. 133, the Consolidated Appropriations Act, 2021: No Surprises Act, surprise medical billing H.R. 2630, Extending Temporary Emergency Scheduling of Fentanyl Analogues Act: Opioids H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills S. 445, Mainstreaming Addiction Treatment Act of 2021: Opioids H.R. 4387, Maternal Health Quality Improvement Act of 2021: Maternal health H.R. 1565, Saving Lives, Saving Costs S. 1475, Saving Lives, Saving Costs S. 610, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness S. 987, CARA 3.0 Act of 2021: Opioids H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids H.R. 7961, SAVE Act: To protect hospital personnel from violence, and for other purposes. H.R.833, Save America's Rural Hospitals: rural pass through H.R.1492, Medical Controlled Substances Transportation Act of 2017: medical controlled substances transportation Pre-authorization; prior authorization Affordable Care Act reform efforts 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Long COVID research Anesthesia workforce shortages CDC Opioid Prescribing Guideline 2023 Labor/HHS/Education appropriations bill Defense Health Agency anesthesia policy Change Healthcare data breach Maternal Mortality/Maternal Care Deserts

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Practice Support/Grants to Practice S.665, Conrad State 30 and Physician Access Reauthorization Act: Foreign physician immigration status Medical liability H.Res. 734: Expressing support for the designation of October 1 as "National Latino and Latina Physician Day" S. 705, Specialty Physicians Advancing Rural Care (SPARC) Act: physician shortages in rural areas Public Law No. 113-5, Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA): preparedness for public health H.R. 467, HALT Act: scheduling of fentanyl-related substances H.R. 7259, Medical Controlled Substances Transportation Act of 2022: to enable physicians to more easily transport controlled substances safely and legally across state lines H.R. 133, the Consolidated Appropriations Act, 2021: No Surprises Act, surprise medical billing H.R. 2630, Extending Temporary Emergency Scheduling of Fentanyl Analogues Act: Opioids H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills S. 445, Mainstreaming Addiction Treatment Act of 2021: Opioids H.R. 4387, Maternal Health Quality Improvement Act of 2021: Maternal health H.R. 1565, Saving Lives, Saving Costs S. 1475, Saving Lives, Saving Costs S. 610, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness S. 987, CARA 3.0 Act of 2021: Opioids H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids H.R. 7961, SAVE Act: To protect hospital personnel from violence, and for other purposes. H.R.833, Save America's Rural Hospitals: rural pass through H.R.1492, Medical Controlled Substances Transportation Act of 2017: medical controlled substances transportation FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Pre-authorization; prior authorization Affordable Care Act reform efforts 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief H.R. 842, Protecting the Right to Organize Act of 2021: PRO Act, labor protections 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, scope of Practice (waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20 Long COVID research Anesthesia workforce shortages CDC Opioid Prescribing Guideline 2023 Labor/HHS/Education appropriations bill Defense Health Agency anesthesia policy

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Practice Support/Grants to Practice Foreign physician immigration status Medical liability H.Res. 734: Expressing support for the designation of October 1 as "National Latino and Latina Physician Day" S. 705, Specialty Physicians Advancing Rural Care (SPARC) Act: physician shortages in rural areas Public Law No. 113-5, Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA): preparedness for public health H.R. 467, HALT Act: scheduling of fentanyl-related substances H.R. 7259, Medical Controlled Substances Transportation Act of 2022: to enable physicians to more easily transport controlled substances safely and legally across state lines H.R. 133, the Consolidated Appropriations Act, 2021: No Surprises Act, surprise medical billing H.R. 2630, Extending Temporary Emergency Scheduling of Fentanyl Analogues Act: Opioids H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills S. 445, Mainstreaming Addiction Treatment Act of 2021: Opioids H.R. 4387, Maternal Health Quality Improvement Act of 2021: Maternal health H.R. 1565, Saving Lives, Saving Costs S. 1475, Saving Lives, Saving Costs S. 610, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness S. 987, CARA 3.0 Act of 2021: Opioids H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids H.R. 7961, SAVE Act: To protect hospital personnel from violence, and for other purposes. H.R.833, Save America's Rural Hospitals: rural pass through H.R.1492, Medical Controlled Substances Transportation Act of 2017: medical controlled substances transportation FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Pre-authorization; prior authorization Affordable Care Act reform efforts 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief H.R. 842, Protecting the Right to Organize Act of 2021: PRO Act, labor protections 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, scope of Practice (waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20 Long COVID research Anesthesia workforce shortages CDC Opioid Prescribing Guideline 2023 Labor/HHS/Education appropriations bill Defense Health Agency anesthesia policy

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Practice Support/Grants to Practice Foreign physician immigration status Medical liability S. 705, Specialty Physicians Advancing Rural Care (SPARC) Act: physician shortages in rural areas Public Law No. 113-5, Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA): preparedness for public health H.R. 467, HALT Act: scheduling of fentanyl-related substances H.R. 7259, Medical Controlled Substances Transportation Act of 2022: to enable physicians to more easily transport controlled substances safely and legally across state lines H.R. 133, the Consolidated Appropriations Act, 2021: No Surprises Act, surprise medical billing H.R. 2630, Extending Temporary Emergency Scheduling of Fentanyl Analogues Act: Opioids H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills S. 445, Mainstreaming Addiction Treatment Act of 2021: Opioids H.R. 4387, Maternal Health Quality Improvement Act of 2021: Maternal health H.R. 1565, Saving Lives, Saving Costs S. 1475, Saving Lives, Saving Costs S. 610, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness S. 987, CARA 3.0 Act of 2021: Opioids H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids H.R. 7961, SAVE Act: To protect hospital personnel from violence, and for other purposes. H.R.833, Save America's Rural Hospitals: rural pass through H.R.1492, Medical Controlled Substances Transportation Act of 2017: medical controlled substances transportation FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Pre-authorization; prior authorization Affordable Care Act reform efforts 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief H.R. 842, Protecting the Right to Organize Act of 2021: PRO Act, labor protections 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, scope of Practice (waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20 Long COVID research Anesthesia workforce shortages CDC Opioid Prescribing Guideline 2023 Labor/HHS/Education appropriations bill Defense Health Agency anesthesia policy

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Practice Support/Grants to Practice Foreign physician immigration status Medical liability S. 4330, Specialty Physicians Advancing Rural Care (SPARC) Act: physician shortages in rural areas Public Law No. 113-5, Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA): preparedness for public health emergencies H.R. 7259, Medical Controlled Substances Transportation Act of 2022: to enable physicians to more easily transport controlled substances safely and legally across state lines H.R. 133, the Consolidated Appropriations Act, 2021: No Surprises Act, surprise medical billing H.R. 2630, Extending Temporary Emergency Scheduling of Fentanyl Analogues Act: Opioids H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills S. 445, Mainstreaming Addiction Treatment Act of 2021: Opioids H.R. 4387, Maternal Health Quality Improvement Act of 2021: Maternal health H.R. 1565, Saving Lives, Saving Costs S. 1475, Saving Lives, Saving Costs S. 610, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness S. 987, CARA 3.0 Act of 2021: Opioids H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids H.R. 7961, SAVE Act: To protect hospital personnel from violence, and for other purposes. H.R.833, Save America's Rural Hospitals: rural pass through H.R.1492, Medical Controlled Substances Transportation Act of 2017: medical controlled substances transportation FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Pre-authorization; prior authorization Affordable Care Act reform efforts 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief H.R. 842, Protecting the Right to Organize Act of 2021: PRO Act, labor protections 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, scope of Practice (waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20 Long COVID research Anesthesia workforce shortages CDC Opioid Prescribing Guideline 2023 Labor/HHS/Education appropriations bill

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

H.R. Res. 1285 - WTO TRIPS Waiver Resolution, Waiver Expansion H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade NegotiatorS. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act (H.R.4369) Securing Americas Medicine Cabinet Act of 2021 (S. 2589)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education on Texas A&M Health Science Center. COVID-19 Response. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021. Appropriations.

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

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

Practice Support/Grants to Practice Foreign physician immigration status Medical liability H.R. 7259, Medical Controlled Substances Transportation Act of 2022: to enable physicians to more easily transport controlled substances safely and legally across state lines H.R. 133, the Consolidated Appropriations Act, 2021: No Surprises Act, surprise medical billing H.R. 2630, Extending Temporary Emergency Scheduling of Fentanyl Analogues Act: Opioids H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills S. 445, Mainstreaming Addiction Treatment Act of 2021: Opioids H.R. 4387, Maternal Health Quality Improvement Act of 2021: Maternal health H.R. 1565, Saving Lives, Saving Costs S. 1475, Saving Lives, Saving Costs S. 610, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness S. 987, CARA 3.0 Act of 2021: Opioids H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids H.R. 7961, SAVE Act: To protect hospital personnel from violence, and for other purposes. FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Pre-authorization; prior authorization Affordable Care Act reform efforts Medical Controlled Substances Transportation 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief H.R. 842, Protecting the Right to Organize Act of 2021: PRO Act, labor protections 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, scope of Practice (waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20 Long COVID research Anesthesia workforce shortages CDC Opioid Prescribing Guideline

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, FY2023 NIH Extramural Research Programs and Funding; Reimbursement Issues, Comparative Effectiveness Related Issues and Initiatives; and Minority Health Issues; HRSA Nursing Programs and Workforce Training; Regenerative Engineering; Indirect Cost Reimbursement Issues; Medicare Accelerated and Advance Payment Programs H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2023, ARS Extramural Research, ARS Buildings and Facilities FDA Nutrition Labeling Regulatory Issues H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, FY2023 NIH Extramural Research Programs and Funding; Reimbursement Issues, Comparative Effectiveness Related Issues and Initiatives; and Minority Health Issues; HRSA Nursing Programs and Workforce Training; Regenerative Engineering; Indirect Cost Reimbursement Issues; Medicare Accelerated and Advance Payment Programs H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2023, ARS Extramural Research, ARS Buildings and Facilities FDA Nutrition Labeling Regulatory Issues H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, university centers of excellence in advanced and continuous pharmaceutical manufacturing, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). H.R. 2617: Consolidated Appropriations Act, 2023 Making consolidated appropriations for the fiscal year ending September 30, 2023, and for providing emergency assistance for the situation in Ukraine, and for other purposes (provisions relating to university centers of excellence in advanced and continuous pharmaceutical manufacturing and the authorization of the Advanced Research Projects Agency-Health). Federal policy changes regarding fetal tissue research, biomedical research involving animals, research security, and facilities and administrative costs associated with research grants. White House and Executive Branch implementation of the CHIPS and Science Act.

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education on Texas A&M Health Science Center. COVID-19 Response. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021. Appropriations

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

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

H.R. 1285: Requesting the President to transmit certain information to the House of Representatives relating to a waiver of intellectual property commitments under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, FY2023 NIH Extramural Research Programs and Funding; Reimbursement Issues, Comparative Effectiveness Related Issues and Initiatives; and Minority Health Issues; HRSA Nursing Programs and Workforce Training; Regenerative Engineering; Indirect Cost Reimbursement Issues; Medicare Accelerated and Advance Payment Programs H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2023, ARS Extramural Research, ARS Buildings and Facilities FDA Nutrition Labeling Regulatory Issues H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 1260: United States Innovation and Competition Act of 2021 A bill to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). H.R. 4521: America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022 Vehicle for the Houses comprehensive innovation and competitiveness legislation (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education; immigration provisions relating to advanced degree holders from U.S. institutions of higher education; and provision relating to university centers of excellence in advanced and continuous pharmaceutical manufacturing). H.R. 4346: CHIPS and Science Act Vehicle for bipartisan legislation to support domestic semiconductor research and development and reauthorize major science agencies (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, university centers of excellence in advanced and continuous pharmaceutical manufacturing, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 2225: National Science Foundation for the Future Act To authorize appropriations for fiscal years 2022, 2023, 2024, 2025, and 2026 for the National Science Foundation, and for other purposes (ALL). H.R. 3593: Department of Energy Science for the Future Act To provide guidance for and investment in the research and development activities of the Department of Energy Office of Science, and for other purposes (ALL). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). S. 4900 SBIR and STTR Extension Act of 2022 A bill to reauthorize the SBIR and STTR programs and pilot programs, and for other purposes (ALL). Federal policy changes regarding fetal tissue research, biomedical research involving animals, research security, and facilities and administrative costs associated with research grants. Pending federal legislation to enhance university climate research, service, and resiliency.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H. Res. 1285: Requesting the President to transmit certain information to the House of Representatives relating to a waiver of intellectual property commitments under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

Client expense: $7,270,000 · Firm income: Not reported

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

National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act (H.R.4369) Securing Americas Medicine Cabinet Act of 2021 (S. 2589)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, FY2023 NIH Extramural Research Programs and Funding; Reimbursement Issues, Comparative Effectiveness Related Issues and Initiatives; and Minority Health Issues; HRSA Nursing Programs and Workforce Training; Regenerative Engineering; Indirect Cost Reimbursement Issues; Medicare Accelerated and Advance Payment Programs H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2023, ARS Extramural Research, ARS Buildings and Facilities FDA Nutrition Labeling Regulatory Issues H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Practice Support/Grants to Practice Foreign physician immigration status Medical liability H.R. 7259, Medical Controlled Substances Transportation Act of 2022: to enable physicians to more easily transport controlled substances safely and legally across state lines H.R. 133, the Consolidated Appropriations Act, 2021: No Surprises Act, surprise medical billing H.R. 2630, Extending Temporary Emergency Scheduling of Fentanyl Analogues Act: Opioids H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills S. 445, Mainstreaming Addiction Treatment Act of 2021: Opioids H.R. 4387, Maternal Health Quality Improvement Act of 2021: Maternal health H.R. 1565, Saving Lives, Saving Costs S. 1475, Saving Lives, Saving Costs S. 610, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness S. 987, CARA 3.0 Act of 2021: Opioids H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids H.R. 7961, SAVE Act: To protect hospital personnel from violence, and for other purposes. FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Pre-authorization; prior authorization Affordable Care Act reform efforts Medical Controlled Substances Transportation 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief H.R. 842, Protecting the Right to Organize Act of 2021: PRO Act, labor protections 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, scope of Practice (waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20 Long COVID research

Client expense: $350,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3694: To direct the Secretary of Health and Human Services, in consultation with the United States Trade Representative and other heads of Federal agencies, to submit to Congress a report the impact of a waiver of certain obligations of member nations under the Agreement on Trade-Related Aspects of Intellectual Property Rights on global COVID-19 vaccine access, and for other purposes - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3811: TRIPP Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

Client expense: $1,110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 1260: United States Innovation and Competition Act of 2021 A bill to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). H.R. 4521: America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022 Vehicle for the Houses comprehensive innovation and competitiveness legislation (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education; immigration provisions relating to advanced degree holders from U.S. institutions of higher education; and provision relating to university centers of excellence in advanced and continuous pharmaceutical manufacturing). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, university centers of excellence in advanced and continuous pharmaceutical manufacturing, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 2225: National Science Foundation for the Future Act To authorize appropriations for fiscal years 2022, 2023, 2024, 2025, and 2026 for the National Science Foundation, and for other purposes (ALL). H.R. 3593: Department of Energy Science for the Future Act To provide guidance for and investment in the research and development activities of the Department of Energy Office of Science, and for other purposes (ALL). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). Federal policy changes regarding fetal tissue research, biomedical research involving animals, research security, and facilities and administrative costs associated with research grants. Pending federal legislation to enhance university climate research, service, and resiliency.

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3694: To direct the Secretary of Health and Human Services, in consultation with the United States Trade Representative and other heads of Federal agencies, to submit to Congress a report on the impact of a waiver of certain obligations of member nations under the Agreement on Trade-Related Aspects of Intellectual Property Rights on global COVID-19 vaccine access, and for other purposes - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3811: TRIPP Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Russia/Ukraine policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

Client expense: $6,340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act (H.R.4369) Securing Americas Medicine Cabinet Act of 2021 (S. 2589)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education on Texas A&M Health Science Center. COVID-19 Response. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021. Appropriations.

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

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

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2023, ARS Extramural Research, ARS Buildings and Facilities FDA Nutrition Labeling Regulatory Issues H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, FY2023 NIH Extramural Research Programs and Funding; Reimbursement Issues, Comparative Effectiveness Related Issues and Initiatives; and Minority Health Issues; HRSA Nursing Programs and Workforce Training; Regenerative Engineering; Indirect Cost Reimbursement Issues; Medicare Accelerated and Advance Payment Programs H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Practice Support/Grants to Practice Foreign physician immigration status Medical liability H.R. 7259, Medical Controlled Substances Transportation Act of 2022: to enable physicians to more easily transport controlled substances safely and legally across state lines H.R. 133, the Consolidated Appropriations Act, 2021: No Surprises Act, surprise medical billing H.R. 2630, Extending Temporary Emergency Scheduling of Fentanyl Analogues Act: Opioids H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills S. 445, Mainstreaming Addiction Treatment Act of 2021: Opioids H.R. 4387, Maternal Health Quality Improvement Act of 2021: Maternal health H.R. 1565, Saving Lives, Saving Costs S. 1475, Saving Lives, Saving Costs S. 610, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness S. 987, CARA 3.0 Act of 2021: Opioids H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Pre-authorization Affordable Care Act reform efforts Medical Controlled Substances Transportation 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief H.R. 842, Protecting the Right to Organize Act of 2021: PRO Act, labor protections 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, scope of Practice (waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20 Long COVID research

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2023, ARS Extramural Research, ARS Buildings and Facilities FDA Nutrition Labeling Regulatory Issues H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, FY2023 NIH Extramural Research Programs and Funding; Reimbursement Issues, Comparative Effectiveness Related Issues and Initiatives; and Minority Health Issues; HRSA Nursing Programs and Workforce Training; Regenerative Engineering; Indirect Cost Reimbursement Issues; Medicare Accelerated and Advance Payment Programs H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.

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

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

H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, FY2022 and FY2023 NIH Extramural Research Programs and Funding; Reimbursement Issues, Comparative Effectiveness Related Issues and Initiatives; and Minority Health Issues; HRSA Nursing Programs and Workforce Training; Regenerative Engineering; Indirect Cost Reimbursement Issues; Medicare Accelerated and Advance Payment Programs H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY2022 and FY2023, ARS Extramural Research, ARS Buildings and Facilities FDA Nutrition Labeling Regulatory Issues H.R. 4369 - Continuous Pharmaceutical Manufacturing Act S.2589 - Securing Americas Medicine Cabinet Act of 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Practice Support/Grants to Practice Foreign physician immigration status Medical liability H.R. 133, the Consolidated Appropriations Act, 2021: No Surprises Act, surprise medical billing H.R. 2630, Extending Temporary Emergency Scheduling of Fentanyl Analogues Act: Opioids H.R. 3502, Protecting People From Surprise Medical Bills Act: Surprise Medical Bills S. 445, Mainstreaming Addiction Treatment Act of 2021: Opioids H.R. 4387, Maternal Health Quality Improvement Act of 2021: Maternal health H.R. 1565, Saving Lives, Saving Costs S. 1475, Saving Lives, Saving Costs S. 610, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness H.R. 1667, Dr. Lorna Breen Health Care Provider Protection Act: Physician wellness S. 987, CARA 3.0 Act of 2021: Opioids H.R. 3259, NOPAIN Act: Opioids S. 586, NOPAIN Act: Opioids S. 1292, Non-Opioid Directive Act: Opioids FY 2021 LHHS Appropriations: Fiscal Year 2021 Appropriations for Subcommittee on Labor, Health and Human Services Pre-authorization Affordable Care Act reform efforts Medical Controlled Substances Transportation 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care Resident Education Deferred Interest Act (REDI Act): Student loan relief Student Loan Forgiveness for Frontline Health Workers Act: Student loan relief H.R. 842, Protecting the Right to Organize Act of 2021: PRO Act, labor protections 21st Century Cures Initiative H.R. 4369, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act: Drug shortages DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Ketamine use by law enforcement Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Brain health Certified Anesthesiologist Assistants Blood management Funding for physician practices impacted by the cancellation of elective surgeries, unique role of anesthesiologists in responding to COVID-19 pandemic, medical liability, scope of Practice (waiver of federal supervision requirement under the Emergency Declaration), insurance moratorium; COVID Update Memorandum 4/21/20

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 1260 and H.R. 2731: United States Innovation and Competition Act of 2021 A bill to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). H.R. 4521: America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022 Vehicle for the Houses comprehensive innovation and competitiveness legislation (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education; immigration provisions relating to advanced degree holders from U.S. institutions of higher education; and provision relating to advanced and continuous pharmaceutical manufacturing university centers of excellence). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, advanced and continuous pharmaceutical manufacturing university centers of excellence, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 2225: National Science Foundation for the Future Act To authorize appropriations for fiscal years 2022, 2023, 2024, 2025, and 2026 for the National Science Foundation, and for other purposes (ALL). H.R. 3593: Department of Energy Science for the Future Act To provide guidance for and investment in the research and development activities of the Department of Energy Office of Science, and for other purposes (ALL). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). Federal policy changes regarding fetal tissue research and research security.

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act (H.R.4369) Securing Americas Medicine Cabinet Act of 2021 (S. 2589) Digital Enterprise and Manufacturing Technologies Consortium Advanced Manufacturing, Materials, and Processes (AMMP) Consortium

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues Russia/Ukraine policy issues WTO TRIPS waiver

Client expense: $8,070,000 · Firm income: Not reported

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

General education on Texas A&M Health Science Center. COVID-19 Response. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.

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

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