Affordable and Safe Prescription Drug Importation Act

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

Client expense: $2,160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act CARES Act, Pub. L. 116-136 H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R.2374 - Stop STALLING Act H.R. 5239 - Prescription Drug Price Reporting Act H.R. 6258 - Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 H.R. 6390 - To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak H.R. 6410 - To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 H.R. 6395/S. 4049 - National Defense Authorization Act for Fiscal Year 2021 HHS PREP Act declaration relating to COVID-19 Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues FDA modernization policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatory recall authority policy issues COVID-19 policy issues Transparency Issues Policy Issue H.R. 2477 - Beneficiary Enrollment Notification and the Eligibility Simplification (BENES) Act of 2019 H.R. 6800 - Heroes Act

Client expense: $660,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

H.R. 1781 - Payment Commission Data Act of 2019 H.R. 269 - PAHPA Reauthorization and Advancing Innovation Act of 2019 S. 97 - Affordable and Safe Prescription Drug Importation Act S. 1416 - Affordable Prescriptions For Patients Act of 2019 S. 1895 - Lower Health Care Costs Act H.R. 3 - Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act H.R. 5333 - OTC Monograph Reform Act H.R. 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act S. 3548 - CARES Act H.R. 6800 - The Heroes Act H.R. 133 - Consolidated Appropriations Act, 2021 no specific bills, importation, supply chain integrity, 304b, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, drug pricing, insulin, international reference pricing

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

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

Support for S. 97/HR 447 Affordable and Safe Prescription Drug Importation Act and S. 61/HR 447 Safe and Affordable Drugs from Canada Act; issues related to personal drug importation.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 1614 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S. 724 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S.340 CREATES Act of 2019 H.R. 985 FAST Generics Act of 2019 S.640 Phair Pricing Act of 2019 S. 97 Affordable and Safe Prescription Drug Importation Act S. 61 Safe and Affordable Drugs from Canada Act of 2019 H.R. 1034 Phair Pricing Act of 2019 H.R. 965 CREATES Act of 2019 H.R. 1478 Affordable Insulin Act of 2019 H.R. 447 Affordable and Safe Prescription Drug Importation Act H.R. 1499 Protecting Consumer Access to Generic Drugs Act H.R. 3417 The Beneficiary Education Tools, Telehealth, and Extenders Re-authorization Act of 2019 H.R. 2296 Fair Accountability and Innovative Research Drug Pricing (FAIR Drug Pricing) Act of 2019 H.R. 1607 Fairness to Pet Owners Act H.R. 3379 Priced Relief, Innovation, and Competition for Essential Drugs (PRICED) Act H.R. 478 Safe and Affordable Drugs from Canada Act of 2019 H.R. 3 Lower Drug Costs Now Act of 2019 H.R. 275 Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448 Medicare Drug Price Negotiation Act H.R. 1046 Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 5304 PBM Transparency in Prescription Drug Costs Act H.R. 5172 NOPAIN Act S. 2543 Prescription Drug Pricing Reduction Act of 2019 S. Rept. 116-120 Prescription Drug Pricing Reduction Act of 2019 S. 2247 Phair Relief Act of 2019 S. 3070 Preventing Pill Mills Through Data Sharing Act H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 19 Lower Costs, More Cures Act on 2019 S. 3129 Lower Costs, More Cures Act on 2019 H.R. 748 Coronavirus Aid, Relief, and Economic Security Act or the CARES Act H.R. 6573 Help our Heroes Access Medicine Act of 2020 H.R. 6557 MAIL Act S. 3979 A bill to amend title 10, United States Code, to authorize the Secretary of Defense to temporarily waive cost-sharing amounts under the TRICARE pharmacy benefits program during certain declared emergencies. H.R.6395 - William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 H.R. 4806 DEBAR Act of 2019 H.R. 3878 Block, Report, and Suspend Suspicious Shipments Act of 2019 H.R. 4812 Ensuring Compliance Against Drug Diversion Act H.R. 4814 Suspicious Order Identification Act of 2019 H.R. 8061 Community Immunity During COVID-19 Act S. 3548 The CARES Act H.R. 6800 The HEROES Act

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Issues concerning BARDA funding; S. 551, Recovering Excessive Funds for Unused and Needless Drugs Act 2019; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; Legislation affecting pharmaceutical pricing including the Lower Heath Care Costs Act of 2019 (S.1895), Affordable Prescriptions for Patients Act of 2019 (S. 1416), Fair Accountability and Innovative Research Drug Pricing Act of 2019 (S. 1391, Transparent Drug Pricing Act of 2019 (S. 977), CREATES Act of 2019 (H.R. 965, S. 340), Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046), Strengthening Health Care and Lowering Prescription Drug Costs Act (H.R. 987). Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). H.R. 2279/S.2546, the Safe Step Act. Policies to ensure an adequate supply of plasma generally and for the development of therapies for COVID-19. Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. Legislation to increase awareness of need for plasma donations including H.R. 7783/S. 4179, the Plasma Donation Awareness Act of 2020. H.R. 133, Consolidated Appropriations Act, 2021, Pub. L. No. 116-260.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. Legislation to increase awareness of need for plasma donations including H.R. 7783/S. 4179, the Plasma Donation Awareness Act of 2020. H.R. 133, Consolidated Appropriations Act, 2021, Pub. L. No. 116-260.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Matters affecting access to and pricing of pharmaceuticals; matters affecting the Orphan Drug Act and therapies for rare diseases; legislation and regulatory activity relating to importation of prescription drugs, including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. H.R. 1407/S.578, ALS Disability Insurance Access Act; and H.R. 7071, Accelerate Access to Critical Therapies for ALS Act. H.R. 133, Consolidated Appropriations Act, 2021, Pub. L. No. 116-260.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding Medicare Part D coverage gap assistance, preventive care services, and dual eligible Medicare and Medicare beneficiaries 2. Proposals to create a premium support or voucher program under Medicare 3. Proposals to "means test" Medicare premiums and benefits 4. Proposals to change federal and state Medicaid cost sharing 5. Proposals to raise the Medicare eligibility age 6. Proposals regarding prescription drug costs for low income Medicare beneficiaries 7. Expansion of Medicare benefits to include hearing, vision, and dental benefits 8. Administration of the Medicare State Health Insurance Assistance Programs 9. Medicare Observation Status Regulations 10. Nursing Home Arbitration Regulations 11. Medicare 340(B) drug reimbursement policy 12. Home care workers and Medicare Reassignment Policy 13. Medicare equitable relief policy 14. S. 340, CREATES Act of 2019, entire bill 15. H.R. 965, CREATES Act of 2019, entire bill 16. H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019, entire bill 17. CMS Proposals on Part D Drug Pricing 18. S. 691, Medicare Extra Rx HELP Act of 2019, entire bill 19. H.R. 1342, EMPOWER Care Act, entire bill 20. S. 548, EMPOWER Care Act, entire bill 21. H.R. 1343, Protecting Married Seniors from Impoverishment Act, entire bill 22. S. 97, Affordable and Safe Prescription Drug Importation Act, entire bill 23. S. 99, Medicare Drug Price Negotiation Act, entire bill 24. H.R. 3, Lower Drug Costs Now Act of 2019, entire bill 25. H.R. 1393, Medicare Dental, Vision and Hearing Benefit Act of 2019, entire bill 26. H.R. 1394, Medigap Consumer Protection Act of 2019, entire bill 27. H.R. 1682, Improving Access to Medicare Coverage Act of 2019, entire bill 28. H.R. 4386, Stop the Wait Act, entire bill 29. Proposals regarding the tiering generic drugs under Medicare Part D 30. Proposals regarding the use of Medicaid waivers during the COVID-19 pandemic 31. S. 3544, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill 32. H.R. 6305, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill 33. Proposals to streamline Medicare enrollment during the COVID-19 pandemic 34. Proposals to expand oral health care under Medicare and Medicaid

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Pension & Welfare Benefits Administration, Pension Benefit Guaranty Corporation (PBGC), SENATE, Social Security Administration (SSA)

Medicare Coverage of Dental Care: H.R. 576 and S. 22, Negotiation of Prescription Drug Prices: S. 99 and H.R. 448 and S. 62 and H.R. 275, Prescription Drug Importation: H.R. 447 and S. 97 and S. 61, Improving Access to Affordable Generics: S. 64. SS Immunization Act: H.R. 5076

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain HR 6800 - Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act S. 3548 - CARES Act H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act

Client expense: $1,190,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R. 1614 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S. 724 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S.340 CREATES Act of 2019 H.R. 985 FAST Generics Act of 2019 S.640 Phair Pricing Act of 2019 S. 97 Affordable and Safe Prescription Drug Importation Act S. 61 Safe and Affordable Drugs from Canada Act of 2019 H.R. 1034 Phair Pricing Act of 2019 H.R. 965 CREATES Act of 2019 H.R. 1478 Affordable Insulin Act of 2019 H.R. 447 Affordable and Safe Prescription Drug Importation Act H.R. 1499 Protecting Consumer Access to Generic Drugs Act H.R. 3417 The Beneficiary Education Tools, Telehealth, and Extenders Re-authorization Act of 2019 H.R. 2296 Fair Accountability and Innovative Research Drug Pricing (FAIR Drug Pricing) Act of 2019 H.R. 1607 Fairness to Pet Owners Act H.R. 3379 Priced Relief, Innovation, and Competition for Essential Drugs (PRICED) Act H.R. 478 Safe and Affordable Drugs from Canada Act of 2019 H.R. 3 Lower Drug Costs Now Act of 2019 H.R. 275 Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448 Medicare Drug Price Negotiation Act H.R. 1046 Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 5304 PBM Transparency in Prescription Drug Costs Act H.R. 5172 NOPAIN Act S. 2543 Prescription Drug Pricing Reduction Act of 2019 S. Rept. 116-120 Prescription Drug Pricing Reduction Act of 2019 S. 2247 Phair Relief Act of 2019 S. 3070 Preventing Pill Mills Through Data Sharing Act H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 19 Lower Costs, More Cures Act on 2019 S. 3129 Lower Costs, More Cures Act on 2019 H.R. 748 Coronavirus Aid, Relief, and Economic Security Act or the CARES Act H.R. 6573 Help our Heroes Access Medicine Act of 2020 H.R. 6557 MAIL Act S. 3979 A bill to amend title 10, United States Code, to authorize the Secretary of Defense to temporarily waive cost-sharing amounts under the TRICARE pharmacy benefits program during certain declared emergencies. H.R.6395 - William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 H.R. 4806 DEBAR Act of 2019 H.R. 3878 Block, Report, and Suspend Suspicious Shipments Act of 2019 H.R. 4812 Ensuring Compliance Against Drug Diversion Act H.R. 4814 Suspicious Order Identification Act of 2019 H.R. 8061 Community Immunity During COVID-19 Act S. 3548 The CARES Act H.R. 6800 The HEROES Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding Medicare Part D coverage gap assistance, preventive care services, and dual eligible Medicare and Medicare beneficiaries 2. Proposals to create a premium support or voucher program under Medicare 3. Proposals to "means test" Medicare premiums and benefits 4. Proposals to change federal and state Medicaid cost sharing 5. Proposals to raise the Medicare eligibility age 6. Proposals regarding prescription drug costs for low income Medicare beneficiaries 7. Expansion of Medicare benefits to include hearing, vision, and dental benefits 8. Administration of the Medicare State Health Insurance Assistance Programs 9. Medicare Observation Status Regulations 10. Nursing Home Arbitration Regulations 11. Medicare 340(B) drug reimbursement policy 12. Home care workers and Medicare Reassignment Policy 13. Medicare equitable relief policy 14. S. 340, CREATES Act of 2019, entire bill 15. H.R. 965, CREATES Act of 2019, entire bill 16. H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019, entire bill 17. CMS Proposals on Part D Drug Pricing 18. S. 691, Medicare Extra Rx HELP Act of 2019, entire bill 19. H.R. 1342, EMPOWER Care Act, entire bill 20. S. 548, EMPOWER Care Act, entire bill 21. H.R. 1343, Protecting Married Seniors from Impoverishment Act, entire bill 22. S. 97, Affordable and Safe Prescription Drug Importation Act, entire bill 23. S. 99, Medicare Drug Price Negotiation Act, entire bill 24. H.R. 3, Lower Drug Costs Now Act of 2019, entire bill 25. H.R. 1393, Medicare Dental, Vision and Hearing Benefit Act of 2019, entire bill 26. H.R. 1394, Medigap Consumer Protection Act of 2019, entire bill 27. H.R. 1682, Improving Access to Medicare Coverage Act of 2019, entire bill 28. H.R. 4386, Stop the Wait Act, entire bill 29. Proposals regarding the tiering generic drugs under Medicare Part D 30. Proposals regarding the use of Medicaid waivers during the COVID-19 pandemic 31. S. 3544, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill 32. H.R. 6305, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill 33. Oklahoma Medicaid waiver application 34. Proposals to streamline Medicare enrollment during the COVID-19 pandemic

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Pension & Welfare Benefits Administration, Pension Benefit Guaranty Corporation (PBGC), SENATE, Social Security Administration (SSA)

S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Issues concerning BARDA funding; S. 551, Recovering Excessive Funds for Unused and Needless Drugs Act 2019; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; Legislation affecting pharmaceutical pricing including the Lower Heath Care Costs Act of 2019 (S.1895), Affordable Prescriptions for Patients Act of 2019 (S. 1416), Fair Accountability and Innovative Research Drug Pricing Act of 2019 (S. 1391, Transparent Drug Pricing Act of 2019 (S. 977), CREATES Act of 2019 (H.R. 965, S. 340), Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046), Strengthening Health Care and Lowering Prescription Drug Costs Act (H.R. 987). Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). H.R. 2279/S.2546, the Safe Step Act. Policies to ensure an adequate supply of plasma generally and for the development of therapies for COVID-19. Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. Legislation to increase awareness of need for plasma donations including H.R. 7783/S. 4179, the Plasma Donation Awareness Act of 2020.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. Legislation to increase awareness of need for plasma donations including H.R. 7783/S. 4179, the Plasma Donation Awareness Act of 2020.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Matters affecting access to and pricing of pharmaceuticals; matters affecting the Orphan Drug Act and therapies for rare diseases; legislation and regulatory activity relating to importation of prescription drugs, including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. H.R. 1407/S.578, ALS Disability Insurance Access Act; and H.R. 7071, Accelerate Access to Critical Therapies for ALS Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

Support for S. 97/HR 447 Affordable and Safe Prescription Drug Importation Act and S. 61/HR 447 Safe and Affordable Drugs from Canada Act; issues related to personal drug importation.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1781 - Payment Commission Data Act of 2019 H.R. 269 - PAHPA Reauthorization and Advancing Innovation Act of 2019 S. 97 - Affordable and Safe Prescription Drug Importation Act S. 1416 - Affordable Prescriptions For Patients Act of 2019 S. 1895 - Lower Health Care Costs Act H.R. 3 - Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act H.R. 5333 - OTC Monograph Reform Act H.R. 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act S. 3548 - CARES Act H.R. 6800 - The Heroes Act no specific bills, importation, supply chain integrity, 304b, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, drug pricing, insulin, international reference pricing

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

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

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

Medicare Coverage of Dental Care: H.R. 576 and S. 22, Negotiation of Prescription Drug Prices: S. 99 and H.R. 448 and S. 62 and H.R. 275, Prescription Drug Importation: H.R. 447 and S. 97 and S. 61, Improving Access to Affordable Generics: S. 64. SS Immunization Act: H.R. 5076

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538, Strengthening Americas Supply Chain and Medical Security Act H.R. 6431, Made in America Emergency Preparedness Act HR 6080, Prevent Drug Shortages Act S. 3432, Securing Americas Medicine Cabinet Act of 2020 H.R. 6670, Prescription for American Drug Independence Act of 2020 H.R. 6930, MADE in America Act HR 4439, Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772, Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370: Coronavirus Vaccine Act S. 3548: CARES Act H.R. 6080: Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400, The Advancing Education on Biosimilars Act of 2019 Vaccines

Client expense: $780,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

Support for S. 97/HR 447 Affordable and Safe Prescription Drug Importation Act and S. 61/HR 447 Safe and Affordable Drugs from Canada Act; issues related to personal drug importation.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

Client expense: $2,160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 1781 - Payment Commission Data Act of 2019 H.R. 269 - PAHPA Reauthorization and Advancing Innovation Act of 2019 S. 97 - Affordable and Safe Prescription Drug Importation Act S. 1416 - Affordable Prescriptions For Patients Act of 2019 S. 1895 - Lower Health Care Costs Act H.R. 3 - Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act H.R. 5333 - OTC Monograph Reform Act H.R. 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act S. 3548 - CARES Act H.R. 6800 - The Heroes Act no specific bills, importation, supply chain integrity, 304b, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, drug pricing, insulin, international reference pricing

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

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

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding Medicare Part D coverage gap assistance, preventive care services, and dual eligible Medicare and Medicare beneficiaries 2. Proposals to create a premium support or voucher program under Medicare 3. Proposals to "means test" Medicare premiums and benefits 4. Proposals to change federal and state Medicaid cost sharing 5. Proposals to raise the Medicare eligibility age 6. Proposals regarding prescription drug costs for low income Medicare beneficiaries 7. Expansion of Medicare benefits to include hearing, vision, and dental benefits 8. Administration of the Medicare State Health Insurance Assistance Programs 9. Medicare Observation Status Regulations 10. Nursing Home Arbitration Regulations 11. Medicare 340(B) drug reimbursement policy 12. Home care workers and Medicare Reassignment Policy 13. Medicare equitable relief policy 14. S. 340, CREATES Act of 2019, entire bill 15. H.R. 965, CREATES Act of 2019, entire bill 16. H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019, entire bill 17. CMS Proposals on Part D Drug Pricing 18. S. 691, Medicare Extra Rx HELP Act of 2019, entire bill 19. H.R. 1342, EMPOWER Care Act, entire bill 20. S. 548, EMPOWER Care Act, entire bill 21. H.R. 1343, Protecting Married Seniors from Impoverishment Act, entire bill 22. S. 97, Affordable and Safe Prescription Drug Importation Act, entire bill 23. S. 99, Medicare Drug Price Negotiation Act, entire bill 24. H.R. 3, Lower Drug Costs Now Act of 2019, entire bill 25. H.R. 1393, Medicare Dental, Vision and Hearing Benefit Act of 2019, entire bill 26. H.R. 1394, Medigap Consumer Protection Act of 2019, entire bill 27. H.R. 1682, Improving Access to Medicare Coverage Act of 2019, entire bill 28. H.R. 4386, Stop the Wait Act, entire bill 29. Proposals regarding the tiering generic drugs under Medicare Part D 30. Proposals regarding the use of Medicaid waivers during the COVID-19 pandemic 31. S. 3544, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill 32. H.R. 6305, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill 33. Oklahoma Medicaid waiver application 34. Proposals to streamline Medicare enrollment during the COVID-19 pandemic

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Pension & Welfare Benefits Administration, Pension Benefit Guaranty Corporation (PBGC), SENATE, Social Security Administration (SSA), U.S. Trade Representative (USTR)

S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Issues concerning BARDA funding; S. 551, Recovering Excessive Funds for Unused and Needless Drugs Act 2019; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; Legislation affecting pharmaceutical pricing including the Lower Heath Care Costs Act of 2019 (S.1895), Affordable Prescriptions for Patients Act of 2019 (S. 1416), Fair Accountability and Innovative Research Drug Pricing Act of 2019 (S. 1391, Transparent Drug Pricing Act of 2019 (S. 977), CREATES Act of 2019 (H.R. 965, S. 340), Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046), Strengthening Health Care and Lowering Prescription Drug Costs Act (H.R. 987). Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). H.R. 2279/S.2546, the Safe Step Act. Policies to ensure an adequate supply of plasma generally and for the development of therapies for COVID-19.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act"), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act").

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Matters affecting access to and pricing of pharmaceuticals; matters affecting the Orphan Drug Act and therapies for rare diseases; legislation and regulatory activity relating to importation of prescription drugs, including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act").

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Importation of prescription drugs (H.R. 447, H.R. 478, H.R. 1478, S. 61, S. 97, S. 658, S. 844) Opioid Abuse - General issues related to opioid drug abuse (Implementation of Public Law 115-271) Implementation of Public Law 113-54 (DSCSA) Issues Related to ARCOS data and suspicious order record requirements & reporting Block, Report, and Suspend Suspicious Shipments Act of 2019 (H.R. 3878)

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

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

H.R. 1614 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S. 724 A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; John S. McCain Opioid Addiction Prevention Act S.340 CREATES Act of 2019 H.R. 985 FAST Generics Act of 2019 S.640 Phair Pricing Act of 2019 S. 97 Affordable and Safe Prescription Drug Importation Act S. 61 Safe and Affordable Drugs from Canada Act of 2019 H.R. 1034 Phair Pricing Act of 2019 H.R. 965 CREATES Act of 2019 H.R. 1478 Affordable Insulin Act of 2019 H.R. 447 Affordable and Safe Prescription Drug Importation Act H.R. 1499 Protecting Consumer Access to Generic Drugs Act H.R. 3417 The Beneficiary Education Tools, Telehealth, and Extenders Re-authorization Act of 2019 H.R. 2296 Fair Accountability and Innovative Research Drug Pricing (FAIR Drug Pricing) Act of 2019 H.R. 1607 Fairness to Pet Owners Act H.R. 3379 Priced Relief, Innovation, and Competition for Essential Drugs (PRICED) Act H.R. 478 Safe and Affordable Drugs from Canada Act of 2019 H.R. 3 Lower Drug Costs Now Act of 2019 H.R. 275 Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448 Medicare Drug Price Negotiation Act H.R. 1046 Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 5304 PBM Transparency in Prescription Drug Costs Act H.R. 5172 NOPAIN Act S. 2543 Prescription Drug Pricing Reduction Act of 2019 S. Rept. 116-120 Prescription Drug Pricing Reduction Act of 2019 S. 2247 Phair Relief Act of 2019 S. 3070 Preventing Pill Mills Through Data Sharing Act H.R. 3055 Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 19 Lower Costs, More Cures Act on 2019 S. 3129 Lower Costs, More Cures Act on 2019 H.R. 748 Coronavirus Aid, Relief, and Economic Security Act or the CARES Act H.R. 6573 Help our Heroes Access Medicine Act of 2020 H.R. 6557 MAIL Act S. 3979 A bill to amend title 10, United States Code, to authorize the Secretary of Defense to temporarily waive cost-sharing amounts under the TRICARE pharmacy benefits program during certain declared emergencies. H.R.6395 - William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Coverage of Dental Care: H.R. 576 and S. 22, Negotiation of Prescription Drug Prices: S. 99 and H.R. 448 and S. 62 and H.R. 275, Prescription Drug Importation: H.R. 447 and S. 97 and S. 61, Improving Access to Affordable Generics: S. 64. SS Immunization Act: H.R. 5076

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Generic drug approval process policy issues PDUFA implementation policy issues 340B drug discount program policy issues Cancer drug vial size policy issues Pharmaceutical supply chain Pharmaceutical quality H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act (COVID 2) H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 2740: Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes H.R. 3772, Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 H.R. 748: CARES Act - Provisions related to Part B, Part D, vaccines, transparency, and transportation H.R. 6074: Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - Provisions related to biomedical research and prescription drug pricing S. 3370: Coronavirus Vaccine Act - Provisions related to NIH funding S. 3548: CARES Act - Provisions related to supplemental appropriations and federal health programs H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues

Client expense: $3,350,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical related provisions

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

Drug safety and drug counterfeiting; H.R. 2905, Medicare IVIG Access Enhancement Act; Policies affecting pre-existing condition protections; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Supply of intravenous immunoglobulin. S.3548/H.R. 748, Coronavirus Aid, Relief, and Economic Security Act; H.R. 6201, Families First Coronavirus Response Act; and H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Matters affecting access to and pricing of pharmaceuticals; matters affecting the Orphan Drug Act and therapies for rare diseases; legislation and regulatory activity relating to importation of prescription drugs, including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; Implementation of the Right to Try Act of 2017. S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; S.3548/H.R. 748, Coronavirus Aid, Relief, and Economic Security Act; H.R. 6201, Families First Coronavirus Response Act; and H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019; Issues concerning BARDA funding; S. 551, Recovering Excessive Funds for Unused and Needless Drugs Act 2019; Drug importation including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; Legislation affecting pharmaceutical pricing including the Lower Heath Care Costs Act of 2019 (S.1895), Affordable Prescriptions for Patients Act of 2019 (S. 1416), Fair Accountability and Innovative Research Drug Pricing Act of 2019 (S. 1391, Transparent Drug Pricing Act of 2019 (S. 977), CREATES Act of 2019 (H.R. 965, S. 340), Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046), Strengthening Health Care and Lowering Prescription Drug Costs Act (H.R. 987). S.3548/H.R. 748, Coronavirus Aid, Relief, and Economic Security Act; H.R. 6201, Families First Coronavirus Response Act; and H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. H.R. 2279/S.2546, the Safe Step Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding Medicare Part D coverage gap assistance, preventive care services, and dual eligible Medicare and Medicare beneficiaries 2. Proposals to create a premium support or voucher program under Medicare 3. Proposals to "means test" Medicare premiums and benefits 4. Proposals to change federal and state Medicaid cost sharing 5. Proposals to raise the Medicare eligibility age 6. Proposals regarding prescription drug costs for low income Medicare beneficiaries 7. Expansion of Medicare benefits to include hearing, vision, and dental benefits 8. Administration of the Medicare State Health Insurance Assistance Programs 9. Medicare Observation Status Regulations 10. Nursing Home Arbitration Regulations 11. Medicare 340(B) drug reimbursement policy 12. Home care workers and Medicare Reassignment Policy 13. Medicare equitable relief policy 14. S. 340, CREATES Act of 2019, entire bill 15. H.R. 965, CREATES Act of 2019, entire bill 16. H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019, entire bill 17. CMS Proposals on Part D Drug Pricing 18. S. 691, Medicare Extra Rx HELP Act of 2019, entire bill 19. H.R. 1342, EMPOWER Care Act, entire bill 20. S. 548, EMPOWER Care Act, entire bill 21. H.R. 1343, Protecting Married Seniors from Impoverishment Act, entire bill 22. S. 97, Affordable and Safe Prescription Drug Importation Act, entire bill 23. S. 99, Medicare Drug Price Negotiation Act, entire bill 24. H.R. 3, Lower Drug Costs Now Act of 2019, entire bill 25. H.R. 1393, Medicare Dental, Vision and Hearing Benefit Act of 2019, entire bill 26. H.R. 1394, Medigap Consumer Protection Act of 2019, entire bill 27. H.R. 1682, Improving Access to Medicare Coverage Act of 2019, entire bill 28. H.R. 4386, Stop the Wait Act, entire bill 29. Proposals regarding the tiering generic drugs under Medicare Part D 30. Proposals regarding the use of Medicaid waivers during the COVID-19 pandemic 31. S. 3544, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill 32. H.R. 6305, Coronavirus Relief for Seniors and People with Disabilities Act of 2020, entire bill

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Pension & Welfare Benefits Administration, Pension Benefit Guaranty Corporation (PBGC), SENATE, Social Security Administration (SSA), U.S. Trade Representative (USTR)

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;

Client expense: $940,000 · Firm income: Not reported

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

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019

Client expense: $440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

Support for S. 97/HR 447 Affordable and Safe Prescription Drug Importation Act and S. 61/HR 447 Safe and Affordable Drugs from Canada Act; issues related to personal drug importation.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE