We PAID Act

Proposals to enhance retirement savings opportunities for employers, employees, and individuals, including self correcting inadvertent plan errors. Small business tax credit. Issues related to Code Section 199A. Issues related to the Department of Labor's regulation defining fiduciary. Required minimum distribution issues. SIMPLE IRAs. H.R. 1938, Small Employer Retirement Savings Auto-Enrollment Credit Act (116th Congress). S. 1770, Retirement Security and Savings Act. S. 321, Retirement Security Act (116th Congress). S. 1272, SIMPLE Plan Modernization Act. H.R. 8083, Preserving Employee Retirement Savings Act (116th Congress). S. 1703, Improving Access to Retirement Savings. H.R. 2954, Securing a Strong Retirement Act. H.R. 8606, To defer the tax of certain sales of employer stock and reduce certain retirement-related excise taxes, and for other purposes (116th Congress). S. 1233, Small Business Tax Fairness and Compliance Simplification Act. H.R. 5376, Build Back Better Act. H.R. 5891, Retirement Improvement and Savings Enhancement Act. S. 2387, Small Business Tax Fairness Act. H.R. 7146/S. 1870, Enhancing Emergency and Retirement Savings Act. H.R. 7310, Protecting Americas Retirement Security Act. H.R. 6782/S. 3712, Auto Reenrollment Act. S. 4808, Enhancing American Retirement Now (EARN) Act. S. 4353, RISE & SHINE Act.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals to enhance retirement savings opportunities for employers, employees, and individuals, including self correcting inadvertent plan errors. Small business tax credit. Issues related to Code Section 199A. Issues related to the Department of Labor's regulation defining fiduciary. Required minimum distribution issues. SIMPLE IRAs. H.R. 1938, Small Employer Retirement Savings Auto-Enrollment Credit Act (116th Congress). S. 1770, Retirement Security and Savings Act. S. 321, Retirement Security Act (116th Congress). S. 1272, SIMPLE Plan Modernization Act. H.R. 8083, Preserving Employee Retirement Savings Act (116th Congress). S. 1703, Improving Access to Retirement Savings. H.R. 2954, Securing a Strong Retirement Act. H.R. 8606, To defer the tax of certain sales of employer stock and reduce certain retirement-related excise taxes, and for other purposes (116th Congress). S. 1233, Small Business Tax Fairness and Compliance Simplification Act. H.R. 5376, Build Back Better Act. H.R. 5891, Retirement Improvement and Savings Enhancement Act. S. 2387, Small Business Tax Fairness Act. H.R. 7146/S. 1870, Enhancing Emergency and Retirement Savings Act. H.R. 7310, Protecting Americas Retirement Security Act. H.R. 6782/S. 3712, Auto Reenrollment Act. Enhancing American Retirement Now (EARN) Act, as approved by the Senate Finance Committee. S. 4353, RISE & SHINE Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals to enhance retirement savings opportunities for employers, employees, and individuals, including self correcting inadvertent plan errors. Small business tax credit. Issues related to Code Section 199A. Issues related to the Department of Labor's regulation defining fiduciary. Required minimum distribution issues. SIMPLE IRAs. H.R. 1938, Small Employer Retirement Savings Auto-Enrollment Credit Act (116th Congress). S. 1770, Retirement Security and Savings Act. S. 321, Retirement Security Act (116th Congress). S. 1272, SIMPLE Plan Modernization Act. H.R. 8083, Preserving Employee Retirement Savings Act (116th Congress). S. 1703, Improving Access to Retirement Savings. H.R. 2954, Securing a Strong Retirement Act. H.R. 8606, To defer the tax of certain sales of employer stock and reduce certain retirement-related excise taxes, and for other purposes (116th Congress). S. 1233, Small Business Tax Fairness and Compliance Simplification Act. H.R. 5376, Build Back Better Act. H.R. 5891, Retirement Improvement and Savings Enhancement Act. S. 2387, Small Business Tax Fairness Act. H.R. 7146/S. 1870, Enhancing Emergency and Retirement Savings Act. H.R. 7310, Protecting Americas Retirement Security Act. H.R. 6782/S. 3712, Auto Reenrollment Act. Enhancing American Retirement Now (EARN) Act, as approved by the Senate Finance Committee. S. 4353, RISE & SHINE Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals to enhance retirement savings opportunities for employers, employees, and individuals, including self correcting inadvertent plan errors. Small business tax credit. Issues related to Code Section 199A. Issues related to the Department of Labor's regulation defining fiduciary. Required minimum distribution issues. SIMPLE IRAs. H.R. 1938, Small Employer Retirement Savings Auto-Enrollment Credit Act (116th Congress). S. 1770, Retirement Security and Savings Act. S. 321, Retirement Security Act (116th Congress). S. 1272, SIMPLE Plan Modernization Act. H.R. 8083, Preserving Employee Retirement Savings Act (116th Congress). S. 1703, Improving Access to Retirement Savings. H.R. 2954, Securing a Strong Retirement Act. H.R. 8606, To defer the tax of certain sales of employer stock and reduce certain retirement-related excise taxes, and for other purposes (116th Congress). S. 1233, Small Business Tax Fairness and Compliance Simplification Act. H.R. 5376, Build Back Better Act. H.R. 5891, Retirement Improvement and Savings Enhancement Act. S. 2387, Small Business Tax Fairness Act. H.R. 7146/S. 1870, Enhancing Emergency and Retirement Savings Act. H.R. 7310, Protecting Americas Retirement Security Act. H.R. 6782/S. 3712, Auto Reenrollment Act

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals to enhance retirement savings opportunities for employers, employees, and individuals, including self correcting inadvertent plan errors. Small business tax credit. Issues related to Code Section 199A. Issues related to the Department of Labor's regulation defining fiduciary. Required minimum distribution issues. SIMPLE IRAs. H.R. 1938, Small Employer Retirement Savings Auto-Enrollment Credit Act (116th Congress). S. 1770, Retirement Security and Savings Act. S. 321, Retirement Security Act (116th Congress). S. 1272, SIMPLE Plan Modernization Act. H.R. 8083, Preserving Employee Retirement Savings Act (116th Congress). S. 1703, Improving Access to Retirement Savings. H.R. 2954, Securing a Strong Retirement Act. H.R. 8606, To defer the tax of certain sales of employer stock and reduce certain retirement-related excise taxes, and for other purposes (116th Congress). S. 1233, Small Business Tax Fairness and Compliance Simplification Act. H.R. 5376, Build Back Better Act. H.R. 5891, Retirement Improvement and Savings Enhancement Act. S. 2387, Small Business Tax Fairness Act. H.R. 7146/S. 1870, Enhancing Emergency and Retirement Savings Act. H.R. 7310, Protecting Americas Retirement Security Act. H.R. 6782/S. 3712, Auto Reenrollment Act

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals to enhance retirement savings opportunities for employers, employees, and individuals, including self correcting inadvertent plan errors. Small business tax credit. Issues related to Code Section 199A. Issues related to the Department of Labor's regulation defining fiduciary. Required minimum distribution issues. SIMPLE IRAs. H.R. 1938, Small Employer Retirement Savings Auto-Enrollment Credit Act (116th Congress). S. 1770, Retirement Security and Savings Act. S. 321, Retirement Security Act (116th Congress). S. 1272, SIMPLE Plan Modernization Act. H.R. 8083, Preserving Employee Retirement Savings Act (116th Congress). S. 1703, Improving Access to Retirement Savings. H.R. 2954, Securing a Strong Retirement Act. H.R. 8606, To defer the tax of certain sales of employer stock and reduce certain retirement-related excise taxes, and for other purposes (116th Congress). S. 1233, Small Business Tax Fairness and Compliance Simplification Act. H.R. 5376, Build Back Better Act. H.R. 5891, Retirement Improvement and Savings Enhancement Act. S. 2387, Small Business Tax Fairness Act.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals to enhance retirement savings opportunities for employers, employees, and individuals, including self correcting inadvertent plan errors. Small business tax credit. Issues related to Code Section 199A. Issues related to the Department of Labor's regulation defining fiduciary. Required minimum distribution issues. SIMPLE IRAs. H.R. 1938, Small Employer Retirement Savings Auto-Enrollment Credit Act (116th Congress). S. 1770, Retirement Security and Savings Act. S. 321, Retirement Security Act (116th Congress). S. 1272, SIMPLE Plan Modernization Act. H.R. 8083, Preserving Employee Retirement Savings Act (116th Congress). S. 1703, Improving Access to Retirement Savings. H.R. 2954, Securing a Strong Retirement Act. H.R. 8606, To defer the tax of certain sales of employer stock and reduce certain retirement-related excise taxes, and for other purposes (116th Congress). S. 1233, Small Business Tax Fairness and Compliance Simplification Act. H.R. 5376, Build Back Better Act. H.R. 5891, Retirement Improvement and Savings Enhancement Act. S. 2387, Small Business Tax Fairness Act.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019

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

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole ---State Attorney General Letter Compulsory licensing ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.2387: We Protect American Investment in Drugs Act of 2019 Diversity in Patenting ---S.4394: Inventor Diversity for Economic Advancement (IDEA) Act of 2020 Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 Inter Partes Review Intellectual Property International Enforcement ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. ---India Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

Client expense: $3,180,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Asia Pacific Economic Cooperation Forum - - - Biologics Regulations - - - Intellectual Property Issues Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

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

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019

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

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior Intellectual Property Issues in Response to coronavirus S. 2387, We Protect American Investment in Drugs Act of 2019 S. 64, Preserve Access to Affordable Generics & Biosimilars Act of 2019

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. 1391 / H.R. 2296: FAIR Accountability and Innovative Research Drug Pricing Act; all provisions. S. 2387: We Protect American Investment in Drugs (PAID) Act; all provisions. S. 2443: Investment in Tomorrow's Pediatric Health Care Workforce Act; all provisions. S. 2546 / H.R. 2279: Safe Step Act; all provisions. H.R. 1379: the Ensuring Lasting Smiles Act; all provisions. H.R. 2781: Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act, section 4. H.R. 3502: Protecting People from Surprise Medical Bills Act; all provisions. H.R. 6074: Coronavirus Preparedness and Response Supplemental Appropriations Act; all provisions. H.R. 6201: Families First Coronavirus Response Act; all provisions. Supporting policies to address prescription drug costs, including funding for personal protective equipment and expanding telemedicine. Funding for the CDC National Neurological Conditions Surveillance System. Research into firearm morbidity and mortality prevention at CDC, fetal tissue research, AHRQ, and the NIH including the BRAIN Initiative. Funding for Congressionally Directed Medical Research Programs at the DoD. Lifting the federal ban restricting HHS from studying a Universal Patient Identifier. Policy to address surprise medical billing. Promoting interoperability in electronic health records.

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

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

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

S. 1384/ H.R. 3805: Prescription Drug Rebate Reform Act of 2019; all provisions. S. 1391 / H.R. 2296: FAIR Accountability and Innovative Research Drug Pricing Act; all provisions. S. 2387: We Protect American Investment in Drugs (PAID) Act; all provisions. S.2443: Investment in Tomorrow's Pediatric Health Care Workforce Act; all provisions. S. 2546 / H.R. 2279: Safe Step Act; all provisions. H.R. 1865: Further Consolidated Appropriations Act, 2020; priorities within this package around outlined below. H.R. 2781: Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act, section 4. H.R. 3030: Patient-Centered Outcomes Research Extension Act of 2019; all provisions. H.R. 3439: Protecting Access to Information for Effective and Necessary Treatment (PATIENTS) Act of 2019; all provisions. H.R. 3502, Protecting People from Surprise Medical Bills Act; all provisions. Supporting policies to address prescription drug costs, including improving drug pricing transparency and eliminating or reducing direct-to-consumer advertising. Funding for the National Neurological Conditions Surveillance System and opposing certain expansions to this program. Research into firearm morbidity and mortality prevention at CDC, fetal tissue research, and the NIH including the BRAIN Initiative. Funding for Congressionally Directed Medical Research Programs at the DoD. Lifting the federal ban restricting HHS from studying a Universal Patient Identifier. Policy to address surprise medical billing. Promoting interoperability in electronic health records

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

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

Maternal Health; Organ Transplant; Surprise Billing; Substance Use Disorders; Substance Use Patient Records Sharing; Laboratory Developed Tests; Video EEG Monitoring; Proton Therapy; S. 2387 We Protect American Investment in Drugs Act; H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act; SNAP; Mental Health.

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

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

HR 3/S 2543-Prescription Drug Affordability and access act, Drug Pricing, HR 965/S 340 (CREATES; Act), HR 2375/S 64-Preserve access to affordable generics and biosimilars act, S 1416-Affordable Prescriptions for Patients Act, HR 2374/S 1224-Stop Stalling Act, HR 1046-Medicare Negotiation and Competitive Licensing Act, HR 3815-PREP access and coverage act, S 2387-We PAID act, HR 3199-TERM act, HR 5133-Affordable Prescriptions for Patients through providing competition act, Affordable drug manufacturing act

Client expense: $130,000 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), Federal Energy Regulatory Commission (FERC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1922/S. 1089 _ Restoring Access to Medicine Act ___ H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency ___ H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1973: Vaccine Access Improvement Act ___ H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing ___ 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 - Provisions related to prescription drug samples ___ H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs ___ H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency ___ H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples ___ H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency ___ H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 2401: American Cures Act - Provisions related to pharmaceutical research and development ___ H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency ___ H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals ___ H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions ___ H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency ___ H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions ___ S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising ___ S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes ___ S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs ___ S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency ___ S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates ___ S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals ___ S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process ___ S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation ___ S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing ___ S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates ___ S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency ___ S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising ___ S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S.1872 _ Protecting Seniors through Immunizations Act of 2019 ___ S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing ___ Transparency policy issues ___ Drug cost and pricing policy issues ___ Drug importation and counterfeiting policy issues ___ HHS Safe Importation Action Plan ___ Prescription drug take back and secure disposal policy issues ___ Policy issues related to prescription drug abuse and opioids ___ Expanded access policy issues ___ Generic drug approval process policy issues ___ High deductible health plans/HSA policy issues ___ Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors ___ Risk Evaluation and Mitigation Strategy (REMS) policy issues ___ 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 ___ Biosimilar approval and reimbursement policy issues ___ Cancer drug vial size policy issues ___ TRICARE pharmacy pilot program ___ Drug shortages policy issues ___ Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $1,360,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing 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 - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2401: American Cures Act - Provisions related to pharmaceutical research and development H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues 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 Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $6,230,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), President of the U.S., SENATE, U.S. Trade Representative (USTR)

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, White House Office

Issues related to P.L. 96-517, the Bayh-Dole Act; H.R. 1046, Medicare Negotiation and Competitive Licensing Act; S. 2387, PAID Act; H.R. 3877, Bipartisan Budget Act of 2019; H.R. 3, Lower Drug Costs Now Act; S. 2543, Prescription Drug Pricing Reduction Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3222 No Federal Funds for Public Charge Act of 2019 - no Federal funds may be used to carry out the proposed rule of the Department of Homeland Security entitled Inadmissibility on Public Charge Grounds H.R.1897 MOMMA's Act - Federal efforts with respect to the prevention of maternal mortality H.R.2115 Public Disclosure of Drug Discounts Act - legislation to provide greater transparency of discounts provided by drug manufacturers. S.340/H.R.965CREATES - facilitate the timely entry of lower-cost generic and biosimilar versions of drugs and biological products H.R. 938 the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 - eligibility for FDA approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval H.R. 1499, the Protecting Consumer Access to Generic Drugs Act of 2019 - pay for delay; prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products H.R.2113 Prescription Drug STAR Act - require drug manufacturer price transparency, to require certain manufacturers to report on product samples provided to certain health care providers, H.R.2296, S.1391 FAIR Drug Pricing Act - Rx pricing transparency, require manufacturers to justify price increases H.R.2376, S.1227 Prescription Pricing for the People Act - directs the Federal Trade Commission to report to Congress on the effect of certain anticompetitive practices in the pharmaceutical supply chain S.Res.134 - A resolution expressing the sense of the Senate that the Department of Justice should reverse its position in Texas v. United States, No. 4:18-cv-00167-O (N.D. Tex.) H.R.1010 - To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect H.R.1868 - Health Care Affordability Act of 2019 - reducing insurance premiums and out-of-pocket costs in the individual and small group markets, both for low-income families and those that are not eligible for tax credits H.R.1425 State Health Care Premium Reduction Act - Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market H.R.986 - Protecting Americans with Preexisting Conditions Act of 2019 - certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect H.R.987Strengthening Health Care and Lowering Prescription Drug Costs Ac- requires the Department of Health and Human Services (HHS) to conduct outreach and educational activities regarding federally-facilitated exchanges (i.e., health insurance exchanges that are established and operated within states by HHS). The activities must inform potential enrollees of the availability of coverage and related financial assistance under the exchanges and must be provided in culturally and linguistically appropriate formats. S.1556No Junk Plans Act - rule entitled Short-Term, Limited Duration Insurance shall have no force or effect. S.1531STOP Surprise Medical Bills Act - provide protections for health insurance consumers from surprise billing H.R.861 - End Surprise Billing Act of 2019 - prevent surprise billing practices and require notification for consumers S.1895 Lower Health Care Costs Act - comprehensive legislation to end surprise medical bills, reduce prescription drug prices, improve health care transparency, improve public health, improve exchange of health information H.R. 3630 No Surprises Act - legislation to protect consumers from surprise medical bills, using median in network rate and an option to go to arbitration for bills above $1250. H.R. 3502 Protecting People From Surprise Medical Bills Act - legislation to protect consumers from surprise medical bills, arbitration as payment mechanism H.R.748, S. 684Middle Class Health Benefits Tax Repeal Act of 2019 - repeal the excise tax on high value employer-sponsored health care coverage, also known as the Cadillac Tax S. 1801 Affordable Medications Act - increase drug price transparency and affordability, spur innovation, and enhance competition S.455/ H.R.987 - MORE Health Education Act - funding for Federal Exchange outreach and educational activities H.R.3180, S. 1770 RISE (Resilience Investment, Support, and Expansion) from Trauma Act - improve the identification and support of children and families who experience trauma S.2387 We Protect American Investment in Drugs Act - prohibits Pharmaceutical companies developing prescription drugs using federally-funded research, like NIH or CDC grants, from charging American consumers unreasonable prices for life-saving drugs H.R.2411/S.1258 Tobacco to 21 Act - prohibit the sale of tobacco products to individuals under the age of 21 H.R.2339 Reversing the Youth Tobacco Epidemic Act - legislation to curb the rise of youth tobacco use H.R. 4548 Asthma Care and Prevention in Rural Communities Act -authorize CDC to award grants to eligible counties for the use of mobile clinics and distance learning and telemedicine to diagnose and treat children with asthma in rural areas and medically underserved communities, H.R.4158 CURE High Drug Prices Act - prohibit price gouging in the sale of drugs H.R.4575 - Improving Provider Directories Act - require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers H.R. 4457 Chronic Condition Copay Elimination Act - require group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for additional preventive care for individuals with chronic conditions without the imposition of cost sharing requirement H.R.2374 Stop STALLING Act - enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition and facilitate the efficient review of petitions filed in good faith to raise legitimate public heath concerns H.R.1983 Community Health Investment, Modernization, and Excellence Act of 2019 - reauthorize and extend funding for community health centers and the National Health Service Corp Legislation to prevent air ambulances from balance billing patients Legislation to require health care facilities and providers to give patients a list of services received upon discharge Legislation to reauthorize the Patient-Centered Outcomes Research Institute (PCORI)

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

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

HR 1046, S 377-Medicare Negotiation and Competitive Licensing Act, S 1987-End Price Gouging for Medications act, HR 3199-TERM Act, S 1895-Lower Health Care Costs Act, S 1209-(REMEDY act), S 1416-Affordable Prescriptions for Patients Act, HR 2374, S 1224-Stop STALLING Act, HR 3379-PRICED Act, HR 2296, S 1391-(FAIR Drug Pricing Act), drug pricing, HR 2296-METRIC Act, S 2004-Emergency Access to Insulin Act, S 2387-We protect American Investments in Drugs Act (We PAID Act), S 2199-Insulin Price Reduction Act, S 977-Transparent Drug Prices Act, S 378-Stop Price Gouging Act, S 340-CREATES Act, HR 3- Patient Advocacy Transparency Act,

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)