Stop STALLING Act

H.R. 5/S. 393, Equality Act H.R. 7/S. 205, Paycheck Fairness Act H.R. 447, National Apprenticeship Act of 2021 H.R. 603/S. 53, Raise the Wage Act of 2021 H.R. 804/S. 248, Family and Medical Insurance Leave (FAMILY) Act H.R. 830, Wage Increase Fairness Act H.R. 842/S. 420, Protecting the Right to Organize Act of 2021 H.R. 1065/S. 1486/S. 4431, Pregnant Workers Fairness Act H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 1284/S. 403, Fair and Open Competition (FOCA) Act H.R. 1277/S. 374, Improving Corporate Governance Through Diversity Act of 2021 H.R. 1319, American Rescue Plan Act of 2021 H.R. 1458/S.490, Unemployment Insurance Technology Modernization Act of 2021 H.R. 1735/S. 673, Journalism Competition and Preservation Act of 2021 H.R. 2491, Wage Equity Act of 2021 H.R. 2668, Consumer Protection and Recovery Act H.R. 2795, DHS Blue Campaign Enhancement Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891/S. 1428, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2926/S. 663, One Agency Act H.R. 3110/S. 1658, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 H.R. 3460/S. 1787, State Antitrust Enforcement Venue Act of 2021 H.R. 3816/S. 2992, American Choice and Innovation Online Act H.R. 3825, Ending Platform Monopolies Act H.R. 3826/S. 3197, Platform Competition and Opportunity Act of 2021 H.R. 3843/S. 228, Merger Filing Fee Modernization Act of 2021 H.R. 3849, Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act of 2021 H.R. 4109/S. 2193, Protections for Socially Good Activities Act H.R. 4350, National Defense Authorization Act for Fiscal Year 2022 H.R. 5017/S. 2710, Open App Markets Act H.R. 5376, Build Back Better Act H.R. 5842, Ending the Monopoly of Power Over Workplace Harassment through Education and Reporting (EMPOWER) Act H.R. 6922/S. 3760, Continued Waiver of Interest on State Unemployment Loans during the Pandemic Act H.R. 7194/S. 3889, Employee Rights Act H.R. 7151, Ensuring Sound Guidance Act H.R. 7309, Workforce Innovation and Opportunity Act of 2022 H.R. 7701, Wage Theft Prevention and Wage Recovery Act H.R. 8295/S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 H.Res. 823, Providing for the consideration of the bill (H.R. 3460) to amend title 28 of the United States Code to prevent the transfer of actions arising under the antitrust laws in which a State is a complainant H.J. Res. 100,To provide for a resolution with respect to the unresolved disputes between certain railroads represented by the National Carriers' Conference Committee of the National Railway Labor Conference and certain of their employees H. Con. Res. 119, Providing for a correction in the enrollment of H.J. Res. 100 S. 225, Competition and Antitrust Law Enforcement Reform Act of 2021 S. 478, Higher Wages for American Workers Act of 2021 S. 977, No Oil Producing and Exporting Cartels (NOPEC) Act of 2021 S. 1074, Trust-Busting for the Twenty-First Century Act S. 1204, Bust Up Big Tech Act S. 1380, Clean Slate Act of 2021 S. 1425, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1636, Save Local Business Act S. 2039, Tougher Enforcement Against Monopolists (TEAM) Act S. 2991, Countering Human Trafficking Act of 2021 S. 3311, FTC Integrity Act S. 3847, Prohibiting Anticompetitive Mergers Act of 2022 S. 3889, Employee Rights Act S. 4145, Consumer Protection Remedies Act of 2022 S. J. Res. 13, A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Equal Employment Opportunity Commission relating to "Update of Commission's Conciliation Procedures" Nomination of Jessica Looman to be Administrator of the Wage and Hour Division Interim final rule on Occupational Exposure to COVID-19; Emergency Temporary Standard (86 Fed. Reg. 32,376-32,628, June 21, 2021) Prohibited Transaction Exemption 2020-02, Improving Investment Advice for Workers & Retirees (85 Fed. Reg. 82,798-82,866, December 18, 2020) Proposed Rule, Department of Labor; Employee or Independent Contractor Classification under the Fair Labor Standards Act (87 Fed. Reg. 62,218-62,275, Oct. 13, 2022) Proposed Rule, National Labor Relations Board; Standard for Determining Joint-Employer Status Under the National Labor Relations Act (87 Fed. Reg. 54,641-54,663, September 7, 2022) Request for Comments, Internal Revenue Service; Prevailing Wage, Apprenticeship, Domestic Content, and Energy Communities Requirements Under the Act Commonly Known as the Inflation Reduction Act of 2022 (Docket No. IRS-2022-0025, Notice 2022-51, November 30, 2022) Request for Comments, International Trade Administration; Artificial Intelligence Export Competitiveness (87 Fed. Reg. 50,288-50,289, August 16, 2022) Proposed Rule, Department of Defense, General Services Administration, and National Aeronautics and Space Administration; Federal Acquisition Regulation: Use of Project Labor Agreements for Federal Construction Projects (87 Fed. Reg. 51,044-51,052, August 19, 2022) Final Rule on Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder Rights (87 Fed. Reg. 73,822-73,886, December 1, 2022) Proposed Rule, Improve Tracking of Workplace Injuries, and Illnesses (87 Fed. Reg. 18,528-18,558, March 3, 2022) Various issues relating to modernization of the unemployment insurance system; application of Kristof Terryn to serve on the Department of Labor's Advisory Committee on Apprenticeship; paid leave including paid family and sick leave; reforms to the Fair Labor Standards Act (P.L. 75-178); independent contractors; unemployment insurance and the coronavirus pandemic; debarment of federal contractors (blacklisting); Equal Employment Opportunity Commission (EEOC) conciliation regulation; the firing of Peter Robb as General Counsel of the National Labor Relations Board (NLRB), and of Alice Stock, Deputy General Counsel of the NLRB; rescission of the joint employer standard under the Fair Labor Standards Act (P.L. 75-718); The FTC's Multilateral Pharmaceutical Merger Taskforce; The USMCA Labor Council; apprenticeships; proposed amendment to the U.S. Longshore and Harbor Workers Compensation Act (Longshore Act), relating to the establishment of statutory presumptions of coverage and compensability for illnesses; potential Wage and Hour Division rulemaking defining and delimiting the exemptions under the Fair Labor Standards Act for Executive, Administrative, Professional, Outside Sales and Computer Employees; potential legislation on the minimum wage; COVID-19 vaccine requirements, including a potential Emergency Temporary Standard from the Occupational Safety and Health Administration relating to employers with more than 100 employees; vaccine requirements for federal contractors; legal and regulatory framework for evaluating mergers and acquisitions; contract terms and their relationship to competition, particularly relating to worker non-compete clauses and exclusive contracts; Federal Trade Commission issues: Freedom of Information Act Requests, Penalty Offense Authority, Zombie Voting, and overall direction of the Commission; anticipated overtime regulations under the Fair Labor Standards Act Office of Federal Contract Compliance Programs, Directive (DIR) 2022-01; filing complaints under the National Labor Relations Act; Executive Order 13999 Protecting Worker Health and Safety; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; Executive Order 14036, Promoting Competition in the American Economy; Executive Order 14063, Use of Project Labor Agreements for Federal Construction Projects; President Bidens Path Out of the Pandemic: COVID Action Plan; unemployment insurance; international concerns in the areas of antitrust, standards and investment; domestic and international antitrust policy; Federal Trade Commission (FTC) section 19/13b authority; Policies and practices related to the FTC expanding its authority; Transparency at the FTC; FTCs Draft Strategic Plan for Fiscal Years 2022 to 2026; section 5 of the Federal Trade Commission Act of 1914; efforts to revise the 1995 Bank Merger Competitive Review Gudelines; efforts to modernize enforcement of the antitrust laws regarding mergers; pregnancy discrimination; oversight addressing the National Labor Relations Board, including implementation and oversight of the National Labor Relations Act (P.L. 74-198); election procedures under the Railway Labor Act (P.L. 69-257); National Labor Relations Board (NLRB) decisions and regulatory agenda; definition of labor organization under the Labor Management Reporting and Disclosure Act (P.L. 86-257)

Client expense: $20,990,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE

Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.

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

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE

Antitrust Consumer welfare standard S. 225 (Competition and Antitrust Law Enforcement Reform Act) H.R. 3460/S. 1787 (State Antitrust Enforcement Venue Act) H.R. 3816/S. 2992 (American Choice and Innovation Online Act) H.R. 3825 (Ending Platform Monopolies Act) H.R. 3826/S. 3197 (Platform Competition and Opportunity Act) H.R. 3843/S. 2039 (Merger Filing Fee Modernization Act) S. 228 (TEAM Act) H.R. 3849 (ACCESS Act) H.R. 5639 (Foreign Merger Subsidy Disclosure Act) House Judiciary Comm. Final Report on Investigation of Competition in Digital Markets S. 1435/H.R. 2873 (Affordable Prescriptions for Patients Through Promoting Competition Act) S. 1425/H.R. 2883 (Stop STALLING Act) S. 1428/H.R. 2891 (Preserve Access to Affordable Generics) S. 4258/H.R. 7839 (Competition and Transparency in Digital Advertising Act) Federal Trade Commission motion to rescind the 2015 Statement of Enforcement Principles Regarding Unfair Methods of Competition (UMC) Under Section 5 of the FTC Act Multilateral Pharmaceutical Merger Task Force (FTC Pharmaceutical Task Force, Project No. P212900) Executive Order 14036 (Promoting Competition in the American Economy) FTC Rescission of 1995 Policy Statement on Prior Approval and Prior Notice Provisions in Merger Cases FTCs counting votes cast by a former commissioner Nominations to Federal Trade Commission positions FTC-Justice Dept. Request for Information on proposed Merger Enforcement Guidelines (FTC-2022-0003) S. 2992 (American Innovation and Choice Online Act) S. 2710 (Open App Markets Act) H.R. 2617 (legislative vehicle for the Consolidated Appropriations Act FY 2023 with Senate amendment #6552) antitrust-related policy riders

Client expense: Not reported · Firm income: $10,000

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

Client expense: $930,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property

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

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

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $1,908,258 · Firm income: Not reported

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

H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

Client expense: $910,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5/S. 393, Equality Act H.R. 7/S. 205, Paycheck Fairness Act H.R. 447, National Apprenticeship Act of 2021 H.R. 603/S. 53, Raise the Wage Act of 2021 H.R. 804/S. 248, Family and Medical Insurance Leave (FAMILY) Act H.R. 830, Wage Increase Fairness Act H.R. 842/S. 420, Protecting the Right to Organize Act of 2021 H.R. 1065/S. 1486/S. 4431, Pregnant Workers Fairness Act H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 1284/S. 403, Fair and Open Competition (FOCA) Act H.R. 1277/S. 374, Improving Corporate Governance Through Diversity Act of 2021 H.R. 1319, American Rescue Plan Act of 2021 H.R. 1458/S.490, Unemployment Insurance Technology Modernization Act of 2021 H.R. 1735/S. 673, Journalism Competition and Preservation Act of 2021 H.R. 2491, Wage Equity Act of 2021 H.R. 2668, Consumer Protection and Recovery Act H.R. 2795, DHS Blue Campaign Enhancement Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891/S. 1428, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2926/S. 663, One Agency Act H.R. 3110/S. 1658, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 H.R. 3460/S. 1787, State Antitrust Enforcement Venue Act of 2021 H.R. 3816/S. 2992, American Choice and Innovation Online Act H.R. 3825, Ending Platform Monopolies Act H.R. 3826/S. 3197, Platform Competition and Opportunity Act of 2021 H.R. 3843/S. 228, Merger Filing Fee Modernization Act of 2021 H.R. 3849, Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act of 2021 H.R. 4109/S. 2193, Protections for Socially Good Activities Act H.R. 4350, National Defense Authorization Act for Fiscal Year 2022 H.R. 4841, Restoring Justice for Workers Act H.R. 5017/S. 2710, Open App Markets Act H.R. 5376, Build Back Better Act H.R. 5842, Ending the Monopoly of Power Over Workplace Harassment through Education and Reporting (EMPOWER) Act H.R. 6922/S. 3760, Continued Waiver of Interest on State Unemployment Loans during the Pandemic Act H.R. 7194/S. 3889, Employee Rights Act H.R. 7151, Ensuring Sound Guidance Act H.R. 7309, Workforce Innovation and Opportunity Act of 2022 H.R. 7701, Wage Theft Prevention and Wage Recovery Act H.R. 8295/S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 H.Res. 823, Providing for the consideration of the bill (H.R. 3460) to amend title 28 of the United States Code to prevent the transfer of actions arising under the antitrust laws in which a State is a complainant S. 225, Competition and Antitrust Law Enforcement Reform Act of 2021 S. 478, Higher Wages for American Workers Act of 2021 S. 977, No Oil Producing and Exporting Cartels (NOPEC) Act of 2021 S. 1074, Trust-Busting for the Twenty-First Century Act S. 1204, Bust Up Big Tech Act S. 1380, Clean Slate Act of 2021 S. 1425, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1636, Save Local Business Act S. 2039, Tougher Enforcement Against Monopolists (TEAM) Act S. 3311, FTC Integrity Act S. 3847, Prohibiting Anticompetitive Mergers Act of 2022 S. 3889, Employee Rights Act S. 4145, Consumer Protection Remedies Act of 2022 S. J. Res. 13, A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Equal Employment Opportunity Commission relating to "Update of Commission's Conciliation Procedures" Draft legislation titled Retirement Savings Modernization Act Nomination of Jessica Looman to be Administrator of the Wage and Hour Division Proposed rule on Joint Employer Status Under the Fair Labor Standards Act, (84 Fed. Reg. 14,043-14,061, April 9, 2019) Interim final rule on Occupational Exposure to COVID-19; Emergency Temporary Standard (86 Fed. Reg. 32,376-32,628, June 21, 2021) Interim final rule on COVID-19 Vaccination and Testing; Emergency Temporary Standard (86 Fed. Reg. 61,402-61,555, November 5, 2021) Advance Notice of Proposed Rulemaking Concerning Heat Injury and Illness Prevention in Outdoor and Indoor Settings (86 Fed. Reg. 59,309-59,326, Oct. 27, 2021) Proposed Amendments to Agriculture Acquisition Regulations (87 Fed. Reg. 9,005-9,021, February 17, 2022) Prohibited Transaction Exemption 2020-02, Improving Investment Advice for Workers & Retirees (85 Fed. Reg. 82,798-82,866, December 18, 2020) Final rule on Financial Factors in Selecting Plan Investments (85 Fed. Reg. 72,846-72,885, November 13, 2020) Final rule on Fiduciary Duties Regarding Proxy Voting and Shareholder Rights (85 Fed. Reg. 81,658-81,695, December 16, 2020) Proposed rule on Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder Rights (86 Fed. Reg. 57,272-57,304, October 13, 2021) Various issues relating to modernization of the unemployment insurance system; application of Kristof Terryn to serve on the Department of Labor's Advisory Committee on Apprenticeship; paid leave including paid family and sick leave; reforms to the Fair Labor Standards Act (P.L. 75-178); independent contractors; unemployment insurance and the coronavirus pandemic; debarment of federal contractors (blacklisting); contractor blacklisting; Equal Employment Opportunity Commission (EEOC) conciliation regulation; rescission of the joint employer standard under the Fair Labor Standards Act (P.L. 75-718); The FTC's Multilateral Pharmaceutical Merger Taskforce; The USMCA Labor Council; apprenticeships; proposed amendment to the U.S. Longshore and Harbor Workers Compensation Act (Longshore Act), relating to the establishment of statutory presumptions of coverage and compensability for illnesses; potential Wage and Hour Division rulemaking defining and delimiting the exemptions under the Fair Labor Standards Act for Executive, Administrative, Professional, Outside Sales and Computer Employees; potential Wage and Hour Division rulemaking on classification of independent contractors and employees; potential legislation on the minimum wage; COVID-19 vaccine requirements, including a potential Emergency Temporary Standard from the Occupational Safety and Health Administration relating to employers with more than 100 employees; vaccine requirements for federal contractors; legal and regulatory framework for evaluating mergers and acquisitions; contract terms and their relationship to competition, particularly relating to worker non-compete clauses and exclusive contracts; Federal Trade Commission issues: Freedom of Information Act Requests, Penalty Offense Authority, Zombie Voting, and overall direction of the Commission; anticipated overtime regulations under the Fair Labor Standards Act Office of Federal Contract Compliance Programs, Directive (DIR) 2022-01; Executive Order 13999 Protecting Worker Health and Safety; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; Executive Order 14036, Promoting Competition in the American Economy; Executive Order 14063, Use of Project Labor Agreements for Federal Construction Projects; President Bidens Path Out of the Pandemic: COVID Action Plan; unemployment insurance; international concerns in the areas of antitrust, standards and investment; domestic and international antitrust policy; Federal Trade Commission (FTC) section 19/13b authority; Policies and practices related to the FTC expanding its authority; Transparency at the FTC; FTCs Draft Strategic Plan for Fiscal Years 2022 to 2026; efforts to revise the 1995 Bank Merger Competitive Review Gudelines; efforts to modernize enforcement of the antitrust laws regarding mergers; competition in the agriculture marketplace; pregnancy discrimination; oversight addressing the National Labor Relations Board, including implementation and oversight of the National Labor Relations Act (P.L. 74-198); election procedures under the Railway Labor Act (P.L. 69-257); National Labor Relations Board (NLRB) decisions and regulatory agenda; definition of labor organization under the Labor Management Reporting and Disclosure Act (P.L. 86-257); GAO study on Fiduciary Investment Advice

Client expense: $23,940,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC)

H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.

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

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE

Antitrust Consumer welfare standard S. 225 (Competition and Antitrust Law Enforcement Reform Act) H.R. 3460/S. 1787 (State Antitrust Enforcement Venue Act) H.R. 3816/S. 2992 (American Choice and Innovation Online Act) H.R. 3825 (Ending Platform Monopolies Act) H.R. 3826/S. 3197 (Platform Competition and Opportunity Act) H.R. 3843/S. 2039 (Merger Filing Fee Modernization Act) S. 228 (TEAM Act) H.R. 3849 (ACCESS Act) H.R. 5639 (Foreign Merger Subsidy Disclosure Act) House Judiciary Comm. Final Report on Investigation of Competition in Digital Markets S. 1435/H.R. 2873 (Affordable Prescriptions for Patients Through Promoting Competition Act) S. 1425/H.R. 2883 (Stop STALLING Act) S. 1428/H.R. 2891 (Preserve Access to Affordable Generics) S. 4258/H.R. 7839 (Competition and Transparency in Digital Advertising Act) Federal Trade Commission motion to rescind the 2015 Statement of Enforcement Principles Regarding Unfair Methods of Competition (UMC) Under Section 5 of the FTC Act Multilateral Pharmaceutical Merger Task Force (FTC Pharmaceutical Task Force, Project No. P212900) Executive Order 14036 (Promoting Competition in the American Economy) FTC Rescission of 1995 Policy Statement on Prior Approval and Prior Notice Provisions in Merger Cases FTCs counting votes cast by a former commissioner Nominations to Federal Trade Commission positions FTC-Justice Dept. Request for Information on proposed Merger Enforcement Guidelines (FTC-2022-0003) S. 2992 (American Innovation and Choice Online Act)

Client expense: Not reported · Firm income: $10,000

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 4127: DISARM Act - Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing and patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S 2938 - Bipartisan Safer Communities Act - budget offset provisions related to Rebate Rule S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Dietary Supplement Health and Education Act Reform Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022

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

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

H.R. 5: Equality Act H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5416: Give Kids a Chance Act H.R. 5566: FORWARD Act of 2021 - Provisions related to orphan-disease remedies H.R. 5585: Advanced Research Projects Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7666: Restoring Hope for Mental Health and Well-Being Act of 2022 - To amend the Public Health Service Act to reauthorize certain programs relating to mental health and substance use disorder, and for other purposes H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2304: DTC Act of 2021 - Provisions related to prescription drug advertising S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3493: Drug Shortages Shelf Life Extension Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4071: Helping Experts Accelerate Rare Treatments Act of 2022 S. 4338: Increasing Transparency in Generic Drug Applications Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $1,457,755 · Firm income: Not reported

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

Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.

Client expense: $82,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE

H.R. 5/S. 393, Equality Act H.R. 7/S. 205, Paycheck Fairness Act H.R. 603/S. 53, Raise the Wage Act of 2021 H.R. 804/S. 248, Family and Medical Insurance Leave (FAMILY) Act H.R. 830, Wage Increase Fairness Act H.R. 842/S. 420, Protecting the Right to Organize Act of 2021 H.R. 1065/S. 1486/S. 4431, Pregnant Workers Fairness Act H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 1284/S. 403, Fair and Open Competition (FOCA) Act H.R. 1277/S. 374, Improving Corporate Governance Through Diversity Act of 2021 H.R. 1319, American Rescue Plan Act of 2021 H.R. 1458/S.490, Unemployment Insurance Technology Modernization Act of 2021 H.R. 1735/S. 673, Journalism Competition and Preservation Act of 2021 H.R. 2491, Wage Equity Act of 2021 H.R. 2668, Consumer Protection and Recovery Act H.R. 2795, DHS Blue Campaign Enhancement Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891/S. 1428, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2926/S. 663, One Agency Act H.R. 3110/S. 1658, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 H.R. 3460/S. 1787, State Antitrust Enforcement Venue Act of 2021 H.R. 3816/S. 2992, American Choice and Innovation Online Act H.R. 3825, Ending Platform Monopolies Act H.R. 3826/S. 3197, Platform Competition and Opportunity Act of 2021 H.R. 3843/S. 228, Merger Filing Fee Modernization Act of 2021 H.R. 3849, Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act of 2021 H.R. 4109/S. 2193, Protections for Socially Good Activities Act H.R. 4350, National Defense Authorization Act for Fiscal Year 2022 H.R. 4841, Restoring Justice for Workers Act H.R. 5017/S. 2710, Open App Markets Act H.R. 5376, Build Back Better Act H.R. 6922/S. 3760, Continued Waiver of Interest on State Unemployment Loans during the Pandemic Act H.R. 7194/S. 3889, Employee Rights Act H.R. 7309, Workforce Innovation and Opportunity Act of 2022 H.R. 7701, Wage Theft Prevention and Wage Recovery Act H.Res. 823, Providing for the consideration of the bill (H.R. 3460) to amend title 28 of the United States Code to prevent the transfer of actions arising under the antitrust laws in which a State is a complainant S. 225, Competition and Antitrust Law Enforcement Reform Act of 2021 S. 478, Higher Wages for American Workers Act of 2021 S. 977, No Oil Producing and Exporting Cartels (NOPEC) Act of 2021 S. 1074, Trust-Busting for the Twenty-First Century Act S. 1204, Bust Up Big Tech Act S. 1380, Clean Slate Act of 2021 S. 1425, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1636, Save Local Business Act S. 2039, Tougher Enforcement Against Monopolists (TEAM) Act S. 3311, FTC Integrity Act S. 3847, Prohibiting Anticompetitive Mergers Act of 2022 S. 3889, Employee Rights Act S. 4145, Consumer Protection Remedies Act of 2022 S. J. Res. 13, A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Equal Employment Opportunity Commission relating to "Update of Commission's Conciliation Procedures" Draft legislation titled Retirement Savings Modernization Act Draft legislation titled Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2023, and for other purposes Nomination of Alvaro Bedoya to be a Member of the Federal Trade Commission Proposed rule on Joint Employer Status Under the Fair Labor Standards Act, (84 Fed. Reg. 14,043-14,061, April 9, 2019) Proposed rule on Independent Contractor status under the Fair Labor Standards Act (85 Fed. Reg. 60,600-60,639, September 25, 2020) Interim final rule on Occupational Exposure to COVID-19; Emergency Temporary Standard (86 Fed. Reg. 32,376-32,628, June 21, 2021) Interim final rule on COVID-19 Vaccination and Testing; Emergency Temporary Standard (86 Fed. Reg. 61,402-61,555, November 5, 2021) Advance Notice of Proposed Rulemaking Concerning Heat Injury and Illness Prevention in Outdoor and Indoor Settings (86 Fed. Reg. 59,309-59,326, Oct. 27, 2021) Proposed Amendments to Agriculture Acquisition Regulations (87 Fed. Reg. 9,005-9,021, February 17, 2022) Prohibited Transaction Exemption 2020-02, Improving Investment Advice for Workers & Retirees (85 Fed. Reg. 82,798-82,866, December 18, 2020) Final rule on Financial Factors in Selecting Plan Investments (85 Fed. Reg. 72,846-72,885, November 13, 2020) Final rule on Fiduciary Duties Regarding Proxy Voting and Shareholder Rights (85 Fed. Reg. 81,658-81,695, December 16, 2020) Proposed rule on Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder Rights (86 Fed. Reg. 57,272-57,304, October 13, 2021) Proposed rule, Improve Tracking of Workplace Injuries and Illnesses (87 Fed. Reg. 18,528-18,558, March 30, 2022) Request for Information, U.S. Department of Agriculture; Access to Fertilizer: Competition and Supply Chain Concerns (87 Fed. Reg. 15,191-15,194, March 17 2022) Notice of Limited Reopening of Comment Period, Occupational Safety and Health Administration; Occupational Exposure to COVID-19 in Healthcare Settings (87 Fed. Reg. 16,426-16,431, March 23, 2022) Proposed Rule, Occupational Safety and Health Administration; Powered Industrial Trucks Design Standard Update (87 Fed. Reg. 8,755-8,764, February 16, 2022) Various issues relating to modernization of the unemployment insurance system; application of Kristof Terryn to serve on the Department of Labor's Advisory Committee on Apprenticeship; paid leave; paid family leave; paid sick leave; reforms to the Fair Labor Standards Act (P.L. 75-178); independent contractors; unemployment insurance and the coronavirus pandemic; contractor blacklisting; Equal Employment Opportunity Commission (EEOC) conciliation regulation; the firing of Peter Robb as General Counsel of the National Labor Relations Board (NLRB), and of Alice Stock, Deputy General Counsel of the NLRB; Rescission of the Joint Employer standard under the Fair Labor Standards Act (P.L. 75-718); The FTC's Multilateral Pharmaceutical Merger Taskforce; The USMCA Labor Council; apprenticeships; proposed amendment to the U.S. Longshore and Harbor Workers Compensation Act (Longshore Act), relating to the establishment of statutory presumptions of coverage and compensability for illnesses; potential Wage and Hour Division rulemaking defining and delimiting the exemptions under the Fair Labor Standards Act for Executive, Administrative, Professional, Outside Sales and Computer Employees; potential Wage and Hour Division rulemaking on classification of independent contractors and employees; potential legislation on the minimum wage; COVID-19 vaccine requirements, including a potential Emergency Temporary Standard from the Occupational Safety and Health Administration relating to employers with more than 100 employees; vaccine requirements for federal contractors; legal and regulatory framework for evaluating mergers and acquisitions; contract terms and their relationship to competition, particularly relating to worker non-compete clauses and exclusive contracts; Federal Trade Commission issues: Freedom of Information Act Requests, Penalty Offense Authority, Zombie Voting, and overall direction of the Commission; anticipated overtime regulations under the Fair Labor Standards Act Office of Federal Contract Compliance Programs, Directive (DIR) 2022-01; Subject: Pay Equity Audits, Effective March 15, 2022; Executive Order 13999 Protecting Worker Health and Safety; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; Executive Order 14063, Promoting Competition in the American Economy; President Bidens Path Out of the Pandemic: COVID Action Plan; paid sick and paid family leave under the Families First Coronavirus Response Act (FFCRA) (P.L. 116-127); unemployment insurance; international concerns in the areas of antitrust, standards and investment; domestic and international antitrust policy; Federal Trade Commission (FTC) section 19/13b authority; Policies and practices related to the FTC expanding its authority; Transparency at the FTC; FTCs Draft Strategic Plan for Fiscal Years 2022 to 2026; efforts to revise the 1995 Bank Merger Competitive Review Guidelines; efforts to modernize enforcement of the antitrust laws regarding mergers; competition in the agriculture marketplace; pregnancy discrimination; oversight addressing the National Labor Relations Board, including implementation and oversight of the National Labor Relations Act (P.L. 74-198); election procedures under the Railway Labor Act (P.L. 69-257); National Labor Relations Board (NLRB) decisions and regulatory agenda; definition of labor organization under the Labor Management Reporting and Disclosure Act (P.L. 86-257); GAO study on Fiduciary Investment Advice

Client expense: $15,800,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC)

Antitrust Consumer welfare standard S. 225 (Competition and Antitrust Law Enforcement Reform Act) H.R. 3460/S. 1787 (State Antitrust Enforcement Venue Act) H.R. 3816/S. 2992 (American Choice and Innovation Online Act) H.R. 3825 (Ending Platform Monopolies Act) H.R. 3826/S. 3197 (Platform Competition and Opportunity Act) H.R. 3843/S. 2039 (Merger Filing Fee Modernization Act) S. 228 (TEAM Act) H.R. 3849 (ACCESS Act) H.R. 5639 (Foreign Merger Subsidy Disclosure Act) House Judiciary Comm. Final Report on Investigation of Competition in Digital Markets S. 1435/H.R. 2873 (Affordable Prescriptions for Patients Through Promoting Competition Act) S. 1425/H.R. 2883 (Stop STALLING Act) S. 1428/H.R. 2891 (Preserve Access to Affordable Generics) S. 4258/H.R. 7839 (Competition and Transparency in Digital Advertising Act) Federal Trade Commission motion to rescind the 2015 Statement of Enforcement Principles Regarding Unfair Methods of Competition (UMC) Under Section 5 of the FTC Act Multilateral Pharmaceutical Merger Task Force (FTC Pharmaceutical Task Force, Project No. P212900) Executive Order 14036 (Promoting Competition in the American Economy) FTC Rescission of 1995 Policy Statement on Prior Approval and Prior Notice Provisions in Merger Cases FTCs counting votes cast by a former commissioner Nominations to Federal Trade Commission positions FTC-Justice Dept. Request for Information on proposed Merger Enforcement Guidelines (FTC-2022-0003)

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform

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

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

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $2,715,700 · Firm income: Not reported

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

Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.

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

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE

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

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

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

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform

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

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

H.R. 5/S. 393, Equality Act H.R. 7/S. 205, Paycheck Fairness Act H.R. 603/S. 53, Raise the Wage Act of 2021 H.R. 804/S. 248, Family and Medical Insurance Leave (FAMILY) Act H.R. 830, Wage Increase Fairness Act H.R. 842/S. 420, Protecting the Right to Organize Act of 2021 H.R. 1065/S. 1486, Pregnant Workers Fairness Act H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 1284/S. 403, Fair and Open Competition (FOCA) Act H.R. 1277/S. 374, Improving Corporate Governance Through Diversity Act of 2021 H.R. 1319, American Rescue Plan Act of 2021 H.R. 1458/S.490, Unemployment Insurance Technology Modernization Act of 2021 H.R. 1735/S. 673, Journalism Competition and Preservation Act of 2021 H.R. 2491, Wage Equity Act of 2021 H.R. 2668, Consumer Protection and Recovery Act H.R. 2795, DHS Blue Campaign Enhancement Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891/S. 1428, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2926/S. 663, One Agency Act H.R. 3110/S. 1658, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 H.R. 3460/S. 1787, State Antitrust Enforcement Venue Act of 2021 H.R. 3816/S. 2992, American Choice and Innovation Online Act H.R. 3825, Ending Platform Monopolies Act H.R. 3826/S. 3197, Platform Competition and Opportunity Act of 2021 H.R. 3843/S. 228, Merger Filing Fee Modernization Act of 2021 H.R. 3849, Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act of 2021 H.R. 4109/S. 2193, Protections for Socially Good Activities Act H.R. 4502, Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R. 4350, National Defense Authorization Act for Fiscal Year 2022 H.R. 4521, America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (America COMPETES) Act of 2022 H.R. 4841, Restoring Justice for Workers Act H.R. 5017/S. 2710, Open App Markets Act H.R. 5376, Build Back Better Act H.R. 6922/S. 3760, Continued Waiver of Interest on State Unemployment Loans during the Pandemic Act H.R. 7194/S. 3889, Employee Rights Act H.Res. 823, Providing for the consideration of the bill (H.R. 3460) to amend title 28 of the United States Code to prevent the transfer of actions arising under the antitrust laws in which a State is a complainant S. 225, Competition and Antitrust Law Enforcement Reform Act of 2021 S. 478, Higher Wages for American Workers Act of 2021 S. 1074, Trust-Busting for the Twenty-First Century Act S. 1204, Bust Up Big Tech Act S. 1380, Clean Slate Act of 2021 S. 1425, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1636, Save Local Business Act S. 2039, Tougher Enforcement Against Monopolists (TEAM) Act S. 3311, FTC Integrity Act S. 3889, Employee Rights Act S. J. Res. 13, A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Equal Employment Opportunity Commission relating to "Update of Commission's Conciliation Procedures" Nomination of David Weil to be Administrator for Department of Labor, Wage and Hour Division Proposed rule on Joint Employer Status Under the Fair Labor Standards Act, (84 Fed. Reg. 14,043-14,061, April 9, 2019) Proposed rule on Independent Contractor status under the Fair Labor Standards Act (85 Fed. Reg. 60,600-60,639, September 25, 2020) Interim final rule on Occupational Exposure to COVID-19; Emergency Temporary Standard (86 Fed. Reg. 32,376-32,628, June 21, 2021) Interim final rule on COVID-19 Vaccination and Testing; Emergency Temporary Standard (86 Fed. Reg. 61,402-61,555, November 5, 2021) Advance Notice of Proposed Rulemaking Concerning Heat Injury and Illness Prevention in Outdoor and Indoor Settings (86 Fed. Reg. 59,309-59,326, Oct. 27, 2021) Proposed Amendments to Agriculture Acquisition Regulations (87 Fed. Reg. 9,005-9,021, February 17, 2022) Prohibited Transaction Exemption 2020-02, Improving Investment Advice for Workers & Retirees (85 Fed. Reg. 82,798-82,866, December 18, 2020) Final rule on Financial Factors in Selecting Plan Investments (85 Fed. Reg. 72,846-72,885, November 13, 2020) Final rule on Fiduciary Duties Regarding Proxy Voting and Shareholder Rights (85 Fed. Reg. 81,658-81,695, December 16, 2020) Proposed rule on Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder Rights (86 Fed. Reg. 57,272-57,304, October 13, 2021) Proposed Rule, Employee Benefits Security Administration, U.S. Department of Labor, Notice of Proposed Rulemaking: Procedures Governing the Filing and Processing of Prohibited Transaction Exemption Applications (87 Fed. Reg. 14,722-14,751, March 15, 2022) Request for Information on Data Sources and Methods for Determining Prevailing Wage Levels for the Temporary and Permanent Employment of Certain Immigrants and Non-Immigrants in the United States, Employment and Training Administration, Department of Labor, (86 Fed. Reg. 17,343-17,346, April 2, 2021) Proposed Rule, Amendments to Agriculture Acquisition Regulations, (87 Fed. Reg. 9,005-9,021, February 17, 2022) Various issues relating to modernization of the unemployment insurance system; application of Kristof Terryn to serve on the Department of Labor's Advisory Committee on Apprenticeship; paid leave; paid family leave; paid sick leave; reforms to the Fair Labor Standards Act (P.L. 75-178); independent contractors; unemployment insurance and the coronavirus pandemic; contractor blacklisting; Equal Employment Opportunity Commission (EEOC) conciliation regulation; the firing of Peter Robb as General Counsel of the National Labor Relations Board (NLRB), and of Alice Stock, Deputy General Counsel of the NLRB; Rescission of the Joint Employer standard under the Fair Labor Standards Act (P.L. 75-718); The FTC's Multilateral Pharmaceutical Merger Taskforce; The USMCA Labor Council; apprenticeships; reauthorization of the Workforce Innovation and Opportunity Act (P.L. 113-128); proposed amendment to the U.S. Longshore and Harbor Workers Compensation Act (Longshore Act), relating to the establishment of statutory presumptions of coverage and compensability for illnesses; potential Wage and Hour Division rulemaking defining and delimiting the exemptions under the Fair Labor Standards Act for Executive, Administrative, Professional, Outside Sales and Computer Employees; potential legislation on the minimum wage; COVID-19 vaccine requirements, including a potential Emergency Temporary Standard from the Occupational Safety and Health Administration relating to employers with more than 100 employees; vaccine requirements for federal contractors; legal and regulatory framework for evaluating mergers and acquisitions; contract terms and their relationship to competition, particularly relating to worker non-compete clauses and exclusive contracts; Federal Trade Commission issues: Freedom of Information Act Requests, Penalty Offense Authority, Zombie Voting, and overall direction of the Commission; Executive Order 13950 Combating Race and Sex Stereotyping; Executive Order 13999 Protecting Worker Health and Safety; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; Executive Order 14036, Promoting Competition in the American Economy; Executive Order 14063, Use of Project Labor Agreements for Federal Construction Projects President Bidens Path Out of the Pandemic: COVID Action Plan; paid sick and paid family leave under the Families First Coronavirus Response Act (FFCRA) (P.L. 116-127); unemployment insurance; international concerns in the areas of antitrust, standards and investment; domestic and international antitrust policy; Federal Trade Commission (FTC) section 19/13b authority; Policies and practices related to the FTC expanding its authority; Transparency at the FTC; FTCs Draft Strategic Plan for Fiscal Years 2022 to 2026; efforts to revise the 1995 Bank Merger Competitive Review Guidelines; efforts to modernize enforcement of the antitrust laws regarding mergers; pregnancy discrimination; oversight addressing the National Labor Relations Board, including implementation and oversight of the National Labor Relations Act (P.L. 74-198); election procedures under the Railway Labor Act (P.L. 69-257); National Labor Relations Board (NLRB) decisions and regulatory agenda; definition of labor organization under the Labor Management Reporting and Disclosure Act (P.L. 86-257); forthcoming regulation regarding numbers on non-immigrant foreign worker visa

Client expense: $18,660,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC)

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1548: ENACT Act of 2021 - To amend the Public Health Service Act to improve the diversity of participants in research on Alzheimers disease, and for other purposes S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Nomination of Robert Califf to FDA Commissioner Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS)

Antitrust Consumer welfare standard S. 225 (Competition and Antitrust Law Enforcement Reform Act) H.R. 3460/S. 1787 (State Antitrust Enforcement Venue Act) H.R. 3816/S. 2992 (American Choice and Innovation Online Act) H.R. 3825 (Ending Platform Monopolies Act) H.R. 3826/S. 3197 (Platform Competition and Opportunity Act) H.R. 3843/S. 2039 (Merger Filing Fee Modernization Act) S. 228 (TEAM Act) H.R. 3849 (ACCESS Act) H.R. 5639 (Foreign Merger Subsidy Disclosure Act) House Judiciary Comm. Final Report on Investigation of Competition in Digital Markets S. 1435/H.R. 2873 (Affordable Prescriptions for Patients Through Promoting Competition Act) S. 1425/H.R. 2883 (Stop STALLING Act) S. 1428/H.R. 2891 (Preserve Access to Affordable Generics) Federal Trade Commission motion to rescind the 2015 Statement of Enforcement Principles Regarding Unfair Methods of Competition (UMC) Under Section 5 of the FTC Act Multilateral Pharmaceutical Merger Task Force (FTC Pharmaceutical Task Force, Project No. P212900) Executive Order 14036 (Promoting Competition in the American Economy) FTC Rescission of 1995 Policy Statement on Prior Approval and Prior Notice Provisions in Merger Cases FTCs counting votes cast by a former commissioner Nominations to Federal Trade Commission positions FTC-Justice Dept. Request for Information on proposed Merger Enforcement Guidelines (FTC-2022-0003)

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 4100/S. 1712: DISARM Act of 2019 Provisions related to antimicrobial drug development H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5801 HELP Copays Act, provisions related to patient assistance H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and HR 19/S 2164, Lower Costs, More Cures Act, provisions related to drug pricing HR 1978/S 912 - Protecting Seniors Through Immunization Act HSA/FSA for Dietary Supplements H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 340B Drug Pricing Program Build Back Better reconciliation package DSHEA 2.0 S. 1619/H.R. 2862: VACCINES Act S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 2304: Strategies To Address Antibiotic Resistance Act Provisions related to antimicrobial resistance (AMR) and other issues S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4760/H.R. 8920: PASTEUR Act (AMR) Veterans' Affairs issues related to product sampling 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)

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

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

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 4100/S. 1712: DISARM Act of 2019 Provisions related to antimicrobial drug development H.R. 4121, PRO Seniors Act, provisions related to drug rebates H.R. 5801 HELP Copays Act, provisions related to patient assistance H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and HR 19/S 2164, Lower Costs, More Cures Act, provisions related to drug pricing HR 1978/S 912 - Protecting Seniors Through Immunization Act HSA/FSA for Dietary Supplements H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 340B Drug Pricing Program Build Back Better reconciliation package DSHEA 2.0 S. 1619/H.R. 2862: VACCINES Act S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 2304: Strategies To Address Antibiotic Resistance Act Provisions related to antimicrobial resistance (AMR) and other issues S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4760/H.R. 8920: PASTEUR Act (AMR) Veterans' Affairs issues related to product sampling 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), 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. 5/S. 393, Equality Act H.R. 7/S. 205, Paycheck Fairness Act H.R. 603/S. 53, Raise the Wage Act of 2021 H.R. 804/S. 248, Family and Medical Insurance Leave (FAMILY) Act H.R. 830, Wage Increase Fairness Act H.R. 842/S. 420, Protecting the Right to Organize Act of 2021 H.R. 1065/S. 1486, Pregnant Workers Fairness Act H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 1277/S. 374, Improving Corporate Governance Through Diversity Act of 2021 H.R. 1319, American Rescue Plan Act of 2021 H.R. 1458/S.490, Unemployment Insurance Technology Modernization Act of 2021 H.R. 1735/S. 673, Journalism Competition and Preservation Act of 2021 H.R. 2491, Wage Equity Act of 2021 H.R. 2668, Consumer Protection and Recovery Act H.R. 2795, DHS Blue Campaign Enhancement Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2891/S. 1428, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2926/S. 663, One Agency Act H.R. 3110/S. 1658, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 H.R. 3460/S. 1787, State Antitrust Enforcement Venue Act of 2021 H.R. 3816/S. 2992, American Choice and Innovation Online Act H.R. 3825, Ending Platform Monopolies Act H.R. 3826/S. 3197, Platform Competition and Opportunity Act of 2021 H.R. 3843/S. 228, Merger Filing Fee Modernization Act of 2021 H.R. 3849, Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act of 2021 H.R. 4109/S. 2193, Protections for Socially Good Activities Act H.R. 4502, Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R. 4350, National Defense Authorization Act for Fiscal Year 2022 H.R. 4841, Restoring Justice for Workers Act H.R. 5017/S. 2710, Open App Markets Act H.R. 5376, Build Back Better Act H.Res. 823, Providing for the consideration of the bill (H.R. 3460) to amend title 28 of the United States Code to prevent the transfer of actions arising under the antitrust laws in which a State is a complainant S. 225, Competition and Antitrust Law Enforcement Reform Act of 2021 S. 478, Higher Wages for American Workers Act of 2021 S. 1074, Trust-Busting for the Twenty-First Century Act S. 1204, Bust Up Big Tech Act S. 1380, Clean Slate Act of 2021 S. 1425, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1636, Save Local Business Act S. 1787, State Antitrust Enforcement Venue Act of 2021 S. 2039, Tougher Enforcement Against Monopolists (TEAM) Act S. 3311, FTC Integrity Act S. J. Res. 13, A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Equal Employment Opportunity Commission relating to "Update of Commission's Conciliation Procedures" Nomination of David Weil to be Administrator for Department of Labor, Wage and Hour Division Proposed rule on Joint Employer Status Under the Fair Labor Standards Act, (84 Fed. Reg. 14,043-14,061, April 9, 2019) Proposed rule on Independent Contractor status under the Fair Labor Standards Act (85 Fed. Reg. 60,600-60,639, September 25, 2020) Interim final rule on Occupational Exposure to COVID-19; Emergency Temporary Standard (86 Fed. Reg. 32,376-32,628, June 21, 2021) Interim final rule on COVID-19 Vaccination and Testing; Emergency Temporary Standard (86 Fed. Reg. 61,402-61,555, November 5, 2021) Prohibited Transaction Exemption 2020-02, Improving Investment Advice for Workers & Retirees (85 Fed. Reg. 82,798-82,866, December 18, 2020) Final rule on Financial Factors in Selecting Plan Investments (85 Fed. Reg. 72,846-72,885, November 13, 2020) Final rule on Fiduciary Duties Regarding Proxy Voting and Shareholder Rights (85 Fed. Reg. 81,658-81,695, December 16, 2020) Proposed rule on Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder Rights (86 Fed. Reg. 57,272-57,304, October 13, 2021) Various issues relating to modernization of the unemployment insurance system; application of Kristof Terryn to serve on the Department of Labor's Advisory Committee on Apprenticeship; paid leave; paid family leave; paid sick leave; reforms to the Fair Labor Standards Act (P.L. 75-178); independent contractors; unemployment insurance and the coronavirus pandemic; contractor blacklisting; Equal Employment Opportunity Commission (EEOC) conciliation regulation; the firing of Peter Robb as General Counsel of the National Labor Relations Board (NLRB), and of Alice Stock, Deputy General Counsel of the NLRB; Rescission of the Joint Employer standard under the Fair Labor Standards Act (P.L. 75-718); The FTC's Multilateral Pharmaceutical Merger Taskforce; The USMCA Labor Council; apprenticeships; reauthorization of the Workforce Innovation and Opportunity Act (P.L. 113-128); proposed amendment to the U.S. Longshore and Harbor Workers Compensation Act (Longshore Act), relating to the establishment of statutory presumptions of coverage and compensability for illnesses; potential legislation on the minimum wage; COVID-19 vaccine requirements, including a potential Emergency Temporary Standard from the Occupational Safety and Health Administration relating to employers with more than 100 employees; vaccine requirements for federal contractors; legal and regulatory framework for evaluating mergers and acquisitions; contract terms and their relationship to competition, particularly relating to worker non-compete clauses and exclusive contracts; Federal Trade Commission issues: Freedom of Information Act Requests, Penalty Offense Authority, Zombie Voting, and overall direction of the Commission; Executive Order 13950 Combating Race and Sex Stereotyping; Executive Order 13999 Protecting Worker Health and Safety; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; Executive Order 14036, Promoting Competition in the American Economy; President Bidens Path Out of the Pandemic: COVID Action Plan; paid sick and paid family leave under the Families First Coronavirus Response Act (FFCRA) (P.L. 116-127); unemployment insurance; international concerns in the areas of antitrust, standards and investment; domestic and international antitrust policy; Federal Trade Commission (FTC) section 19/13b authority; Policies and practices related to the FTC expanding its authority; Transparency at the FTC; FTCs Draft Strategic Plan for Fiscal Years 2022 to 2026; pregnancy discrimination; oversight addressing the National Labor Relations Board, including implementation and oversight of the National Labor Relations Act (P.L. 74-198); election procedures under the Railway Labor Act (P.L. 69-257); National Labor Relations Board (NLRB) decisions and regulatory agenda; definition of labor organization under the Labor Management Reporting and Disclosure Act (P.L. 86-257); forthcoming regulation regarding numbers on non-immigrant foreign worker visa

Client expense: $19,560,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Bureau of Investigation (FBI), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Aeronautics & Space Administration (NASA), Natl Economic Council (NEC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Science Foundation (NSF), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Fish & Wildlife Service (USFWS), U.S. Trade Representative (USTR), White House Office

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Client expense: $1,918,904 · Firm income: Not reported

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

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 6000: Cures 2.0 Act - Provisions related to health research S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3394: Emergency Use Transparency Act - Provisions related to FDA emergency use authorizations 21st Century Cures 2.0 American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Biosimilar approval and reimbursement policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Comprehensive Plan for Addressing High Drug Prices; A Report in Response to the Executive Order on Competition in the American Economy (September 9, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020)

Client expense: $7,160,000 · Firm income: Not reported

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

Supply chain issues; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); Reduced Costs and Continued Cures Act (RCCCA) (H.R. 5260, H.R. 5237); drug pricing policy; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209)/H.R. 3812); Give Kids a Chance Act (H.R. 5416); FDA Modernization Act of 2021 (H.R. 2565).

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

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

Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.

Client expense: $60,000 · 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), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)

Antitrust Consumer welfare standard S. 225 (Competition and Antitrust Law Enforcement Reform Act) H.R. 842 (Protecting the Right to Organize (PRO) Act) H.R. 3460/S. 1787 (State Antitrust Enforcement Venue Act) H.R. 3816/S. 2992 (American Choice and Innovation Online Act) H.R. 3825 (Ending Platform Monopolies Act) H.R. 3826 (Platform Competition and Opportunity Act) H.R. 3843 (Merger Filing Fee Modernization Act) H.R. 3849 (ACCESS Act) House Judiciary Comm. Final Report on Investigation of Competition in Digital Markets S. 1435/H.R. 2873 (Affordable Prescriptions for Patients Through Promoting Competition Act) S. 1425/H.R. 2883 (Stop STALLING Act) S. 1428/H.R. 2891 (Preserve Access to Affordable Generics) Federal Trade Commission motion to rescind the 2015 Statement of Enforcement Principles Regarding Unfair Methods of Competition (UMC) Under Section 5 of the FTC Act Multilateral Pharmaceutical Merger Task Force (FTC Pharmaceutical Task Force, Project No. P212900) Executive Order 14036 (Promoting Competition in the American Economy) FTC Rescission of 1995 Policy Statement on Prior Approval and Prior Notice Provisions in Merger Cases FTCs counting votes cast by a former commissioner

Client expense: Not reported · Firm income: $10,000

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)

Client expense: $75,000 · 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), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)

Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements)

Client expense: $40,000 · 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), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Client expense: $1,918,904 · Firm income: Not reported

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

H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2347: Strengthening the Vaccines for Children Program Act of 2021 - Provisions related to COVID-19 vaccines H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3684: Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4418: SPIKE Act - Provisions related to prescription drug pricing transparency H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5416: Give Kids a Chance Act (RACE 2.0) - Provisions related to pediatric investigations S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 917: Short on Competition Act - Provisions related to FDA policy and prescription drug pricing S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2814: Vital Medication Affordability Act - Provisions related to 340B drug discount program S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program 21st Century Cures 2.0 (discussion draft) American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Executive Order 14036, Promoting Competitition in the American Economy (July 9, 2021) Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14005, Ensuring the Future Is Made in All of America by All of Americas Workers (January 25, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13987, Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security (January 20, 2021) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients DSHEA 2.0 HSA/FSA eligibility for Dietary Supplements Quit because of COVID Act Provisions related to Medicare's noninterference clause 340B Drug Pricing Program Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates S. Con. Res. Setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031. House of Representatives Build Back Better Act package- Rx and tax offset provisions Senate Build Back Better deliberations

Client expense: $1,200,000 · Firm income: Not reported

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

Prescription Drug Costs. Drug Pricing. Biden Executive Order on Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Carter Bill on Section 505(j)(10) Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Legislation to incentivize domestic manufacturing. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. H.R.5388/S.2740: PREPARE Act. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Biosimilars Misinformation. FDA Inspections. FDA and Future Public Health Emergencies. FDA-PTO Collaboration. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications.

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), 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), SENATE, U.S. Trade Representative (USTR)

Clinical Trial Diversity; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; Pediatric study requirements for drugs; Transparency of EUA Information; Induced Infringement; Biosimilarity; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; proposed amendments to the National Childhood Vaccine Injury Act; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Build Back Better Act (H.R. 5376); drug pricing policy; drug quality issues; Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act (S. 1209/H.R. 3812)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1425, Stop STALLING Act, S. 1428, Preserve Access to Affordable Generics and Biosimilars Act, S. 1388, Prescription Pricing for the People Act of 2021, and S. 1435, Affordable Prescriptions for Patients Act of 2021.

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

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

H.R. 5: Equality Act H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2347: Strengthening the Vaccines for Children Program Act of 2021 - Provisions related to COVID-19 vaccines H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2623: Camerons Law - Provisions related to orphan drugs H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4418: SPIKE Act - Provisions related to prescription drug pricing transparency H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5416: To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 917: Short on Competition Act - Provisions related to FDA policy and prescription drug pricing S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2814: Vital Medication Affordability Act - Provisions related to 340B drug discount program S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program 21st Century Cures 2.0 (discussion draft) American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Executive Order 14036, Promoting Competitition in the American Economy (July 9, 2021) Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14005, Ensuring the Future Is Made in All of America by All of Americas Workers (January 25, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13987, Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security (January 20, 2021) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $7,440,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021

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

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

S.1388, Prescription Pricing for the People Act of 2021 S.1425, Stop STALLING Act S.1428, Preserve Access to Affordable Generics and Biosimilars Act S.1435, Affordable Prescriptions for Patients Act of 2021 Issues related to prescription antitrust

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

Government targets: Consumer Product Safety Commission (CPSC), Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Natl Highway Traffic Safety Administration (NHTSA), SENATE, Transportation, Dept of (DOT), White House Office

S. 1425 - Stop STALLING Act S. 1428 - Preserve Access to Affordable Generics and Biosimilars Act S. 1435 -Affordable Prescriptions for Patients Act Correspondence with United States Senate in opposition to S. 1425 (the Stop STALLING Act); S. 1428 (the Preserve Access to Affordable Generics and Biosimilars Act); and S. 1435 (the Affordable Prescriptions for Patients Act); research relating thereto.

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE