The PASTEUR Act

H.R. 1319, American Rescue Plan Act of 2021, medical provisions H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 1978, Protecting Seniors Through Immunization Act of 2021 H.R. 2061, Advancing Emergency Preparedness Through One Health Act of 2021 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 3173, Improving Seniors Timely Access to Care Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act S. 1435, Affordable Prescriptions for Patients Act of 2021 H.R. 3, (116th Congress) Lower Drug Costs Now Act of 2019 H.R. 19 (116th Congress) Lower Costs, More Cures Act of 2019 S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 H.R. 4100/S. 1712 (116th Congress) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. H.R. 8920/S. 4760, (116th Congress) The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2020 S. 1895 (116th Congress) Lower Health Care Costs Act Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340B drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Vaccines; HIV, PrEP provisions; COVID-19 vaccines; COVID-19 therapeutics coverage issues; Vaccines catch up; Vaccine provisions; Vaccine Issues, including access and pandemic-related policy; Package inserts and labeling issues; Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2022 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; One Health Issues; Rural Broadband Issues.

Client expense: $1,700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 4100 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS H.R. 8920 (116TH CONGRESS): THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2020; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 1002: A BILL TO PROHIBIT FALSE OR MISLEADING ADVERTISING FOR HEALTH INSURANCE COVERAGE, REQUIRE WARNINGS AND REPORTING WITH RESPECT TO NONCOMPREHENSIVE HEALTH PLANS, ENCOURAGE ENROLLMENT IN HEALTH PLANS, AND FOR OTHER PURPOSES; ALL PROVISIONS S. 1556 (116TH CONGRESS): NO JUNK PLANS ACT; ALL PROVISIONS S. 1712 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS

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

H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 8920 (116TH CONGRESS): THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2020; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING FISCAL YEAR 2022 APPROPRIATIONS; PROVISIONS RELATED TO FUNDING FOR HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S. 4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920);Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D noninterference; Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); S.164 - Advancing Education on Biosimilars Act of 2021; Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; 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. 2387, STOP GAMES Act of 2019; H.R. 4384, Patient Safety and Drug Labeling Improvement; Transparency of EUA Information and FDA-State Information Sharing; Cures 2.0 Act Discussion Draft; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Clinical Trial Diversity; S. 1644, Promising Pathway Act; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); STOP Fentanyl Act of 2021 (S. 1457/H.R. 2366); S. 1508 - A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes; S. 1260, United States Innovation and Competition Act of 2021; H.R. 2731, Endless Frontier Act; draft Fiscal Year 2022 Labor, Health and Human Services, Education, and Related Agencies funding bill; draft legislation to amend provisions of the National Childhood Vaccination Injury Act to establish new criteria and procedures for covering vaccines in the Vaccine Injury Compensation Program; Country of origin labeling; Supply chain issues; Quality Systems; National Institute of Standards and Technologys (NIST) January 4, 2021 Notice of Proposed Rulemaking (NPRM) on 37 CFR Parts 401 and 404, the implementing regulations of the Bayh-Dole Act; Health Advanced Research Projects Agency (HARPA) proposal.

H.R. 597, Pandemic Treatment Access and Affordability Act of 2021 H.R. 1319, American Rescue Plan Act of 2021, medical provisions H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 1978, Protecting Seniors Through Immunization Act of 2021 H.R. 2061, Advancing Emergency Preparedness Through One Health Act of 2021 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 3173, Improving Seniors Timely Access to Care Act of 2021 S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 2076, Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 H.R. 3, (116th Congress) Lower Drug Costs Now Act of 2019 H.R. 19 (116th Congress) Lower Costs, More Cures Act of 2019 S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 H.R. 4100/S. 1712 (116th Congress) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. H.R. 8920/S. 4760, (116th Congress) The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2020 S. 1895 (116th Congress) Lower Health Care Costs Act Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340 drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Vaccines; HIV, PrEP provisions; COVID-19 vaccines; COVID-19 therapeutics coverage issues; Vaccines catch up; Vaccine provisions; Vaccine Issues, including access and pandemic-related policy; Package inserts and labeling issues; Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2022 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; One Health Issues; Rural Broadband Issues.

Signed a Protecting Access to Pain Relief (PAPR) Coalition letter urging HHS to explore and support new efforts and support new efforts to promote the work and recommendations of the HHS Pain Management Best Practices Inter-Agency Task Force. Signed letter in support of H.R. 8920, the Pioneering Antimicrobial Subscriptions to End Up surging Resistance (PASTEUR) Act

Client expense: Not reported · Firm income: Not reported

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

H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 8920 (116TH CONGRESS): THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2020; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING FISCAL YEAR 2022 APPROPRIATIONS; PROVISIONS RELATED TO FUNDING FOR HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 4100 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS H.R. 8920 (116TH CONGRESS): THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2020; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 1002: A BILL TO PROHIBIT FALSE OR MISLEADING ADVERTISING FOR HEALTH INSURANCE COVERAGE, REQUIRE WARNINGS AND REPORTING WITH RESPECT TO NONCOMPREHENSIVE HEALTH PLANS, ENCOURAGE ENROLLMENT IN HEALTH PLANS, AND FOR OTHER PURPOSES; ALL PROVISIONS S. 1556 (116TH CONGRESS): NO JUNK PLANS ACT; ALL PROVISIONS S. 1712 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS

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

Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); Fairness in Orphan Drug Exclusivity Act (S. 250/ H.R. 4712); S. 415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity; S.164 - Advancing Education on Biosimilars Act of 2021; Preserve Access to Affordable Generics and Biosimilars Act (S. 64/HR 2375); Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; Unnamed bill regarding FDA demand reporting with respect to drugs.

Regulation of COVID-19 diagnostic tests and Clinical laboratories COVID-19 Relief Timely and Effective Systematic Testing Act S. 4163 PASTEUR Act H.R. 8920, S. 4760

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

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 133: Consolidated Appropriations Act, 2021; Discussions surrounding additional coronavirus relief measures; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 2507: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions H.R. 4100: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions H.R. 4386: Stop the Wait Act; all provisions H.R. 4932: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions H.R. 6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 8920: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions S. 1712: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions S. 2158: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions S. 2496: Stop the Wait Act; all provisions S. 2741: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions S. 4421: Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act; all provisions S. 4557: COVID Enrollment Response (COVER) Act; all provisions S. 4760: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions

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

H.J. Res. 110: Extension of Continuing Appropriations Act, 2021; provisions related to funding for Health and Human Services and related agencies, Food and Drug Administration and related agencies, funding for nutrition assistance programs, and medical expense deduction H.R. 133: Consolidated Appropriations Act, 2021; Discussions surrounding additional coronavirus relief measures; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research, funding for Department of Health and Human Services (HHS) and related agencies, Food and Drug Administration (FDA) and related agencies H.R. 2507: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions H.R. 4932: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions H.R. 6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act; Provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 8920: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions S. 2158: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions S. 2741: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions S. 4760: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions

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

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency H.R. 7647: To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - Provisions related to accumulator adjustment programs H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers S. 4427: SAVE Act - Provisions related to the FDA drug approval process S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatory recall authority policy issues Pharmaceutical supply chain policy issues COVID-19 policy issues Final Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26)

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 19, Lower Costs, More Cures Act of 2019 H.R. 133, Consolidated Appropriations Act of 2021, including provision relating to vaccine funding and vaccinations H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. including provisions relating to Anti-microbial Resistance H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act H.R. 6197, Increasing Access to Biosimilars Act of 2020 H.R. 8061, Community Immunity During COVID-19 Act of 2020 H.R. 8920, The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2020 S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 4760, The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act 2020 Issues relating to, 340B Reforms; 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340 drug pricing program; Drug pricing; Anti-microbial Resistance; Biosimilars; Maternal Health; Cost and value of medicines; Vaccines; Supply chain; COVID-19 vaccines; COVID-19 issues; Vaccines catch up; General pharmaceutical issues; Average Manufacture Price (AMP) cap; Executive Order 13937, Access to Affordable Life-Saving Medications; Department of Agriculture Center for Veterinary Biologics (CVB) funding.

Client expense: $1,210,000 · Firm income: Not reported

Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Prescription Drug User Fee Act reauthorization; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Orange Book Transparency Act of 2020 (H.R. 1503); Purple Book Continuity Act of 2020 (H.R. 1520); Consolidated Appropriations Act, 2021 (H.R. 133); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180.

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 a Provisions related to prescription drug pricing and access H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavi-rus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency H.R. 7647: To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - Provisions related to accumulator adjustment programs H.R. 7838: To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes - Provisions related to the 340B drug discount program H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 4864/H.R. 8725: HAPI Act; Medicaid financial barriers S. 1619/H.R. 2862: VACCINES Act CMSS. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity CMS rule on Value Based Payment purchasing, 85 FR 37286, CMS-2482-P, provisions related to the definition of line-extension drugs. S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing CBD DSHEA 2.0 S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways Transparency policy issues S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers S. 4427: SAVE Act - Provisions related to the FDA drug approval process S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatoruy recall authority policy issues Pharmaceutical supply chain policy issues COVID-19 policy issues Final Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Combating Public Health Emergencies and Strengthening Na- tional Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26) Amendments to HHS Covid-19 Declaration

COVID-19 crisis - Engaged with Congress and the administration to advocate for greater regulatory flexibility and appropriate reimbursement for hospitals through development, passage and ongoing implementation of coronavirus relief legislation: HEROES Act (H.R. 6800) Heroes Act 2.0 (H.R. 925) Health, Economic Assistance, Liability Protection and Schools (HEALS) Act (S. 178) The Consolidated Appropriations Act (H.R. 133) Hospital Provider Relief Fund - Urged Congress to provide additional funding for the Provider Relief Fund. Advocated in Congress and with HHS to revert to initial June guidance defining "lost revenue". Liability protections - Advocated for Congress to include liability protections for health care workers and facilities responding to the COVID-19 crisis. Front-line Health Care Worker Hazard Pay - Advocated for Congress to provide funding to enhance payment for essential health care workers. Hospital Group Purchasing - Offered recommendations and insights to support access to essential personal protective equipment, medications and supplies for hospitals treating patients and supply chain stability for the national response to the COVID-19 crisis. 340B Drug Pricing Program - Urged HHS to act to enforce guidance regarding 340B discounts through contract pharmacies. Vaccine distribution, administration and communications - Advocated to provide states with financial support and other resources to enhance communications and for transparency, including support regarding vaccine distribution, administration and post-market processes, considering both providers needs and states needs. Surprise Billing - Supported inclusion of provisions to provide for an independent dispute resolution process in legislation to address surprise bills (H.R. 3630; H.R. 2328; S. 1895; H.R. 133). Urged Congress to oppose benchmark payment rates in COVID relief legislation. Advocated for passage of the Pasteur Act (S. 4760; H.R. 8920)