Supply Chain Security and Pharmaceutical Authentication Act of 2020

H.R. 2209: Fixing Global Freeloading Act - Provisions related to trade policy issues and international pharmaceutical drug pricing issues H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 6049: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety H.R. 6393: Strengthening America's Supply Chain and National Security Act - Provisions related to prescription drug supply chains H.R. 6482: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains H.R. 6690: Bring Entrepreneurial Advancements To Consumers Here In North America Act - Provisions related to prescription drug supply chains and manufacturing tax incentives H.R. 6731: Securing America's Pharmaceutical Supply Chain Act - Provisions related to prescription drug supply chains H.R. 6879: Buy American Medical Supply Chain Act of 2020 - Provisions related to prescription drug and medical device supply chains H.R. 6930: MADE in America Act of 2020 - Provisions related prescription drug supply chains and manufacturing tax incentives H.R. 8508: COVID-19 Vaccine Distribution and Production Act - Provisions related to prescription drug supply chains Provisions related to vaccine hesitancy H.R. 8943: 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, to elevate the Director of the Defense Logistics Agency as the head of the COVID-19 Joint Acquisition Task Force, to require the Director of the Defense Logistics Agency to establish a system for States and localities to access covered items during a covered emergency, and for other purposes - Provisions related to prescription drug supply chains H.R. 8987: To amend the Public Health Service Act to incentivize the manufacture of certain medicines in the United States and to enhance the security of the United States pharmaceutical supply chain, and for other purposes - Provisions related to prescription drug manufacturing and supply chains H.R. 8905: To amend the Federal Food, Drug, and Cosmetic Act to reduce the threat of counterfeit drugs to the pharmaceutical supply chain, and to make the pharmaceutical supply chain more robust, while ensuring the authenticity, content, purity, and manufacturing location and batch number of drugs (including COVID-19 therapeutics and vaccines) and allowing patient verification of authenticity, and for other purposes - Provisions related to prescription drug manufacturing and supply chains H.R. 8921: To direct the Secretary of Health and Human Services to reimburse qualified health care providers for the costs of purchasing, leasing, installing, and operating qualified equipment for cold storage of COVID-19 vaccines - Provisions related to prescription drug manufacturing and supply chains S. 3343: Medical Supply Chain Security Act - Provisions related to prescription drug supply chains and drug safety S. 3635: Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Provisions related to prescription drug supply chains S. 3942: A bill to establish the position of Chief Pharmaceutical and Medical Supply Chain Negotiator in the Office of the United States Trade Representative, to be responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, to advance domestic production of life-saving medicines, and to secure the United States medical supply chain to eliminate reliance on foreign governments, and for other purposes - Provisions related to prescription drug supply chains S. 4175: Pharmaceutical Supply Chain Defense and Enhancement Act - Provisions related to pharmaceutical supply chains and manufacturing S. 4194: National Institute of Manufacturing Act - Provisions related to domestic manufacturing Trade Agreements including USMCA and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain and China Task Force policy issues

Client expense: $750,000 · 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)

Free Trade Agreements - Intellectual Property and Transparency Provisions - Free Trade Agreements China Agreement UK Agreement Intellectual Property Access to Medicines Issues Global Health Issues India, China and Canada IP and Market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Regulatory Cooperation USTR Special 301 Report/National Trade Estimate Trade Policy Tariffs CFIUS USMCA Pharmaceutical supply chain H.R. 2209 - Fixing Global Freeloading Act H.R. 6049 - Medical Supply Chain Security Act H.R. 6482 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 H.R. 6690 - Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6731 - Securing America's Pharmaceutical Supply Chain Act H.R. 6879 - Buy American Medical Supply Chain Act of 2020 H.R. 7492 - To designate all of Puerto Rico as an opportunity zone H.R. 7505 - American Innovation Act of 2020: Provisions related to manufacturing tax incentives H.R. 7574 - Strengthening America's Strategic National Stockpile Act of 2020 H.R. 7955 - 21st Century Buy American Act S. 3343 - Medical Supply Chain Security Act S. 3478 - To establish a commission to assess, evaluate, and address the dependence of the United States on medications, devices, and medical equipment from foreign countries S. 3537 - A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes S. 3942 - Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act S. 3945 - A bill to amend the Internal Revenue Code of 1986 to provide incentives for relocating manufacturing of pharmaceuticals and medical supplies and devices to the United States H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6393 - Strengthening America's Supply Chain and National Security Act H.R. 6930 - MADE in America Act of 2020 H.R. 8943 - Pandemic Supplies Production Act H.R. 8987 - Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020 H.R. 8905 - Supply Chain Security and Pharmaceutical Authentication Act of 2020 S. 3635 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 S. 4175 - Pharmaceutical Supply Chain Defense and Enhancement Act S. 4194 - National Institute of Manufacturing Act Pricing and reimbursement policy issues Supply chain and China Task Force policy issues

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

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

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: 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. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Client expense: $1,260,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)