Pharmaceutical Supply Chain Defense and Enhancement Act
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Pharmaceutical Supply Chain Defense and Enhancement Act This bill requires the Department of Health and Human Services (HHS) to enter into contracts with U.S. entities to manufacture certain critical drugs within the United States and otherwise addresses drug manufacturing. HHS must periodically report to Congress a list of drugs that are critical to public health or national security. The Biomedical Advanced Research and Development Authority within HHS must enter into contracts for qualified U.S. entities to manufacture in the United States the drugs on this list (and ingredients for such drugs). The contracts must impose certain conditions, such as those requiring the manufacturing entity to (1) develop and maintain a redundancy risk management and continuity of business plan, and (2) commit to selling the drugs and ingredients manufactured under the contract at reasonable prices. Beginning in FY2024, certain federal agencies (including the Department of Defense and the Bureau of Prisons) must, in procuring drugs on the HHS critical drugs list, give priority to high-quality drugs that are manufactured in the United States. This bill also requires the Federal Trade Commission to submit annually to Congress a report on foreign investment in the U.S. pharmaceutical industry. The report must address, among other topics, the effect of the industry's reliance on foreign manufacturing.
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Filing registrants (4)
2020 · fourth_quarter · Trade (domestic/foreign)
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 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
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $5,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
2020 · fourth_quarter · Trade (domestic/foreign)
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
2020 · third_quarter · Trade (domestic/foreign)
General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. Pharmaceutical Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. Carter Supply Chain Legislation. S.4175: Pharmaceutical Supply Chain Defense and Enhancement Act. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. Secretary Azar Importation Plan.
Client expense: $940,000 · 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), Justice, Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office