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Medical Innovation Act of 2020 This bill requires certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a relevant settlement agreement regarding specified violations must pay 0.75%-1.5% of its net income to the Department of Health and Human Services for each of its covered blockbuster drugs. A covered blockbuster drug is a drug that has at least $1 billion in net sales in a year and was developed, in whole or in part, through federal investments in medical research. Payments are divided between the FDA and the NIH in proportion to the discretionary funding of those agencies, excluding FDA user fees. Payments are not disbursed if appropriations for the FDA or the NIH are lower than in the prior fiscal year. Priorities for payments must include advancing regulatory science for medical products and research related to diseases that disproportionately account for federal health care spending. A covered blockbuster drug for which a manufacturer has not made a required payment is considered misbranded and subject to prohibitions on introducing or receiving misbranded drugs in interstate commerce.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (2)
2019 · fourth_quarter · Budget/Appropriations
H.R. 3055/S. 2584 Commerce, Justice, Science and Related Agencies Appropriations Act, 2020, Title I, all provisions relating to production weather, oceanic and atmospheric research, system acquisition, and research supercomputing (on behalf of Cray); weather data (on behalf of PlanetIQ), and unmanned surface vehicles (on behalf of Saildrone); and Title III, all provisions relating to production weather, oceanic and atmospheric research, system acquisition, and research supercomputing (on behalf of Cray). H.R. 2968 /S. 2474, Department of Defense Appropriations Act, 2020, Title III, all provisions relating to Navy shipbuilding (on behalf of Austal USA), unmanned aerial vehicles (on behalf of General Atomics Aeronautical Systems Inc), high performance computing (on behalf of Cray and Hewlett-Packard Enterprise), edge computing (on behalf of Hewlett-Packard Enterprise), tactical radios (on behalf of Thales USA), and surveying equipment or systems (on behalf of Trimble); Title IV, all provisions relating to assured access to space (on behalf of Arianespace), ship development (on behalf of Austal USA), biomedical technology (on behalf of Battelle Memorial Institute), high performance computing (on behalf of Cray and Hewlett Packard Enterprise), edge computing (on behalf of Hewlett-Packard Enterprise), advanced power electronics (on behalf of Cree), tactical and intelligence data analysis (on behalf of Esri), unmanned aerial vehicles (on behalf of General Atomics Aeronautical Systems Inc), unexplained physiological episode research and human performance in extreme environments (on behalf of the Florida Institute for Human Machine Cognition), weather data (on behalf of PlanetiQ), aerospace sensors and technology transition (on behalf of Wright State Research Institute), major test and evaluation investment (on behalf of SRI International); and title VI, all provisions relating to blood products (on behalf of Cerus). H.R. 2960 /S. 2740 Energy and Water Development Act, 2020, Title III, all provisions relating to advanced scientific computing research and advanced simulation and computing (on behalf of Cray and Hewlett-Packard Enterprise), and advanced robotics (on behalf of Florida Institute for Human Machine Cognition). H.R. 3052/S. 2580, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2020, Title I, all provisions relating to U.S. Geological Surveys maps (on behalf of Esri) and U.S. Park Service procurement of surveying equipment or systems (on behalf of Trimble). H.R. 3931/S. 2582, Department of Homeland Security Appropriations Act, 2020, Title II, all provisions relating to enterprise information geospatial services (on behalf of ESRI). H.R. 2740/S. ____Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2020, Title II, all provisions relating to blood products (on behalf of Cerus). H.S. 3163 /S. 2520 Department of Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act, 2020, Title I, all provisions relating to use of geospatial technologies (on behalf of Esri) and funding for infrastructure (on behalf of Trimble).
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: Not reported · Firm income: Not reported
2019 · fourth_quarter · Medical/Disease Research/Clinical Labs
P.L. 114-255, 21st Century Cures Act, Division A Issue: Support implementation of 21st Century Cures Act, including the Innovation Fund, increased funding for medical research, reducing administrative and regulatory burden on scientists and research institutions, and supporting young investigators. H.R. 4667, The Biomedical Innovation Expansion Act H.R. 3, The Elijah E. Cummings Lower Drug Costs Now Act, Title VII Issue: Support investments in medical research. S. 3163, National Biomedical Research Act Issue: Support investments in medical research and regulatory science. Issue: Explore opportunities to improve research with cannabinoids. Educate NIH regarding stakeholder perspectives on data management and sharing activities related to public access and open science.
Client expense: $1,137,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Director of National Intelligence (ODNI), Education, Dept of, Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office
2019 · third_quarter · Budget/Appropriations
H.R. 3055/S. 2584 Commerce, Justice, Science and Related Agencies Appropriations Act, 2020, Title I, all provisions relating to production weather, oceanic and atmospheric research, system acquisition, and research supercomputing (on behalf of Cray); weather data (on behalf of PlanetIQ), and unmanned surface vehicles (on behalf of Saildrone); and Title III, all provisions relating to production weather, oceanic and atmospheric research, system acquisition, and research supercomputing (on behalf of Cray). H.R. 2968 /S. 2474, Department of Defense Appropriations Act, 2020, Title III, all provisions relating to Navy shipbuilding (on behalf of Austal USA), unmanned aerial vehicles (on behalf of General Atomics Aeronautical Systems Inc), high performance computing (on behalf of Cray and Hewlett-Packard Enterprise), edge computing (on behalf of Hewlett-Packard Enterprise), tactical radios (on behalf of Thales USA), and surveying equipment or systems (on behalf of Trimble); Title IV, all provisions relating to assured access to space (on behalf of Arianespace), ship development (on behalf of Austal USA), biomedical technology (on behalf of Battelle Memorial Institute), high performance computing (on behalf of Cray and Hewlett Packard Enterprise), edge computing (on behalf of Hewlett-Packard Enterprise), advanced power electronics (on behalf of Cree), tactical and intelligence data analysis (on behalf of Esri), unmanned aerial vehicles (on behalf of General Atomics Aeronautical Systems Inc), unexplained physiological episode research and human performance in extreme environments (on behalf of the Florida Institute for Human Machine Cognition), weather data (on behalf of PlanetiQ), aerospace sensors and technology transition (on behalf of Wright State Research Institute), major test and evaluation investment (on behalf of SRI International); and title VI, all provisions relating to blood products (on behalf of Cerus). H.R. 2960 /S. 2740 Energy and Water Development Act, 2020, Title III, all provisions relating to advanced scientific computing research and advanced simulation and computing (on behalf of Cray and Hewlett-Packard Enterprise), and advanced robotics (on behalf of Florida Institute for Human Machine Cognition). H.R. 3052/S. 2580, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2020, Title I, all provisions relating to U.S. Geological Surveys maps (on behalf of Esri) and U.S. Park Service procurement of surveying equipment or systems (on behalf of Trimble). H.R. 3931/S. 2582, Department of Homeland Security Appropriations Act, 2020, Title II, all provisions relating to enterprise information geospatial services (on behalf of ESRI). H.R. 2740/S. ____Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2020, Title II, all provisions relating to blood products (on behalf of Cerus). H.S. 3163 /S. 2520 Department of Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act, 2020, Title I, all provisions relating to use of geospatial technologies (on behalf of Esri) and funding for infrastructure (on behalf of Trimble).
Client expense: Not reported · Firm income: $10,000
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