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Preventing Essential Medical Device Shortages Act of 2020
Legislative Progress
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Preventing Essential Medical Device Shortages Act of 2020 This bill requires manufacturers to notify the Food and Drug Administration (FDA) of potential disruptions to the supply of essential medical devices. Specifically, a manufacturer of an essential medical device must notify the FDA of a permanent discontinuance or temporary interruption that is likely to lead to a meaningful disruption in the supply of the device in the United States.
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 (6)
2020 · fourth_quarter · Health 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
HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity
Client expense: $1,010,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2020 · fourth_quarter · Health Issues
HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity
Client expense: $940,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2020 · fourth_quarter · Health Issues
HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity
Client expense: $940,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2020 · second_quarter · Health Issues
Medical Device Servicing HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 Defense Production Act for Ventilators COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade
Client expense: $1,190,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2020 · first_quarter · Health Issues
Medical Device Servicing HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 Defense Production Act for Ventilators COVID-19 response
Client expense: $1,690,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2020 · fourth_quarter · Health Issues
- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions - Issues related to social determinants of health - H.R. 5076/S. 1872, "Protecting Seniors Through Immunization", regarding all provisions - H.R.6062, "To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes", regarding all provisions. - H.R.6952, "To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19", regarding all provisions - S.3942, "Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act", regarding all provisions - S.3945, "Bring Entrepreneurial Advancements To Consumers Here In North America Act", regarding all provisions - S.3780, "HOME Act", regarding all provisions - S.3781, "PART Act", regarding all provisions - Issues related to diversity in clinical trials - Issues related to 340B - S.4613, The Contact Lens Rule Modernization Act, regarding all provisions - H.R.3107, "Improving Seniors Timely Access to Care Act of 2019, regarding all provisions - Executive Order 13948: Lowering Drug Prices by Putting America First - Executive Order 13939: Lowering Prices for Patients by Eliminating Kickbacks to Middlemen - Executive Order 13938: Increasing Drug Importation To Lower Prices for American Patients - Executive Order 13937: Access to Affordable Life-Saving Medications -H.R.133 - Consolidated Appropriations Act, 2021, including legislation regarding average sales price (ASP) reporting requirements for certain hyaluronic acid (HA) products that are classified as devices, but reimbursed as drugs under Medicare Part B
2020 · fourth_quarter · Health Issues
Issues related to value-based health care and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. P.L 116-136, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act. Issues related to telemedicine and remote patient monitoring including the H.R. 7885, The RPM Access Act. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards.
Client expense: $771,000 · Firm income: Not reported
2020 · fourth_quarter · Health Issues
HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020 Health Care Cybersecurity
Client expense: $940,000 · Firm income: Not reported
2020 · third_quarter · Health Issues
Public Law 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. Public Law 116-136 CARES (Coronavirus Aid, Relief, and Economic Security) Act. S. 3468 Preventing Essential Medical Device Shortages Act. S. 3780 The Help Onshore Manufacturing Efficiencies (HOME)for Drugs and Devices Act. Proposals regarding S. 3942, H.R. 6062 and H.R. 6952 (related to Supply Chain issues). Proposals regarding regulatory policies affected by public health emergencies. Proposals related to the use of coronavirus testing in CLIA waived settings. Proposals related to recommendations on diagnostic testing for traumatic brain injury. Proposals related to testing for malaria. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).
Client expense: $990,000 · Firm income: Not reported
2020 · second_quarter · Health Issues
Public Law 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. Public Law 116-136 CARES (Coronavirus Aid, Relief, and Economic Security) Act. S. 3468 Preventing Essential Medical Device Shortages Act. S. 3780 The Help Onshore Manufacturing Efficiencies (HOME)for Drugs and Devices Act. Proposals regarding H.R. 6062 and H.R. 6952 (related to Supply Chain issues). Proposals regarding regulatory policies affected by public health emergencies. Proposals related to the use of coronavirus testing in CLIA waived settings. Proposals related to telehealth implementation.
Client expense: $1,080,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · third_quarter · Health Issues
Public Law 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. Public Law 116-136 CARES (Coronavirus Aid, Relief, and Economic Security) Act. S. 3468 Preventing Essential Medical Device Shortages Act. S. 3780 The Help Onshore Manufacturing Efficiencies (HOME)for Drugs and Devices Act. Proposals regarding S. 3942, H.R. 6062 and H.R. 6952 (related to Supply Chain issues). Proposals regarding regulatory policies affected by public health emergencies. Proposals related to the use of coronavirus testing in CLIA waived settings. Proposals related to recommendations on diagnostic testing for traumatic brain injury. Proposals related to testing for malaria. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).
Client expense: $930,000 · Firm income: Not reported
2020 · third_quarter · Health Issues
Issues related to value-based health care and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. P.L 116-136, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act. Issues related to telemedicine and remote patient monitoring. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards.
Client expense: $1,867,000 · Firm income: Not reported
2020 · third_quarter · Health Issues
HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 Defense Production Act for Ventilators COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade HR 7574 - Strengthening America's Strategic National Stockpile Act of 2020 HR 7956 - Critical Medical Infrastructure Right-to-Repair Act of 2020 S 4473 - Critical Medical Infrastructure Right-to-Repair Act of 2020
Client expense: $850,000 · Firm income: Not reported
2020 · third_quarter · Health Issues
- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions - Issues related to social determinants of health - H.R. 5076/S. 1872, "Protecting Seniors Through Immunization", regarding all provisions - H.R.6062, "To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes", regarding all provisions. - H.R.6952, "To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19", regarding all provisions - S.3942, "Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act", regarding all provisions - S.3945, "Bring Entrepreneurial Advancements To Consumers Here In North America Act", regarding all provisions - S.3780, "HOME Act", regarding all provisions - S.3781, "PART Act", regarding all provisions - Issues related to diversity in clinical trials - Issues related to 340B - S.4613, The Contact Lens Rule Modernization Act, regarding all provisions - H.R.3107, "Improving Seniors Timely Access to Care Act of 2019, regarding all provisions - Executive Order 13948: Lowering Drug Prices by Putting America First - Executive Order 13939: Lowering Prices for Patients by Eliminating Kickbacks to Middlemen - Executive Order 13938: Increasing Drug Importation To Lower Prices for American Patients - Executive Order 13937: Access to Affordable Life-Saving Medications
2020 · second_quarter · Health Issues
Medical Device Servicing HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 Defense Production Act for Ventilators COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade
Client expense: $1,180,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2020 · second_quarter · Health Issues
- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions - Issues related to social determinants of health - H.R. 5076/S. 1872, "Protecting Seniors Through Immunization", regarding all provisions - H.R.6062, "To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes", regarding all provisions. - H.R.6952, "To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19", regarding all provisions - S.3942, "Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act", regarding all provisions - S.3945, "Bring Entrepreneurial Advancements To Consumers Here In North America Act", regarding all provisions - S.3780, "HOME Act", regarding all provisions - S.3781, "PART Act", regarding all provisions - Issues related to diversity in clinical trials
2020 · second_quarter · Health Issues
Issues related to value-based health care and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. P.L 116-136, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act. Issues related to telemedicine and remote patient monitoring. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0.
Client expense: $1,019,000 · Firm income: Not reported
2020 · second_quarter · Health Issues
Medical Device Servicing HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 Defense Production Act for Ventilators COVID-19 response Energy and Water Appropriations Health and Human Services Appropriations Healthcare trade
Client expense: $1,180,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2020 · second_quarter · Health Issues
Public Law 116-123 Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. Public Law 116-136 CARES (Coronavirus Aid, Relief, and Economic Security) Act. S. 3468 Preventing Essential Medical Device Shortages Act. S. 3780 The Help Onshore Manufacturing Efficiencies (HOME)for Drugs and Devices Act. Proposals regarding H.R. 6062 and H.R. 6952 (related to Supply Chain issues). Proposals regarding regulatory policies affected by public health emergencies. Proposals related to the use of coronavirus testing in CLIA waived settings. Proposals related to telehealth implementation.
Client expense: $930,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · first_quarter · Health Issues
Issues related to post-market surveillance of medical devices and unique device identifiers. Issues related to third-party servicing of medical devices. H.R. 748, CARES Act (Issues related to reporting of supply disruptions) H.R. 748, CARES Act (Issues related to the capacity of the health care system) S.3468, Preventing Essential Medical Devices Shortages Act H.R. 6062, To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes. S.3343 / H.R. 6049, Medical Supply Chain Security Act
Client expense: $460,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2020 · first_quarter · Health Issues
Medical Device Servicing HR 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019. S 2543 - Prescription Drug Pricing Reduction Act of 2019. S 551 - Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 HR 5238 - Better and Robust Screening Today Act S 2955 - Better and Robust Screening Today Act HR 3224 Deborah Sampson Act S 3343 - Medical Supply Chain Security Act S 3468 - Preventing Essential Medical Device Shortages Act of 2020 Defense Production Act for Ventilators COVID-19 response
Client expense: $1,670,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2020 · first_quarter · Health Issues
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. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1323: Rural Hospital Frontier Fairness Act - Provisions related to the 340B drug discount program H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5382: To create a mechanism whereby insulin manufacturers may sell directly to consumers at current net prices. - Provisions related to prescription drug pricing H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6173: Covering Coronavirus Test Act of 2020 - Provisions related to medical device pricing and coverage H.R. 6213: No Cost for COVID-19 Testing Act - Provisions related to medical device pricing and coverage H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6253: To expand certain securities exemptions to respond to COVID-19, to establish an X-prize for creating an effective COVID-19 vaccine, and for other purposes - Provisions related to prescription drug research and development H.R. 6261: To provide for coverage of testing for COVID-19 at no cost sharing for Indians receiving health services through the Indian Health Service, and for other purposes - Provisions related to medical device pricing and coverage H.R. 6264: To prohibit price gouging during a state of emergency declaration, and for other purposes - Provisions related to prescription drug and medical device pricing H.R. 6351: To authorize the Secretary of Health and Human Services to administer vaccinations for COVID-19, once available, at no cost to the inoculated, in response to the COVID-19 outbreak, and for other purposes - Provisions related to prescription drug patient access and cost sharing 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 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. 340: 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 S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 801: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and foreign reference pricing S. 1089: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates 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. 1567: Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 - Provisions related to rare disease research and funding S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals 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. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3180: Responsibility in Drug Advertising Act of 2020 - Provisions related to prescription drug direct-to-consumer advertising S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3442: Care for COVID-19 Act - Provisions related to prescription drug pricing and access S. 3468 Preventing Essential Medical Device Shortages Act of 2020 - Provisions related to medical device shortage reporting requirements S. 3499: A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Provisions related to medical device pricing and access S. 3505: A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Provisions related to prescription drug pricing and access S. 3545: A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes - Provisions related to FDA prescription drug marketing approvals S. 3564: A bill to amend title XIX of the Social Security Act to require States to provide medical assistance for COVID-19 treatment services for individuals who are diagnosed with COVID-19, and for other purposes - Provisions related to prescription drug pricing and access S. 3568: 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 S. 3570: A bill to provide for the expedited procurement of equipment needed to combat COVID-19 under the Defense Production Act of 1950 - Provisions related to the Defense Production Act Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Antimicrobial resistance policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program 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 Cancer drug vial size policy issues Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
2020 · first_quarter · Health Issues
Issues related to value based health care and modernization of fraud and abuse laws. The Patient Affordability Value and Efficiency Act; issues pertaining to protections for value-based arrangements. Issues related to medical device, non-oral opioid pain treatment alternatives, including in implementation of the SUPPORT for Patients and Communities Act (P.L. 115-271) and H.R. 5172, the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act.
Client expense: $1,346,000 · Firm income: Not reported
2020 · first_quarter · Health Issues
- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions
Client expense: $1,450,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
Client expense: $1,760,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Transportation, Dept of (DOT), U.S. Trade Representative (USTR)
Client expense: $9,020,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Transportation, Dept of (DOT)
Client expense: $1,480,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office