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Preventing Drug Shortages Act This bill expands existing manufacturer reporting requirements related to shortages of life-saving drugs and contains other related provisions. The bill requires a manufacturer of an active pharmaceutical ingredient of a life-saving drug to notify the Food and Drug Administration (FDA) of an interruption that is likely to lead to a meaningful disruption in the ingredient's supply, whereas under current law this requirement generally applies only to the manufacturer of a life-saving drug that faces a supply disruption. The notification must contain specified information, including any alternative sources for the ingredient. The bill also requires a manufacturer of a life-saving drug or an active pharmaceutical ingredient for such a drug to include in its annual product registration the specific facilities where the drug or ingredient is manufactured. The FDA may also require the manufacturer to conduct periodic risk assessments to address vulnerabilities in its supply chain. The Government Accountability Office shall report to Congress on the FDA's intra-agency coordination in assessing drug shortage risks.
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 (12)
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2020 · second_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: $540,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security 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 H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
2020 · third_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security 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 H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
2020 · second_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security 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 H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
2020 · second_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security 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 H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency Medical Supply Chain - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
| Republican |
| FL |
| John Joyce | Republican | PA |
| Kurt Schrader | Democratic | OR |
| Michael T. McCaul | Republican | TX |
| Richard Hudson | Republican | NC |
Client expense: $2,030,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
Client expense: $2,750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
Client expense: $1,930,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
Client expense: $1,930,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · fourth_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: $830,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: $810,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative 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, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative 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, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $2,160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative 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, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
Cancer Drug Parity Act (HR 1740/S 741) Safe Step Act (HR 2279/S 2546) Mitigating Emergency Drug Shortages Act (S 2723/HR 6080) Palliative Care Hospice Education and Training Act (HR 647/S 2080) The Prescription Drug Pricing Reduction Act (S 2543) Access to Infertility Treatment and Care Act (HR 2308/S 1461)
Client expense: $85,311 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Manufacturing
HR 6080 - Preventing Drug Shortages Act. To amend the Federal Food, Drug, and Cosmetic Act to reduce drug shortages, and for other purposes.
Client expense: $34,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_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. 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)
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 · Pharmacy
Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $310,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security 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 H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $2,020,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · fourth_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. 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
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)
S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act CARES Act, Pub. L. 116-136 H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines 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, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R.2374 - Stop STALLING Act H.R. 5239 - Prescription Drug Price Reporting Act H.R. 6258 - Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 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 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 H.R. 6395/S. 4049 - National Defense Authorization Act for Fiscal Year 2021 HHS PREP Act declaration relating to COVID-19 Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues FDA modernization 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 COVID-19 policy issues Transparency Issues Policy Issue H.R. 2477 - Beneficiary Enrollment Notification and the Eligibility Simplification (BENES) Act of 2019 H.R. 6800 - Heroes Act
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 · fourth_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative 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, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,090,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
Work on medical supply chain issues related to HR 133, the Consolidated Appropriations Act. Advocate for market-based reforms concerning inpatient drug shortages including, S.2723 the Mitigating Emergency Drug Shortages Act; HR 6080, the Preventing Drug Shortages Act; and S. 3343, the Medical Supply Chain Security Act.
Client expense: Not reported · Firm income: $40,000
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)
2020 · third_quarter · Manufacturing
HR 6080 - Preventing Drug Shortages Act. To amend the Federal Food, Drug, and Cosmetic Act to reduce drug shortages, and for other purposes.
Client expense: $34,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Pharmacy
H.R. 3, Lower Drug Costs Now Act of 2019 Issue: Support policies to reduce prescription drug prices H.R. 6080, Preventing Drug Shortages Act S. 2723, Mitigating Emergency Drug Shortages Act Issue: Support legislation to reduce drug shortages
Client expense: $1,095,000 · 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), Education, Dept of, Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), 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), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office
2020 · third_quarter · Health Issues
H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements 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. 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. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency 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. 7676: Health Care PRICE Transparency Act - Provisions related to hospital & insurer price transparency 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. 7942: Public Health Emergency COBRA Extension Act - Provisions related to health insurance coverage 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. 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. 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. 4439: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) 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 Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 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, 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) Executive Order 13937, Access to Affordable Life-saving Medications (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
Client expense: $1,210,000 · 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)
2020 · third_quarter · Health Issues
Cancer Drug Parity Act (HR 1740/S 741) Safe Step Act (HR 2279/S 2546) Mitigating Emergency Drug Shortages Act (S 2723/HR 6080) Palliative Care Hospice Education and Training Act (HR 647/S 2080) The Prescription Drug Pricing Reduction Act (S 2543) Access to Infertility Treatment and Care Act (HR 2308/S 1461)
Client expense: $219,650 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements 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. 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. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency 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. 7676: Health Care PRICE Transparency Act - Provisions related to hospital & insurer price transparency 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. 7942: Public Health Emergency COBRA Extension Act - Provisions related to health insurance coverage 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. 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. 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. 4439: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) 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 Transparency policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 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, 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) Executive Order 13937, Access to Affordable Life-saving Medications (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
Client expense: $5,960,000 · 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), Justice, Dept of (DOJ), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
2020 · third_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package. Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act.
Client expense: $340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Pharmacy
Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act Support H.R. 1035, Prescription Drug Price Transparency Act Support S. 476, C-THRU Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act. H.R. 2115, Public Disclosure of Drug Discounts Act H.R. 2376/S. 1227, Prescription Pricing for the People Act Support sunscreen related provisions in H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products (Provisions included in CARES Act, H.R. 748). Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548).
Client expense: $340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain HR 6800 - Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act S. 3548 - CARES Act H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines 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, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act
Client expense: $1,190,000 · 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), White House Office
2020 · third_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative 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, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $1,600,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security 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 H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $2,710,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · third_quarter · Health Issues
Advocate for market-based reforms concerning inpatient drug shortages including, S.2723 the Mitigating Emergency Drug Shortages Act; HR 6080, the Preventing Drug Shortages Act; and S. 3343, the Medical Supply Chain Security Act.
Client expense: Not reported · Firm income: $40,000
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)
2020 · second_quarter · Health Issues
H.R. 748, CARES Act 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.1730, Cancer Drug Parity Act of 2019 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 S1872/HR5076, Protecting Seniors Through Immunization Act 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. 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. 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. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6457: Disaster and Emergency Pricing Abuse Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6472: COVID-19 Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing HR6711, Medical Supply Transparency and Delivery Act, DPA impact on Rx manufacturers H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7269: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes - Provisions related to FDA provisional approval pathways H.R. 7288: To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development related to COVID-19, and for other purposes - Provisions related to prescription drug research and development and transparency H.R. 7296: To require any COVID-19 drug developed in whole or in part with Federal support to be affordable and accessible by prohibiting monopolies and price gouging, and for other purposes - Provisions related to prescription drug pricing and transparency 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. 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. 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. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions 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. 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. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S3780, HOME Act 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 H.R. 7288: Taxpayer Research and Coronavirus Knowledge (TRACK) Act of 2020 - Provisions related to database of federal biomedical investment information for COVID-19 H.R. 7296: Make Medicines Affordable by Preventing Pandemic Pricegouging (MMAPPP) Act of 2020 Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) 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 Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors FDA modernization policy issues PDUFA 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 Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 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 CARES ACT-Monograph Reform Support for Arthritis Caucus
Client expense: $870,000 · 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)
2020 · second_quarter · Pharmacy
H.R. 985, The Fair Access for Safe and Timely (FAST) Generics Act of 2019 H.R. 3, Lower Drug Costs Now Act of 2019 Issue: Support policies to reduce prescription drug prices H.R. 6080, Preventing Drug Shortages Act S. 2723, Mitigating Emergency Drug Shortages Act Issue: Support legislation to reduce drug shortages
Client expense: $1,316,000 · 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), Education, Dept of, Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), 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), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office
S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act) H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538, Strengthening Americas Supply Chain and Medical Security Act H.R. 6431, Made in America Emergency Preparedness Act HR 6080, Prevent Drug Shortages Act S. 3432, Securing Americas Medicine Cabinet Act of 2020 H.R. 6670, Prescription for American Drug Independence Act of 2020 H.R. 6930, MADE in America Act HR 4439, Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772, Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370: Coronavirus Vaccine Act S. 3548: CARES Act H.R. 6080: Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400, The Advancing Education on Biosimilars Act of 2019 Vaccines
Client expense: $780,000 · 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), White House Office
2020 · second_quarter · Manufacturing
H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security 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 H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $1,910,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Health Issues
S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security 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 H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency Medical Supply Chain - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing
Client expense: $1,910,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Health Issues
Cancer Drug Parity Act (HR 1740/S 741) Safe Step Act (HR 2279/S 2546) Mitigating Emergency Drug Shortages Act (S 2723/HR 6080) Palliative Care Hospice Education and Training Act (HR 647/S 2080) The Prescription Drug Pricing Reduction Act (S 2543) Access to Infertility Treatment and Care Act (HR 2308/S 1461)
Client expense: $110,174 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_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. 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. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements 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. 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: Medical Supply Chain Emergency Act of 2020 - 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. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6457: Disaster and Emergency Pricing Abuse Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6472: COVID-19 Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7269: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes - Provisions related to FDA provisional approval pathways H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency 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. 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. 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. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions 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. 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. 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: TRICARE Retail Pharmacy Prescription Medication Expansion Act of 2020 - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: Creating Hope Reauthorization Act - Provisions related to priority review vouchers Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) 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 Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues PDUFA 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 Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 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
Client expense: $5,410,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), 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), Homeland Security, Dept of (DHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
2020 · second_quarter · Health Issues
Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)
Client expense: $540,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Trade (domestic/foreign)
H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative 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, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions
Client expense: $2,160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Health Issues
Advocate for market-based reforms concerning inpatient drug shortages including, S.2723 the Mitigating Emergency Drug Shortages Act; HR 6080, the Preventing Drug Shortages Act; and S. 3343, the Medical Supply Chain Security Act.
Client expense: Not reported · Firm income: $40,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · second_quarter · Health Issues
Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency.
Client expense: $340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE