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Prescription Drug Price Relief Act of 2019
Legislative Progress
Introduced
January 10, 2019
Latest Action
January 10, 2019
Primary Sponsor
Bernard SandersIndependent(VT)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 5,086 other S bills in the 116th — cohort avg 30d
Prescription Drug Price Relief Act of 2019 This bill establishes a series of oversight and disclosure requirements relating to the prices of brand-name drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to review at least annually all brand-name drugs for excessive pricing; HHS must also review prices upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug. Under the bill, a price is considered excessive if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of the aforementioned countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including cost, revenue, and the size of the affected patient population. The bill also requires drug manufacturers to report specified financial information for brand-name drugs, including research and advertising expenditures.
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 (32)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2026 · second_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · third_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · second_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| CA |
| Kirsten E. Gillibrand | Democratic | NY |
| Richard Blumenthal | Democratic | CT |
2025 · first_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · fourth_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019; issues related to Safe Step Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · third_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019; issues related to Safe Step Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · second_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019; issues related to Safe Step Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2024 · first_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019; issues related to Safe step Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · fourth_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019; issues related to Safe step Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · third_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019; issues related to Safe step Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · second_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019; issues related to Safe step Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2023 · first_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019; issues related to Safe step Act
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Health Issues
H.R.5015, the Medicaid DSH Payment Adjustment Fairness Act, Hospital funding formula Monitor the following: H.R.5376, Build Back Better Act S.2110, Better Care Better Jobs Act Nurse Overtime and Patient Safety Act H.R.1195, Workplace Violence Prevention for Health Care and Social Service Workers Act, Entirety S.632, Health Force and Resilience Force Act, H.R.959/S.346, Black Maternal Health Momnibus Act Student Loan Forgiveness for Frontline Health Workers S.102, the Prescription Drug Price Relief Act S.99, the Medicare Drug Price Negotiation Act S.97, the Affordable and Safe Prescription Drug Importation Act H.R.1391/S.482, Taxpayer Research and Coronavirus Knowledge Act, Entirety H.R.7296/S.4439, Make Medications Affordable by Preventing Pandemic Pricegouging Act, Entirety Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues The National Nurse Act, Entirety Health Equity Issues during COVID Pandemic H.R.728/S.187, Pandemic Emergency Manufacturing Act of 2021, Entirety Support Medicare/ACA enrollment H.R. 6637, Health Equity and Accountability Act, Entirety Delivery of healthcare services to students during COVID pandemic Telehealth issues H.R.1227/S.386, Medicare X Choice Act Rural Healthcare related issues and initiatives Federal response to COVID-19 Pandemic
Client expense: $400,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Education, Dept of, HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, White House Office
2021 · fourth_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Health Issues
Monitor the following: S.2110, Better Care Better Jobs Act Nurse Overtime and Patient Safety Act H.R.1195, Workplace Violence Prevention for Health Care and Social Service Workers Act, Entirety S.632, Health Force and Resilience Force Act, H.R.959/S.346, Black Maternal Health Momnibus Act Student Loan Forgiveness for Frontline Health Workers S.102, the Prescription Drug Price Relief Act S.99, the Medicare Drug Price Negotiation Act S.97, the Affordable and Safe Prescription Drug Importation Act H.R.1391/S.482, Taxpayer Research and Coronavirus Knowledge Act, Entirety H.R.7296/S.4439, Make Medications Affordable by Preventing Pandemic Pricegouging Act, Entirety Executive actions on An America-First Healthcare Plan Executive Order on Lowering Drug Prices by Putting America First Executive Order on Improving Rural Health and Telehealth Access Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Executive Order on Increasing Drug Importation to Lower Prices for American Patients Executive Order on Access to Affordable Life-saving Medications Lower Drug Costs Now Act, Entirety Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues The National Nurse Act, Entirety Health Equity Issues during COVID Pandemic H.R.728/S.187, Pandemic Emergency Manufacturing Act of 2021, Entirety Support Medicare/ACA enrollment H.R. 6637, Health Equity and Accountability Act, Entirety Delivery of healthcare services to students during COVID pandemic Telehealth issues H.R.1227/S.386, Medicare X Choice Act Rural Healthcare related issues and initiatives
Client expense: $450,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Education, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE, White House Office
2021 · third_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · second_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · second_quarter · Health Issues
CARE Act Nurse Overtime and Patient Safety Act H.Res.304, Black Maternal Health Week H.R.1195, Workplace Violence Prevention for Health Care and Social Service Workers Act, Entirety Monitor the following: S.632, Health Force and Resilience Force Act, S.263, Worker Health Coverage Protection Act (COBRA support) H.R.959/S.346, Black Maternal Health Momnibus Act Student Loan Forgiveness for Frontline Health Workers, lobb Hazard pay for healthcare workers, lobby Domestic Policy Council, Department of Health and Human Services S.102, the Prescription Drug Price Relief Act S.99, the Medicare Drug Price Negotiation Act S.97, the Affordable and Safe Prescription Drug Importation Act H.R.1391/S.482, Taxpayer Research and Coronavirus Knowledge Act, Entirety H.R.7296/S.4439, Make Medications Affordable by Preventing Pandemic Pricegouging Act, Entirety Executive actions on An America-First Healthcare Plan Executive Order on Lowering Drug Prices by Putting America First Executive Order on Improving Rural Health and Telehealth Access Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Executive Order on Increasing Drug Importation to Lower Prices for American Patients Executive Order on Access to Affordable Life-saving Medications Healthcare extenders: continued delay of cuts to payments supporting disproportionate share hospitals and an extension of funding for Community Health Centers Lower Drug Costs Now Act, Entirety Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues The National Nurse Act, Entirety Health Equity Issues during COVID Pandemic Pandemic Responder Service Award Act, Entirety H.R.728/S.187, Pandemic Emergency Manufacturing Act of 2021, Entirety Support Medicare/ACA enrollment H.R. 6637, Health Equity and Accountability Act, Entirety Delivery of healthcare services to students during COVID pandemic Telehealth issues H.R.1227/S.386, Medicare X Choice Act Rural Healthcare related issues and initiatives
Client expense: $380,000 · Firm income: Not reported
Government targets: Education, Dept of, Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, White House Office
2021 · second_quarter · Health Issues
Legislative issues related to access to pharmaceuticals, including H.R. 3 Lower Drug Costs Now, S. 102 Prescriptions Drug Price Relief Act of 2019, and FY22 Agriculture Appropriations
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · first_quarter · Health Issues
S.632, Health Force and Resilience Force Act, S.263, Worker Health Coverage Protection Act (COBRA support) H.R.959/S.346, Black Maternal Health Momnibus Act Student Loan Forgiveness for Frontline Health Workers, lobb Hazard pay for healthcare workers, lobby Domestic Policy Council, Department of Health and Human Services S.102, the Prescription Drug Price Relief Act S.99, the Medicare Drug Price Negotiation Act S.97, the Affordable and Safe Prescription Drug Importation Act H.R.1195, Workplace Violence Prevention for Health Care and Social Service Workers Act, Entirety Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act, Entirety H.R.1391/S.482, Taxpayer Research and Coronavirus Knowledge Act, Entirety H.R.7296/S.4439, Make Medications Affordable by Preventing Pandemic Pricegouging Act, Entirety COVID-19 related issues and initiatives, generally Monitor the following: Executive actions on An America-First Healthcare Plan Executive Order on Lowering Drug Prices by Putting America First Executive Order on Improving Rural Health and Telehealth Access Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Executive Order on Increasing Drug Importation to Lower Prices for American Patients Executive Order on Access to Affordable Life-saving Medications Healthcare extenders: continued delay of cuts to payments supporting disproportionate share hospitals and an extension of funding for Community Health Centers Lower Drug Costs Now Act, Entirety Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues Nurse Overtime and Patient Safety Act, Entirety The National Nurse Act, Entirety Health Equity Issues during COVID Pandemic Pandemic Responder Service Award Act, Entirety H.R.728/S.187, Pandemic Emergency Manufacturing Act of 2021, Entirety Support Medicare/ACA enrollment H.R. 6637, Health Equity and Accountability Act, Entirety Delivery of healthcare services to students during COVID pandemic Telehealth issues H.R.1227/S.386, Medicare X Choice Act Rural Healthcare related issues and initiatives
Client expense: $340,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Education, Dept of, Executive Office of the President (EOP), Federal Communications Commission (FCC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2021 · first_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · first_quarter · Health Issues
Legislative issues related to access to pharmaceuticals, including H.R. 3 Lower Drug Costs Now, S. 102 Prescriptions Drug Price Relief Act of 2019, and FY22 Agriculture Appropriations
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) 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 · Health Issues
H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) 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 · Health Issues
H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) 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
1) Maintain Taxpayers Against Illicit Opioids. No specific legislation. 2) For ensuring speedy access to new gene and cell therapies. No specific legislation. 3) Oppose efforts to remove consumer protections for contact lens wearers - S. 4613 4) Oppose importing foreign price controls through international reference pricing - S. 977, S. 102, H.R. 3 5) Oppose FDA graphic warning labels on cigarettes 6) Support increasing biosimilar adoption. No specific legislation. 7) Oppose banning flavored e-cigarettes. No specific legislation. 8) Oppose rate-setting on surprise medical bills - S. 1895 9) Support Independent Dispute Resolution for surprise medical bills - H.R. 3502 10) Oppose imposing International Pricing Index executive order. 11) Oppose expanding the Medicaid Drug Rebate Program - Docket No. CMS-2482-P 12) Support reforming telehealth and improving access to virtual care. No specific legislation.
Client expense: Not reported · 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), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
H.R. 3 Lower Drug Costs Now; S. 102 Prescriptions Drug Price Relief Act of 2019
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Legislative issues related to access to pharmaceuticals, including H.R. 3 Lower Drug Costs Now, S. 102 Prescriptions Drug Price Relief Act of 2019, and FY21 Agriculture Appropriations
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Copyright/Patent/Trademark
H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
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 · Health Issues
S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020
Client expense: $330,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2020 · fourth_quarter · Copyright/Patent/Trademark
H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Client expense: $750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377 - Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772 - The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129 - Lower Costs, More Cures Act of 2019 S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457 - Preserving Patient Access to Home Infusion Act H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P) Reimbursement for cell therapy products S. 3353/H.R. 5534 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134 - Increasing Access to Biosimilars Act of 2020 S. 102 - Prescription Drug Price Relief Act of 2019 CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P) H.R. 8624 - Protecting Access to Innovation During COVID-19 Act H.R. 8702 - Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 S. 1895 - Lower Health Care Costs Act S. 4199 - Prescription Drug Pricing Reduction Act of 2020 S. 4274 - Legalizing Drug Discounts for Seniors Act of 2020 Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related issues ASP reporting policy issues Non-covered drugs policy issues Drug wastage rebates policy issues
Client expense: $660,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2020 · fourth_quarter · Health Issues
Biosimilars, no specific bill Prescription drug value issues, no specific bill FDA issues, no specific bill S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act, a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act S.659 - the Biologics Patent Transparency Act Supply Chain Issues, no specific bill
Client expense: $2,560,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of
2020 · fourth_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.
Client expense: $1,260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Advertising
S. 2543, the "Prescription Drug Pricing Reduction Act of 2019"; S. 102, the "Prescription Drug Price Relief Act of 2019"; S. 977, the "Transparent Drug Pricing Act of 2019"; S. 1356 and H.R. 2592, the "Honest Ads Act"; and H.R. 1, the "For the People Act".
Client expense: $90,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2020 · fourth_quarter · Copyright/Patent/Trademark
Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole ---State Attorney General Letter Compulsory licensing ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.2387: We Protect American Investment in Drugs Act of 2019 Diversity in Patenting ---S.4394: Inventor Diversity for Economic Advancement (IDEA) Act of 2020 Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 Inter Partes Review Intellectual Property International Enforcement ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. ---India Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions
Client expense: $3,180,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2020 · fourth_quarter · Health Issues
H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) 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 · Copyright/Patent/Trademark
Changes to section 101 of patent law, related to determining what is patentable (no bill yet) S. 102/H.R.465 Prescription Drug Price Relief Act of 2019 (sections related to compulsory licensing) S.2082/H.R.3666 - STRONGER Patents Act (all) S.1273/H.R. 2426 Copyright Alternative in Small-Claims Enforcement Act (all) Discussion with NIST re: potential Bayh-Dole regulations
Client expense: $70,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), SENATE
2020 · fourth_quarter · Health Issues
1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding high risk insurance pools, implementation of state based health exchanges, eligibility for health insurance premium subsidies, cost sharing subsidies, proposals for special enrollment period 2. Proposals to repeal the Patient Protection and Affordable Health Care Act 3. Stabilization of Affordable Care Act insurance marketplaces 4. Administration proposals on prescription drug pricing 5. Proposals for long term care health policies 6. H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions Act or the HEROES Act, provisions regarding COBRA subsidies 7. S. 102, Prescription Drug Price Relief Act of 2019, entire bill 8. H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act, entire bill 9. H.R. 3630, No Surprises Act, entire bill 10. H.R. 3, Lower Drug Costs Now Act of 2019, entire bill 11. H.R. 3162, Affordable Drug Manufacturing Act of 2019, entire bill 12. S. 3162, Affordable Drug Manufacturing Act of 2019, entire bill 13. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act or the CARES Act, entire bill 14. S. 995, Lifespan Respite Care Reauthorization Act of 2019, entire bill 15. H.R.6487, Advancing Connectivity during the Coronavirus to Ensure Support for Seniors Act or the ACCESS Act, entire bill 16. S. 3517, Advancing Connectivity during the Coronavirus to Ensure Support for Seniors Act or the ACCESS Act, entire bill 17. S. 3768, Nursing Home COVID-19 Protection and Prevention Act of 2020, entire bill 18. Prescription Drug User Fee Act reauthorization proposals 19. Implementation of the Biosimilar User Fee Act and proposed uses of user fees 20. Extension of COBRA coverage during the COVID-19 pandemic
Client expense: $70,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Pension & Welfare Benefits Administration, Pension Benefit Guaranty Corporation (PBGC), SENATE, Social Security Administration (SSA)
2020 · first_quarter · Advertising
S. 2543, the "Prescription Drug Pricing Reduction Act of 2019"; S. 102, the "Prescription Drug Price Relief Act of 2019"; S. 977, the "Transparent Drug Pricing Act of 2019"; S. 1356 and H.R. 2592, the "Honest Ads Act"; H.R. 1, the "For the People Act"; discussion draft of prescription drug legislation
Client expense: $90,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2020 · second_quarter · Advertising
S. 2543, the "Prescription Drug Pricing Reduction Act of 2019"; S. 102, the "Prescription Drug Price Relief Act of 2019"; S. 977, the "Transparent Drug Pricing Act of 2019"; S. 1356 and H.R. 2592, the "Honest Ads Act"; and H.R. 1, the "For the People Act".
Client expense: $90,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2020 · third_quarter · Advertising
S. 2543, the "Prescription Drug Pricing Reduction Act of 2019"; S. 102, the "Prescription Drug Price Relief Act of 2019"; S. 977, the "Transparent Drug Pricing Act of 2019"; S. 1356 and H.R. 2592, the "Honest Ads Act"; and H.R. 1, the "For the People Act".
Client expense: $90,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2020 · fourth_quarter · Copyright/Patent/Trademark
S. 2082/H.R. 3666 (STRONGER Patents Act) Trade-related intellectual property policy/practices/encroachment by foreign countries/companies against U.S. competitiveness interests - China, Committee on Foreign Investment in the United States review of Chinese acquisitions and joint ventures, United States-Mexico-Canada Agreement IP chapter, International Trade Commission exclusion of U.S. patent-infringing imports, ITC baseband chip set patent infringement remedy, intellectual property exclusivity and protections in trade agreements Piracy of online and streaming copyrighted content Compulsory licensing - S. 377/H.R. 1046 (Medicare Negotiation and Competitive Licensing Act), S. 102/H.R. 465 (Prescription Drug Price Relief Act), S. 977 (Transparent Drug Pricing Act) NIST Return on Investment Initiative for Unleashing American Innovation S. 344/H.R. 990 (Hatch-Waxman Integrity Act) FTC/patent licensing as exclusive property right Bayh-Dole Act/technology transfer, misuse of march-in rights Procedural and evidentiary standards used at Patent Trial and Appeal Board PTO patentable subject matter eligibility guidance Section 101 patentable subject matter reform Injunctive relief from willful infringement DOJ-DOC withdrawal of 2013 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments S. 1273/H.R. 2426 (Copyright Alternative in Small-Claims Enforcement (CASE) Act) S. 1416 (Affordable Prescriptions for Patients Act) Obviousness/No Combination Drug Patents Act H.R. 4398/H.R. 5133 (Affordable Prescriptions for Patients Through Promoting Competition Act) H.R. 3991 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5478 (Inventor Rights Act) Patent licensing/standards-essential patents/U.S. technological leadership in 5G and other technologies/economic and national security implications DOJ-PTO-NIST 2019 revised Joint Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments Efficient infringement Digital Millennium Copyright Act modernization Patent Trial & Appeal Board Covered Business Methods program PTAB Rules of Practice for Instituting on All Challenged Patent Claims and All Grounds and Eliminating the Presumption at Institution Favoring Petitioner as to Testimonial Evidence (Docket No. PTO-P-2019-0024) S. 3630 (Facilitating Innovation to Fight Coronavirus Act) Denial of rights of exclusivity for COVID-19-related innovations H.R. 7366 (Restoring Americas Leadership in Innovation Act) S. 3835 (SCRIPT Act) Proposed policy requiring privately produced, privately funded, copyrighted, peer-reviewed journal articles be given away free upon publication if they discuss any underlying research supported by a government grant Patent Trial and Appeal Board Covered Business Methods program statutory expiration Appointments Clause and the constitutionality of AdministrativePatent Judges invalidation of patents Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board (RIN:0651-AD47) Discretion to Institute Trials Before the Patent Trial and Appeal Board (Docket No. PTO-C-2020-0055) H.R. 133 (Consolidated Appropriations Act FY 2021 provisions related to Patent & Trademark Office, CASE Act, and copyright infringement via streaming loophole reform)
Client expense: Not reported · Firm income: $10,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2020 · second_quarter · Health Issues
H.R. 965, S. 340 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019: Issues regarding processes by which generic manufacturers can obtain sufficient quantities of brand drug samples for testing. H.R. 3253 - Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019: Regarding all provisions. S. 1895 - The Lower Health Care Costs Act: Issues related to rural health access; health equity; Medicare Advantage; Medicaid Rebates; Medicaid Expansion; Rate Notice and Call Letter; Medicare Part D; NBPP, Part D Donut Hole; Privacy; Universal Coverage. H.R. 861 - End Surprise Billing Act, H.R. 3630 - No Surprises Act, H.R. 3502 - Protecting People from Surprise Medical Bills Act, H.R. 5800 - Ban Surprise Billing Act, H.R. 5826 - Consumer Protections Against Surprise Medical Bills Act of 2020: Issues related to surprise billing, including benchmark payments, arbitration models, and out of network billing. S. 916 - MOMMAs Act, H.R. 2602, S. 1343 - MOMMIES Act: Issues related to options for states to extend coverage for pregnant women eligible for Medicaid via the pregnancy pathway to 365 days, Minority Maternity Care, Social Determinants of Health. S. 657 - Drug Price Transparency (DPT) Act, S. 2543 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug and price transparency. H.R. 3- Lower Drug Costs Now Act of 2019, S. 102 - Prescription Drug Pricing Reduction Act of 2019: Issues related to drug costs and prescription rebates. H.R. 19 - Lower Costs, More Cures Act of 2019: Issues related to prescription drug pricing S. 2546, H.R.2279 - Safe Step Act: Issues related to managed care, prior authorization. S. 3374 - Protecting Jessica Grubb's Legacy Act: Issues regarding HIPPA, confidentiality of substance abuse records H.R. 6139 - Health Care Protection Act: Issues related to COVID-19, funding for surveillance testing and treatment, financial assistance for individual health insurance, COBRA, financial assistance to maintain employer health plan coverage, and emergency funding for hospitals and providers. H.R. 6800 - HEROES ACT: Issues related to COVID-19, Federal Medical Assistance Percentages, Medicaid and COBRA. H.R. 1425 - Patient Protection and Affordable Care Enhancement ACT: Issues related to COVID-19, Medicaid expansion, and prescription drugs. Issues related to drug and price transparency, including the Administrations rule on interoperability and Executive order on transparency.
Client expense: $980,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE